Journal of Midwifery & Women’s Health
www.jmwh.org
Updates from the Literature Sharon Bond, CNM, PhD STUDY USES BIRTH CERTIFICATE DATA TO REFUTE SAFETY OF OUT-OF-HOSPITAL BIRTH
Gr¨unebaum A, McCullough LB, Sapra KJ, et al. Apgar score of 0 at 5 minutes and neonatal seizures or serious neurologic dysfunction in relation to birth setting. Am J Obstet Gynecol 2013;209(4):323.e1-e6. doi: 10.1016/j.ajog.2013.06.025. Although several studies have demonstrated that planned home birth and birth center birth provide safe options for low-risk women,1–3 Gr¨unebaum et al examine birth certificate data from the National Center for Health Statistics (NCHS) to compare 5-minute Apgar scores, seizures, and serious neurologic dysfunction by birth setting and by birth attendant using hospital births by physicians as the reference or gold standard. Researchers used data from the publicly accessible NCHS database of birth certificate data, housed within the Centers for Disease Control and Prevention (CDC), which contains information on 4 million births occurring in the United States each year. This study abstracted data from births that occurred from 2007 to 2010. Variables that were abstracted include maternal age, parity, race/ethnicity, newborn weight, weeks’ gestation, location of birth, birth attendant, Apgar scores, and newborn seizures. Birth certificates denote multiple options for both birth setting and birth attendant. These authors combined birth setting and birth attendant into 4 categories: hospital-based physician, hospital-based midwife, freestanding birth center midwife, and home-based midwife. This categorization appears to have combined planned and unplanned home births—and also combined certified nurse-midwives/certified midwives and other midwives. While many states were not required to report seizures or neurologic dysfunction on birth certificates during the entire study period, rates were calculated from states that did report this variable, which is estimated to include 56% of all births. Analyses were conducted to determine if characteristics of the mothers and infants differed by the 4 birth site and birth attendant groups with relative risk (RR) scores obtained4 (see Box 1). The reference standard to which all births were compared was physician-attended births in the hospital setting. For characteristics with multiple variables such as age and race, the assigned referent group was non-Hispanic white women aged younger than 25 years. Chi-square statistics were calculated for each analysis, and RRs were calculated using 95% confidence intervals (CIs) for each outcome of the 4 groups. During this study period, 16,693,987 births were recorded in the United States. Gr¨unebaum et al examined birth certificate data from 13,891,274 singleton births that occurred at 37 weeks’ gestation or more of newborns weighing at least 2500 grams; born in a hospital, birth center, or at home; and attended by a physician or midwife. Apgar scores were available for 98.8% of all states—and for neonatal seizures and serious neurologic dysfunction in 97.5% of those states that reported neonatal seizures and neurologic dysfunction.
100
1526-9523/09/$36.00 doi:10.1111/jmwh.12166
Among the almost 14 million births, 91.6% (n = 12,663,051) were physician-attended hospital births; 8.05% (n = 1,118,678) were midwife-attended hospital births; 0.30% (n = 42,216) were midwife-attended birth center births; and 0.49% (n = 67,429) were midwife-attended home births. Authors note that women giving birth at home were significantly more likely to be multiparous, non-Hispanic white, aged 30 years or older, and beyond 41 weeks’ gestation—with a newborn whose birth weight exceeded 4000 and 4500 grams (P ⬍ .0001)—than were women who gave birth in a hospital or a freestanding birth center. Three tables detail findings describing characteristics of the study population; 5-minute Apgar scores by birth setting, attendant, and parity; and neonatal seizures and neurologic dysfunction by birth setting, attendant, and parity. The most striking findings are those showing a significantly increased risk of a 5-minute Apgar score of 0 and neonatal seizures in newborns born at home when compared to newborns born in a hospital. The RR of a 5-minute Apgar score of 0 for a midwife-attended home birth was 10.55 (95% confidence interval [CI], 8.62-12.93) and was higher for nulliparous women (RR = 14.24; 95% CI, 10.16-19.96). Among birth center midwife-attended births, the RR was lower than that of home births and higher than hospital births attended by physicians or midwives (RR = 3.56; 95% CI, 2.36-5.36). In the hospital setting, midwife-attended births had lower RRs than those attended by physicians (RR = 0.55; 95% CI, 0.450.68 vs RR = 1.00). With respect to hospital births attended
Box 1. What Is Relative Risk?
Relative risk (RR) is an epidemiologic concept often used in case-control or cohort studies to assess whether there is an association between exposure to a condition and subsequent development of a disease or an adverse effect. For example, if the RR = 1, the risk of disease in an exposed person equals the risk in the unexposed person. In other words, when RR = 1, there is no evidence of any increased risk of disease whether or not one is exposed to the condition under study. An RR greater than 1 is described as a positive association and implies that risk in the exposed group is greater than in the nonexposed group. In this study, authors ascribe an RR of 1 to birth in a hospital by a physician, which they believe is the reference or gold standard to which Apgar scores from other birth settings and by other intrapartum care providers are compared. When noted, associations do not convey cause. Associations may be real or false, and they depend on many factors such as the study’s design, strength of the relationship, doseresponse, replication of findings, biologic plausibility, consideration of alternate explanations, specificity of the association, and others.
c 2013 by the American College of Nurse-Midwives
by midwives, RRs for neonatal seizures or neurologic dysfunction were also lower than those of physicians in each category: all births (RR = 0.74; 95% CI, 0.62-0.89 vs RR = 1.00), parity of 0 (RR = 0.90; 95% CI, 0.72-1.14 vs RR = 1.00), and parity greater than 0 (RR = 0.57; 95% CI, 0.42-0.77 vs RR = 1.00). Since the CDC data are not able to distinguish those women who were transferred from home to the hospital setting due to complications, data of transferred women are attributed to hospital births rather than home birth, negatively skewing RR of adverse outcomes for the hospital setting. One strength of this study is the large sample size of births within the 4-year period and the use of a comprehensive birthcertificate data set. However, the study has significant limitations that call into question the strength of these findings. For example, the birth certificate data note if a home birth is planned or unplanned. The authors do not state if unplanned home births were included in the home-based midwife category. Overall, the number of infants with an Apgar score of 0 at 5 minutes was small. Out of almost 14 million births, only 23 newborns with an Apgar score of 0 were born at home. The incidence of an Apgar score of 0 in each of the 4 categories was the following: 0.16% in the home birth group, 0.05% in the freestanding birth centers, 0.009% in midwife-hospital births, and 0.016 in the physician-hospital group. Thus, although the RRs between these groups may be statistically significant, the numbers are very small and the difference may not be clinically significant. In addition, birth certificate data suffer from several limitations of quality and accuracy that are well known.5 In particular with regard to seizures and neurologic dysfunction, the birth certificate form does not distinguish among possible causes of neurologic dysfunction— specifically whether its origin may be genetic, intrapartum, prenatal, neonatal, or otherwise unrelated to site of birth or attendant. Although a study such as this may suggest avenues for further research, it is critical to recognize that high RRs and associations do not reflect causation. Furthermore, there is no
discussion of the validity or the process by which an RR = 1 was ascribed to a physician-attended birth in the hospital setting. Had the authors selected midwife-attended birth in the hospital setting as their reference standard, these data would have clearly demonstrated a lower risk of poor outcomes in women who were attended by a midwife at their birth. A disturbing perspective is the degree to which Gr¨unebaum et al consider their findings so compelling that they recommend against any further study, such as a randomized controlled clinical trial comparing out-of-hospital versus hospital births, as ethically unacceptable. Furthermore, they invoke physicians’ sense of professional responsibility to counsel women who may express an interest against any planned out-of-hospital births. Clearly, women’s health care providers must work conscientiously and purposefully to address women’s legitimate concerns about site for birth, choice of attendant, and risks versus benefits of hospital procedures and interventions. Responsible discussions with women must reflect the best evidence available, and providers have a responsibility to ensure that all births are made safer—whether occurring in the home, the birth center, or hospital—with a woman’s attendant of choice. 1.Olsen O, Clausen JA. Planned hospital birth versus planned homebirth. Cochrane Database of Systematic Reviews. 2012;9:CD0000352. http://dx.doi.org/10.1002/14651858.CD000352. pub2. 2.Hodnett ED, Downe S, Walsh D. Alternative versus conventional institutional settings for birth. Cochrane Database of Systematic Reviews. 2012;8:CD000012. http://dx.doi.org.10.1002/14651858. CD000012.pub.4. 3.Stapleton SR, Osborne C, Illuzzi J. Outcomes of care in birth centers: Demonstration of a durable model. J Midwifery & Womens Health. 2013;58:3-14. 4.Gordis L. Estimating risk: Is there an association? In Gordis L, ed. Epidemiology. 3rd ed. Philadelphia, PA: Elsevier Saunders; 2004:177-190. 5.Grimes D. Epidemiologic research using administrative databases: Garbage in, garbage out. Obstet Gynecol. 2010;116:1018-1019.
MATERNAL USE OF OPIOIDS NEAR CONCEPTION MAY INCREASE RISK OF NEURAL TUBE DEFECTS
Yazdy MM, Mitchell AA, Tinker SC, Parker SE, Werler MM. Periconceptional use of opioids and the risk of neural tube defects. Obstet Gynecol. 2013;122(4):838-834. Opioids are commonly used to relieve pain and considered highly effective analgesics. Classified as Schedule II drugs by the US Controlled Substances Act,1 more than 200 million prescriptions for opioids were dispensed in the United States in 2009.2 Opioids include legally prescribed medications such as hydrocodone, oxycodone, meperedine, hydromorphone, morphine, propoxyphene, and fentanyl, as well as illegal substances such as heroin and cocaine.3 Opioids have a high potential for abuse. In 2008, more than 36,000 deaths occurred in the United States due to prescription pain relievers; 75% of these resulted from prescribed pain relievers.4 Previously published animal studies have linked opioid exposure during gestation to central nervous system anomalies.5, 6 While studies conducted among humans have used small numbers, 2 epidemiologic studies have suggested Journal of Midwifery & Women’s Health r www.jmwh.org
associations between neural tube defects (NTDs) and the use of opioids.7 Researchers recognize that opioid receptors are involved in cell proliferation in the developing brain, organ development, and DNA synthesis—and that they function as a negative growth regulator; hence, these pathways have been suggested as possible mechanisms of action.8 The intention of these researchers was to investigate if risks of NTDs were increased in women who used opioids in early pregnancy, ascertain if these risks were associated with certain subgroups of opioids, and examine the timing of neural tube development in the fetus. Yazdy et al used data from the Birth Defects Study, a casecontrol study9 (see Box 2) that began in 1976 and is ongoing through the Slone Epidemiology Center at Boston University. Data used were inclusive of the years 1998 to 2010. Cases were identified from hospitals and tertiary care facilities from a few large cities in the United States and Canada— and from birth defects registries in Boston and New York City. Cases were defined as living infants, induced abortions, and 101
Box 2. What Is a Case-Control Study?
Case control refers to a study designed to examine a possible relationship between exposure to a stated factor (in this study, fetal exposure to opioids) and subsequent development of a disease or other outcome (in this case, neural tube defect [NTD]). It begins with identification of the condition under study—cases (infants born with NTDs) and compares these to controls (infants born without NTDs) based on an exposure to a drug, illness, or condition under investigation (opioid use during early pregnancy). Researchers identify the proportion of exposed cases to unexposed to determine if an association exists. Statistical testing determines if a relationship exists and how strong or weak it may be. An association presumes that those in whom the exposure occurs are more likely to develop the disease or outcome under consideration. How likely the disease or outcome occurs as a result of the exposure is expressed in terms of odds ratios and confidence intervals.
fetal deaths after 20 weeks’ gestation diagnosed with anencephaly, encephalocele, or spina bifida. Excluded cases were conjoined twins and infants affected by chromosome disorders, amniotic bands, body wall defects, or Mendelian inherited disorders. Live born infants with major malformations were selected for the control group from the same birth hospital as cases from a random sample of birth records. Within 6 months of birth, nurses trained to conduct computer-assisted interviews contacted the mothers by telephone. Interview questions consisted of demographic information, reproductive history, parental occupation, behavioral factors during pregnancy (eg, smoking, alcohol, caffeine use), medications, and vitamins. When asked about medication use, rather than identify specific drugs of interest, study nurses asked mothers if they had used medications for migraine, headache, backache, joint or muscle pain, or other types of pain during their pregnancy. There was no prompting to elicit responses from the mothers regarding illegal or any other specific drug use. For this study, exposure was defined as reported use of an opioid in the two 28-day months (56 days) after the last menstrual period. Data collected from women who reported opioid use at any other time during the pregnancy or were unsure of their last menstrual periods were not included in the analyses. Timing and distribution of opioid exposure among the mothers was compared between the infants with NTDs and those without. A logistic regression model was created to estimate odds ratios (ORs) and 95% CIs by adding one factor at a time into the model. If the OR for opioid use changed by 10%, then that factor was added to the model. Recall bias is a frequent criticism of case-control study design and occurs when participants’ recollection of prior exposure differs between those in the case and control groups.10 To decrease the possibility of recall bias, Yazdy et al added a second control group that included mothers whose infants were born with a variety of birth defects, other than NTDs, because their recollections were assumed to be as accurate as those of the mothers of infants with NTDs (case group). 102
Three hundred and five infants with NTDs were identified: 220 had spina bifida, 51 had anencephaly, 30 had encephalocele, 3 had both spina bifida and encephalocele, and one had both spina bifida and anencephaly. The control group (without NTDs or other birth defects) contained 7,125 infants and the second control group (those with birth defects that were not NTDs) contained 13,405 infants. Mothers reported use of 15 different opioids during the periconceptional time frame under study. These included codeine, oxycodone, hydrocodone, morphine, propoxyphene, meperidine, methadone, tramadol, hydromorphone, butorphanol, heroin, fentanyl, buprenorphine, nalbuphine, and diphenoxylate. Codeine, oxycodone, and hydrocodone were the most commonly reported drugs. Sixty-five percent of the control group mothers and 68% of mothers in the case group (with any malformation including NTDs) participated in the interviews. The most common reasons given for opioid use varied among the mothers and included pain, infections, headache, dental procedures, medical procedures, other conditions (eg, allergies, asthma, seizures, sleep disorders, vaginal bleeding, yeast infections), or other unspecified conditions. Mothers also reported heroin, oxycodone, and hydrocodone in ways suggestive of abuse and subsequent treatment (eg, methadone). Mothers whose infants were born with NTDs (3.9%) reported more opioid use than mothers whose infants had no malformations (1.6%) and mothers whose infants had malformations other than NTDs (2.0%). Mean duration of opioid use was 87.4 days in the case group, 84.8 days in the control group, and 89.3 days in the second control group. When compared to the control group of infants without NTDs, the adjusted OR for infants with NTDs whose mothers reported any use of opioids during the periconceptional period was 2.2 (95% CI, 1.2-4.2). When reviewing data only for spina bifida cases, the adjusted OR was 2.5 (95% CI, 1.3-5.0). When compared to the control group of infants without NTDs, and when calculated only for live born infants, ORs for NTDs were 2.4 (95% CI, 1.2-4.9) among the control group without birth defects and 2.2 (95% CI, 1.1-4.3) among the second control group having birth defects other than NTDs. Among the general population, estimates of prevalence of NTDs come from the National Birth Defects Prevention Network, which found a weighted prevalence of 2.69 NTDs per 10,000 births.11 Yazdy et al state that their findings support a 2-fold increase in NTDs, particularly spina bifida, among infants whose mothers used opioids in early gestation. Their findings are consistent with previous epidemiologic research showing similar relationships. A moderate risk such as described here would result in an NTD prevalence of 5.9 per 10,000 live births among women who use opioids. Although folic acid, found in most prenatal vitamins, is known to protect against spina bifida, Yazdy et al found that use of prenatal vitamins containing folic acid did not act as a confounding factor with respect to any associations between opioid use and NTDs. Limitations to this study include overall small numbers of exposed mothers and some CIs that included 1.0. Since medication doses were not assessed, it is not possible to evaluate any dose-response associations. There are insufficient numbers to assess any associations with specific opioids. Authors state that they are unable to confirm whether their Volume 59, No. 1, January/February 2014
findings result from an underlying indication for the drug (such as pain), although they consider this unlikely. A clear strength of this work is the addition of a second control group—one that contained multiple birth defects excluding NTDs—to minimize recall bias. Midwives educate women about the importance of nutrition and optimal physical and mental health before pregnancy. We teach women to avoid drugs, especially in early pregnancy when fetal cell differentiation is occurring and vital organs are forming. We guide women in making informed decisions about medication use based on medical necessity and risks versus benefits. We must reinforce health messages that we share with women and help them identify safer methods to manage pain and to avoid potentially harmful substances, prescribed or otherwise. 1.United States Food and Drug Administration. Controlled Substances Act. http://www.fda.gov/regulatoryinformation/legislation/ ucm148726.htm. Accessed October 29, 2013. 2.Volkow ND, McLellan TA, Cotto JH, Karithanom M, Weiss SRB. Characteristics of opioid prescriptions in 2009. JAMA. 2011;305(13):12991301. 3.National Institute of Drug Abuse. Prescription drugs: Abuse and
addiction. http://www.drugabuse.gov/publications/research-reports/ prescription-drugs/opioids/what-are-opioids. Accessed October 29, 2013. 4.CDC. Vital signs: Overdoses of prescription opioid pain relievers— United States, 1999–2008. MMWR. 2011;60:1-6. 5.Geber W, Schramm L. Congenital malformations of the central nervous system produced by narcotic analgesics in the hamster. IS J Obstet Gynecol. 1975;123:705-713. 6.Jurand A. Malformations of the central nervous system induced by neurotropic drugs in mouse embryos. Dev Growth Differ. 1980;22:6178. 7.Broussard CS, Rasmussen SA, Reefhuis J, Friedman JM, Jann MW, Riehle-Colarusso T, et al. Maternal treatment with opioid analgesics and risk for birth defects. Am J Obstet Gynecol. 2011;204(4):314.e111. 8.Zagon IS, Wu Y, MacLaughlin PJ. Opioid growth factor and organ development in rat and human embryos. Brain Res. 1999;839:313-312. 9.Gordis L. Epidemiology. 3rd ed. Philadelphia, PA: Elsevier Saunders; 2004. 10.Raphael K. Recall bias: A proposal for assessment and control. Int J Epid. 1987;16(2):167-170. 11.Parker SE, Mai CT, Canfield MA, et al. for the National Birth Defects prevention Network. Updated national birth prevalence estimates for selected birth defects in the United States, 2004–2006. Birth Defects Res A Clin Mol Teratol. 88:1008-1016. doi:10.1002/bdra.20735.
UNSAFE USE OF COMBINED HORMONAL CONTRACEPTIVES POSES HEALTH RISKS FOR WOMEN WITH MEDICAL CONDITIONS
Yu J, Hu XH. Inappropriate use of combined hormonal contraceptives for birth control among women of reproductive age in the United States. J Women’s Health (Larchmt). 2013;22(7):595-603. Prevention of unintended pregnancy is an important health behavior for women and recommended by professional associations and governmental and health-related organizations.1–4 Half of all pregnancies in the United States are unintended, and although many of these become wanted and welcomed, 4 in 10 unintended pregnancies end in induced abortion.4 Hormonal contraceptives are an important choice among women of reproductive age who want to avoid pregnancy. Of women practicing contraception, 30% use the pill or an injectable, implant, patch, or vaginal ring.4 More than 10 million women in the United States used the pill between 2006 and 2008.5 It is widely recognized that the use of combined oral contraceptives (containing estrogen and progestin) can increase a woman’s risk of cardiovascular events and venous thromboembolism, relative to the actions of estrogen, based on older epidemiologic studies6 and reexamined in more recent studies that included specific progestins.7 The intent of this study was to describe inappropriate use of combined hormonal contraceptives (CHCs) according to US Medical Eligibility Criteria (MEC). The US MEC are adapted from a World Health Organization document and define medical criteria and categories of use for contraceptive methods. Four categories are defined within the MEC: 1) a condition for which there is no restriction for the use of the contraceptive method; 2) a condition for which the advantages of using the method generally outweigh theoretical or proven risks; 3) a condition for which the theoretical or proven risks Journal of Midwifery & Women’s Health r www.jmwh.org
usually outweigh the advantages of using the method; and 4) a condition that represents an unacceptable health risk if the method is chosen.8 Authors investigated use of CHCs by accessing data from Kantar Health’s 2010 National Health and Wellness Survey (NHWS), a large international patient survey database providing a cross-sectional, self-report of 75,000 US adults aged 18 and older. It is administered annually through the Internet and surveys demographic information, medical conditions, disease history, comorbidities, use of prescription medication, health-related attitudes and behaviors, income, education, quality of life, and health care resources accessed within 6-month recall time periods and more. Respondents are recruited from a consumer panel of more than 3 million people living in the United States. For this study, Jingo and Hu constructed a random sampling framework to mimic the US census according to age, gender, and ethnicity. Individuals randomly selected from the database were females aged 18 to 44 who were not currently pregnant and who reported use of CHC for contraception within the previous 6 months. Researchers were specifically interested in CHC use by women who were considered high risk, defined as those who met criteria for MEC categories 3 and 4. Conditions found in categories 3 and 4 include current breast cancer, deep vein thrombosis, hypertension (systolic blood pressure [BP] ≥ 140 or diastolic BP ≥ 90) or with vascular disease, ischemic heart disease, liver tumors, pulmonary embolism, stroke, diabetes mellitus, migraine headache, complicated valvular heart disease, multiple risk factors for cardiovascular disease, and use of anticonvulsant therapy. Additional risk conditions not captured by this survey include early postpartum (⬍ one month breastfeeding or ⬍ 21 if not breastfeeding), severe cirrhosis, peripartum cardiomyopathy, antiretroviral therapy, and a few 103
others. Women with migraine headaches were further questioned regarding their experiences with symptoms such as visual aura and flashing lights. Women with diabetes were further questioned regarding complications such as nephropathy, retinopathy, and neuropathy— as well as the year that diabetes was diagnosed. Women with hypertension whose systolic BP was 160 or higher or whose diastolic BP of 100 or higher were considered as category 4 (unacceptable risk). For their analyses, researchers grouped women according to disease group and patient characteristics. Proportions were calculated using 95% CIs. An examination of the database showed that 14,905 nonpregnant women identified were considered representative of 45.44 million (weighted) women in the United States. Of these, 19.9% (2963) reported using CHCs within the past 6 months, representing 9.25 million (weighted) women in the United States. Analyses are based on the 2963 CHC users. The mean age of CHC users was 29, and 80% were younger than 35. With respect to race/ethnicity, 63% were white, 13.0% were African American, 10.3% were Hispanic, 8.6% were Asian or Pacific Islander, and 4.8% were unknown. Among all CHC users identified, 23.3% had at least one high-risk condition, translating to 2.19 million women in the United States. The top 3 most common high-risk conditions were migraine (12.3%), multiple risk factors for arterial cardiovascular events (9.2%), and hypertension (6.3%). Among women with multiple risk factors for cardiovascular events, more than 273 were obese and current cigarette smokers. Nearly one in 10 women (9.2%) reported at least one condition that was considered an unacceptable risk, corresponding to 860,000 women in the United States. The most common condition categorized as an unacceptable risk was migraine headache (without aura and age ≥ 35 years or with aura at any age) at 7.7%. This study identifies an excessive number of women using CHCs who may be placing their health at further risk. Although Jingo and Hu argue that contraception may be less risky to women’s health than pregnancy, safer and more widespread use might actually decrease overall prevalence of venous thromboembolism by reducing unintended pregnancies, thus minimizing heightened risk during pregnancy and
postpartum. This study highlights the importance of familiarizing midwives and other health professionals with the MEC document and educating them in its use. It is essential to purposefully assess the risk of cardiovascular events and weigh the benefits and risks of CHCs with each woman, especially those with existing medical conditions such as migraine, hypertension, and common cardiovascular risk factors. When prescribing CHCs, midwives should individualize each assessment and consider use of progestin-only methods or nonhormonal contraceptives when estrogen is contraindicated. The CDC provides charts of the 2010 MEC in English and Spanish, as well as a downloadable application to guide providers in safely selecting contraceptive methods for women with medical conditions.8
OTHER LITERATURE OF INTEREST
its and completed the Uterine Fibroid Symptom and Quality of Life questionnaire, a fibroid-specific health-related quality of life (QOL) scale1 that assesses bleeding and perceived effects of fibroids on QOL. Women in the green tea group showed a significant decrease in fibroid volume and severity of symptoms—and a significant improvement in QOL compared with the placebo group. No adverse effects were detected.
Green Tea Extract Shows Promise for Treatment of Uterine Fibroids
Roshdy E, Rajaratnam V, Maitra S, Sabry M, Allah AS, AlHendy A. Treatment of symptomatic uterine fibroids with green tea extract: A pilot randomized controlled clinical study. Int J Women’s Health 2013;5:477-486. Thirty-three women with symptomatic uterine fibroids measuring 2 cm or larger by transvaginal ultrasound were randomized to a daily oral treatment with 800 mg of green tea extract or placebo for 4 months. Participants attended vis-
104
1.American College of Nurse Midwives Core Competencies. http:// midwife.org/ACNM/files/ACNMLibraryData/UPLOADFILENAME/ 000000000050/Core%20Comptencies%20Dec%202012.pdf. Accessed October 29, 2013. 2.U.S. Department of Health and Human Services. Healthy People 2020 Topics and Objectives. http://www.healthypeople.gov/ 2020/topicsobjectives2020/overview.aspx?topicid 13. Accessed October 29, 2013. 3.The National Campaign to Prevent Teen and Unplanned Pregnancies. http://www.thenationalcampaign.org/about-us/default.aspx. Accessed October 29, 2013. 4.Mosher WD, Jones J. Use of contraception in the United States: 1982–2008. National Center for Health Statistics. Vital Health Stat. 29(23);2010:1–44. 5.Benson-Gold R. Wise investment: Reducing the steep cost to Medicaid of unintended pregnancy in the United States. Guttmacher Policy Review. 2011;14(3):6–10. http://www.guttmacher.org/ pubs/gpr/14/3/gpr140306.html. Accessed October 29, 2013. 6.Inman W, Vessey M, Westerholm B, Engelund A. Thromboembolic disease and the steroidal content of oral contraceptives. A report to the committee on safety of drugs. Br Med J. 1970;2:203-209. 7.Lidegaard Ø, Nielsen LH, Skovlund CW, Skjeldestad FE, Løkkegaard E. Risk of venous thromboembolism from use of oral contraceptives containing different progestogens and oestrogen doses: Danish cohort study, 2001–2009. BMJ. 2011;343:d6423. doi:10.1136/bmj.d6423. 8.Centers for Disease Control and Prevention. United States medical eligibility criteria (US MEC) for contraceptive use, 2010. http://www. cdc.gov/reproductivehealth/unintendedpregnancy/usmec.htm. Accessed October 29, 2013.
1.Spies JB, Coyne K, Guaou Guaou N, Boyle D, Skyrnarz-Murphy K, Gonzalves SM. The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata. Obstet Gynecol. 2002;99:290-300.
Volume 59, No. 1, January/February 2014
Emerging Therapies for Bacterial Vaginosis
Menard JP. Antibacterial treatment of bacterial vaginosis: Current and emerging therapies. Int J Women’s Health. 2011;3:295-305. Interest in bacterial vaginosis (BV) continues to grow as ongoing research links BV with several gynecologic and obstetric morbidities and definitive treatments remain elusive. Menard reviews the efficacy of well-known therapies such as metronidazole, clindamycin, and tinidazole, and scrutinizes Further Study Needed to Show Clear Benefit of Aromatherapy for Stress Reduction in Pregnancy
Igarashi T. Physical and psychological effects of aromatherapy inhalation on pregnant women: A randomized controlled trial. J Altern Complement Med. 2013;19(10): 805-810. Igarashi used the Profile of Mood States questionnaire to assess physical and psychological effects of inhaled aromatherapy on pregnant women using essential oils high in Larger Workforce Needed to Meet Increased Demands for Women’s Health Services in 2020
Dall TM, Chakrabarti R, Storm MV, Elwell EC, Rayburn WF. Estimated demand for women’s health services by 2020. J Women’s Health. 2013;22(7):643-647. Authors used a simulation model, based on national utilization standards, to project demands for women’s health services in each state by 2020. Data included descriptions of services provided by the 2010 American Medical Association Masterfile; thus, only physician data were surveyed. A representative population sample of women was obtained from the US Census Bureau and combined with health profile data from the Behavioral Risk Factor Surveillance System. Health-seeking behaviors were generated from about 70,000 women from the Medical Expenditure Panel Survey. The Qualitative Study Explores Help-Seeking Behaviors in Women With Sexual Dysfunction
Azar M, Bradbury-Jones C, Kroll T. Patterns of help-seeking in women when problems arise in their sexual life: A discussion paper. J Clin Nursing. 2013;22(23–24):3587–3596. A literature review was conducted using Vogel’s Model to frame the extraction of data from peer-reviewed papers and organize a discussion. Vogel’s Model comprises encoding and interpreting, generating options, decision making, and evaluation of behavior. Authors found key concerns associated with help-seeking behavior were women’s personal awareness
Journal of Midwifery & Women’s Health r www.jmwh.org
the literature comparing these drugs head-to-head. He discusses prevention of recurrence, novel drug delivery systems, and acidification of the vagina. A discussion on the concurrence of BV in women with Candida vaginitis makes a good argument for treating BV simultaneously with an antifungal and metronidazole. Emerging therapies include some essential oils having antiseptic properties, prebiotics, and probiotics. For midwives who see women with chronic and recurrent BV, this review may offer some hope and new therapies to consider. linalool and linalyl acetate (eg, lavender, petitgrain, and bergamot). Both linalool and linalyl acetate are considered safe to use in pregnancy. Though blinding was not possible, 13 participants at 28 weeks’ gestation were randomly assigned to an aromatherapy or a control group. Activity of the sympathetic and parasympathetic nerves was measured using a portable heart rate monitor. Although the aromatherapy was effective for improving temporary mood, increasing parasympathetic activity, and relaxing effects, Igarashi expressed the need for further study. overall projection for women’s health services is forecast to grow by 6% between 2010 and 2020. Most of the growth in the female population will occur in women aged 65 years and older, a group who uses fewer women’s health services. Most of the demand for women’s health care providers is expected to stem from 3 sectors: states experiencing rapid population growth (eg, Texas, Florida), some Western states due to an historic imbalance of women’s health providers, and a growing population of Hispanic women in the United States. Authors state that the challenge for certified nurse-midwives (CNMs) is the lack of state-level data to identify those CNMs who are self-employed and those CNMs who are working with physician practices. States need strategies to encourage more women’s health providers to work in underserved communities. Of note, this study was supported in part by the American Congress of Obstetricians and Gynecologists. and interaction with their environment. Women’s health care providers can focus on developing public awareness, enriching women’s empowerment, and providing effective sexual health care.
AUTHOR
Sharon Bond, CNM, PhD, FACNM, is an associate professor at the Medical University of South Carolina (MUSC), College of Nursing. She teaches in the Doctor of Nursing Program, researches cervical cancer prevention, and is in clinical practice at MUSC Women’s Health and Planned Parenthood.
105
www.jmwh.org
Updates from the Literature Sharon Bond, CNM, PhD STUDY USES BIRTH CERTIFICATE DATA TO REFUTE SAFETY OF OUT-OF-HOSPITAL BIRTH
Gr¨unebaum A, McCullough LB, Sapra KJ, et al. Apgar score of 0 at 5 minutes and neonatal seizures or serious neurologic dysfunction in relation to birth setting. Am J Obstet Gynecol 2013;209(4):323.e1-e6. doi: 10.1016/j.ajog.2013.06.025. Although several studies have demonstrated that planned home birth and birth center birth provide safe options for low-risk women,1–3 Gr¨unebaum et al examine birth certificate data from the National Center for Health Statistics (NCHS) to compare 5-minute Apgar scores, seizures, and serious neurologic dysfunction by birth setting and by birth attendant using hospital births by physicians as the reference or gold standard. Researchers used data from the publicly accessible NCHS database of birth certificate data, housed within the Centers for Disease Control and Prevention (CDC), which contains information on 4 million births occurring in the United States each year. This study abstracted data from births that occurred from 2007 to 2010. Variables that were abstracted include maternal age, parity, race/ethnicity, newborn weight, weeks’ gestation, location of birth, birth attendant, Apgar scores, and newborn seizures. Birth certificates denote multiple options for both birth setting and birth attendant. These authors combined birth setting and birth attendant into 4 categories: hospital-based physician, hospital-based midwife, freestanding birth center midwife, and home-based midwife. This categorization appears to have combined planned and unplanned home births—and also combined certified nurse-midwives/certified midwives and other midwives. While many states were not required to report seizures or neurologic dysfunction on birth certificates during the entire study period, rates were calculated from states that did report this variable, which is estimated to include 56% of all births. Analyses were conducted to determine if characteristics of the mothers and infants differed by the 4 birth site and birth attendant groups with relative risk (RR) scores obtained4 (see Box 1). The reference standard to which all births were compared was physician-attended births in the hospital setting. For characteristics with multiple variables such as age and race, the assigned referent group was non-Hispanic white women aged younger than 25 years. Chi-square statistics were calculated for each analysis, and RRs were calculated using 95% confidence intervals (CIs) for each outcome of the 4 groups. During this study period, 16,693,987 births were recorded in the United States. Gr¨unebaum et al examined birth certificate data from 13,891,274 singleton births that occurred at 37 weeks’ gestation or more of newborns weighing at least 2500 grams; born in a hospital, birth center, or at home; and attended by a physician or midwife. Apgar scores were available for 98.8% of all states—and for neonatal seizures and serious neurologic dysfunction in 97.5% of those states that reported neonatal seizures and neurologic dysfunction.
100
1526-9523/09/$36.00 doi:10.1111/jmwh.12166
Among the almost 14 million births, 91.6% (n = 12,663,051) were physician-attended hospital births; 8.05% (n = 1,118,678) were midwife-attended hospital births; 0.30% (n = 42,216) were midwife-attended birth center births; and 0.49% (n = 67,429) were midwife-attended home births. Authors note that women giving birth at home were significantly more likely to be multiparous, non-Hispanic white, aged 30 years or older, and beyond 41 weeks’ gestation—with a newborn whose birth weight exceeded 4000 and 4500 grams (P ⬍ .0001)—than were women who gave birth in a hospital or a freestanding birth center. Three tables detail findings describing characteristics of the study population; 5-minute Apgar scores by birth setting, attendant, and parity; and neonatal seizures and neurologic dysfunction by birth setting, attendant, and parity. The most striking findings are those showing a significantly increased risk of a 5-minute Apgar score of 0 and neonatal seizures in newborns born at home when compared to newborns born in a hospital. The RR of a 5-minute Apgar score of 0 for a midwife-attended home birth was 10.55 (95% confidence interval [CI], 8.62-12.93) and was higher for nulliparous women (RR = 14.24; 95% CI, 10.16-19.96). Among birth center midwife-attended births, the RR was lower than that of home births and higher than hospital births attended by physicians or midwives (RR = 3.56; 95% CI, 2.36-5.36). In the hospital setting, midwife-attended births had lower RRs than those attended by physicians (RR = 0.55; 95% CI, 0.450.68 vs RR = 1.00). With respect to hospital births attended
Box 1. What Is Relative Risk?
Relative risk (RR) is an epidemiologic concept often used in case-control or cohort studies to assess whether there is an association between exposure to a condition and subsequent development of a disease or an adverse effect. For example, if the RR = 1, the risk of disease in an exposed person equals the risk in the unexposed person. In other words, when RR = 1, there is no evidence of any increased risk of disease whether or not one is exposed to the condition under study. An RR greater than 1 is described as a positive association and implies that risk in the exposed group is greater than in the nonexposed group. In this study, authors ascribe an RR of 1 to birth in a hospital by a physician, which they believe is the reference or gold standard to which Apgar scores from other birth settings and by other intrapartum care providers are compared. When noted, associations do not convey cause. Associations may be real or false, and they depend on many factors such as the study’s design, strength of the relationship, doseresponse, replication of findings, biologic plausibility, consideration of alternate explanations, specificity of the association, and others.
c 2013 by the American College of Nurse-Midwives
by midwives, RRs for neonatal seizures or neurologic dysfunction were also lower than those of physicians in each category: all births (RR = 0.74; 95% CI, 0.62-0.89 vs RR = 1.00), parity of 0 (RR = 0.90; 95% CI, 0.72-1.14 vs RR = 1.00), and parity greater than 0 (RR = 0.57; 95% CI, 0.42-0.77 vs RR = 1.00). Since the CDC data are not able to distinguish those women who were transferred from home to the hospital setting due to complications, data of transferred women are attributed to hospital births rather than home birth, negatively skewing RR of adverse outcomes for the hospital setting. One strength of this study is the large sample size of births within the 4-year period and the use of a comprehensive birthcertificate data set. However, the study has significant limitations that call into question the strength of these findings. For example, the birth certificate data note if a home birth is planned or unplanned. The authors do not state if unplanned home births were included in the home-based midwife category. Overall, the number of infants with an Apgar score of 0 at 5 minutes was small. Out of almost 14 million births, only 23 newborns with an Apgar score of 0 were born at home. The incidence of an Apgar score of 0 in each of the 4 categories was the following: 0.16% in the home birth group, 0.05% in the freestanding birth centers, 0.009% in midwife-hospital births, and 0.016 in the physician-hospital group. Thus, although the RRs between these groups may be statistically significant, the numbers are very small and the difference may not be clinically significant. In addition, birth certificate data suffer from several limitations of quality and accuracy that are well known.5 In particular with regard to seizures and neurologic dysfunction, the birth certificate form does not distinguish among possible causes of neurologic dysfunction— specifically whether its origin may be genetic, intrapartum, prenatal, neonatal, or otherwise unrelated to site of birth or attendant. Although a study such as this may suggest avenues for further research, it is critical to recognize that high RRs and associations do not reflect causation. Furthermore, there is no
discussion of the validity or the process by which an RR = 1 was ascribed to a physician-attended birth in the hospital setting. Had the authors selected midwife-attended birth in the hospital setting as their reference standard, these data would have clearly demonstrated a lower risk of poor outcomes in women who were attended by a midwife at their birth. A disturbing perspective is the degree to which Gr¨unebaum et al consider their findings so compelling that they recommend against any further study, such as a randomized controlled clinical trial comparing out-of-hospital versus hospital births, as ethically unacceptable. Furthermore, they invoke physicians’ sense of professional responsibility to counsel women who may express an interest against any planned out-of-hospital births. Clearly, women’s health care providers must work conscientiously and purposefully to address women’s legitimate concerns about site for birth, choice of attendant, and risks versus benefits of hospital procedures and interventions. Responsible discussions with women must reflect the best evidence available, and providers have a responsibility to ensure that all births are made safer—whether occurring in the home, the birth center, or hospital—with a woman’s attendant of choice. 1.Olsen O, Clausen JA. Planned hospital birth versus planned homebirth. Cochrane Database of Systematic Reviews. 2012;9:CD0000352. http://dx.doi.org/10.1002/14651858.CD000352. pub2. 2.Hodnett ED, Downe S, Walsh D. Alternative versus conventional institutional settings for birth. Cochrane Database of Systematic Reviews. 2012;8:CD000012. http://dx.doi.org.10.1002/14651858. CD000012.pub.4. 3.Stapleton SR, Osborne C, Illuzzi J. Outcomes of care in birth centers: Demonstration of a durable model. J Midwifery & Womens Health. 2013;58:3-14. 4.Gordis L. Estimating risk: Is there an association? In Gordis L, ed. Epidemiology. 3rd ed. Philadelphia, PA: Elsevier Saunders; 2004:177-190. 5.Grimes D. Epidemiologic research using administrative databases: Garbage in, garbage out. Obstet Gynecol. 2010;116:1018-1019.
MATERNAL USE OF OPIOIDS NEAR CONCEPTION MAY INCREASE RISK OF NEURAL TUBE DEFECTS
Yazdy MM, Mitchell AA, Tinker SC, Parker SE, Werler MM. Periconceptional use of opioids and the risk of neural tube defects. Obstet Gynecol. 2013;122(4):838-834. Opioids are commonly used to relieve pain and considered highly effective analgesics. Classified as Schedule II drugs by the US Controlled Substances Act,1 more than 200 million prescriptions for opioids were dispensed in the United States in 2009.2 Opioids include legally prescribed medications such as hydrocodone, oxycodone, meperedine, hydromorphone, morphine, propoxyphene, and fentanyl, as well as illegal substances such as heroin and cocaine.3 Opioids have a high potential for abuse. In 2008, more than 36,000 deaths occurred in the United States due to prescription pain relievers; 75% of these resulted from prescribed pain relievers.4 Previously published animal studies have linked opioid exposure during gestation to central nervous system anomalies.5, 6 While studies conducted among humans have used small numbers, 2 epidemiologic studies have suggested Journal of Midwifery & Women’s Health r www.jmwh.org
associations between neural tube defects (NTDs) and the use of opioids.7 Researchers recognize that opioid receptors are involved in cell proliferation in the developing brain, organ development, and DNA synthesis—and that they function as a negative growth regulator; hence, these pathways have been suggested as possible mechanisms of action.8 The intention of these researchers was to investigate if risks of NTDs were increased in women who used opioids in early pregnancy, ascertain if these risks were associated with certain subgroups of opioids, and examine the timing of neural tube development in the fetus. Yazdy et al used data from the Birth Defects Study, a casecontrol study9 (see Box 2) that began in 1976 and is ongoing through the Slone Epidemiology Center at Boston University. Data used were inclusive of the years 1998 to 2010. Cases were identified from hospitals and tertiary care facilities from a few large cities in the United States and Canada— and from birth defects registries in Boston and New York City. Cases were defined as living infants, induced abortions, and 101
Box 2. What Is a Case-Control Study?
Case control refers to a study designed to examine a possible relationship between exposure to a stated factor (in this study, fetal exposure to opioids) and subsequent development of a disease or other outcome (in this case, neural tube defect [NTD]). It begins with identification of the condition under study—cases (infants born with NTDs) and compares these to controls (infants born without NTDs) based on an exposure to a drug, illness, or condition under investigation (opioid use during early pregnancy). Researchers identify the proportion of exposed cases to unexposed to determine if an association exists. Statistical testing determines if a relationship exists and how strong or weak it may be. An association presumes that those in whom the exposure occurs are more likely to develop the disease or outcome under consideration. How likely the disease or outcome occurs as a result of the exposure is expressed in terms of odds ratios and confidence intervals.
fetal deaths after 20 weeks’ gestation diagnosed with anencephaly, encephalocele, or spina bifida. Excluded cases were conjoined twins and infants affected by chromosome disorders, amniotic bands, body wall defects, or Mendelian inherited disorders. Live born infants with major malformations were selected for the control group from the same birth hospital as cases from a random sample of birth records. Within 6 months of birth, nurses trained to conduct computer-assisted interviews contacted the mothers by telephone. Interview questions consisted of demographic information, reproductive history, parental occupation, behavioral factors during pregnancy (eg, smoking, alcohol, caffeine use), medications, and vitamins. When asked about medication use, rather than identify specific drugs of interest, study nurses asked mothers if they had used medications for migraine, headache, backache, joint or muscle pain, or other types of pain during their pregnancy. There was no prompting to elicit responses from the mothers regarding illegal or any other specific drug use. For this study, exposure was defined as reported use of an opioid in the two 28-day months (56 days) after the last menstrual period. Data collected from women who reported opioid use at any other time during the pregnancy or were unsure of their last menstrual periods were not included in the analyses. Timing and distribution of opioid exposure among the mothers was compared between the infants with NTDs and those without. A logistic regression model was created to estimate odds ratios (ORs) and 95% CIs by adding one factor at a time into the model. If the OR for opioid use changed by 10%, then that factor was added to the model. Recall bias is a frequent criticism of case-control study design and occurs when participants’ recollection of prior exposure differs between those in the case and control groups.10 To decrease the possibility of recall bias, Yazdy et al added a second control group that included mothers whose infants were born with a variety of birth defects, other than NTDs, because their recollections were assumed to be as accurate as those of the mothers of infants with NTDs (case group). 102
Three hundred and five infants with NTDs were identified: 220 had spina bifida, 51 had anencephaly, 30 had encephalocele, 3 had both spina bifida and encephalocele, and one had both spina bifida and anencephaly. The control group (without NTDs or other birth defects) contained 7,125 infants and the second control group (those with birth defects that were not NTDs) contained 13,405 infants. Mothers reported use of 15 different opioids during the periconceptional time frame under study. These included codeine, oxycodone, hydrocodone, morphine, propoxyphene, meperidine, methadone, tramadol, hydromorphone, butorphanol, heroin, fentanyl, buprenorphine, nalbuphine, and diphenoxylate. Codeine, oxycodone, and hydrocodone were the most commonly reported drugs. Sixty-five percent of the control group mothers and 68% of mothers in the case group (with any malformation including NTDs) participated in the interviews. The most common reasons given for opioid use varied among the mothers and included pain, infections, headache, dental procedures, medical procedures, other conditions (eg, allergies, asthma, seizures, sleep disorders, vaginal bleeding, yeast infections), or other unspecified conditions. Mothers also reported heroin, oxycodone, and hydrocodone in ways suggestive of abuse and subsequent treatment (eg, methadone). Mothers whose infants were born with NTDs (3.9%) reported more opioid use than mothers whose infants had no malformations (1.6%) and mothers whose infants had malformations other than NTDs (2.0%). Mean duration of opioid use was 87.4 days in the case group, 84.8 days in the control group, and 89.3 days in the second control group. When compared to the control group of infants without NTDs, the adjusted OR for infants with NTDs whose mothers reported any use of opioids during the periconceptional period was 2.2 (95% CI, 1.2-4.2). When reviewing data only for spina bifida cases, the adjusted OR was 2.5 (95% CI, 1.3-5.0). When compared to the control group of infants without NTDs, and when calculated only for live born infants, ORs for NTDs were 2.4 (95% CI, 1.2-4.9) among the control group without birth defects and 2.2 (95% CI, 1.1-4.3) among the second control group having birth defects other than NTDs. Among the general population, estimates of prevalence of NTDs come from the National Birth Defects Prevention Network, which found a weighted prevalence of 2.69 NTDs per 10,000 births.11 Yazdy et al state that their findings support a 2-fold increase in NTDs, particularly spina bifida, among infants whose mothers used opioids in early gestation. Their findings are consistent with previous epidemiologic research showing similar relationships. A moderate risk such as described here would result in an NTD prevalence of 5.9 per 10,000 live births among women who use opioids. Although folic acid, found in most prenatal vitamins, is known to protect against spina bifida, Yazdy et al found that use of prenatal vitamins containing folic acid did not act as a confounding factor with respect to any associations between opioid use and NTDs. Limitations to this study include overall small numbers of exposed mothers and some CIs that included 1.0. Since medication doses were not assessed, it is not possible to evaluate any dose-response associations. There are insufficient numbers to assess any associations with specific opioids. Authors state that they are unable to confirm whether their Volume 59, No. 1, January/February 2014
findings result from an underlying indication for the drug (such as pain), although they consider this unlikely. A clear strength of this work is the addition of a second control group—one that contained multiple birth defects excluding NTDs—to minimize recall bias. Midwives educate women about the importance of nutrition and optimal physical and mental health before pregnancy. We teach women to avoid drugs, especially in early pregnancy when fetal cell differentiation is occurring and vital organs are forming. We guide women in making informed decisions about medication use based on medical necessity and risks versus benefits. We must reinforce health messages that we share with women and help them identify safer methods to manage pain and to avoid potentially harmful substances, prescribed or otherwise. 1.United States Food and Drug Administration. Controlled Substances Act. http://www.fda.gov/regulatoryinformation/legislation/ ucm148726.htm. Accessed October 29, 2013. 2.Volkow ND, McLellan TA, Cotto JH, Karithanom M, Weiss SRB. Characteristics of opioid prescriptions in 2009. JAMA. 2011;305(13):12991301. 3.National Institute of Drug Abuse. Prescription drugs: Abuse and
addiction. http://www.drugabuse.gov/publications/research-reports/ prescription-drugs/opioids/what-are-opioids. Accessed October 29, 2013. 4.CDC. Vital signs: Overdoses of prescription opioid pain relievers— United States, 1999–2008. MMWR. 2011;60:1-6. 5.Geber W, Schramm L. Congenital malformations of the central nervous system produced by narcotic analgesics in the hamster. IS J Obstet Gynecol. 1975;123:705-713. 6.Jurand A. Malformations of the central nervous system induced by neurotropic drugs in mouse embryos. Dev Growth Differ. 1980;22:6178. 7.Broussard CS, Rasmussen SA, Reefhuis J, Friedman JM, Jann MW, Riehle-Colarusso T, et al. Maternal treatment with opioid analgesics and risk for birth defects. Am J Obstet Gynecol. 2011;204(4):314.e111. 8.Zagon IS, Wu Y, MacLaughlin PJ. Opioid growth factor and organ development in rat and human embryos. Brain Res. 1999;839:313-312. 9.Gordis L. Epidemiology. 3rd ed. Philadelphia, PA: Elsevier Saunders; 2004. 10.Raphael K. Recall bias: A proposal for assessment and control. Int J Epid. 1987;16(2):167-170. 11.Parker SE, Mai CT, Canfield MA, et al. for the National Birth Defects prevention Network. Updated national birth prevalence estimates for selected birth defects in the United States, 2004–2006. Birth Defects Res A Clin Mol Teratol. 88:1008-1016. doi:10.1002/bdra.20735.
UNSAFE USE OF COMBINED HORMONAL CONTRACEPTIVES POSES HEALTH RISKS FOR WOMEN WITH MEDICAL CONDITIONS
Yu J, Hu XH. Inappropriate use of combined hormonal contraceptives for birth control among women of reproductive age in the United States. J Women’s Health (Larchmt). 2013;22(7):595-603. Prevention of unintended pregnancy is an important health behavior for women and recommended by professional associations and governmental and health-related organizations.1–4 Half of all pregnancies in the United States are unintended, and although many of these become wanted and welcomed, 4 in 10 unintended pregnancies end in induced abortion.4 Hormonal contraceptives are an important choice among women of reproductive age who want to avoid pregnancy. Of women practicing contraception, 30% use the pill or an injectable, implant, patch, or vaginal ring.4 More than 10 million women in the United States used the pill between 2006 and 2008.5 It is widely recognized that the use of combined oral contraceptives (containing estrogen and progestin) can increase a woman’s risk of cardiovascular events and venous thromboembolism, relative to the actions of estrogen, based on older epidemiologic studies6 and reexamined in more recent studies that included specific progestins.7 The intent of this study was to describe inappropriate use of combined hormonal contraceptives (CHCs) according to US Medical Eligibility Criteria (MEC). The US MEC are adapted from a World Health Organization document and define medical criteria and categories of use for contraceptive methods. Four categories are defined within the MEC: 1) a condition for which there is no restriction for the use of the contraceptive method; 2) a condition for which the advantages of using the method generally outweigh theoretical or proven risks; 3) a condition for which the theoretical or proven risks Journal of Midwifery & Women’s Health r www.jmwh.org
usually outweigh the advantages of using the method; and 4) a condition that represents an unacceptable health risk if the method is chosen.8 Authors investigated use of CHCs by accessing data from Kantar Health’s 2010 National Health and Wellness Survey (NHWS), a large international patient survey database providing a cross-sectional, self-report of 75,000 US adults aged 18 and older. It is administered annually through the Internet and surveys demographic information, medical conditions, disease history, comorbidities, use of prescription medication, health-related attitudes and behaviors, income, education, quality of life, and health care resources accessed within 6-month recall time periods and more. Respondents are recruited from a consumer panel of more than 3 million people living in the United States. For this study, Jingo and Hu constructed a random sampling framework to mimic the US census according to age, gender, and ethnicity. Individuals randomly selected from the database were females aged 18 to 44 who were not currently pregnant and who reported use of CHC for contraception within the previous 6 months. Researchers were specifically interested in CHC use by women who were considered high risk, defined as those who met criteria for MEC categories 3 and 4. Conditions found in categories 3 and 4 include current breast cancer, deep vein thrombosis, hypertension (systolic blood pressure [BP] ≥ 140 or diastolic BP ≥ 90) or with vascular disease, ischemic heart disease, liver tumors, pulmonary embolism, stroke, diabetes mellitus, migraine headache, complicated valvular heart disease, multiple risk factors for cardiovascular disease, and use of anticonvulsant therapy. Additional risk conditions not captured by this survey include early postpartum (⬍ one month breastfeeding or ⬍ 21 if not breastfeeding), severe cirrhosis, peripartum cardiomyopathy, antiretroviral therapy, and a few 103
others. Women with migraine headaches were further questioned regarding their experiences with symptoms such as visual aura and flashing lights. Women with diabetes were further questioned regarding complications such as nephropathy, retinopathy, and neuropathy— as well as the year that diabetes was diagnosed. Women with hypertension whose systolic BP was 160 or higher or whose diastolic BP of 100 or higher were considered as category 4 (unacceptable risk). For their analyses, researchers grouped women according to disease group and patient characteristics. Proportions were calculated using 95% CIs. An examination of the database showed that 14,905 nonpregnant women identified were considered representative of 45.44 million (weighted) women in the United States. Of these, 19.9% (2963) reported using CHCs within the past 6 months, representing 9.25 million (weighted) women in the United States. Analyses are based on the 2963 CHC users. The mean age of CHC users was 29, and 80% were younger than 35. With respect to race/ethnicity, 63% were white, 13.0% were African American, 10.3% were Hispanic, 8.6% were Asian or Pacific Islander, and 4.8% were unknown. Among all CHC users identified, 23.3% had at least one high-risk condition, translating to 2.19 million women in the United States. The top 3 most common high-risk conditions were migraine (12.3%), multiple risk factors for arterial cardiovascular events (9.2%), and hypertension (6.3%). Among women with multiple risk factors for cardiovascular events, more than 273 were obese and current cigarette smokers. Nearly one in 10 women (9.2%) reported at least one condition that was considered an unacceptable risk, corresponding to 860,000 women in the United States. The most common condition categorized as an unacceptable risk was migraine headache (without aura and age ≥ 35 years or with aura at any age) at 7.7%. This study identifies an excessive number of women using CHCs who may be placing their health at further risk. Although Jingo and Hu argue that contraception may be less risky to women’s health than pregnancy, safer and more widespread use might actually decrease overall prevalence of venous thromboembolism by reducing unintended pregnancies, thus minimizing heightened risk during pregnancy and
postpartum. This study highlights the importance of familiarizing midwives and other health professionals with the MEC document and educating them in its use. It is essential to purposefully assess the risk of cardiovascular events and weigh the benefits and risks of CHCs with each woman, especially those with existing medical conditions such as migraine, hypertension, and common cardiovascular risk factors. When prescribing CHCs, midwives should individualize each assessment and consider use of progestin-only methods or nonhormonal contraceptives when estrogen is contraindicated. The CDC provides charts of the 2010 MEC in English and Spanish, as well as a downloadable application to guide providers in safely selecting contraceptive methods for women with medical conditions.8
OTHER LITERATURE OF INTEREST
its and completed the Uterine Fibroid Symptom and Quality of Life questionnaire, a fibroid-specific health-related quality of life (QOL) scale1 that assesses bleeding and perceived effects of fibroids on QOL. Women in the green tea group showed a significant decrease in fibroid volume and severity of symptoms—and a significant improvement in QOL compared with the placebo group. No adverse effects were detected.
Green Tea Extract Shows Promise for Treatment of Uterine Fibroids
Roshdy E, Rajaratnam V, Maitra S, Sabry M, Allah AS, AlHendy A. Treatment of symptomatic uterine fibroids with green tea extract: A pilot randomized controlled clinical study. Int J Women’s Health 2013;5:477-486. Thirty-three women with symptomatic uterine fibroids measuring 2 cm or larger by transvaginal ultrasound were randomized to a daily oral treatment with 800 mg of green tea extract or placebo for 4 months. Participants attended vis-
104
1.American College of Nurse Midwives Core Competencies. http:// midwife.org/ACNM/files/ACNMLibraryData/UPLOADFILENAME/ 000000000050/Core%20Comptencies%20Dec%202012.pdf. Accessed October 29, 2013. 2.U.S. Department of Health and Human Services. Healthy People 2020 Topics and Objectives. http://www.healthypeople.gov/ 2020/topicsobjectives2020/overview.aspx?topicid 13. Accessed October 29, 2013. 3.The National Campaign to Prevent Teen and Unplanned Pregnancies. http://www.thenationalcampaign.org/about-us/default.aspx. Accessed October 29, 2013. 4.Mosher WD, Jones J. Use of contraception in the United States: 1982–2008. National Center for Health Statistics. Vital Health Stat. 29(23);2010:1–44. 5.Benson-Gold R. Wise investment: Reducing the steep cost to Medicaid of unintended pregnancy in the United States. Guttmacher Policy Review. 2011;14(3):6–10. http://www.guttmacher.org/ pubs/gpr/14/3/gpr140306.html. Accessed October 29, 2013. 6.Inman W, Vessey M, Westerholm B, Engelund A. Thromboembolic disease and the steroidal content of oral contraceptives. A report to the committee on safety of drugs. Br Med J. 1970;2:203-209. 7.Lidegaard Ø, Nielsen LH, Skovlund CW, Skjeldestad FE, Løkkegaard E. Risk of venous thromboembolism from use of oral contraceptives containing different progestogens and oestrogen doses: Danish cohort study, 2001–2009. BMJ. 2011;343:d6423. doi:10.1136/bmj.d6423. 8.Centers for Disease Control and Prevention. United States medical eligibility criteria (US MEC) for contraceptive use, 2010. http://www. cdc.gov/reproductivehealth/unintendedpregnancy/usmec.htm. Accessed October 29, 2013.
1.Spies JB, Coyne K, Guaou Guaou N, Boyle D, Skyrnarz-Murphy K, Gonzalves SM. The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata. Obstet Gynecol. 2002;99:290-300.
Volume 59, No. 1, January/February 2014
Emerging Therapies for Bacterial Vaginosis
Menard JP. Antibacterial treatment of bacterial vaginosis: Current and emerging therapies. Int J Women’s Health. 2011;3:295-305. Interest in bacterial vaginosis (BV) continues to grow as ongoing research links BV with several gynecologic and obstetric morbidities and definitive treatments remain elusive. Menard reviews the efficacy of well-known therapies such as metronidazole, clindamycin, and tinidazole, and scrutinizes Further Study Needed to Show Clear Benefit of Aromatherapy for Stress Reduction in Pregnancy
Igarashi T. Physical and psychological effects of aromatherapy inhalation on pregnant women: A randomized controlled trial. J Altern Complement Med. 2013;19(10): 805-810. Igarashi used the Profile of Mood States questionnaire to assess physical and psychological effects of inhaled aromatherapy on pregnant women using essential oils high in Larger Workforce Needed to Meet Increased Demands for Women’s Health Services in 2020
Dall TM, Chakrabarti R, Storm MV, Elwell EC, Rayburn WF. Estimated demand for women’s health services by 2020. J Women’s Health. 2013;22(7):643-647. Authors used a simulation model, based on national utilization standards, to project demands for women’s health services in each state by 2020. Data included descriptions of services provided by the 2010 American Medical Association Masterfile; thus, only physician data were surveyed. A representative population sample of women was obtained from the US Census Bureau and combined with health profile data from the Behavioral Risk Factor Surveillance System. Health-seeking behaviors were generated from about 70,000 women from the Medical Expenditure Panel Survey. The Qualitative Study Explores Help-Seeking Behaviors in Women With Sexual Dysfunction
Azar M, Bradbury-Jones C, Kroll T. Patterns of help-seeking in women when problems arise in their sexual life: A discussion paper. J Clin Nursing. 2013;22(23–24):3587–3596. A literature review was conducted using Vogel’s Model to frame the extraction of data from peer-reviewed papers and organize a discussion. Vogel’s Model comprises encoding and interpreting, generating options, decision making, and evaluation of behavior. Authors found key concerns associated with help-seeking behavior were women’s personal awareness
Journal of Midwifery & Women’s Health r www.jmwh.org
the literature comparing these drugs head-to-head. He discusses prevention of recurrence, novel drug delivery systems, and acidification of the vagina. A discussion on the concurrence of BV in women with Candida vaginitis makes a good argument for treating BV simultaneously with an antifungal and metronidazole. Emerging therapies include some essential oils having antiseptic properties, prebiotics, and probiotics. For midwives who see women with chronic and recurrent BV, this review may offer some hope and new therapies to consider. linalool and linalyl acetate (eg, lavender, petitgrain, and bergamot). Both linalool and linalyl acetate are considered safe to use in pregnancy. Though blinding was not possible, 13 participants at 28 weeks’ gestation were randomly assigned to an aromatherapy or a control group. Activity of the sympathetic and parasympathetic nerves was measured using a portable heart rate monitor. Although the aromatherapy was effective for improving temporary mood, increasing parasympathetic activity, and relaxing effects, Igarashi expressed the need for further study. overall projection for women’s health services is forecast to grow by 6% between 2010 and 2020. Most of the growth in the female population will occur in women aged 65 years and older, a group who uses fewer women’s health services. Most of the demand for women’s health care providers is expected to stem from 3 sectors: states experiencing rapid population growth (eg, Texas, Florida), some Western states due to an historic imbalance of women’s health providers, and a growing population of Hispanic women in the United States. Authors state that the challenge for certified nurse-midwives (CNMs) is the lack of state-level data to identify those CNMs who are self-employed and those CNMs who are working with physician practices. States need strategies to encourage more women’s health providers to work in underserved communities. Of note, this study was supported in part by the American Congress of Obstetricians and Gynecologists. and interaction with their environment. Women’s health care providers can focus on developing public awareness, enriching women’s empowerment, and providing effective sexual health care.
AUTHOR
Sharon Bond, CNM, PhD, FACNM, is an associate professor at the Medical University of South Carolina (MUSC), College of Nursing. She teaches in the Doctor of Nursing Program, researches cervical cancer prevention, and is in clinical practice at MUSC Women’s Health and Planned Parenthood.
105
