Journal of Midwifery & Women’s Health

www.jmwh.org

Original Review

Induction of Labor: Update and Review Carrie F. Bonsack, CNM, MS, Anthony Lathrop, CNM, PhD, RDMS, Mary Blackburn, CNM, MSN

CEU

Rates of labor induction in the United States have more than doubled in the past 2 decades. Trends of indications and risk factors related to induction of labor are also increasing. Professional organizations such as the American College of Obstetricians and Gynecologists and The Joint Commission have taken steps to discourage elective induction of labor prior to 39 weeks’ gestation and have created new definitions of early-term, full-term, late-term, and postterm gestation to guide clinicians in the timing of birth for specified indications. Induction of labor is associated with potential risks to both the woman and her fetus. The cost associated with induction of labor and the impact on the health care system is of growing concern. Education of women and the process of shared decision making when obtaining informed consent are key factors in reducing early elective births. Use of tools such as scheduling forms, hard stop methods, induction of labor indication tools, and informed consents may aid the provider in reducing overdiagnosis, overtreatment, and disease creep. This article provides a review of the trends of induction of labor, medical indications and criteria, associated risks, cost and health system impact, and initiatives to lower the incidence of induction of labor. c 2014 by the American College of Nurse-Midwives. J Midwifery Womens Health 2014;59:606–615  Keywords: induction of labor, cost, decision making, informed consent, labor, birth, patient education, trends, women

Address correspondence to Carrie Bonsack, CNM, MS; 9301 Rachel Drive Yorktown, IN 47396. E-mail: [email protected]

pertensive complications of pregnancy, and maternal diabetes complicating pregnancy.5–7 It is concerning that the rate of medically indicated labor inductions is likely to further increase. One of the most worrisome developments in the United States is the increasing prevalence of obesity in women during the reproductive years.8 In 2012, 35.8% of women aged 20 years or older were overweight or obese.3 With increasing rates of obesity come increasing rates of type 2 diabetes, hypertension, stillbirth, dysfunctional labor, and cesarean.8 In 2012, 11.9% of women were diagnosed with diabetes, gestational hypertension, preeclampsia, or chronic hypertension.3 One analysis of international trends found that, unlike the other countries studied, the US sample demonstrated a 2.3% (95% confidence interval [CI], 1.9%-2.7%) increase in the incidence of gestational hypertension and a 2.4% (95% CI, 1.5%- 3.3%) increase in the incidence of preeclampsia during the 9-year study period.9 Maternal obesity without comorbidities also increases the likelihood of prolonged pregnancy and the consequent need for IOL.10 In addition to IOL for medical indications, there is evidence to suggest that the incidence of elective IOL is rising.11 In a cohort of 289,576 women who gave birth between1997 and 2008 in the Kaiser system in Southern California, the rate of elective IOL increased from 5.4% to 9.9%.12 Indicated IOL increased from 3.4% to 5.7% in the same time period.12 Women whose labors were electively induced were more likely to be white, educated, and have initiated care early in their pregnancies. Another retrospective analysis of 7 million births in a 3-state US area found an 86% increase in elective IOL between 1995 and 2009.13 In this analysis, women whose labors were electively induced were more likely to be white, older, educated, and have private insurance.13 More recent data suggest a possible plateau in the rate of elective labor inductions, especially those before 39 completed weeks’ gestation. After 20 years of consecutive increases in the overall US rate of IOL, rates were relatively stable in the range of 23% of all births for 2010, 2011, and 2012.4 For some

606

 c 2014 by the American College of Nurse-Midwives

INTRODUCTION

Hippocrates first described methods for induction of labor (IOL) through mammary stimulation and mechanical cervical dilation.1 From the second century ad onward, practitioners have used methods such as artificial rupture of membranes and manual dilation of the cervix.1 More recent developments, including medications and mechanical devices, have offered providers increasingly effective means of inducing labor. At the same time, questions about the most appropriate use of IOL have arisen. The purposes of this review are to examine IOL with regard to the current trends; risks; initiatives to improve quality, safety, and costs of IOL and its impact on the health care system; and to make recommendations for the most appropriate use of IOL, including how women are counseled and consented. BACKGROUND

Recent trends have shown a significant increase in IOL from a relatively rare event to an increasingly common procedure.2 From 1990 to 2012, the rate of IOL more than doubled from 9.5% to 22.8% of all births in the United States.3 The increase in the rate of IOL in the past decade has not been accompanied by a proportionate improvement in perinatal outcomes.2 IOL has been defined as the initiation of uterine contractions for the purpose of birth before the spontaneous onset of labor.4 IOL can be either medically indicated or elective. Elective IOL refers to those that are performed in the absence of medical indications for reasons such as convenience, logistics, or patient or provider preference. Medical indications for IOL include conditions for which the benefits of expediting birth outweigh the risks of continuing the pregnancy.5,6 Common indications include postterm pregnancy, suspected intrauterine growth restriction, prelabor rupture of membranes, hy-

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✦ Induction of labor has risen to nearly one-quarter of all births. ✦ Elective labor inductions should rarely be performed, and maternity care providers are encouraged to work with institutional quality teams to eliminate elective labor inductions prior to 39 weeks’ gestation. ✦ The development of indication tools, such as those for postdates, fetal growth restriction, and hypertensive disorders, may help providers determine if diagnostic criteria have been met before engaging the woman on the path to labor induction, and may reduce overdiagnosis, overtreatment, and disease creep. ✦ Informed consent is essential in aiding women to understand the risks and benefits of induction of labor.

gestational ages, IOL rates have declined. For example, women whose births were induced in the 37th and 38th weeks of gestation peaked at 21% in 2005 but progressively fell in subsequent years to 18.4% by 2012.4 This decline in IOL prior to 39 weeks’ gestation may be partly due to recent recommendations and quality measures discussed more fully later in this article. RISKS OF INDUCTION OF LABOR

Concerns about the safety for women and newborns secondary to IOL include the effects of excessive uterine activity; a potential increase in the rate of cesarean; increased risk for postpartum hemorrhage (PPH); and adverse effects on the newborn such as fetal intolerance of labor, infection, and respiratory distress syndrome. There is a considerable body of literature regarding adverse perinatal outcomes associated with IOL; however, it is often difficult to distinguish causation from association due to the methodological weaknesses of existing research. Tachysystole

Excessive uterine activity can occur during spontaneous or induced labor and with any of the pharmacologic methods used for IOL.14 Recently, expert interdisciplinary panels have sought to clarify terminology related to excessive uterine activity, defining uterine tachysystole as the preferred term.15 Results of tachysystole for the fetus can include hypoxia, acidemia, acidosis, brain damage, or death if the tachysystole persists uncorrected. Fetuses at increased risk for acidemia secondary to growth restriction, infection, or other complications are particularly vulnerable.16 Uterine rupture, although rare, is a possible maternal complication of tachysystole.5 In one study of women whose labors were being induced with oxytocin (Pitocin), 98% demonstrated at least one occurrence of tachysystole.17 Induction of Labor and Cesarean

Increased rates of cesarean have frequently been cited as an undesirable effect of IOL,18,19 but the evidence for a causal relationship is uncertain because in many cases the same conditions for which IOL is indicated can independently increase the likelihood of cesarean. Research findings on the risks associated with medically indicated IOL differ from the Journal of Midwifery & Women’s Health r www.jmwh.org

research findings of risks associated with elective IOL. In one large retrospective cohort of nulliparous women at term who had a singleton fetus in a vertex presentation (N = 7804) with various medical indications for birth, the overall odds ratio (OR) for cesarean was 2 times greater for those whose labors were induced (OR, 2.67; 95% CI, 2.40-2.96), with IOL accounting for 20% of the overall cesarean risk.20 The odds of cesarean in the women in this analysis who did not have medical complications and whose labors were electively induced was 2.03 (95% CI, 1.73-2.38). Other studies excluding women with complications for which IOL was indicated have demonstrated contrary findings. A retrospective comparison of elective IOL versus expectant management at various term gestational ages found that at each gestational age, the OR for cesarean following elective IOL was about one-half that of expectant management.21 Two systematic reviews of randomized trials that compared expectant management to IOL found a decreased rate of cesarean among those whose labor was induced, with ORs of 0.83 (95% CI, 0.76-0.92)22 and 0.87 (95% CI, 0.80-0.96),23 respectively. Because these studies only included women who were potentially candidates for expectant management, they may provide a more accurate picture of the contribution of IOL to the risk of cesarean. Other studies have shown that a woman’s risk of failed IOL and/or cesarean may be increased by individual factors such as nulliparity, low Bishop score, high body mass index, and diabetes.24–27 Postpartum Hemorrhage

Evidence about the risk of PPH among women whose labor is induced is limited. In a study of otherwise low-risk women, IOL increased the risk of PPH (OR, 1.22; 95% CI, 1.04-1.42) and severe PPH (OR, 1.9; 95% CI, 1.11-2.20).28 Oxytocin was associated with greater odds of PPH (OR, 1.52; 95% CI, 1.191.93) than prostaglandins (OR, 1.22; 95% CI, 0.97-1.51).28 In contrast, Malabarey et al found that prostaglandins but not oxytocin were associated with an increased risk of PPH.29 One systematic review concluded that there is insufficient evidence to determine whether IOL increases the risk of PPH.19 Effects on the Newborn

Recently, concerns for newborn complications resulting from IOL have focused on gestational age at the time of birth. 607

Morbidity and mortality are both higher for infants born before 39 completed weeks’ gestation. Neonatal mortality is higher at 37 weeks’ (OR, 1.9; 95% CI, 1.6-2.2) and 38 weeks’ (OR, 1.4; 95% CI, 1.2-1.6) than at 39 weeks’ gestation.30 Morbidity is also significantly higher for newborns before 39 weeks’ gestation. Birth between 37 and 39 weeks’ gestation is associated with a 2 times higher rate of neonatal intensive care unit (NICU) admission.21 In one retrospective cohort, elective IOL accounted for a disproportionate share of NICU admissions; elective IOL represented 32% of the sample but 40.9% of NICU admissions.31 Newborns born at 37 weeks’ gestation are also at higher risk for respiratory distress syndrome (OR, 3.1; 95% CI, 2.5-3.7) than those born after 39 weeks’ gestation.32 Additional increased risks include sepsis, transient tachypnea of the newborn, pneumonia, ventilator use, hypoglycemia, cerebral palsy, and developmental delays.33 When matched for gestational age, newborn outcomes appear to be similar for women managed expectantly and those who have elective IOL. A systematic review found no differences in the rates of transient tachypnea of the newborn, neonatal sepsis, seizures, hypoglycemia, jaundice, or depressed Apgar scores.19 Another review found decreased rates of meconium-stained fluid in those whose labors were induced but no difference in meconium aspiration syndrome.11 A recent epidemiologic study raised new concerns about IOL and the risk of autism.34 After controlling for some potential confounders, these authors found that IOL was associated with an increased risk of autism (OR, 1.23; 95% CI, 1.02-1.47), which was higher among male offspring (OR, 3.04; 95% CI, 2.86-3.24).34 Citing evidence of the influence of oxytocin on social and cognitive functions, the authors hypothesized that the prevalent use of oxytocin for IOL could account for the observed difference in rates of autism.34 Because the analysis did not distinguish between elective and indicated IOL, and because data were not available for all possible confounders, it is possible that the increased autism risk could be attributable to the presence of maternal conditions for which IOL was indicated. In summary, it is difficult to distinguish between the risks of IOL per se and the risks associated with early birth with the conditions for which IOL may be medically indicated. Based on what is known about the risks of IOL, it does appear that in the presence of maternal or fetal conditions known to increase the risks of continuing pregnancy, the risks of IOL are marginal and/or manageable. In the absence of such conditions, it is more difficult to justify unnecessary exposure to the risks of IOL, even when the evidence for these risks is incomplete or contradictory. INITIATIVES TO LOWER THE INCIDENCE OF INDUCTION OF LABOR

In response to emerging evidence of increased risks to newborns born at 37 and 38 weeks’ gestational age, perinatal advisory bodies issued revised definitions and recommendations to guide practice. In 2009, the American College of Obstetricians and Gynecologists (ACOG) recommended the delay of elective births until after 39 weeks’ gestation due to increased risk of neonatal morbidity before 39 weeks’ gestation, even with a mature fetal lung test result.5 Other measures and qual608

Table 1. Definitions for Gestational Age Categories

Definition

Description

Late preterm

34 0/7-36 6/7 weeks

Early term

37 0/7-38 6/7 weeks

Full term

39 0/7-40 6/7 weeks

Late term

41 0/7-41 6/7 weeks

Postterm

42 0/7 weeks 36

Adapted from C. Spong et al.

ity initiatives to reduce early elective births, including hard stop measures, patient education, and shared decision making are further discussed in this section. Definitions of Term Pregnancy

Neonatal outcomes vary among the 5-week range previously defined as term births, and the risk for adverse outcomes is greater at 37 to 38 weeks’ gestation than 39 weeks’ gestation.35 Based upon this evidence, ACOG and other professional organizations met in 2012 to reevaluate the definition of term pregnancy. The previous definition of term included a 5-week range of 37 6/7 to 41 6/7 weeks’ gestation.36 The panel recommended new definitions to categorize gestational ages in accordance with the evidence about newborn outcomes at varying gestational ages (Table 1). Medically Indicated Births Less Than 39 Weeks’ Gestation

In 2013, ACOG and the Society for Maternal–Fetal Medicine (SMFM) published a committee opinion regarding medically indicated late-preterm (34 0/7-36 6/7 weeks’ gestation) and early-term (37 0/7-38 6/7 weeks’ gestation) births.7 While acknowledging the neonatal risks of birth before 39 weeks’ gestation, the committee recognized that in some conditions the risks of continuing pregnancy may be such that birth before 39 weeks’ gestation may be warranted, either for maternal or newborn benefit, or both.7 For a list of specific conditions, ACOG/SMFM published suggestions for specific timing while acknowledging that these recommendations were based largely on consensus and observational studies.7 A full list of common medical indications for birth with suggested timing is presented in Table 2. Measures to Reduce Early Elective Births

Over the past several years, the effort to reduce the incidence of early elective births has been a joint collaboration of numerous organizations such as ACOG, the March of Dimes, the Centers for Medicare & Medicaid Services, and The Joint Commission.37 These efforts have produced quality initiatives through quality measures and quality improvement projects, in addition to strict policies in which reimbursement for early elective births is being declined. Each year, The Joint Commission determines mandatory reporting requirements for accredited hospitals on performance of specific items in an effort to improve quality and safety of care.38 The Perinatal Care Core Measure Set is one of 6 core performance measures for 2014 for accredited Volume 59, No. 6, November/December 2014

Table 2. Selected Pregnancy Conditions and Recommended Timing of Birth for Late Preterm and Early Term Birthsa

Pregnancy Condition

Recommended Gestational Age at Which Birth Should Occur

Growth restriction, singleton, otherwise uncomplicated

38 0/7-39 6/7 weeks

Growth restriction, singleton, with oligohydramnios, abnormal

34 0/7-37 6/7 weeks

Doppler studies, or maternal comorbidity Oligohydramnios

36 0/7-37 6/7 weeks

Twins: di-di

38 0/7-38 6/7 weeks

Twins: mono-di

34 0/7-37 6/7 weeks

Gestational diabetes well controlled on diet or medications

Early birth not indicated

Gestational diabetes uncontrolled

Individualized management

Pregestational diabetes well controlled

Early birth not indicated

Pregestational diabetes uncontrolled

Early birth individualized

Pregestational diabetes with vascular complications

37 0/7-39 6/7 weeks

Placenta previa

36 0/7-37 6/7 weeks

Placenta previa with suspicion for percreta, accreta, or increta

34 0/7-35 6/7 weeks

History of classical cesarean

36 0/7-37 6/7 weeks

History of myomectomy

37 0/7-38 6/7 weeks

Abbreviations: ACOG, American College of Obstetricians and Gynecologists; di-di, dichorionic and diamnionic; mono-di, monochorionic and diamniotic. a The reader is referred to ACOG for a comprehensive list of indications for induction of labor in these gestational ages.7 Adapted from ACOG.7

hospitals with 1100 births or more per year, and it includes PC-01: Elective Delivery.38 The measure, endorsed by the National Quality Forum, requires hospitals to report on the number of elective births (both vaginal and cesarean) that occur after 37 weeks’ gestation but before 39 weeks’ gestation.39 Hospitals set their own target range for each of these measures based on national benchmarks and goals set by third-party payers. This reporting process encourages hospitals to take accountability in understanding their own level of performance and set goals to improve performance based on their organizational data and national data.38 Increasingly, hospital reimbursement has been tied to quality measures. Nationally, more and more insurers are adopting policies to decline reimbursement for early elective births.40 In 2011, South Carolina and Texas adopted such policies.40 Recently, the Indiana Health Coverage Programs issued a reimbursement policy of nonpayment for early elective births (⬍ 39 weeks’ gestation), effective July 1, 2014.37 Quality-improvement projects range from changing hospital IOL policies and requiring or recommending the use of scheduling forms and checklists to national campaigns targeted to help reduce early elective births, with the subsequent result of decreased iatrogenic prematurity. National campaigns such as the Healthy Babies are Worth the Wait41 program, the Prematurity Prevention Network,42 the Preterm Labor Assessment Toolkit,43 and the Less than 39 Weeks Toolkit44 from the March of Dimes are all aimed at community education and awareness, research, and collaboration between clinicians and key stakeholder organizations to use best practices to help encourage spontaneous labor and reduce early elective births and preterm birth rates.45 Oshiro et al implemented a quality improvement program aimed at decreasing early-term births, NICU admissions, and neonatal mortality rates through the Big 5 State Prematurity Initiative, a perinatal quality-improvement colJournal of Midwifery & Women’s Health r www.jmwh.org

laborative of advocates; academic health centers; public and private hospitals; and state health departments in California, Florida, Illinois, New York, and Texas.46 The authors implemented scheduling policies and procedures for elective births, used a scheduling form, and instituted a hard stop measure that required physician approval and provided patient and health care provider education through the Elimination of Non-medically Indicated (Elective) Deliveries Before 39 Weeks Toolkit. Elective cesarean births decreased by 84% (43.5% to 7.1%, P ⬍ .001) and elective labor inductions decreased by 72% (9.5% to 2.7%, P ⬍ .001).42 However, statistically significant reductions in the rate of NICU admissions or fetal mortality were not found in this study.46 In a recent study, one institution nearly eliminated elective IOL before 39 weeks’ gestation through implementation of an IOL scheduling and consent form.47 Their tool included the use of standardized medical indications, confirmation of gestational age, Bishop’s score, and a hard stop for IOL that did not meet criteria.47 Our own hospital, an urban academic health center in the Midwest, has been proactive in decreasing early elective births. Since 2011, our maternity center has implemented the requirement of a scheduling form for all scheduled births (labor inductions and cesareans), followed by a hard stop measure requiring review of all scheduled births by the nurse manager, clinical director, and physician leader. The process includes use of an informed consent from for the IOL, as well as maternity center based multidisciplinary task forces aimed at reducing early elective births and primary cesarean. The use of the aforementioned initiatives and interprofessional committees are examples of how to deal with the issue of disease creep. An example of our institution’s informed consent and scheduling form may be found in the online supporting information (Supporting Appendix S1 and Supporting Appendix S2). 609

Different strategies to reduce elective births described by Clark et al ranged from a strict, policy-enforced, hard stop of no elective births before 39 weeks’ gestation to education only.48 The hard stop strategy was found to reduce the rate of elective births from 9.6% to 4.3% and resulted in an estimated savings of one billion dollars. One driver of increased costs of elective birth was neonatal intensive care. The hard stop policy was estimated to save 500,000 days of newborn intensive care.48 Use of the aforementioned measures to reduce early elective births is recommended not only for patient safety and improved outcomes but also to reduce the astounding costs associated with IOL, as further discussed in the next section. Patient Education and Shared Decision Making

Education of women and the process of shared decision making when obtaining informed consent are key factors in reducing early elective births. Adding standardized education, comprised of elective IOL risks and benefits to hospital childbirth preparation classes, was effective in reducing rates of elective IOL by 20% (P = .01).49 A recent qualitative investigation surveyed a cohort of women (N = 29) to evaluate factors influencing their decisions about IOL.50 Major themes included safety of the newborn, a woman’s trust in her clinician, relief of discomfort or anxiety, diminished potential or actual risks, and lack of informed decision making.50 The authors found significant discordance between the information provided in providers’ offices and the information provided in hospitals. The information provided by the clinicians focused on rationale, safety of the newborn, and logistics related to the day and time of IOL, while the hospital information included types of medications and risks, process, steps, time frame of IOL, and restrictions (eg, food, mobility, no water birth).50 Findings from the Listening to Mothers III survey suggested that many women are misinformed by their care providers in ways that could influence their decisions about elective IOL.51 For example, only 21% of respondents correctly identified 39 weeks’ gestation as the earliest safe time in gestation for elective birth51 ; only 41% were correctly informed about risks associated with IOL; and more than onehalf erroneously identified concern for a large newborn as a legitimate medical indication for IOL.51 Fifteen percent felt pressured by their providers to have their labor induced.51 The most prevalent reason (44%) that mothers were told their labors were induced was that they were close to their due date.51 Only 20% understood their labor induction to be a matter of choice.51 The prevalence of misinformation, confusion about indications, and pressure from providers suggests that many women are not receiving adequate informed consent prior to IOL. COSTS AND IMPACT OF INDUCTION OF LABOR

In addition to concerns about individual patient outcomes, increasing rates of IOL—particularly elective IOL—raise concerns about the costs of care and the impact of IOL on the health care system. Childbirth is the leading reason for hospital admission,52 and pregnancy and childbirth account for 5% of all hospital costs.53 Medicaid finances 45% of all births in 610

the United States.54 Births resulting from IOL are 17.4% more expensive than those resulting from spontaneous labor.55 Cesarean rates rose from 21% in 1997 to 33% in 2008, with a $4.3 billion dollar cost to the US health care system.52 With the increases in IOL and cesareans, it is not surprising to learn that the rate of hospitalizations for normal pregnancy and birth declined by 58% from 2008 to 2011.56 Kozhimannil et al studied hospital payer trends and obstetric interventions including IOL, cesarean, and episiotomy, and found an increase in obstetric interventions over time regardless of payer.54 The rate of cesareans increased over this time period: the average rate was 30.9%, whereas the IOL rate increased from 16.4% to 19.1%.54 Interestingly, privately insured patients had higher rates of obstetric interventions compared to those covered by Medicaid.54 Self-pay and Medicaid births were less likely to have IOL or cesarean and more likely to have a vaginal birth after cesarean.54 The authors suggested that as more women who would have previously been insured through Medicaid are enrolled through the Affordable Care Act, both costs and interventions of childbirth may increase.54 One study of IOL found that IOL costs the US health care system billions of dollars annually.57 Increased costs are related to the labor and birth resources needed to provide care for labor inductions and the increased risk for cesareans and subsequent neonatal morbidity.57 The authors recommended a reduction in elective IOL and provided criteria to define the appropriateness of IOL, including consistency with the woman’s autonomy and desires, improvement of outcomes including psychological well-being, accordance with evidencebased practice, and cost-effectiveness.57

DISCUSSION

The increasing incidence of IOL may be attributed to multiple possible causes. Increasing trends of maternal morbidity, which as previously discussed may increase the number of medical indications for IOL, are one possible cause. However, the fact that higher remunerative payers are associated with higher rates of IOL suggests that nonclinical factors such as provider or patient preference may also play a role. The World Health Organization and the American College of Nurse-Midwives (ACNM) both advocate that IOL should only be performed when there is a clear medical indication supported in the literature and the benefits outweigh the potential harms.8,18 A 2009 ACOG Practice Bulletin lists common medical indications for IOL, as previously mentioned, but also notes that psychosocial or logistical reasons such as distance from the hospital or risk for precipitous birth are acceptable reasons for IOL.5 While the rates of IOL continue to rise, elective IOL should be considered as a matter of ethical concern.19 The cost versus convenience of elective IOL must be considered; in no other health care specialty would one risk the use of medication and the potential for harm when the issue (labor) may resolve spontaneously.58 In light of the high cost of IOL, elective allocation of scarce resources to medically unnecessary procedures seems in conflict with the ethical principal of wise stewardship. Volume 59, No. 6, November/December 2014

Table 3. Early Term and Late Preterm Births for Hypertensive Disordersa

Recommended Diagnostic Condition Chronic HTN

Diagnostic Criteria BP 140/90 prior to conception

ICD- Code

Timing for Birth

642.00

No medications: 38 0/7-39 6/7 weeks

or Diagnosed before 20 weeks’ gestation

On medications: 37 0/7-39 6/7 weeks

Well-documented history and on antihypertensive

Uncontrolled: 36 0/7-37 6/7 weeks

medications Gestational HTN

sBP ࣙ 140 or dBP ࣙ 90 or both on 2 occasions at least 4

642.30

37 0/7-38 6/7 weeks

642.40

At diagnosis; after 37 0/7 weeks

642.50

At diagnosis; after 34 0/7 weeks

hours apart after 20 weeks’ gestation Absence of proteinuria or other systemic findings Preeclampsia (without severe features)

BP: sBP ࣙ 140 or dBP ࣙ 90 or both on 2 occasions at least 4 hours apart after 20 weeks’ gestation If 160/110, can be diagnosed in shortened interval. and Proteinuria: 300 mg in 24-hour urine collection, or protein/creatinine level ࣙ 0.3. Urine dipstick ࣙ 1+ warrants further evaluation. or (in the absence of proteinuria) Thrombocytopenia (⬍ 100,000) LFTs elevated twice over normal levels New or worsening renal insufficiency Serum creatinine ⬎ 1.1 or doubled over previous level Pulmonary edema New onset headaches or visual disturbances

Severe preeclampsia

Any of the following findings: BP: sBP ࣙ 160 or dBP ࣙ 110 on 2 occasions 4 hours apart while on bed rest Thrombocytopenia (⬍ 100,000) LFTs elevated twice over normal levels Severe persistent RUQ or epigastric pain not responsive to pain medication, other diagnoses ruled out Renal insufficiency-advancing, serum creatinine doubling, or greater than 1.1 mg/dL Pulmonary edema Headaches or visual disturbances

Abbreviations: BP, blood pressure; dBP, diastolic blood pressure; HTN, hypertension; ICD, International Classification of Diseases; LFTs, liver function tests; RUQ, right upper quadrant; sBP, systolic blood pressure. a Hypertension is defined as systolic BP ࣙ 140 mm Hg, diastolic BP 90 mm Hg, or both. Mild to moderate hypertension is defined as systolic BP ࣙ 140-ࣘ 159 mm Hg or diastolic BP ࣙ 90-99 mm Hg. Severe hypertension is defined as systolic BP ࣙ 160 mm Hg or diastolic BP ࣙ 110 mm Hg. Adapted from American College of Obstetricians and Gynecologists.7,63

The use of scheduling forms and checklists based on research findings can guide the provider into evidence-based practice. An excellent example of this is the hard stop process that was developed to limit elective labor inductions prior to 39 completed weeks’ gestation to decrease the incidence of iatrogenic preterm birth.48 Reduced hospital costs and improved outcomes have been associated with implementation of such tools.48 Elective IOL has been described as the normalization of nonevidence-based care.58 There is an emerging body of scholarship concerned with overdiagnosis, overtreatment, Journal of Midwifery & Women’s Health r www.jmwh.org

and disease creep.59,60 According to this school of thought, broadening definitions of disease and looser interpretation of diagnostic criteria can expose healthy people to harmful side effects of treatment without conferring any health benefit. Recent findings questioning the benefit of antihypertensive medication for individuals with mild hypertension61 and the benefit of statins for primary prevention of coronary heart disease62 have highlighted these concerns, particularly the questionable value of treatment for mild, borderline, or at-risk conditions. In light of ACOG’s recently published guidelines for medically indicated births and their likely effect on IOL 611

Table 4. Guide for Shared Decision Making on Induction of Labor: Engage and Inform Women

Indication

Include diagnostic criteria for medical indication, dating criteria for gestational age, and time frame

Risks to woman

Risks associated with medical indication for not giving birth: Varies depending on medical indication Risks associated with IOL: Higher risk for cesarean in nulliparous women with an unfavorable cervix Possible need for increased interventions: fetal scalp electrode, intrauterine pressure catheter, artificial rupture of membranes Side effects of medications and unintended adverse reactions Longer labors Postpartum hemorrhage Infection Failed IOL

Risks to fetus

Fetal intolerance of labor Infection Respiratory distress syndrome

Medication options: risks and

Include medications commonly used for IOL, when used, and relative effectiveness of each

relative effectiveness Restrictions during IOL

Food/drink, monitoring per hospital policy, use of tub for hydrotherapy and water birth per hospital

Logistics

Date and time of IOL, location, parking, preparation before (eat breakfast, shower)

policy, visitor policy

Abbreviation: IOL, induction of labor. Source: Moore et al.50

rates, it is worthwhile to consider these potential pitfalls with regard to their impact on the incidence of IOL. For example, consider the ACOG/SMFM committee guideline regarding the timing of birth for women with mild preeclampsia: Based on expert opinion and the available research evidence, the committee concluded that after 37 weeks’ gestation the risks of continued pregnancy with mild preeclampsia outweigh the risks associated with IOL.7 It is important to remember, however, that published research is based on strictly defined inclusion criteria. Individuals with questionable or borderline cases—those who almost meet diagnostic criteria for preeclampsia—are excluded from analysis. Nevertheless, clinicians in practice may feel pressure to recommend IOL for women who have suspicious signs or borderline findings, thus exposing them to the potential risks of IOL without corresponding benefit.

RECOMMENDATIONS FOR PRACTICE

In light of the finding that implementation of elective birth checklists can decrease the number of elective births prior to 39 weeks’ gestation, similar checklists could be implemented for indicated births. Table 3 provides an example of a checklist for hypertensive disorders in pregnancy, including conditions, diagnostic criteria, coding, and recommended timing for birth. Clinicians who must complete a checklist documenting the presence of strict diagnostic criteria might be less likely to order IOL for borderline or almost indications. This, in turn, could help reduce the potential for overtreatment and subsequent exposure to risks of IOL in cases for which there is no evidence of benefit. 612

In addition to ensuring that diagnostic criteria for IOL indications are strictly met, clinicians may be able to reduce unnecessary IOL by increased attention to the accuracy of assessments that may create IOL indications. For example, ensuring accurate gestational dating early in pregnancy could reduce the misdiagnosis of postdates pregnancy or misinterpretation of fetal growth parameters later in pregnancy. Diligent adherence to research-based assessment procedures, such as those for estimating amniotic fluid volume or maternal blood pressure, could reduce misdiagnoses of oligohydramnios or gestational hypertension and thus eliminate spurious indications for IOL. Informed consent may play a role in reducing elective IOL, reducing cost, and improving the quality of care for mothers and newborns.47 Midwives are trained to discuss risks and concerns in plain, culturally appropriate language. ACNM’s 2010 position statement highlights the importance of informed consent with the woman, which includes a thorough discussion and education of the potential risks and benefits of IOL.18 Similarly, ACOG’s 2011 Patient Safety Checklist for scheduling IOL recommends patient counseling on the risks versus benefits, alternatives, and use of a consent form as indicated by institutional policies.5 Discussion with women about IOL, indication, and risks should be robust. A recommended guide for informing and engaging women in a shared decision-making process is illustrated in Table 4.

CONCLUSION

The authors of this article maintain that elective IOL should only be performed in rare or extraordinary circumstances, Volume 59, No. 6, November/December 2014

only when the mother has completed 39 weeks of pregnancy, and only when it would be beneficial to the mother and not cause harm to the newborn. IOL should not be performed for reasons of convenience for the provider. Following evidence-based medical indications and the diagnostic criteria for disease conditions are paramount to reducing the nation’s high IOL rate. Elective labor inductions should rarely be performed, and maternity care providers are encouraged to work with institutional quality teams to eliminate elective IOL prior to 39 weeks’ gestation. Hard stops for elective IOL through use of scheduling forms, checklists, and written informed consent are recommended evidence-based practices. We also recommend utilization and further development of indication tools for medically indicated IOL such as postdates, fetal growth restriction, and hypertensive disorders. Indication tools may help providers determine if diagnostic criteria have been met before engaging the woman on the path to labor induction and also may reduce overdiagnosis and overtreatment. Midwives and other maternity care providers can positively impact the rate of IOL by providing culturally sensitive and motivational counseling on health promotion and disease prevention. The need to promote health literacy and healthy lifestyles is a fundamental part of midwives’ professional mission. Furthermore, educating women about the lifetime positive effects of physiologic birth practices on the maternalinfant dyad can influence the woman’s desire toward patience and trust in her ability to give birth without unnecessary intervention. AUTHORS

Carrie F. Bonsack, CNM, MS, is Associate Manager of HealthNet Midwifery Services, a community health center affiliated with Indiana University Health, Indianapolis, IN. She is currently a doctoral student at Ball State University. Anthony Lathrop, CNM, PhD, RDMS, is in clinical practice with HealthNet, a community health center affiliated with Indiana University Health, Indianapolis, IN. He also serves as adjunct faculty at the University of Indianapolis. Mary H. Blackburn, CNM, MSN, is Manager of HealthNet Midwifery Services, a community health center affiliated with Indiana University Health, Indianapolis, IN. CONFLICT OF INTEREST

The authors of this article have no conflicts of interest to disclose. ACKNOWLEDGMENTS

The authors acknowledge the support given by HealthNet Community Health Centers located in Indianapolis, IN. SUPPORTING INFORMATION

Additional Supporting Information may be found in the online version of this article at the publisher’s Web site: Appendix S1. Induction of Labor Consent Form Appendix S2. Induction of Labor Scheduling Form Journal of Midwifery & Women’s Health r www.jmwh.org

REFERENCES 1.Sanchez-Ramos, L, Kaunitz A. Induction of labor. Glob Libr Women’s Med. (ISSN: 1756-2228) 2009; DOI 10.3843/GLOWM.10130 2.Glantz JC. Obstetric variation, intervention, and outcomes: Doing more but accomplishing less. Birth. 2012;39(4):286-290. 3.Martin JA, Hamilton BE, Osterman JK, Curtin SC, Mathews TJ. Births: Final data for 2012. National vital statistics reports; vol 62 no 9. Hyattsville, MD: National Center for Health Statistics. www.cdc.gov/ nchs/data/nvsr/nvsr62/nvsr62 09.pdf. Accessed October 2014. 4.Osterman, JK, Martin, JA. National Center for Health Statistics: Recent declines in induction of labor by gestational age. Centers for Disease Control and Prevention Web site. http://www. cdc.gov/nchs/data/databriefs/db155.pdf. Accessed June 30, 2014 . 5.American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No 107: Induction of labor. Obstet Gynecol. 2009;114(2):386397. doi: 10.1097/AOG.0b013e3181b48ef5. 6.World Health Organization. WHO Recommendations for Induction of Labour. Geneva, Switzerland: WHO Press; 2011. http://www. who.int/reproductivehealth/publications/maternal˙perinatal˙health/ 9789241501156/en/. Accessed July 2, 2014. 7.American College of Obstetricians and Gynecologists. ACOG committee opinion No. 560: Medically indicated late-preterm and earlyterm deliveries. Obstet Gynecol. 2013;121(4):908-910. 8.Wolfe KB, Rossi RA, Warshak CR. The effect of maternal obesity on the rate of failed induction of labor. Am J Obstet Gynecol. 2011;205(2):128.e1-e7. 9.Roberts CL, Ford JB, Algert CS, et al. Population-based trends in pregnancy hypertension and pre-eclampsia: An international comparative study. BMJ. 2011;1:e000101. doi:10.1136/bmjopen-2011-000101 10.Arrowsmith S, Wray S, Quenby S. Maternal obesity and labour complications following induction of labour in prolonged pregnancy. BJOG. 2011;118(5):578-588. 11.Caughey A, Sundaram V, Kaimal AJ, Gienger A, Cheng YW, McDonald, KM, et al. Systematic review: Elective induction of labor versus expectant management of pregnancy. Ann Intern Med. 2009;151(4): 252-263. 12.Getahun D, Dublin S, Fassett M. Recent trends in induction of labor. Clin Med Res. 2011;9(3-4):178. 13.Kozhimannil K, Macheras M, Lorch S. Trends in childbirth before 39 weeks’ gestation without medical indication. Medical Care. 2014;52(7):649-657. 14.Crane JM, Young DC, Butt KD, Bennett KA, Hutchens D. Excessive uterine activity accompanying induced labor. Obstet Gynecol. 2001;97(6):926-931. 15.Macones GA, Hankins GD, Spong CY, et al. The 2008 National Institute of Child Health and Human Development Research workshop report on electronic fetal heart rate monitoring. Obsetet Gynecol. 2008;112(3):661-666. 16.Greiss FC. Uterine and placental blood flow. Glob Libr Women’s Med Labor Deliv. (ISSN: 1756-2228) 2008; DOI 10.3843/GLOWM. 10197doi:10.3843/GLOWM.10197. http://www.glowm.com/section view/heading/Uterine%20and%20Placental%20Blood%20Flow/item/ 197. Accessed July 2, 2014. 17.Kunz MK, Loftus RJ, Nichols AA. Incidence of uterine tachysystole in women induced with oxytocin. J Obstet Gynecol Neonatal Nurs. 2012;42(1):12-18. 18.American College of Nurse Midwives. Position Statement: Induction of Labor. Silver Spring, MD: American College of Nurse Midwives; 2010. 19.Caughey AB, Sundaram V, Kaimal AJ, Cheng YW, Gienger A, Little SE, et al. Maternal and neonatal outcomes of elective induction of labor. In: Evidence Report/Technology Assessment No. 176. AHRQ Publication No. 09-E005. Rockville, MD: Agency for Healthcare Research and Quality; March 2009. 20.Ehrenthal DB, Jiang X, Strobino DM. Labor induction and the risk of a cesarean delivery among nulliparous women at term. Obstet Gynecol. 2010;116(1):35-42.

613

21.Darney BG, Snowden JM, Cheng YW, Jacob L, Nicholson JM, Kaimal A, et al. Elective induction of labor at term compared with expectant management: Maternal and neonatal outcomes. Obstet Gynecol. 2013;122(4):761-769. 22.Wood S, Cooper S, Ross S. Does induction of labour increase the risk of caesarean section? A systematic review and meta-analysis of trials in women with intact membranes. BJOG. 2013;121(6):674-685. 23.Wennerholm UB, Hagberg H, Brorsson B, Bergh C. Induction of labor versus expectant management for post-date pregnancy: is there sufficient evidence for a change in clinical practice? Acta Obstet Gynecol Scand. 2009;88(1):6-17. 24.Ennen CS, Bofill JA, Magann EF, Bass JD, Chauhan SP, Morrison JC. Risk factors for cesarean delivery in preterm, term and post-term patients undergoing induction of labor with an unfavorable cervix. Gynecol Obstet Invest. 2009;67(2):113-117. 25.Park KH, Hong JS, Shin DM, Kang WS. Prediction of failed labor induction in parous women at term: role of previous obstetric history, digital examination and sonographic measurement of cervical length. J Obstet Gynaecol Res. 2009;35(2):301-306. 26.Uyar Y, Erbay G, Demir BC, Baytur Y. Comparison of the Bishop score, body mass index and transvaginal cervical length in predicting the success of labor induction. Arch Gynecol Obstet. 2009;280(3):357362. 27.Clark SL, Miller DD, Belfort MA, Dildy GA, Frye DK, Meyers JA. Neonatal and maternal outcomes associated with elective term delivery. Am J Obstet Gynecol. 2009; 200:156e1-156e4. 28.Khireddine I, Ray CL, Dupont C, Deneux-Tharaux C. Induction of labor and risk of postpartum hemorrhage in low risk parturients. PLoS One. 2013;8(1):e54858. doi: 10.1371/journal.pone.0054858. 29.Malabarey O, Almog B, Brown R, Abenhaim H, Shirm A. Postpartum hemorrhage in low risk population. J Perinat Med. 2011;39(5):495498. 30.Donovan EF, Besl J, Paulson J, Rose B, Iams J, Ohio Perinatal Qualitive Collaborative. Infant death among Ohio resident infants born at 32 to 41 weeks of gestation. Am J Obstet Gynecol. 2010;203(1):58.e1-58.e5. doi: 10.1016/j.ajog.2010.01.071. 31.Hoffmire C, Chess P, Saad TB, Glantz JC. Elective delivery before 39 weeks: The risk of infant admission to the neonatal intensive care unit. MCHJ. 2012;16(5):1053-1062. 32.Hibbard JU, Wilkins I, Sun L, et al. The consortium on safe labor: Respiratory morbidity in late preterm births. JAMA. 2010;304(4):419-425. 33.Jensen JR, White WM, Coddington, CC. Maternal and neonatal complications of elective early-term deliveries. Mayo Clin Proc. 2013;88(11):1312-1317. 34.Gregory SG, Anthopolos R, Osgood CE, Grotegut CA, Miranda ML. Association of autism with induced or augmented childbirth in North Carolina birth record (1990-1998) and education research (1997-2007) databases. JAMA Pediatr. 2013;167(10):959-966. 35.American College of Obstetricians and Gynecologists. ACOG Committee Opinion No. 561: nonmedically indicated early term deliveries. Obstet Gynecol. 2013;121:911-915. 36.Spong C. Defining “term” pregnancy: Recommendations from the defining “term” pregnancy workgroup. JAMA. 2013;309(23):24452446. 37.IHCP implements early elective delivery policy. Indiana Health Coverage Programs Web site. http://provider.indianamedicaid.com/ ihcp/Bulletins/BT201421.pdf Updated on May 5, 2014. Accessed on June 19, 2014. 38.Specifications manual for joint commission national quality core measure V2014A1. The Joint Commission Web site. https://manual. jointcommission.org/releases/TJC2014A1/rsrc/Manual/TableOfContentsTJC/PC˙2014A1.pdf/ Updated on January 30, 2014. Accessed on June 19, 2014. 39.National Quality Forum. Endorsement Summary: Perinatal and reproductive health measures. National Quality Forum Web site. http://www.qualityforum.org/News˙And˙Resources/Endorsement˙ Summaries/Endorsement˙Summaries.aspx. Last updated October 29, 2013. Accessed on June 20, 2014.

614

40.States, insurers penalize hospitals for early elective deliveries: Some payers offer rewards to facilities with few early deliveries. The Advisory Board Company Web site: http://www.advisory.com/DailyBriefing/2013/01/24/States-insurers-penalize-hospitals-for-earlyelective-deliveries Updated on January 24, 2013. Accessed on June 19, 2014. R 41.March of Dimes. Healthy Babies are Worth the Wait . March of Dimes web site. http://www.marchofdimes.com/professionals/ healthy-babies-are-worth-the-wait.aspx. Accessed July 2, 2014. 42.March of Dimes. Prematurity Prevention Network. March of Dimes web site. https://www.prematurityprevention.org/portal/server.pt. Accessed July 2, 2014. 43.March of Dimes. Preterm Labor Assessment Toolkit. March of Dimes web site. http://www.marchofdimes.com/professionals/pretermlabor-assessment-toolkit.aspx. Accessed July 2, 2014. 44.March of Dimes. Less than 39 Weeks Toolkit. March of Dimes web site. http://www.marchofdimes.com/professionals/less-than-39weeks-toolkit.aspx. Accessed July 2, 2014. 45.March of Dimes. Prematurity campaign 2013 progress report. March of Dimes web site. http://www.marchofdimes.com/ materials/prematurity-campaign-progress-report-2013.pdf Updated on March 2013. Accessed on June 19, 2014. 46.Oshiro B, Kowalewski L, Sappenfield W, et al. A multistate quality improvement program to decrease elective deliveries before 39 weeks of gestation. Obstet Gynecol. 2013;121(5):1025-1031. 47.Doyle JL, Kenny TH, von Gruenigen VE, Butz AM, Burkett AM. Implementing an induction scheduling procedure and consent form to improve quality of care. J Obstet Gynecol Neonatal Nurs. 2012;41(4):462-473. 48.Clark S, Frye D, Meyers JA, et al. Reduction in elective delivery at ⬍39 weeks of gestation: Comparative effectiveness of 3 approaches to change and the impact on neonatal intensive care admission and stillbirth. Am J Obstet Gynecol. 2010;203(5):449e1-449e6. 49.Rice Simpson K, Newman G, Chirino, OR. Patients’ perspectives on the role of prepared childbirth education in decision making regarding elective induction on labor. J Perinat Educ. 2010;19(3): 21-32. 50.Moore JE, Kane Low L, Titler MG, Dalton VK, Sampselle CM. Moving toward patient-centered care: Women’s decisions, perceptions, and experiences of the induction of labor process. Birth. 2014;41(2):138-146. 51.Declercq ER, Sakala C, Corry MP, et al. Listening to Mothers III: Pregnancy and Birth. New York, NY: Childbirth Connection, 2013. 52.Podulka J, Stranges MS, Steiner C. Healthcare cost and utilization project: Statistical brief # 110 hospitalizations related to childbirth. AHRQ Web site. http://www.hcup-us.ahrq.gov/reports/ statbriefs/sb146.pdf. Updated January 2013. Accessed on March 20, 2014. 53.Pfuntner A, Wier LM, Steiner C. Healthcare cost and utilization project:Statistical brief # 146 costs for hospital stays in the United States, 2010. AHRQ Web site. http://www.hcup-us.ahrq.gov/reports/ statbriefs/sb110.pdf. Updated April, 2011. Accessed on March 20, 2014 54.Kozhimannil KB, Shippee TP, Adegoke O, Vemig BA. Trends in hospital-based childbirth care: the role of health insurance. Am J Manag Care. 2013;19(4):e125-e132. 55.Seyb ST, Berka RJ, Socol ML, Dooley SL. Risk of cesarean delivery with elective induction of labor at term in nulliparous women. Obstet Gynecol. 1999;94,600-607. 56.Pfuntner A, Wier LM, Stocks C. Healthcare cost and utilization project: Statistical brief # 162 most frequent conditions in U.S. hospitals, 2011. AHRQ Web site. http://www.hcupus.ahrq.gov/reports/statbriefs/sb162.pdf. Updated September 2013. Accessed on March 20, 2014. 57.Chauhan SP, Ananth CV. Induction of labor in the United States: A critical appraisal of appropriateness and reducibility. Semin Perinatol. 2012;36(5):336-343. 58.Simpson KR. Reconsideration of the costs of convenience. J Perinat Neonatal Nurs. 2010;24(1):43-52.

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59.Lenzer J. Disease creep: How we’re fooled into using more medicine than we need. New Americal Foundation Web site. http://health. newamerica.net/blogposts/2011/disease creep how were fooled into using more medicine than we need-61818. Updated 2011. Accessed on February 15, 2014. 60.Moynihan R, Doust J, Henry D. Preventing overdiagnosis: How to stop harming the healthy. BMJ. 2012;e3502. doi: 10.1136/bmj. e3502. 61.Diao D, Wright JM, Dundiff DK, Gueffier F. Pharmacotherapy for mild hypertension. Cochrane Database Syst Rev 2012;8:CD006742. DOI:10.1002/14651858.CD006742.pub2. 62.Therapeutics Initiative Evidence Based Drug Therapy. Do statins have a role in primary prevention? An update. Therapeutics Initiative

Journal of Midwifery & Women’s Health r www.jmwh.org

Web site. http://www.ti.ubc.ca/sites/ti.ubc.ca/files/77.pdf. Updated on March 2010. Accessed on July 8, 2014. 63.American College of Obstetricians and Gynecologists. Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists’ Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013;122(5):1122-1131.

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