The Journal of Maternal-Fetal & Neonatal Medicine
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The outcome of midwife-led labor in low-risk women within an obstetric referral unit Enrico Ferrazzi, Elena Visconti, Andrea M. Paganelli, Carmen M. Campi, Cristina Lazzeri, Federico Cirillo, Stefania Livio & Cinzia Piola To cite this article: Enrico Ferrazzi, Elena Visconti, Andrea M. Paganelli, Carmen M. Campi, Cristina Lazzeri, Federico Cirillo, Stefania Livio & Cinzia Piola (2015) The outcome of midwifeled labor in low-risk women within an obstetric referral unit, The Journal of Maternal-Fetal & Neonatal Medicine, 28:13, 1530-1536, DOI: 10.3109/14767058.2014.958995 To link to this article: http://dx.doi.org/10.3109/14767058.2014.958995
Accepted author version posted online: 05 Sep 2014. Published online: 19 Sep 2014. Submit your article to this journal
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Date: 13 November 2015, At: 09:04
http://informahealthcare.com/jmf ISSN: 1476-7058 (print), 1476-4954 (electronic) J Matern Fetal Neonatal Med, 2015; 28(13): 1530–1536 ! 2014 Informa UK Ltd. DOI: 10.3109/14767058.2014.958995
ORIGINAL ARTICLE
The outcome of midwife-led labor in low-risk women within an obstetric referral unit
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Enrico Ferrazzi, Elena Visconti, Andrea M. Paganelli, Carmen M. Campi, Cristina Lazzeri, Federico Cirillo, Stefania Livio, and Cinzia Piola Department of the Women, Mother and Neonate, Buzzi Mother and Child Hospital, Medical School of Biomedical and Clinical Sciences, University of Milan, Milan, Italy Abstract
Keywords
Objective: To analyze maternal and neonatal outcomes of midwife-led labor in low-risk women at term. Methods: Prospective observational cohort of 1788 singleton low-risk pregnancies in spontaneous term labor, managed according to a specific midwife-led labor protocol. Primary outcomes were mode of delivery, episiotomy, 3rd–4th degree lacerations, post-partum hemorrhage (PPH), need for blood transfusions, pH and Apgar score and NICU admissions. Results: A total 1754 low-risk women (50.3% of all deliveries) were included in the analysis. Epidural analgesia was performed in 29.8% of cases. The rate of cesarean section was 3.7%. Episiotomy was performed in 17.6% of women. PPH41000 ml occurred in 1.7% of cases. 3.2% and 0.3% of the cases had an Apgar score 57 and pH57.10, respectively, while 0.3% of the newborns were admitted to NICU. Consultant-led labor was required for emerging risk factors during 1st and 2nd stage of labor in 16.1 and 8.6% of cases, respectively. Although maternal outcome were worse in women with emerging risk factors in labor, while neonatal outcomes were not affected by the presence these complications. Conclusions: In hospital settings, midwife-led labor in low-risk women might unfold its major advantages without additional risks of medicalization for the mother and the neonate.
Apgar score, cesarean section, labor and delivery, midwifery, women’s health issues
Introduction There is an on-going argument on the ‘‘best’’ approach to manage labor and delivery. Some authors claim that medicalization can improve maternal and neonatal outcome[1–3], while others favor care by midwifes only in low-risk women, and medical intervention only when indicated [4,5]. In radical parlance Hospital Obstetric Units are the place for ‘‘medicalization’’, while Midwifes Units, either stand-alone or alongside, or home settings are the places for ‘‘normal birth’’. Integrated options of professional collaboration in which women are attended from initial booking to the post-natal period by the midwife are represented by caseload midwifery care with planned birth in Obstetric Units [6,7] or team midwife-led continuity models [4]. In these integrated teamwork, obstetricians are requested, not to overview physiology, but to counsel or attend high-risk pregnancies or women with emerging risks in labor. However, among those that support the idea to empower physiology, the best setting for labor and delivery (planned home delivery, standAddress for correspondence: Enrico Ferrazzi, Chair Dept Woman Mother and Neonate, Buzzi Mother and Child Hospital. Biomedical and Clinical Sciences School of Medicine, University of Milan, Milan, Italy. E-mail: [email protected]
History Received 18 May 2014 Revised 9 August 2014 Accepted 25 August 2014 Published online 19 September 2014
alone midwifery units, case-load midwifery in Obstetrics Units) is still a matter of scientific debate [8–10] and ethical research [11]. In many areas, the steamroller effect of the idea of ‘‘safe labor’’ mixed with poor scientific evidence brought pregnancy and labor as a whole under the constitution of medical doctors. In some areas of the world not even the ‘‘perineum at crowning and the very delivery of the newborn’’ is attended by certified midwifes, in others, low-risk pregnancies are attended certified obstetricians or by general practitioners, hollowing out the professional contents of midwifery. As a result, in these areas, obstetrics became probably the only medical discipline in which certified specialist are ‘‘actively attending’’ physiological processes. This was probably an unplanned effect of the process of the safe labor in hospitals that underwent a dramatic acceleration since the second post-war years. This welcomed attitude was met by poor scientific evidence and led to a progressive increase in iatrogenic interventions. The weak evidence of a progressive regular centimetric dilatation in active labor, based on few inhomogeneous laboring women [12], eventually proved wrong in recent years [2,13,14]. However, in the meantime, it was the ‘‘scientific’’ base for millions of diagnosis of ‘‘cervical dystocia’’, and subsequent labor
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DOI: 10.3109/14767058.2014.958995
Midwife-led labor in low-risk women within an obstetric unit
augmentation or cesarean sections. Similarly, the active management of labor morphed from a prevention of prolonged labor: ‘‘When progressive dilatation of the cervix is not occurring early transfer to hospital is advisable’’ [15], into a generalized use of amniorexis and/or oxytocin augmentation [2]. In 2009, Clark, Simpson, Knox and Garite analyzed universal oxytocin augmentation and concluded: ‘‘We know of no other area of medicine in which a potentially dangerous drug is administered to hasten the completion of a physiologic process that would, if left to its own devices, usually complete itself without incurring the risk of drug administration’’ [16]. We hypothesized that, within a hospital setting, team midwife-led labor in low-risk women at admission in Obstetric Units might represent a feasible and pragmatic way toward safe de-medicalization [17] of labor and delivery in many countries, where the hospital setting is by far the preferred place of birth, especially when the health care system is not able to efficiently support emergency transfer of women in labor throughout busy traffic in metropolitan areas and last but not least, case-load midwife care is not even considered by health care workers contracts provided by public or private healthcare systems. The objective of this study was to analyze the outcome of midwife-led labor in low-risk women within a tertiary Obstetric referral Unit.
Materials and methods This was a prospective observational cohort study based on a clinical protocol for low-risk women at admission for labor at term. This protocol was applied within the same ward (outpatients latent phase of labor observation area and six labor and delivery rooms), whereas high-risk patients were delivered at our University Tertiary Referral Maternity Hospital of a large metropolitan area of Milan, Italy, between September 2010 and August 2011. The protocol was notified to and approved by our Ethical Local Committee, provided a strict adherence to the privacy regulations. Low-risk criteria Patients admitted in labor at term were triaged by midwives and a final diagnosis of low or high risk was made at admission by the consultant on duty according to the criteria shown in Table 1. Gestational age was assessed by last menstrual period, or first trimester ultrasound measurements when conflicting of more than seven days. Each woman in labor was assigned to one midwife without medical supervision. A ‘‘one to one care’’ during 12 h shifts was the objective of this organization. If any risk factors in stage 1 or in stage 2 occurred (Table 1), midwives ‘‘transferred’’ their patient to the consultant on duty just by signing it on the clinical record and at the opening of the door of the labor and delivery room. Management of labor After the 40-minute CTG admission test, fetal wellbeing was monitored by CTG recordings for 10 min with every 30 min interval. Cervical dilatation was assessed every two hours, and active maternal postures were favored. Fetal trunk posterior
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Table 1. Low-risk criteria at admission and emerging risks in labor and delivery. Low-risk criteria at admission Normal medical and obstetrical history, including threatened preterm labor 532 weeks of gestation. Gestational age between 37 + 0 to 41 + 2 weeks. Singleton fetus in cephalic presentation. Normally inserted placenta. Normal fetal growth. Absence of known congenital anomalies or mother-to-child transmitted infectious diseases. Spontaneous labor. Intact membranes or ruptured membranes 512 h with WBC count 514 000, no leucocytosis, normal PCR. CTG Category 1 (*). Emerging risks in labor and delivery Stained amniotic fluid 42. Abnormal evolution stage 1: contractions 53 in 10 min or poor strength at palpation, delayed dilatation progression 43 h. Prolonged passive phase of second stage 41 h. CTG category 2 or 3. (*) Obstructed or prolonged active phase of 2nd stage. CTG Piquard category 41 in active phase of second stage. Any condition which, according to the midwife, requires a re-assessment by the specialist on duty. (*) ACOG Practice Bulletin 106, 2009 [19]. Non-recurrent variable decelerations with compensatory acceleration and restitution to normal baseline and normal variability in between contraction had been classified as Category I. Except for bradycardia, Category II heart rate pattern should be consistently last for at least 30 min. In our standard of practice, fetal stimulation is not adopted.
positions in labor were treated by active maternal positions, amniotomy was considered in case of a cervical dilatation 46 cm; active second stage was managed by preferred maternal postures. Treatment of pain in labor Epidural in labor was performed on demand. Pain in women without epidural was treated by care, respiratory autogenic training, active walking, massage, warm showers, labor and delivery bathtub (in one room), and petidine. Passive second stage of labor At full dilatation, engagement was favored by active maternal postures. The passive phase was allowed to last up to two hours in the presence of a normal CTG (category 1), assumed that feto-pelvic disproportion was ruled out. Active second stage of labor Maternal active pushing was encouraged at engagement of the flexed head in the upper part of the pelvic canal. Active postures and modes of pushing were chosen by the midwife with the laboring woman. Fetal well-being was assessed by CTG recordings every five minutes. Perineum treatment Episiotomy was performed only on indication; when needed, a medio-lateral episiotomy was preferred. Third stage Third stage was managed using 10 units of oxytocin i.m. until delivery; late cord clamping (cord clamping at cessation of
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pulsation or within two minutes) and delicate active placental extraction at first signs of detachment were performed. Graduated plastic wraps were used to measure the amount of blood loss. Cord blood arterial pH was routinely performed in all cases. The newborn was placed skin to skin on the mother belly.
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Outcome measurement The primary outcomes considered for this analysis were chosen for their prevalence and the size of the cohort: mode of delivery, medio-lateral episiotomy, pH and Apgar score at 5 min, post-partum hemorrhage, need for blood transfusions and admission to NICU. Third and fourth degree lacerations, hysterectomy, intra-partum and neonatal mortality were recorded and analyzed even if their prevalence might not reach an adequate statistical power. Weight and sex of the neonate were recorded to calculate the prevalence of small for gestational age (SGA) and large for gestational age (LGA) newborns according to local standards. Maternal age, weight, parity and ethnicity were recorded. When at least one of these complications occurred during labor and delivery, the patient was transferred under the care of the medical staff. Understaffed midwife shifts, with necessary supportive interventions by medical members, and interference of the attending private specialist with midwife management were recorded as violations of protocol. The study was conducted according to the standard of GMP and the declaration of Helsinki. Statistical analysis Descriptive statistics and parametric and non-parametric analysis were adopted when adequate for demographic, outcome and comparisons between subgroups of patients and women were analyzed accordingly. Relative risks of adverse maternal and neonatal outcome were calculated for women with emerging risk factors in labor. Composite maternal and neonatal adverse outcomes were obtained by the sum of operative deliveries, episiotomies, blood loss, and low pH, low Apgar score at 5 min and admission to NICU, respectively. Multivariate analysis was performed to assess independent significant correlations between any emerging risk factor in labor and composite adverse outcome. Missing data were checked on the original clinical records. A p value less than 0.05 was considered significant, p values between 0.05 and 0.09 were reported and commented. All data were analyzed using ‘‘StataÕ’’ 2011 edition (StataCorp, College Station, TX).
Results During the 12 months period considered in this study, 3487 consecutive patients at low and high risk were delivered at our referral Maternity Hospital. Median maternal age was 34 years (IQR 31-37), while median maternal weight was 70 kg (IQR 63-77 kg); both maternal age and weight were not significantly different between Caucasian (78.7%) and non-Caucasian women (21.3%).
J Matern Fetal Neonatal Med, 2015; 28(13): 1530–1536
Table 2. Low-risk women at admission in labor: primary outcome per protocol for the whole cohort of nulliparous and multiparous. Low-risk women in labor Number of patients (*) Vaginal delivery Vaginal operative delivery Cesarean section (**) Mediolateral episiotomy PPH (***) PPH41000 ml Transfusions pH57.10 Apgar score 57 at 50 Admission to NICU
1754 87.5 8.8 3.7 17.6 11.3 1.7 0.2 3.2 0.3 0.6
PPH: post-partum hemorrhage; NICU: neonatal intensive care unit. (*) 34 violations of protocol are excluded. (**) CS rate was 5.7% in nulliparous and 1.2% in pluriparous women. (***) PPH4500 ml was computed for vaginal deliveries, and PPH4700ml for cesarean deliveries. Values reported as percentages.
A total of 1699 patients (48.7%) were proved to be at risk at admission. Main causes of risk in labor were term or postterm inductions (798 cases, 22.3%), medical and/or obstetrical indications and premature deliveries (494 patients, 13.5%). Cesarean section was scheduled in 407 patients (11.8%); among these, only 37 women had a cesarean section on request without any medical reason, based on woman’s preference only, as allowed by Italian law. During this study period, the overall rate of cesarean sections and vaginal operative deliveries was 21.6 and 8.3%, respectively. No intra-partum or neonatal death occurred in fetuses delivered at term without somatic or cardiovascular malformations. Women considered to be at low risk at admission, according to the criteria shown in Table 1, were 1788. Violation of protocol occurred in 34 cases understaffed shifts, or women followed by private gynecologists); these cases were not included in the current analysis. According to our protocol, midwives managed 1754 women (50.3%) during labor and delivery. Large for gestational age newborns were not diagnosed in labor in 3.6 and 6.6% of nulliparous and multiparous women, respectively; similarly, 1.1 and 0.8% of small for gestational age newborns were not diagnosed in labor. These cases were included in the analysis. Table 2 describes the primary outcomes of the whole cohort of nulliparous and multiparous women. Figure 1 shows the population study flowchart of low-risk women at admission according to emerging risk factors during the first and second stage of labor. Epidural analgesia on demand during the first stage was performed in 29.8% of cases (523 women). For local medicolegal reasons, this group was classified as high risk and required consultant supervision. Table 3 compares the main outcomes in women who had versus those who did not have epidural anesthesia during labor. The occurrence of operative delivery, either vaginal or cesarean section, was twice significantly higher in the epidural than in the non-epidural group.
Midwife-led labor in low-risk women within an obstetric unit
DOI: 10.3109/14767058.2014.958995
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Post-partum hemorrhage was more common in women who had epidural, although it did not reach statistical significance. Finally, adverse neonatal outcome was not significantly different between the two groups. Tables 4 and 5 compare the primary outcomes in low-risk nulliparous and multiparous women managed only by midwives with those with emerging risk factor during stage 1 and 2 requiring consultant-led management. Significant or borderline correlations were observed in multiparous women between oxytocin augmentation and adverse maternal (p50.01) and fetal (p50.08) outcomes. Complications associated with major hemorrhage and transfusions did not result in hysterectomy in any of the cases included in the study.
1788 LOW RISK WOMEN AT ADMISSION IN LABOR Protocol violaon # 34 (1.9%) 1st STAGE: 1754 WOMEN EPIDURAL
1st STAGE: 1231 WOMEN EMERGING RISKS
2nd STAGE: 949 WOMEN EMERGING RISKS
Discussion Main findings The findings from this study showed that midwife-led labor in low-risk pregnancies is safe and feasible and it is not associated with an increased risk of medicalization, thus representing a valid option in large busy obstetric units. Low risk, high risk case mix in our Obstetric Centre During the study period, low-risk pregnant women in spontaneous labor at term attended by midwife-led care represented 50.3% of all deliveries (1754/3487). This percentage of lowrisk laboring women is similar to that reported by the Dutch low and high risk prospective survey [8], by the UK collaborative group [10] and by the New Zealand Midwifery Maternity Provider Organization (MMPO) database [18]. This similar prevalence might support the validity of our selection criteria and allow for possible comparisons between other reported cohorts. Transfers from midwife-led care to consultant-led care
# 523 (29.8%) # 282 (16.1%)
STAINED A.F. 48.9 % CTG CATEGORY 2-3 31.2 % OX PERFUSION 19.9 %
# 151 (8.6%)
STAINED A.F. 37.7 % CTG PIQUARD>1 35.1 % OX PERFUSION 27.2 %
798 LABOR AND DELIVERY ATTENDED ONLY BY MIDWIFES Figure 1. Midwife-led labor and delivery in an Obstetric referral Unit. Flow chart of low-risk women at admission in labor with emerging risks during first and second stage according to our protocol.
During 1st and 2nd stage of labor, midwives identified emerging risk factors in 282 (16.1%) and in 151 (8.6%) women, respectively, including stained amniotic fluid, grade 3 or thick meconium, CTG class 2 or 3 according to ACOG intra-partum fetal heart rate monitoring criteria [19], and oxytocin perfusion for labor augmentation. Altogether this represents 24.7% of referrals to gynecologists of low-risk women attended by midwives from admission in labor in our Obstetric referral Unit. This figure is similar to that reported in a recent Dutch survey (29.4%) [8]. Furthermore, our result is also is similar to that of a previous Dutch study on a large cohort of 280 097 women derived from the Dutch midwifery database that reported 31.9% of transfer in labor [20]. Both figures are lower than those reported by the Birthplace England Collaborative Group [10] for home deliveries, freestanding midwifery units, or alongside midwifery units to secondary care obstetrics unit (36 to 45% in nulliparous women, 9 to 13% in multiparous women).
Table 3. Low-risk women at admission in labor: primary outcome per protocol for women without epidural analgesia throughout labor and delivery versus women who chose epidural analgesia at any time during 1st stage.
Number of patients Vaginal delivery Vaginal operative delivery Cesarean section Medio-lateral episiotomy PPH (*) PPH41000 ml Transfusions pH57.10 Apgar score 57 at 50 Admitted to NICU
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Low-risk women without epidural analgesia
Low-risk women with epidural analgesia
p5
1231 91.4 5.9 2.7 12.5 7.7 1.5 0.2 2.8 0.3 0.7
523 80.7 13.4 5.9 26.8 15.1 2.5 0.2 3.3 0.6 0.8
50.0001 50.0001 50.002 50.0001 50.0001 50.2 50.8 50.7 50.3 50.9
RR (C.I. 95%) 0.45 1.09 1.03 1.20 1.09
(0.35–0.58) (1.05–1.13) (1.01–1.06) (1.13–1.26) (1.05–1.13) n.s. n.s. n.s. n.s. n.s.
Violations of protocol are excluded from analysis of outcome. Values are reported as percentages. Relative risks (RR) are reported when significant. PPH: post-partum hemorrhage; NICU: neonatal intensive care unit. (*) PPH4500 ml was computed for vaginal deliveries, and PPH4700 ml for cesarean deliveries.
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J Matern Fetal Neonatal Med, 2015; 28(13): 1530–1536
Table 4. Low-risk nulliparous at admission in labor: primary outcome per protocol for nulliparous according to emerging risk factors diagnosed by midwives during 1st and 2nd stage.
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Number of patients Vaginal delivery Vaginal operative delivery Cesarean section Medio-lateral episiotomy PPH (*) PPH41000 ml Transfusions pH57.10 Apgar score 57 at 50 Admitted to NICU
Nulliparous without emerging risks in labor
Nulliparous with emerging risks in labor
p5
311 100 0 0 9.3 6.1 0.6 0.3 1.6 0.3 0.3
260 67.4 22.9 9.7 33.3 15.1 3.1 0.0 6.6 0.8 1.5
n.d. 0.0001 0.0002 0.0001 0.0007 0.05 n.s. 0.004 n.s. n.s.
RR (C.I. 95%) n.d. (1.21-1.39) (1.06-1.15) (1.24-1.49) (1.04-1.17) (1.00-1.04) n.s. 1.05 (1.01-1.09) n.s. n.s. 1.30 1.11 1.36 1.11 1.02
Violations of protocol are excluded from analysis of outcome. Values are reported as percentages. Relative risks are reported when significant. n.d. ¼ not determined because vaginal delivery was an entry criteria in column 1; n.s. ¼ not significant; PPH ¼ post-partum hemorrhage; NICU ¼ neonatal intensive care unit. (*) PPH4500 ml was computed for vaginal deliveries, and PPH4700 ml for cesarean deliveries.
Table 5. Low-risk multiparous at admission in labor: primary outcome per protocol for multiparous according to emerging risk factors diagnosed by midwives during 1st and 2nd stage.
Number of patients Vaginal delivery Vaginal operative delivery Cesarean section Mediolateral episiotomy PPH (*) PPH41000 ml Transfusions pH57.10 Apgar score 57 at 50 Admitted to NICU
Multiparous without emerging risks in labor
Multiparous with emerging risk in labor
p5
487 100 0 0 3.6 4 1.1 0 1.5 0 0
173 87.1 8.2 4.7 12.3 10.5 1.8 1.2 2.9 0.6 2.3
n.d. 0.00001 0.00001 0.001 0.002 n.s. n.s. n.s. n.s. 0.004
RR (C.I. 95%) n.d. (1.04–1.14) (1.02–1.08) (1.04–1.16) (1.02–1.13) n.s. n.s. n.s. n.s. 1.04 (1.00-1.05)
1.09 1.05 1.09 1.07
Values are reported as percentages. Relative risks are reported when significant. n.d. ¼ not determined because vaginal delivery was an entry criteria in column 1; n.s. ¼ not significant; PPH ¼ post-partum hemorrhage; NICU ¼ neonatal intensive care unit. (*) PPH4500 ml was computed for vaginal deliveries, and PPH4700 ml for cesarean deliveries.
Transfers occurring in planned deliveries outside Obstetric Units are not adverse events per se´ and they are usually performed in safe conditions, with no harm for both the mother and the fetus. This encourages teamwork and allows early diagnosis and intervention. Cesarean section rate Cesarean section rate might be singled out from other primary outcomes. In fact, this figure somewhat summarizes the quality of care in low-risk women in spontaneous labor. In our cohort, the cesarean section rate in midwife-led labor and delivery was 3.7% (5.7% of nulliparous women and 1.2% in multiparous women, respectively). These findings are similar to those reported by a large prospective multi-institutional survey on prevalence of cesarean sections in tertiary referral centers in Robson classes 1 and 3 (13.1 and 2.7%, respectively) [21], by a Dutch prospective survey on low-risk laboring women (5.7%) [8], and by the Birthplace England Collaborative Group [10]. Unfortunately, the MMPO database
does not report the cesarean section rate according to parity. In this study, emergency cesarean sections rate occurred in 2.6% of 1826 planned home deliveries, in spite of the fact that multiparity accounted for 73% of attended deliveries. As regards to this robust index of care in low-risk women in labor, it appears that midwife-led labor in a hospital setting does compare well with different settings. Primary outcomes In the current study, the primary maternal outcomes observed in cases requiring medical supervision compare well with the traditional model of hospital setting and medical supervised labor and delivery. Post-partum hemorrhage 41000 ml occurred in 1.7% of women (1.4 and 0.8% of deliveries in nulliparous women and multiparous women) and never resulted in hysterectomy. Two cases of 3rd or 4th degree laceration were observed. The anatomic landmark of lacerations is well defined, yet underreporting might happen despite daily morning debriefing in labor and delivery unit.
DOI: 10.3109/14767058.2014.958995
Midwife-led labor in low-risk women within an obstetric unit
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Similarly, transfusions occurred at a very low rate from 1 in thousands in nulliparous women with emerging risks in labor to one in 250 in multiparous women. pH57.10 and Apgar score57 at 5 min occurred in 3.2 and 0.3% of cases, respectively. 0.6% of the newborns (0.9 and 0.3% in nulliparous and multiparous women, respectively) were admitted to NICU. Despite the relative small size of this cohort, the prevalence of Apgar score 57 was lower although not significantly different from the prevalence observed in the Dutch midwifery database (0.7%; p50.06) [20]. The incidence of several adverse neonatal outcomes was similar to that reported in studies where midwife-led delivery takes place outside an Obstetric Unit. Oxytocin perfusion was adopted in 7.7% of cases, vaginal operative deliveries occurred in 8.8%, episiotomy was performed in 17.6% of cases and cesarean section was performed in 3.7% of women. Primary maternal and fetal outcome in low-risk women referred to consultant-led care As expected, maternal outcomes, such as mode of delivery, episiotomy and PPH, were significantly higher in women with compared to those without emerging risks identified by midwives. On the other hand, fetal outcomes were not significantly different between the two groups. This might be interpreted as a consequence of the quality of midwives assessment of risk during labor, which allowed for early diagnosis and prompt treatment of incoming complications. Although the transfer of care from midwives to consultants is not an adverse outcome per se, women transferred to higher level of care experienced a significant increase in the occurrence of maternal complications when compared to low-risk mothers. This figure was similar to that observed in the Dutch prospective cohort; in this survey the admissions to NICU in women referred to consultant care were 13.7%, while the corresponding figure in the newborns delivered in primary care was 2.3%. Furthermore, an Apgar score57 was observed in 5.3% of urgent referrals in the Dutch midwifery registry and the prevalence of perinatal deaths was one in every 100 deliveries. The authors of this survey concluded ‘‘the neonatal outcome is good, even in the group of women referred during labor’’. This is obviously a statement that must be put in relation to the local cultural and social background. The size of our cohort does not allow to estimate the prevalence of fetal and neonatal death; however, the estimated risk of death in the first day of life (either intra- or post-, excluding premature deliveries and malformed fetuses) has been reported to be around 0.30 per thousand in UK and 0.26 per thousand in the USA, thus making an estimation of the occurrence of this outcome extremely difficult, in view of the fact that a very large sample size should be required in order to estimate this effect [22]. Epidural analgesia A total of 523 women who requested epidural pain treatment were classified to be at high risk and supervised by obstetricians because of local medico-legal issues. In our protocol, epidural dosage does not prevent women to actively move during first stage in order to reduce posterior trunk and occiput position at second stage [23]. Despite this,
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epidural was associated with higher rates of operative deliveries, in absence of a significantly increased in any of the adverse perinatal outcomes. According to larger reported reviews [24], epidural does not increase the rate of cesarean section, but it is likely to raise the rate of operative vaginal deliveries [25]. Limitations This study has several limitations: the relatively small sample size, and the single center of recruitment, a large tertiary referral center. However, the proportion of low risk-high risk patients admitted during the study period, the prevalence of referrals to consultant-led management for emerging risks, and the proportion of women that asked for epidural analgesia, allowed us to compare our primary outcome with those obtained in different settings, and larger multicenter cohorts. With these limitations, we believe that our findings, well in agreement with other similar models of care [4,6,26], confer validity to the core criteria of midwife-led to labor in low-risk women within the setting of an Obstetric referral Unit. A prompt intervention for any emerging risk avoids delayed diagnosis and treatment, which might cause worse neonatal outcome in midwife-led labor outside hospital facilities [8–10]. Exceptions could be considered when major geographical conditions require a complex network to provide safe deliveries in low- and high-risk pregnancies [27,28].
Conclusions Access to health care is actually a key factor to reduce adverse events during labor and delivery even in contemporary developed countries [29]. The way adequate access to health care is achieved in obstetrics is largely dependent upon local cultural and social background, with dramatic differences observed between the wealthy and poor areas of the planet. The balance between access and excess of health care is a difficult issue despite of the multitude of attempts in defining adequate standards for good clinical practice in some European countries. The excess of cure, the idea that medical intervention can always do better than nature in all laboring women is causing unprecedented and unwanted changes in obstetrical practice in most countries both at high and low income such as: (i) a generalized increase of induction of labor [21]; (ii) the recommended universal use of oxytocin to accelerate labor in spite of its potential unexpected damages [16,27]; (iii) the use of continuous CTG monitoring without any solid evidence suggesting its universal use [30]; (iv) the excessive dosages of epidural drugs, and finally, (v) a dramatic increase in cesarean sections. In our opinion, appropriate models of good clinical practice in obstetrics, should avoid ideological attitudes based on local or national traditions, and carefully take into account only factors objectively proved to be associated with adverse maternal and neonatal outcomes, in order to minimize an excessive medicalization of a physiological event such as a normal labor. Our findings are in agreement with previously reported in the literature and showed how women who receive continuous support in labor, by means of midwife care, had an overall
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reduced rate of operative vaginal and cesarean deliveries [4,30]. Women delivered with continuous support are more likely to think that they have coped well during labor [7]. These women will share with peer’s similar expectations in a positive virtuous circle. Our protocol of midwife-led care in Obstetric Unit confirms that midwife-led labor is safe and feasible in modern westernized hospitals, especially in busy tertiary referral Units. The link between impersonal standard of procedures, designed to maximize efficacy and efficiency, and the empowerment of physiology by midwifery care should be at no additional risks for the mother and the neonate.
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Declaration of interest No conflict of interest is reported. We are grateful to the Giorgio Pardi Research Foundation, and the CURE-onlus research Foundation for supporting this study.
References 1. Wei S, Wo BL, Qi H-P, et al. Early amniotomy and early oxytocin for prevention of, or therapy for, delay in first stage spontaneous labor compared with routine care. Cochrane Database Syst Rev 2012;4:1–63. 2. Zhang J, Branch DW, Ramirez MM, et al. Oxytocin regimen for labor augmentation, labor progression, and perinatal outcomes. Obstet Gynecol 2011;118:249–56. 3. Brown HC, Paranjothy S, Dowswell T, Thomas J. Package of care for active management in labor for reducing caesarean section rates in low-risk women. Cochrane Database Syst Rev 2008;4:1–45. 4. Sandall J, Soltani H, Gates S, et al. Midwife-led continuity models versus other models of care for childbearing women (Review). Cochrane Database Syst Rev 2013;8:1–107. 5. Begley C, Devane D, Clarke M, et al. Comparison of midwife-led and consultant-led care of healthy women at low risk of childbirth complications in the Republic of Ireland: a randomised trial. BMC Preg Childbirth 2011;11:85–91. 6. Tracy SK, Hartz DL, Tracy MB, et al. Caseload midwifery care versus standard maternity care forwomen of any risk: M@NGO, a randomised controlled trial. Lancet 2013;382:1723–32. 7. McLachlan HL, Forster DA, Davey MA, et al. Effects of continuity of care by a primary midwife (caseload midwifery) on caesarean section rates in women of low obstetric risk: the COSMOS randomised controlled trial. BJOG 2012;119:1483–92. 8. Evers ACC, Brouwers HAA, Hukkelhoven CWPM, et al. Perinatal mortality and severe morbidity in low and high risk term pregnancies in the Netherlands: prospective cohort study. BMJ 2010;341:c5639. 9. Wax JR, Lucas FL, Lamont M, et al. Maternal and newborn outcomes in planned home birth vs planned hospital births: a metaanalysis. Am J Obstetr Gynecol 2010;203:243.e1–e8.
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10. Birthplace in England Collaborative Group. Perinatal and maternal outcomes by planned place of birth for healthy women with low risk pregnancies: the Birthplace in England national prospective cohort study. BMJ 2011;343:d7400. 11. Chervenak FA, McCullough LB, Brent RL, et al. Clinical opinion. Am J Obstetr Gynecol 2013;208:31–8. 12. Friedman JE. Primigravid labor: a graphicostastistical analysis. Obstetr Gynecol 1955;6:567–89. 13. Incerti M, Locatelli A, Ghidini A. Variability in rate of cervical dilation in nulliparous women at term. Birth 2011;38:30–5. 14. Caughey AB, Cahill AG, Guise JM, Rouse DJ. Safe prevention of the primary cesarean delivery. Am J Obstetr Gynecol 2014;123: 693–711. 15. O’Driscoll K, Jackson RJ, Gallagher JT. Prevention of prolonged labour. BMJ 1969;2:477–80. 16. Clark SL, Simpson KR, Knox GE, Garite TJ. Oxytocin: new perspectives on an old drug. Am J Obstetr Gynecol 2009;200: 35.e1–e6. 17. Johanson R, Newburn M, Macfarlane A. Has the medicalisation of childbirth gone too far? BMJ 2002;324:892–5. 18. Davis D, Baddock S, Pairman S, et al. Planned place of birth in New Zealand: does it affect mode of birth and intervention rates among low-risk women? Birth 2011;38:111–19. 19. Committee A. Intrapartum fetal rate heart rate monitoring: nomenclature, interpretation, and general management principles. Obstet Gynecol 2009;114:192–202. 20. Amelink-Verburg MP, Verloove-Vanhorick SP, Hakkenberg R, et al. Evaluation of 280 000 cases in Dutch midwifery practices: a descriptive study. BJOG 2007;115:570–8. 21. Brennan DJ, Robson MS, Murphy M, O’Herlihy C. Comparative analysis of international cesarean delivery rates using 10-group classification identifies significant variation in spontaneous labor. Am J Obstetr Gynecol 2010;201:308.e1–e8. 22. Walker KF, Cohen AL, Walker SH, et al. The dangers of the day of birth. BJOG 2014;121:714–18. 23. Blasi I, D’amico R, Fenu V, et al. Sonographic assessment of fetal spine and head position during the first and second stages of labor for the diagnosis of persistent occiput posterior position: a pilot study. Ultrasound Obstet Gynecol 2010;35:210–15. 24. Anim-Somuah M, Smyth R, Jomes L. Epidural versus non-epidural or no analgesia in labour (Review). Cochrane Library 2011;12: 1–124. 25. Lieberman E, Davidson K, Lee-Parritz A, Shearer E. Changes in fetal position during labor and their association with epidural analgesia. Obstet Gynecol 2005;105:974–82. 26. Biro MA, Waldenstro¨m U, Pannifex JH. Team midwifery care in a tertiary level obstetric service: a randomized controlled trial. Birth 2000;27:168–73. 27. Oscarsson ME, Amer-Wa˚hlin I, Rydhstroem H, Ka¨lle´n K. Outcome in obstetric care related to oxytocin use. A population-based study. Acta Obstet Gynecol Scand 2006;85:1094–8. 28. Holt J, Vold IN, Backe B, et al. Child births in a modified midwife managed unit: selection and transfer according to intended place of delivery. Acta Obstet Gynecol Scand 2001;80:206–12. 29. Kaunitz AM, Spence C, Danielson TS, et al. Perinatal and maternal mortality in a religious group avoiding obstetric care. Am J Obstet Gynecol 1984;150:826–31. 30. Hodnett ED, Downe S, Walsh D, Weston J. Alternative versus conventional institutional settings for birth. Cochrane Database Syst Rev 2010;9:1–53.
ISSN: 1476-7058 (Print) 1476-4954 (Online) Journal homepage: http://www.tandfonline.com/loi/ijmf20
The outcome of midwife-led labor in low-risk women within an obstetric referral unit Enrico Ferrazzi, Elena Visconti, Andrea M. Paganelli, Carmen M. Campi, Cristina Lazzeri, Federico Cirillo, Stefania Livio & Cinzia Piola To cite this article: Enrico Ferrazzi, Elena Visconti, Andrea M. Paganelli, Carmen M. Campi, Cristina Lazzeri, Federico Cirillo, Stefania Livio & Cinzia Piola (2015) The outcome of midwifeled labor in low-risk women within an obstetric referral unit, The Journal of Maternal-Fetal & Neonatal Medicine, 28:13, 1530-1536, DOI: 10.3109/14767058.2014.958995 To link to this article: http://dx.doi.org/10.3109/14767058.2014.958995
Accepted author version posted online: 05 Sep 2014. Published online: 19 Sep 2014. Submit your article to this journal
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http://informahealthcare.com/jmf ISSN: 1476-7058 (print), 1476-4954 (electronic) J Matern Fetal Neonatal Med, 2015; 28(13): 1530–1536 ! 2014 Informa UK Ltd. DOI: 10.3109/14767058.2014.958995
ORIGINAL ARTICLE
The outcome of midwife-led labor in low-risk women within an obstetric referral unit
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Enrico Ferrazzi, Elena Visconti, Andrea M. Paganelli, Carmen M. Campi, Cristina Lazzeri, Federico Cirillo, Stefania Livio, and Cinzia Piola Department of the Women, Mother and Neonate, Buzzi Mother and Child Hospital, Medical School of Biomedical and Clinical Sciences, University of Milan, Milan, Italy Abstract
Keywords
Objective: To analyze maternal and neonatal outcomes of midwife-led labor in low-risk women at term. Methods: Prospective observational cohort of 1788 singleton low-risk pregnancies in spontaneous term labor, managed according to a specific midwife-led labor protocol. Primary outcomes were mode of delivery, episiotomy, 3rd–4th degree lacerations, post-partum hemorrhage (PPH), need for blood transfusions, pH and Apgar score and NICU admissions. Results: A total 1754 low-risk women (50.3% of all deliveries) were included in the analysis. Epidural analgesia was performed in 29.8% of cases. The rate of cesarean section was 3.7%. Episiotomy was performed in 17.6% of women. PPH41000 ml occurred in 1.7% of cases. 3.2% and 0.3% of the cases had an Apgar score 57 and pH57.10, respectively, while 0.3% of the newborns were admitted to NICU. Consultant-led labor was required for emerging risk factors during 1st and 2nd stage of labor in 16.1 and 8.6% of cases, respectively. Although maternal outcome were worse in women with emerging risk factors in labor, while neonatal outcomes were not affected by the presence these complications. Conclusions: In hospital settings, midwife-led labor in low-risk women might unfold its major advantages without additional risks of medicalization for the mother and the neonate.
Apgar score, cesarean section, labor and delivery, midwifery, women’s health issues
Introduction There is an on-going argument on the ‘‘best’’ approach to manage labor and delivery. Some authors claim that medicalization can improve maternal and neonatal outcome[1–3], while others favor care by midwifes only in low-risk women, and medical intervention only when indicated [4,5]. In radical parlance Hospital Obstetric Units are the place for ‘‘medicalization’’, while Midwifes Units, either stand-alone or alongside, or home settings are the places for ‘‘normal birth’’. Integrated options of professional collaboration in which women are attended from initial booking to the post-natal period by the midwife are represented by caseload midwifery care with planned birth in Obstetric Units [6,7] or team midwife-led continuity models [4]. In these integrated teamwork, obstetricians are requested, not to overview physiology, but to counsel or attend high-risk pregnancies or women with emerging risks in labor. However, among those that support the idea to empower physiology, the best setting for labor and delivery (planned home delivery, standAddress for correspondence: Enrico Ferrazzi, Chair Dept Woman Mother and Neonate, Buzzi Mother and Child Hospital. Biomedical and Clinical Sciences School of Medicine, University of Milan, Milan, Italy. E-mail: [email protected]
History Received 18 May 2014 Revised 9 August 2014 Accepted 25 August 2014 Published online 19 September 2014
alone midwifery units, case-load midwifery in Obstetrics Units) is still a matter of scientific debate [8–10] and ethical research [11]. In many areas, the steamroller effect of the idea of ‘‘safe labor’’ mixed with poor scientific evidence brought pregnancy and labor as a whole under the constitution of medical doctors. In some areas of the world not even the ‘‘perineum at crowning and the very delivery of the newborn’’ is attended by certified midwifes, in others, low-risk pregnancies are attended certified obstetricians or by general practitioners, hollowing out the professional contents of midwifery. As a result, in these areas, obstetrics became probably the only medical discipline in which certified specialist are ‘‘actively attending’’ physiological processes. This was probably an unplanned effect of the process of the safe labor in hospitals that underwent a dramatic acceleration since the second post-war years. This welcomed attitude was met by poor scientific evidence and led to a progressive increase in iatrogenic interventions. The weak evidence of a progressive regular centimetric dilatation in active labor, based on few inhomogeneous laboring women [12], eventually proved wrong in recent years [2,13,14]. However, in the meantime, it was the ‘‘scientific’’ base for millions of diagnosis of ‘‘cervical dystocia’’, and subsequent labor
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DOI: 10.3109/14767058.2014.958995
Midwife-led labor in low-risk women within an obstetric unit
augmentation or cesarean sections. Similarly, the active management of labor morphed from a prevention of prolonged labor: ‘‘When progressive dilatation of the cervix is not occurring early transfer to hospital is advisable’’ [15], into a generalized use of amniorexis and/or oxytocin augmentation [2]. In 2009, Clark, Simpson, Knox and Garite analyzed universal oxytocin augmentation and concluded: ‘‘We know of no other area of medicine in which a potentially dangerous drug is administered to hasten the completion of a physiologic process that would, if left to its own devices, usually complete itself without incurring the risk of drug administration’’ [16]. We hypothesized that, within a hospital setting, team midwife-led labor in low-risk women at admission in Obstetric Units might represent a feasible and pragmatic way toward safe de-medicalization [17] of labor and delivery in many countries, where the hospital setting is by far the preferred place of birth, especially when the health care system is not able to efficiently support emergency transfer of women in labor throughout busy traffic in metropolitan areas and last but not least, case-load midwife care is not even considered by health care workers contracts provided by public or private healthcare systems. The objective of this study was to analyze the outcome of midwife-led labor in low-risk women within a tertiary Obstetric referral Unit.
Materials and methods This was a prospective observational cohort study based on a clinical protocol for low-risk women at admission for labor at term. This protocol was applied within the same ward (outpatients latent phase of labor observation area and six labor and delivery rooms), whereas high-risk patients were delivered at our University Tertiary Referral Maternity Hospital of a large metropolitan area of Milan, Italy, between September 2010 and August 2011. The protocol was notified to and approved by our Ethical Local Committee, provided a strict adherence to the privacy regulations. Low-risk criteria Patients admitted in labor at term were triaged by midwives and a final diagnosis of low or high risk was made at admission by the consultant on duty according to the criteria shown in Table 1. Gestational age was assessed by last menstrual period, or first trimester ultrasound measurements when conflicting of more than seven days. Each woman in labor was assigned to one midwife without medical supervision. A ‘‘one to one care’’ during 12 h shifts was the objective of this organization. If any risk factors in stage 1 or in stage 2 occurred (Table 1), midwives ‘‘transferred’’ their patient to the consultant on duty just by signing it on the clinical record and at the opening of the door of the labor and delivery room. Management of labor After the 40-minute CTG admission test, fetal wellbeing was monitored by CTG recordings for 10 min with every 30 min interval. Cervical dilatation was assessed every two hours, and active maternal postures were favored. Fetal trunk posterior
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Table 1. Low-risk criteria at admission and emerging risks in labor and delivery. Low-risk criteria at admission Normal medical and obstetrical history, including threatened preterm labor 532 weeks of gestation. Gestational age between 37 + 0 to 41 + 2 weeks. Singleton fetus in cephalic presentation. Normally inserted placenta. Normal fetal growth. Absence of known congenital anomalies or mother-to-child transmitted infectious diseases. Spontaneous labor. Intact membranes or ruptured membranes 512 h with WBC count 514 000, no leucocytosis, normal PCR. CTG Category 1 (*). Emerging risks in labor and delivery Stained amniotic fluid 42. Abnormal evolution stage 1: contractions 53 in 10 min or poor strength at palpation, delayed dilatation progression 43 h. Prolonged passive phase of second stage 41 h. CTG category 2 or 3. (*) Obstructed or prolonged active phase of 2nd stage. CTG Piquard category 41 in active phase of second stage. Any condition which, according to the midwife, requires a re-assessment by the specialist on duty. (*) ACOG Practice Bulletin 106, 2009 [19]. Non-recurrent variable decelerations with compensatory acceleration and restitution to normal baseline and normal variability in between contraction had been classified as Category I. Except for bradycardia, Category II heart rate pattern should be consistently last for at least 30 min. In our standard of practice, fetal stimulation is not adopted.
positions in labor were treated by active maternal positions, amniotomy was considered in case of a cervical dilatation 46 cm; active second stage was managed by preferred maternal postures. Treatment of pain in labor Epidural in labor was performed on demand. Pain in women without epidural was treated by care, respiratory autogenic training, active walking, massage, warm showers, labor and delivery bathtub (in one room), and petidine. Passive second stage of labor At full dilatation, engagement was favored by active maternal postures. The passive phase was allowed to last up to two hours in the presence of a normal CTG (category 1), assumed that feto-pelvic disproportion was ruled out. Active second stage of labor Maternal active pushing was encouraged at engagement of the flexed head in the upper part of the pelvic canal. Active postures and modes of pushing were chosen by the midwife with the laboring woman. Fetal well-being was assessed by CTG recordings every five minutes. Perineum treatment Episiotomy was performed only on indication; when needed, a medio-lateral episiotomy was preferred. Third stage Third stage was managed using 10 units of oxytocin i.m. until delivery; late cord clamping (cord clamping at cessation of
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pulsation or within two minutes) and delicate active placental extraction at first signs of detachment were performed. Graduated plastic wraps were used to measure the amount of blood loss. Cord blood arterial pH was routinely performed in all cases. The newborn was placed skin to skin on the mother belly.
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Outcome measurement The primary outcomes considered for this analysis were chosen for their prevalence and the size of the cohort: mode of delivery, medio-lateral episiotomy, pH and Apgar score at 5 min, post-partum hemorrhage, need for blood transfusions and admission to NICU. Third and fourth degree lacerations, hysterectomy, intra-partum and neonatal mortality were recorded and analyzed even if their prevalence might not reach an adequate statistical power. Weight and sex of the neonate were recorded to calculate the prevalence of small for gestational age (SGA) and large for gestational age (LGA) newborns according to local standards. Maternal age, weight, parity and ethnicity were recorded. When at least one of these complications occurred during labor and delivery, the patient was transferred under the care of the medical staff. Understaffed midwife shifts, with necessary supportive interventions by medical members, and interference of the attending private specialist with midwife management were recorded as violations of protocol. The study was conducted according to the standard of GMP and the declaration of Helsinki. Statistical analysis Descriptive statistics and parametric and non-parametric analysis were adopted when adequate for demographic, outcome and comparisons between subgroups of patients and women were analyzed accordingly. Relative risks of adverse maternal and neonatal outcome were calculated for women with emerging risk factors in labor. Composite maternal and neonatal adverse outcomes were obtained by the sum of operative deliveries, episiotomies, blood loss, and low pH, low Apgar score at 5 min and admission to NICU, respectively. Multivariate analysis was performed to assess independent significant correlations between any emerging risk factor in labor and composite adverse outcome. Missing data were checked on the original clinical records. A p value less than 0.05 was considered significant, p values between 0.05 and 0.09 were reported and commented. All data were analyzed using ‘‘StataÕ’’ 2011 edition (StataCorp, College Station, TX).
Results During the 12 months period considered in this study, 3487 consecutive patients at low and high risk were delivered at our referral Maternity Hospital. Median maternal age was 34 years (IQR 31-37), while median maternal weight was 70 kg (IQR 63-77 kg); both maternal age and weight were not significantly different between Caucasian (78.7%) and non-Caucasian women (21.3%).
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Table 2. Low-risk women at admission in labor: primary outcome per protocol for the whole cohort of nulliparous and multiparous. Low-risk women in labor Number of patients (*) Vaginal delivery Vaginal operative delivery Cesarean section (**) Mediolateral episiotomy PPH (***) PPH41000 ml Transfusions pH57.10 Apgar score 57 at 50 Admission to NICU
1754 87.5 8.8 3.7 17.6 11.3 1.7 0.2 3.2 0.3 0.6
PPH: post-partum hemorrhage; NICU: neonatal intensive care unit. (*) 34 violations of protocol are excluded. (**) CS rate was 5.7% in nulliparous and 1.2% in pluriparous women. (***) PPH4500 ml was computed for vaginal deliveries, and PPH4700ml for cesarean deliveries. Values reported as percentages.
A total of 1699 patients (48.7%) were proved to be at risk at admission. Main causes of risk in labor were term or postterm inductions (798 cases, 22.3%), medical and/or obstetrical indications and premature deliveries (494 patients, 13.5%). Cesarean section was scheduled in 407 patients (11.8%); among these, only 37 women had a cesarean section on request without any medical reason, based on woman’s preference only, as allowed by Italian law. During this study period, the overall rate of cesarean sections and vaginal operative deliveries was 21.6 and 8.3%, respectively. No intra-partum or neonatal death occurred in fetuses delivered at term without somatic or cardiovascular malformations. Women considered to be at low risk at admission, according to the criteria shown in Table 1, were 1788. Violation of protocol occurred in 34 cases understaffed shifts, or women followed by private gynecologists); these cases were not included in the current analysis. According to our protocol, midwives managed 1754 women (50.3%) during labor and delivery. Large for gestational age newborns were not diagnosed in labor in 3.6 and 6.6% of nulliparous and multiparous women, respectively; similarly, 1.1 and 0.8% of small for gestational age newborns were not diagnosed in labor. These cases were included in the analysis. Table 2 describes the primary outcomes of the whole cohort of nulliparous and multiparous women. Figure 1 shows the population study flowchart of low-risk women at admission according to emerging risk factors during the first and second stage of labor. Epidural analgesia on demand during the first stage was performed in 29.8% of cases (523 women). For local medicolegal reasons, this group was classified as high risk and required consultant supervision. Table 3 compares the main outcomes in women who had versus those who did not have epidural anesthesia during labor. The occurrence of operative delivery, either vaginal or cesarean section, was twice significantly higher in the epidural than in the non-epidural group.
Midwife-led labor in low-risk women within an obstetric unit
DOI: 10.3109/14767058.2014.958995
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Post-partum hemorrhage was more common in women who had epidural, although it did not reach statistical significance. Finally, adverse neonatal outcome was not significantly different between the two groups. Tables 4 and 5 compare the primary outcomes in low-risk nulliparous and multiparous women managed only by midwives with those with emerging risk factor during stage 1 and 2 requiring consultant-led management. Significant or borderline correlations were observed in multiparous women between oxytocin augmentation and adverse maternal (p50.01) and fetal (p50.08) outcomes. Complications associated with major hemorrhage and transfusions did not result in hysterectomy in any of the cases included in the study.
1788 LOW RISK WOMEN AT ADMISSION IN LABOR Protocol violaon # 34 (1.9%) 1st STAGE: 1754 WOMEN EPIDURAL
1st STAGE: 1231 WOMEN EMERGING RISKS
2nd STAGE: 949 WOMEN EMERGING RISKS
Discussion Main findings The findings from this study showed that midwife-led labor in low-risk pregnancies is safe and feasible and it is not associated with an increased risk of medicalization, thus representing a valid option in large busy obstetric units. Low risk, high risk case mix in our Obstetric Centre During the study period, low-risk pregnant women in spontaneous labor at term attended by midwife-led care represented 50.3% of all deliveries (1754/3487). This percentage of lowrisk laboring women is similar to that reported by the Dutch low and high risk prospective survey [8], by the UK collaborative group [10] and by the New Zealand Midwifery Maternity Provider Organization (MMPO) database [18]. This similar prevalence might support the validity of our selection criteria and allow for possible comparisons between other reported cohorts. Transfers from midwife-led care to consultant-led care
# 523 (29.8%) # 282 (16.1%)
STAINED A.F. 48.9 % CTG CATEGORY 2-3 31.2 % OX PERFUSION 19.9 %
# 151 (8.6%)
STAINED A.F. 37.7 % CTG PIQUARD>1 35.1 % OX PERFUSION 27.2 %
798 LABOR AND DELIVERY ATTENDED ONLY BY MIDWIFES Figure 1. Midwife-led labor and delivery in an Obstetric referral Unit. Flow chart of low-risk women at admission in labor with emerging risks during first and second stage according to our protocol.
During 1st and 2nd stage of labor, midwives identified emerging risk factors in 282 (16.1%) and in 151 (8.6%) women, respectively, including stained amniotic fluid, grade 3 or thick meconium, CTG class 2 or 3 according to ACOG intra-partum fetal heart rate monitoring criteria [19], and oxytocin perfusion for labor augmentation. Altogether this represents 24.7% of referrals to gynecologists of low-risk women attended by midwives from admission in labor in our Obstetric referral Unit. This figure is similar to that reported in a recent Dutch survey (29.4%) [8]. Furthermore, our result is also is similar to that of a previous Dutch study on a large cohort of 280 097 women derived from the Dutch midwifery database that reported 31.9% of transfer in labor [20]. Both figures are lower than those reported by the Birthplace England Collaborative Group [10] for home deliveries, freestanding midwifery units, or alongside midwifery units to secondary care obstetrics unit (36 to 45% in nulliparous women, 9 to 13% in multiparous women).
Table 3. Low-risk women at admission in labor: primary outcome per protocol for women without epidural analgesia throughout labor and delivery versus women who chose epidural analgesia at any time during 1st stage.
Number of patients Vaginal delivery Vaginal operative delivery Cesarean section Medio-lateral episiotomy PPH (*) PPH41000 ml Transfusions pH57.10 Apgar score 57 at 50 Admitted to NICU
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Low-risk women with epidural analgesia
p5
1231 91.4 5.9 2.7 12.5 7.7 1.5 0.2 2.8 0.3 0.7
523 80.7 13.4 5.9 26.8 15.1 2.5 0.2 3.3 0.6 0.8
50.0001 50.0001 50.002 50.0001 50.0001 50.2 50.8 50.7 50.3 50.9
RR (C.I. 95%) 0.45 1.09 1.03 1.20 1.09
(0.35–0.58) (1.05–1.13) (1.01–1.06) (1.13–1.26) (1.05–1.13) n.s. n.s. n.s. n.s. n.s.
Violations of protocol are excluded from analysis of outcome. Values are reported as percentages. Relative risks (RR) are reported when significant. PPH: post-partum hemorrhage; NICU: neonatal intensive care unit. (*) PPH4500 ml was computed for vaginal deliveries, and PPH4700 ml for cesarean deliveries.
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Table 4. Low-risk nulliparous at admission in labor: primary outcome per protocol for nulliparous according to emerging risk factors diagnosed by midwives during 1st and 2nd stage.
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Number of patients Vaginal delivery Vaginal operative delivery Cesarean section Medio-lateral episiotomy PPH (*) PPH41000 ml Transfusions pH57.10 Apgar score 57 at 50 Admitted to NICU
Nulliparous without emerging risks in labor
Nulliparous with emerging risks in labor
p5
311 100 0 0 9.3 6.1 0.6 0.3 1.6 0.3 0.3
260 67.4 22.9 9.7 33.3 15.1 3.1 0.0 6.6 0.8 1.5
n.d. 0.0001 0.0002 0.0001 0.0007 0.05 n.s. 0.004 n.s. n.s.
RR (C.I. 95%) n.d. (1.21-1.39) (1.06-1.15) (1.24-1.49) (1.04-1.17) (1.00-1.04) n.s. 1.05 (1.01-1.09) n.s. n.s. 1.30 1.11 1.36 1.11 1.02
Violations of protocol are excluded from analysis of outcome. Values are reported as percentages. Relative risks are reported when significant. n.d. ¼ not determined because vaginal delivery was an entry criteria in column 1; n.s. ¼ not significant; PPH ¼ post-partum hemorrhage; NICU ¼ neonatal intensive care unit. (*) PPH4500 ml was computed for vaginal deliveries, and PPH4700 ml for cesarean deliveries.
Table 5. Low-risk multiparous at admission in labor: primary outcome per protocol for multiparous according to emerging risk factors diagnosed by midwives during 1st and 2nd stage.
Number of patients Vaginal delivery Vaginal operative delivery Cesarean section Mediolateral episiotomy PPH (*) PPH41000 ml Transfusions pH57.10 Apgar score 57 at 50 Admitted to NICU
Multiparous without emerging risks in labor
Multiparous with emerging risk in labor
p5
487 100 0 0 3.6 4 1.1 0 1.5 0 0
173 87.1 8.2 4.7 12.3 10.5 1.8 1.2 2.9 0.6 2.3
n.d. 0.00001 0.00001 0.001 0.002 n.s. n.s. n.s. n.s. 0.004
RR (C.I. 95%) n.d. (1.04–1.14) (1.02–1.08) (1.04–1.16) (1.02–1.13) n.s. n.s. n.s. n.s. 1.04 (1.00-1.05)
1.09 1.05 1.09 1.07
Values are reported as percentages. Relative risks are reported when significant. n.d. ¼ not determined because vaginal delivery was an entry criteria in column 1; n.s. ¼ not significant; PPH ¼ post-partum hemorrhage; NICU ¼ neonatal intensive care unit. (*) PPH4500 ml was computed for vaginal deliveries, and PPH4700 ml for cesarean deliveries.
Transfers occurring in planned deliveries outside Obstetric Units are not adverse events per se´ and they are usually performed in safe conditions, with no harm for both the mother and the fetus. This encourages teamwork and allows early diagnosis and intervention. Cesarean section rate Cesarean section rate might be singled out from other primary outcomes. In fact, this figure somewhat summarizes the quality of care in low-risk women in spontaneous labor. In our cohort, the cesarean section rate in midwife-led labor and delivery was 3.7% (5.7% of nulliparous women and 1.2% in multiparous women, respectively). These findings are similar to those reported by a large prospective multi-institutional survey on prevalence of cesarean sections in tertiary referral centers in Robson classes 1 and 3 (13.1 and 2.7%, respectively) [21], by a Dutch prospective survey on low-risk laboring women (5.7%) [8], and by the Birthplace England Collaborative Group [10]. Unfortunately, the MMPO database
does not report the cesarean section rate according to parity. In this study, emergency cesarean sections rate occurred in 2.6% of 1826 planned home deliveries, in spite of the fact that multiparity accounted for 73% of attended deliveries. As regards to this robust index of care in low-risk women in labor, it appears that midwife-led labor in a hospital setting does compare well with different settings. Primary outcomes In the current study, the primary maternal outcomes observed in cases requiring medical supervision compare well with the traditional model of hospital setting and medical supervised labor and delivery. Post-partum hemorrhage 41000 ml occurred in 1.7% of women (1.4 and 0.8% of deliveries in nulliparous women and multiparous women) and never resulted in hysterectomy. Two cases of 3rd or 4th degree laceration were observed. The anatomic landmark of lacerations is well defined, yet underreporting might happen despite daily morning debriefing in labor and delivery unit.
DOI: 10.3109/14767058.2014.958995
Midwife-led labor in low-risk women within an obstetric unit
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Similarly, transfusions occurred at a very low rate from 1 in thousands in nulliparous women with emerging risks in labor to one in 250 in multiparous women. pH57.10 and Apgar score57 at 5 min occurred in 3.2 and 0.3% of cases, respectively. 0.6% of the newborns (0.9 and 0.3% in nulliparous and multiparous women, respectively) were admitted to NICU. Despite the relative small size of this cohort, the prevalence of Apgar score 57 was lower although not significantly different from the prevalence observed in the Dutch midwifery database (0.7%; p50.06) [20]. The incidence of several adverse neonatal outcomes was similar to that reported in studies where midwife-led delivery takes place outside an Obstetric Unit. Oxytocin perfusion was adopted in 7.7% of cases, vaginal operative deliveries occurred in 8.8%, episiotomy was performed in 17.6% of cases and cesarean section was performed in 3.7% of women. Primary maternal and fetal outcome in low-risk women referred to consultant-led care As expected, maternal outcomes, such as mode of delivery, episiotomy and PPH, were significantly higher in women with compared to those without emerging risks identified by midwives. On the other hand, fetal outcomes were not significantly different between the two groups. This might be interpreted as a consequence of the quality of midwives assessment of risk during labor, which allowed for early diagnosis and prompt treatment of incoming complications. Although the transfer of care from midwives to consultants is not an adverse outcome per se, women transferred to higher level of care experienced a significant increase in the occurrence of maternal complications when compared to low-risk mothers. This figure was similar to that observed in the Dutch prospective cohort; in this survey the admissions to NICU in women referred to consultant care were 13.7%, while the corresponding figure in the newborns delivered in primary care was 2.3%. Furthermore, an Apgar score57 was observed in 5.3% of urgent referrals in the Dutch midwifery registry and the prevalence of perinatal deaths was one in every 100 deliveries. The authors of this survey concluded ‘‘the neonatal outcome is good, even in the group of women referred during labor’’. This is obviously a statement that must be put in relation to the local cultural and social background. The size of our cohort does not allow to estimate the prevalence of fetal and neonatal death; however, the estimated risk of death in the first day of life (either intra- or post-, excluding premature deliveries and malformed fetuses) has been reported to be around 0.30 per thousand in UK and 0.26 per thousand in the USA, thus making an estimation of the occurrence of this outcome extremely difficult, in view of the fact that a very large sample size should be required in order to estimate this effect [22]. Epidural analgesia A total of 523 women who requested epidural pain treatment were classified to be at high risk and supervised by obstetricians because of local medico-legal issues. In our protocol, epidural dosage does not prevent women to actively move during first stage in order to reduce posterior trunk and occiput position at second stage [23]. Despite this,
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epidural was associated with higher rates of operative deliveries, in absence of a significantly increased in any of the adverse perinatal outcomes. According to larger reported reviews [24], epidural does not increase the rate of cesarean section, but it is likely to raise the rate of operative vaginal deliveries [25]. Limitations This study has several limitations: the relatively small sample size, and the single center of recruitment, a large tertiary referral center. However, the proportion of low risk-high risk patients admitted during the study period, the prevalence of referrals to consultant-led management for emerging risks, and the proportion of women that asked for epidural analgesia, allowed us to compare our primary outcome with those obtained in different settings, and larger multicenter cohorts. With these limitations, we believe that our findings, well in agreement with other similar models of care [4,6,26], confer validity to the core criteria of midwife-led to labor in low-risk women within the setting of an Obstetric referral Unit. A prompt intervention for any emerging risk avoids delayed diagnosis and treatment, which might cause worse neonatal outcome in midwife-led labor outside hospital facilities [8–10]. Exceptions could be considered when major geographical conditions require a complex network to provide safe deliveries in low- and high-risk pregnancies [27,28].
Conclusions Access to health care is actually a key factor to reduce adverse events during labor and delivery even in contemporary developed countries [29]. The way adequate access to health care is achieved in obstetrics is largely dependent upon local cultural and social background, with dramatic differences observed between the wealthy and poor areas of the planet. The balance between access and excess of health care is a difficult issue despite of the multitude of attempts in defining adequate standards for good clinical practice in some European countries. The excess of cure, the idea that medical intervention can always do better than nature in all laboring women is causing unprecedented and unwanted changes in obstetrical practice in most countries both at high and low income such as: (i) a generalized increase of induction of labor [21]; (ii) the recommended universal use of oxytocin to accelerate labor in spite of its potential unexpected damages [16,27]; (iii) the use of continuous CTG monitoring without any solid evidence suggesting its universal use [30]; (iv) the excessive dosages of epidural drugs, and finally, (v) a dramatic increase in cesarean sections. In our opinion, appropriate models of good clinical practice in obstetrics, should avoid ideological attitudes based on local or national traditions, and carefully take into account only factors objectively proved to be associated with adverse maternal and neonatal outcomes, in order to minimize an excessive medicalization of a physiological event such as a normal labor. Our findings are in agreement with previously reported in the literature and showed how women who receive continuous support in labor, by means of midwife care, had an overall
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reduced rate of operative vaginal and cesarean deliveries [4,30]. Women delivered with continuous support are more likely to think that they have coped well during labor [7]. These women will share with peer’s similar expectations in a positive virtuous circle. Our protocol of midwife-led care in Obstetric Unit confirms that midwife-led labor is safe and feasible in modern westernized hospitals, especially in busy tertiary referral Units. The link between impersonal standard of procedures, designed to maximize efficacy and efficiency, and the empowerment of physiology by midwifery care should be at no additional risks for the mother and the neonate.
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Declaration of interest No conflict of interest is reported. We are grateful to the Giorgio Pardi Research Foundation, and the CURE-onlus research Foundation for supporting this study.
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