Risks Of Inducing Labor At 41 Weeks – Study of induction of labor at 41 weeks compared with induction of labor at 42 weeks and expectant management (Swedish Post-Term Induction Study, SWEPIS): multicenter, open-label, randomized, superiority study 2019; 367 doi: https://doi.org/10.1136/.l6131 (Published November 20, 2019) Cited in: 2019;367:l6131 Linked Editorial When to initiate late-term pregnancy?
Objective To evaluate whether induction of labor at 41 weeks improves perinatal and maternal outcomes compared with waiting and induction of labor at 42 weeks in women with low-risk pregnancies.
Contents
Risks Of Inducing Labor At 41 Weeks
Participants were randomly selected (1:1) from 2760 women with low-risk, uncomplicated singleton pregnancies through the Swedish Pregnancy Registry. 1381 women were assigned to the induction group and 1379 women were assigned to the expectancy management group.
Think Twice About Inducing Labor
MAIN OUTCOME MEASURES The primary outcome was one or more stillbirths, neonatal mortality, Apgar score less than 7 at five minutes, pH less than 7.00, or metabolic acidosis (pH 12 mmol/L). The composite containing perinatal outcome. Bachial plexus injury to the umbilical artery, hypoxic ischemic encephalopathy, intracranial hemorrhage, convulsions, meconium aspiration syndrome, mechanical ventilation within 72 hours, or obstetrics. The primary analysis was intention-to-treat.
Results The study was stopped early because the perinatal mortality rate was significantly higher in the expectant management group. The composite primary perinatal outcome did not differ between groups: 2.4% (33/1381) in the induction group and 2.2% (31/1379) in the expectant management group (relative risk 1.06, 95% confidence interval 0.65 to 1, 73; p =0.90). No perinatal deaths occurred in the induction group, but six (five stillbirths and one early neonatal death) occurred in the waiting group (p=0.03). The rate of cesarean section, instrumental vaginal delivery, or any major maternal illness did not differ between groups.
Conclusions This study comparing expectant management with induction of labor at 41 weeks and induction at 42 weeks does not show any significant differences in the primary composite adverse perinatal outcomes. However, a reduction in the secondary outcome perinatal mortality was observed without an increase in adverse maternal outcomes. Although the results should be interpreted with caution, induction of labor should be offered to women no later than 41 weeks and may be one of the (few) interventions that reduce the rate of stillbirth.
Adverse perinatal outcomes gradually increase after the 40th week of gestation and increase significantly postpartum (≥42 weeks (≥294 days)).12 The risk of stillbirth has been shown to increase postpartum 12345 and up to 14% worldwide. Still births. is associated with prolonged pregnancy.2 Additionally, as the duration of pregnancy increases after 40 weeks, maternal complications increase.1 So far, there is no agreement on how to manage the late period (41 weeks + 0 days to 42 weeks + 0 days). pregnancy. The World Health Organization recommends induction of labor at 41 weeks, 6 and many countries recommend induction of labor between 41 and 42 weeks to avoid prolonged pregnancy.78
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Randomized controlled trials have compared induction of labor with expectant management in long-term pregnancies; most are inconclusive in terms of perinatal mortality and major morbidity. Comparison of operative vaginal delivery in the induction group with the expectant management group.9 Since the last Cochrane review and the initiation of this study, 10 two large randomized controlled trials examining low-risk pregnancies have been published. A large study from the United States, ARRIVE (A randomized induction and expectant management trial), compared induction of labor between 39 weeks + 0 days and 39 weeks + 4 days with expectant management up to 41 weeks + 0 days in nulliparous women. . Although the frequency of cesarean section was significantly lower in the early induction group, there was no significant difference in perinatal outcomes between the groups. Another recent large study from the Netherlands, INDEX (induction of labor at 41 weeks with an expectancy management policy up to 42 weeks), compared induction of labor at 41 weeks + 0 days with induction of labor at 41 weeks + 1 day with induction of labor at 42 weeks + 1 day. 0 days.12 Results failed to confirm that expectant management was noninferior to adverse perinatal outcomes; instead, a significantly higher risk of adverse perinatal outcome was found in the expectant management group. No significant difference was found in the cesarean delivery rate.
Current practice in many centers in the UK and Scandinavia is to induce labor no later than 42 weeks, but some studies suggest that the risk of perinatal mortality and morbidity actually increases significantly at 41 weeks. It increases 13 times from the 39th week of pregnancy and exponentially as the pregnancy approaches the 42nd week,
Therefore, we found it clinically justified to compare induction of labor at 41 weeks with expectant management and induction at 42 weeks in terms of maternal and perinatal outcomes. At the start of the current study, only two of the 30 studies included in the Cochrane review (one was an abstract) specifically compared labor induction at 41 weeks with expectant management until 42 weeks.1415
We evaluated whether induction of labor at 41 weeks + 0-2 days was superior to expectant management and induction of labor at 42 weeks + 0-1 days in terms of perinatal outcomes in healthy women with low-risk pregnancies.
Methods For Inducing Labor Naturally
SWEPIS (Swedish Post-Term Induction Study) was a multicenter, open-label, randomized controlled superiority study conducted in Sweden from May 2016 to October 2018. The trial was registry-based, with randomization and most data collection performed using the Swedish Pregnancy Registry. 16 hospitals with antenatal clinics linked to the registry are participating. Five of the hospitals are university clinics and nine are district hospitals; Of the 115,000 to 120,000 annual births in Sweden, there are approximately 60,000 births per year. The trial was conducted according to CONSORT guidelines. The protocol is available online (www-ncbi-nlm-nih-gov.proxy.kib.ki.se/pubmed/26951777) and in publication. (SNAKES).
Pregnant women were eligible to participate if they were 18 years of age or older, understood verbal and written information, and had a singleton pregnancy with a fetus in cephalic presentation between 40 weeks + 6 days and 41 weeks + 1 day according to ultrasound-based dating. In pregnancies in the first or early second trimester or after assisted reproduction, depending on the date of oocyte retrieval. Exclusion criteria included prior cesarean delivery or other uterine surgery, pregestational and insulin-dependent gestational diabetes, hypertensive disorder of pregnancy, known oligohydramnios (amniotic fluid index <50 mm or deepest vertical pocket <20 mm), or small-for-gestational-age fetus (estimated). It was located. fetal weight). ≤ 2 standard deviations relative to the Swedish reference for sex and gestational age), 17 diagnosed fetal malformations, contraindications to vaginal birth, and any other maternal condition affecting progression of pregnancy to week 42.
General information about the study was given in the form of posters or videos in the waiting rooms of antenatal clinics and through advertisements in local newspapers. More detailed information is provided on the research website. When pregnancies were approximately 40 weeks, midwives gave women oral information about the study in Swedish or provided written information in any of 17 other languages available to non-Swedish women. In the Stockholm region (five clinics), women are enrolled with the 41-week ultrasound scan offered to all pregnant women in the region. This is a voluntary procedure with almost 100% coverage that aims to confirm a normal pregnancy (defined as mean fetal abdominal diameter >110 mm and normal amniotic fluid) before proceeding to week 42. The midwife who performed the ultrasonography answered questions about the study and performed the randomization process after written consent was obtained. At all other centres, women wishing to participate were invited to visit a research midwife who managed consent and randomisation. Outside of the Stockholm region, 41-week scans are not routinely offered.
Randomization was done between 40 weeks + 6 days and 41 weeks + 1 day. Enrolled women were allocated to the baseline group or the expectancy management group (controls). In the induction group, labor was initiated within 24 hours after randomization (i.e., the same or next day) but not earlier than 41 weeks + 0 days. In the anticipatory treatment group, labor was initiated between 42 weeks + 0 days and 42 weeks. + 1 day.
Routine Induction At 41 Weeks
1:1 allocation to a trial group was achieved using centralized online randomization via dynamic allocation, a method that actively minimizes imbalance between groups for each new patient randomized. Center and parity (primality vs. multiparity) are used as minimization variables.
The Swedish Pregnancy Registry 16 has embedded the randomization module, which is included in the registry but separate from the registry data. Access to the randomization module uses a separate login system. The module also included an electronic case report form. After birth and during the neonatal period, we used women’s unique personal identification number to retrieve data on prenatal, birth and neonatal characteristics from the Swedish Pregnancy Register and the Swedish Newborn Quality Register. The work can be done relatively quickly and at low cost.
Induction of labor was carried out in the same way
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