Dataset Information

Neonatal and maternal outcomes at early vs. full term following induction of labor; A secondary analysis of the OBLIGE randomized trial.

ABSTRACT:

Introduction

Birth at early term (37⁺⁰-38⁺⁶ completed gestational weeks [GW] and additional days) is associated with adverse neonatal outcomes compared with waiting to ≥39 GW. Most studies report outcomes after elective cesarean section or a mix of all modes of births; it is unclear whether these adverse outcomes apply to early-term babies born after induction of labor (IOL). We aimed to determine, in women with a non-urgent induction indication (elective/planned >48 h in advance), if IOL at early and late term was associated with adverse neonatal and maternal outcomes compared with IOL at full term.

Material and methods

An observational cohort study as a secondary analysis of a multicenter randomized controlled trial of 1087 New Zealand women with a planned IOL ≥37⁺⁰ GW. Multivariable logistic regression was used to analyze neonatal and maternal outcomes in relation to gestational age; 37⁺⁰-38⁺⁶ (early term), 39⁺⁰-40⁺⁶ (full term) and ≥41⁺⁰ (late term) GW. Neonatal outcome analyses were adjusted for sex, birthweight, mode of birth and induction indication, and maternal outcome analyses for parity, age, body mass index and induction method. The primary neonatal outcome was admission to neonatal intensive care unit (NICU) for >4 hours; the primary maternal outcome was cesarean section.

Results

Among the 1087 participants, 266 had IOL at early term, 480 at full term, and 341 at late term. Babies born following IOL at early term had increased odds for NICU admission for >4 hours (adjusted odds ratio [aOR] 2.16, 95% confidence intervals (CI) 1.16-4.05), compared with full term. Women having IOL at early term had no difference in emergency cesarean rates but had an increased need for a second induction method (aOR 1.70, 95% CI 1.15-2.51) and spent 4 h longer from start of IOL to birth (Hodges-Lehmann estimator 4.10, 95% CI 1.33-6.95) compared with those with IOL at full term.

Conclusions

IOL for a non-urgent indication at early term was associated with adverse neonatal and maternal outcomes and no benefits compared with IOL at full term. These findings support international guidelines to avoid IOL before 39 GW unless there is an evidence-based indication for earlier planned birth and will help inform women and clinicians in their decision-making about timing of IOL.

SUBMITTER: Carlhall S

PROVIDER: S-EPMC11019511 | biostudies-literature | 2024 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Neonatal and maternal outcomes at early vs. full term following induction of labor; A secondary analysis of the OBLIGE randomized trial.

Carlhäll Sara S Alsweiler Jane J Battin Malcolm M Wilson Jessica J Sadler Lynn L Thompson John M D JMD Wise Michelle R MR

Acta obstetricia et gynecologica Scandinavica 20240111 5

<h4>Introduction</h4>Birth at early term (37<sup>+0</sup>-38<sup>+6</sup> completed gestational weeks [GW] and additional days) is associated with adverse neonatal outcomes compared with waiting to ≥39 GW. Most studies report outcomes after elective cesarean section or a mix of all modes of births; it is unclear whether these adverse outcomes apply to early-term babies born after induction of labor (IOL). We aimed to determine, in women with a non-urgent induction indication (elective/planned >4 ...[more]

PMID: 38212889

Similar Datasets

Project description:ObjectiveThe aim of the study is to evaluate the association between amniotomy at various time points during labor induction and maternal and neonatal outcomes among term, nulliparous women.Study designSecondary analysis of a randomized trial of term labor induction versus expectant management in low-risk, nulliparous women (2014-2017) was conducted. Women met inclusion criteria if they underwent induction ≥38 weeks' gestation using oxytocin with documented time and type of membrane rupture. Women with antepartum stillbirth or fetal anomaly were excluded. The primary outcome was cesarean delivery. Secondary outcomes included maternal and neonatal complications. Maternal and neonatal outcomes were compared among women with amniotomy versus women with intact membranes and no amniotomy at six 2-hour time intervals: before oxytocin initiation, 0 to <2 hours after oxytocin, 2 to <4 hours after, 4 to <6 hours after, 6 to <8 hours after, and 8 to <10 hours after. Multivariable logistic regression adjusted for maternal age, body mass index, race/ethnicity, modified Bishop score on admission, treatment group, and hospital (as a random effect).ResultsOf 6,106 women in the parent trial, 2,854 (46.7%) women met inclusion criteria. Of these 2,340 (82.0%) underwent amniotomy, and majority of the women had amniotomy performed between 2 and <6 hours after oxytocin. Cesarean delivery was less frequent among women with amniotomy 6 to <8 hours after oxytocin compared with women without amniotomy (21.9 vs. 29.7%; adjusted odds ratio 0.61, 95% confidence interval 0.42-0.89). Amniotomy at time intervals ≥4 hours after oxytocin was associated with lower odds of labor duration >24 hours. Amniotomy at time intervals ≥2 hours and <8 hours after oxytocin was associated with lower odds of maternal hospitalization >3 days. Amniotomy was not associated with postpartum or neonatal complications.ConclusionAmong a contemporary cohort of nulliparous women undergoing term labor induction, amniotomy was associated with either lower or similar odds of cesarean delivery and other adverse outcomes, compared with no amniotomy.

Project description:ImportanceElective induction of labor at 39 weeks of gestation is common. Thus, there is a need to assess maternal labor-related complications and neonatal outcomes associated with elective induction of labor.ObjectiveTo examine maternal labor-related complications and neonatal outcomes following elective induction of labor at 39 weeks compared with expectant management.Data sourcesA systematic review of the literature was conducted using the MEDLINE (Ovid), Embase (Ovid), Cochrane Central Library, World Health Organization, and ClinicalTrials.gov databases and registries to search for articles published between database inception and December 8, 2022.Study selectionThis systematic review and meta-analysis included randomized clinical trials, cohort studies, and cross-sectional studies reporting perinatal outcomes following induction of labor at 39 weeks vs expectant management.Data extraction and synthesisTwo reviewers independently assessed study eligibility, extracted data, and assessed studies for bias. Pooled odds ratios (ORs) and 95% CIs were calculated using a random-effects model. This study is reported per the Preferred Reporting Items for Systematic Reviews and Meta-analyses 2020 guideline, and the protocol was prospectively registered with PROSPERO.Main outcomes and measuresMaternal outcomes of interest included emergency cesarean section, perineal injury, postpartum hemorrhage, and operative vaginal birth. Neonatal outcomes of interest included admission to the neonatal intensive care unit, low 5-minute Apgar score (<7) after birth, macrosomia, and shoulder dystocia.ResultsOf the 5827 records identified in the search, 14 studies were eligible for inclusion in this review. These studies reported outcomes for 1 625 899 women birthing a singleton pregnancy. Induction of labor at 39 weeks of gestation was associated with a 37% reduced likelihood of third- or fourth-degree perineal injury (OR, 0.63 [95% CI, 0.49-0.81]), in addition to reductions in operative vaginal birth (OR, 0.87 [95% CI, 0.79-0.97]), macrosomia (OR, 0.66 [95% CI, 0.48-0.91]), and low 5-minute Apgar score (OR, 0.62 [95% CI, 0.40-0.96]). Results were similar when confined to multiparous women only, with the addition of a substantial reduction in the likelihood of emergency cesarean section (OR, 0.61 [95% CI, 0.38-0.98]) and no difference in operative vaginal birth (OR, 1.01 [95% CI, 0.84-1.21]). However, among nulliparous women only, induction of labor was associated with an increased likelihood of shoulder dystocia (OR, 1.22 [95% CI, 1.02-1.46]) compared with expectant management.Conclusions and relevanceIn this study, induction of labor at 39 weeks was associated with improved maternal labor-related and neonatal outcomes. However, among nulliparous women, induction of labor was associated with shoulder dystocia. These results suggest that elective induction of labor at 39 weeks may be safe and beneficial for some women; however, potential risks should be discussed with nulliparous women.

Project description:Objective This study aimed to evaluate maternal and neonatal outcomes by method of cervical ripening for labor induction among low-risk nulliparous individuals.Study design This is a secondary analysis of a multicenter randomized trial of labor induction at 39 weeks versus expectant management in low-risk nulliparous participants. Participants undergoing cervical ripening for labor induction in either group were included. Participants were excluded for preripening membrane rupture, abruption, chorioamnionitis, fetal demise, or cervical dilation ≥3.5 cm. Cervical ripening was defined by the initial method used: prostaglandin only (PGE; referent), Foley with concurrent prostaglandin (Foley-PGE), Foley only (Foley), and Foley with concurrent oxytocin (Foley-oxytocin). Coprimary outcomes were adverse maternal and neonatal composites. Secondary outcomes included cesarean delivery and length of labor and delivery (L&D) stay. Multivariable analysis was used to adjust for patient characteristics.Results Of 6,106 participants included in the trial, 2,376 (38.9%) met criteria for this analysis. Of these, 1,247 (52.4%) had cervical ripening with PGE, 290 (12.2%) had Foley-PGE, 385 (16.2%) had Foley, and 454 (19.1%) had Foley-oxytocin. The maternal composite outcome was similar among participants who received Foley-PGE (24.1%, adjusted relative risk [aRR] = 1.21, 95% confidence interval [CI]: 0.96-1.52), Foley (21.3%, aRR = 1.16, 95% CI: 0.92-1.45), or Foley-oxytocin (19.4%, aRR = 1.04, 95% CI: 0.83-1.29), compared with PGE (19.7%). The neonatal composite outcome was less frequent in participants who received the Foley-PGE (2.4%, aRR = 0.35, 95% CI: 0.16-0.75) or Foley (3.6%, aRR = 0.51, 95% CI: 0.29-0.89) but did not reach statistical significance for participants who received Foley-oxytocin (4.6%, aRR = 0.63, 95% CI: 0.40-1.01) compared with PGE only (6.8%). Participants who received Foley-PGE or Foley-oxytocin had a shorter L&D stay (adjusted mean difference = -1.97 hours, 95% CI: -3.45 to -0.49 and -5.92 hours, 95% CI: -7.07 to -4.77, respectively), compared with PGE.Conclusion In term low-risk nulliparous participants, Foley alone or concurrent with PGE is associated with a lower risk of adverse neonatal outcomes than with PGE alone. Length of L&D stay was the shortest with concurrent Foley-oxytocin.Key points· Adverse maternal outcomes are similar among different methods of cervical ripening in low-risk women.. · Adverse neonatal outcomes are less frequent with use of Foley alone or in combination with PGE.. · The use of Foley alone, or in combination with other agents, appears to be beneficial..

Project description:IntroductionInduction of labor is a common procedure, and in Denmark, approximately one in four vaginal deliveries are induced. The association between induction and maternal postpartum infections such as endometritis, surgical site infection after cesarean section, urinary tract infection, and sepsis has been sparsely investigated. Our objective was to investigate the association between induction of labor and risk of maternal postpartum infection and to identify potential risk factors for infection.Material and methodsIn a nationwide cohort study, all deliveries with live-born singletons from January 1, 2007, to December 31, 2017 (n = 546 864) were included. Deliveries were grouped into categories of spontaneous onset of labor, induction of labor, and elective cesarean section. The primary outcome was any infection within 30 days postpartum based on discharge diagnosis codes and redeemed antibiotic prescriptions for endometritis, surgical site infection, urinary tract infection, and sepsis. Analyses were done using logistic regression.ResultsInfection within 30 days postpartum was found among 8.5% of the women undergoing induction of labor compared to 6.8% of the women with spontaneous onset of labor. In adjusted logistic regression analyses, the risk of postpartum infection was significantly increased after induction of labor compared to spontaneous onset of labor (adjusted ORs [aOR], 1.24; 95% confidence interval [CI], 1.21-1.27). Women with rupture of membranes were not at increased risk of postpartum infection (aOR 1.01; 95%CI 0.94-1.09). The risk of postpartum maternal sepsis was not significantly associated with induction of labor. Antibiotic treatment during pregnancy, pre-eclampsia, and long education were all associated with increased risk of maternal postpartum infection, while either a low or high body mass index and previous deliveries were associated with decreased risk.ConclusionsInduction of labor was associated with an increased risk of maternal postpartum infection. However, the absolute risk was 1.7% higher for the women with induced labor compared to spontaneous onset of labor, which we believe should not be a cause for concern. Unexpectedly, low and high body mass index was associated with decreased risk of infection, and rupture of membranes was not associated with increased risk after induction of labor, which might reflect actual clinical management.

Project description:ObjectiveOptimal management of pregnancies at 39 weeks gestational age is unknown. Therefore, we sought to perform a comparative effectiveness analysis of elective induction of labor (eIOL) at 39 weeks among nulliparous women with non-anomalous singleton, vertex fetuses as compared to expectant management (EM) which included IOL for medical or obstetric indications or at 41 weeks in undelivered mothers.Materials and methodsA Monte Carlo micro-simulation model was constructed modeling two mutually exclusive health states: eIOL at 39 weeks, or EM with IOL for standard medical or obstetrical indications or at 41 weeks if undelivered. Health state distribution probabilities included maternal and perinatal outcomes and were informed by a review of the literature and data derived from the Consortium of Safe Labor. Analyses investigating preferences for maternal versus infant health were performed using weighted utilities. Primary outcome was determining which management strategy posed less maternal and neonatal risk. Secondary outcomes were rates of cesarean deliveries, maternal morbidity and mortality, stillbirth, neonatal morbidity and mortality, and preferences regarding the importance of maternal and perinatal health.ResultsA management strategy of eIOL at 39 weeks resulted in less maternal and neonatal risk as compared to EM with IOL at 41 weeks among undelivered patients. Cesarean section rates were higher in the EM arm (35.9% versus 13.9%, p<0.01). When analysis was performed only on patients with an unfavorable cervix, 39 week eIOL still resulted in fewer cesarean deliveries as compared to EM (8.0% versus 26.1%, p<0.01). There was no statistical difference in maternal mortality (eIOL 0% versus EM 0.01%, p = 0.32) but there was an increase in maternal morbidity among the EM arm (21.2% versus 16.5, p<0.01). There were more stillbirths (0.13% versus 0%, p<0.0003), neonatal deaths (0.25% versus 0.12%, p< 0.03), and neonatal morbidity (12.1% versus 9.4%, p<0.01) in the EM arm as compared to the eIOL arm. Preference modeling revealed that 39 week eIOL was favored over EM.Conclusions and relevanceMathematical modeling revealed that eIOL at 39 weeks resulted in lower population risks as compared to EM with induction of labor at 41 weeks. Specifically, eIOL at 39 weeks resulted in a lower cesarean section rate, lower rates of maternal morbidity, fewer stillbirths and neonatal deaths, and lower rates of neonatal morbidity.

Project description:BackgroundThe safety of methods of labor induction in women with previous cesarean deliveries is still debated. We investigated perinatal outcomes associated with labor induction among women with a trial of labor after one cesarean delivery.MethodsThis retrospective study included 339 women with a trial of labor after one prior cesarean and a singleton term fetus in cephalic presentation in 2013-2016 in a French maternity unit. Labor induction was performed with oxytocin, artificial rupture of membranes and/or prostaglandin E2, according to the Bishop score. The primary outcome was a composite of uterine rupture, low Apgar score, neonatal resuscitation or admission to a neonatal unit. The secondary outcomes included cesarean delivery after onset of labor, postpartum hemorrhage and maternal hospital stay after delivery. We used logistic regression to estimate odds ratios adjusted (aOR) for potential confounders.ResultsIn our sample, 67.3% of women had spontaneous labor and 32.7% were induced. More than half of the women received oxytocin during labor regardless of the mode of labor. The proportions of the composite outcome and of cesarean after onset of labor were higher in the induced group compared to the spontaneous group (26.1% vs 15.8%, p = 0.02 and 45.0% vs 27.6%, p<0.01, respectively). There were 9 uterine ruptures (2.6%) and this proportion was higher in the induced group compared to the spontaneous group, although this difference was not statistically significant (3.6% vs 2.2%, p = 0.48). After adjustment, labor induction was associated with higher risks of the composite outcome (aOR = 2.45, 95% CI: 1.29-4.65), cesarean after onset of labor (aOR = 2.06, 95% CI: 1.15-3.68) and maternal hospital stay after delivery ≥6 days (aOR = 6.20, 95% CI: 3.25-11.81). No association was found with postpartum hemorrhage.ConclusionLabor induction after one prior cesarean was associated with a higher risk of adverse perinatal outcome. Nevertheless, the higher proportion of uterine rupture did not differ significantly from that in the spontaneous labor group.

Project description:ObjectiveTo assess neonatal and maternal outcomes when the second stage of labor was prolonged according to American College of Obstetricians and Gynecologists guidelines.MethodsElectronic medical record data from a retrospective cohort (2002-2008) from 12 U.S. clinical centers (19 hospitals), including 43,810 nulliparous and 59,605 multiparous singleton deliveries at 36 weeks of gestation or greater, vertex presentation, who reached 10-cm cervical dilation were analyzed. Prolonged second stage was defined as: nulliparous women with epidural greater than 3 hours and without greater than 2 hours and multiparous women with epidural greater than 2 hours and without greater than 1 hour. Maternal and neonatal outcomes were compared and adjusted odds ratios calculated controlling for maternal race, body mass index, insurance, and region.ResultsProlonged second stage occurred in 9.9% and 13.9% of nulliparous and 3.1% and 5.9% of multiparous women with and without an epidural, respectively. Vaginal delivery rates with prolonged second stage compared with within guidelines were 79.9% compared with 97.9% and 87.0% compared with 99.4% for nulliparous women with and without epidural, respectively, and 88.7% compared with 99.7% and 96.2% compared with 99.9% for multiparous women with and without epidural, respectively (P<.001 for all comparisons). Prolonged second stage was associated with increased chorioamnionitis and third-degree or fourth-degree perineal lacerations. Neonatal morbidity with prolonged second stage included sepsis in nulliparous women (with epidural: 2.6% compared with 1.2% [adjusted odds ratio (OR) 2.08, 95% confidence interval (CI) 1.60-2.70]; without epidural: 1.8% compared with 1.1% [adjusted OR 2.34, 95% CI 1.28-4.27]); asphyxia in nulliparous women with epidural (0.3% compared with 0.1% [adjusted OR 2.39, 95% CI 1.22-4.66]) and perinatal mortality without epidural (0.18% compared with 0.04% for nulliparous women [adjusted OR 5.92, 95% CI 1.43-24.51]); and 0.21% compared with 0.03% for multiparous women (adjusted OR 6.34, 95% CI 1.32-30.34). However, among the offspring of women with epidurals whose second stage was prolonged (3,533 nulliparous and 1,348 multiparous women), there were no cases of hypoxic-ischemic encephalopathy or perinatal death.ConclusionsBenefits of increased vaginal delivery should be weighed against potential small increases in maternal and neonatal risks with prolonged second stage.Level of evidence: II.

Project description:IntroductionSince Friedman's seminal publication on laboring women, numerous publications have sought to define normal labor progress. However, there is paucity of data on contemporary labor cervicometry incorporating both maternal and neonatal outcomes. The objective of this study is to establish intrapartum prediction models of unfavorable labor outcomes using machine-learning algorithms.Materials and methodsConsortium on Safe Labor is a large database consisting of pregnancy and labor characteristics from 12 medical centers in the United States. Outcomes, including maternal and neonatal outcomes, were retrospectively collected. We defined primary outcome as the composite of following unfavorable outcomes: cesarean delivery in active labor, postpartum hemorrhage, intra-amniotic infection, shoulder dystocia, neonatal morbidity, and mortality. Clinical and obstetric parameters at admission and during labor progression were used to build machine-learning risk-prediction models based on the gradient boosting algorithm.ResultsOf 228,438 delivery episodes, 66,586 were eligible for this study. Mean maternal age was 26.95 ± 6.48 years, mean parity was 0.92 ± 1.23, and mean gestational age was 39.35 ± 1.13 weeks. Unfavorable labor outcome was reported in 14,439 (21.68%) deliveries. Starting at a cervical dilation of 4 cm, the area under receiver operating characteristics curve (AUC) of prediction models increased from 0.75 (95% confidence interval, 0.75-0.75) to 0.89 (95% confidence interval, 0.89-0.90) at a dilation of 10 cm. Baseline labor risk score was above 35% in patients with unfavorable outcomes compared to women with favorable outcomes, whose score was below 25%.ConclusionLabor risk score is a machine-learning-based score that provides individualized and dynamic alternatives to conventional labor charts. It predicts composite of adverse birth, maternal, and neonatal outcomes as labor progresses. Therefore, it can be deployed in clinical practice to monitor labor progress in real time and support clinical decisions.

Dataset Information

Neonatal and maternal outcomes at early vs. full term following induction of labor; A secondary analysis of the OBLIGE randomized trial.

Introduction

Material and methods

Results

Conclusions

Publications

Neonatal and maternal outcomes at early vs. full term following induction of labor; A secondary analysis of the OBLIGE randomized trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets