Planned early delivery versus expectant management for hypertensive disorders from 34 weeks gestation to term.
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ABSTRACT:
SUBMITTER: Cluver C
PROVIDER: S-EPMC6465052 | biostudies-literature | 2017 Jan
REPOSITORIES: biostudies-literature
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Planned early delivery versus expectant management for hypertensive disorders from 34 weeks gestation to term.
Cluver Catherine C Novikova Natalia N Koopmans Corine M CM West Helen M HM
The Cochrane database of systematic reviews 20170115
<h4>Background</h4>Hypertensive disorders in pregnancy are significant contributors to maternal and perinatal morbidity and mortality. These disorders include well-controlled chronic hypertension, gestational hypertension (pregnancy-induced hypertension) and mild pre-eclampsia. The definitive treatment for these disorders is planned early delivery and the alternative is to manage the pregnancy expectantly if severe uncontrolled hypertension is not present, with close maternal and fetal monitorin ...[more]
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Project description:BackgroundClinicians caring for the nearly 10% of patients in the United States with nonsevere hypertensive disorders in late pregnancy need better evidence to balance risks and benefits of clinician-initiated delivery.MethodsWe conducted a record-based cohort study of maternal and infant health outcomes among deliveries from 2002-2013 at Women & Infants Hospital of Rhode Island. Participants had gestational hypertension or nonsevere preeclampsia before 39 weeks' gestation (N=4,295). For each gestational week from 34 to 38, we compared outcomes between clinician-initiated deliveries (induction of labor or prelabor cesarean) and those not initiated in that week, using propensity score models to control confounding by indication.ResultsThe analysis predicted an increment in risk of adverse maternal and infant outcomes sustained through week 37 if all patients underwent clinician-initiated delivery, with risk differences on the order of 0.2 for maternal outcomes and 0.3 for infant outcomes weeks 34 and 35. For women undergoing clinician-initiated delivery, the analysis identified increased risk of progression to severe disease in weeks 35 and 36, increases in all adverse infant outcomes only in week 34, increases in Neonatal Intensive Care Unit admission and infant hospital stay in weeks 35 and 36, and no meaningful increase in any of the adverse outcomes in weeks 37 or 38.ConclusionsWe estimate that hypertensive pregnancies chosen for intervention were minimally harmed by early delivery after 34 weeks' gestation but predict benefit from extension to 37 weeks. Our study also showed adverse infant health consequences associated with routine delivery prior to 37 weeks.
| S-EPMC8810678 | biostudies-literature
Project description:ObjectiveTo develop models to predict vaginal delivery in low-risk, nulliparous women contemplating elective induction of labor or expectant management at 39 weeks of gestation.MethodsWe conducted a secondary analysis of a randomized controlled trial of planned elective induction of labor at 39 weeks of gestation compared with expectant management for low-risk nulliparous women. Two groups were included for this analysis: 1) women who were randomized to the induction of labor group and underwent elective induction at 39 0/7-39 4/7 weeks of gestation and 2) women who were randomized to the expectant management group who experienced spontaneous labor or medically indicated delivery (including postterm). Multivariable logistic regression models were developed for each group using patient characteristics that would be available at the time of counseling. Model selection was based on k-fold cross-validation using backward elimination and variables that remained significant at P<.05 were retained. To compare estimated with observed rates, the elective induction of labor model was then applied to each woman in both groups to estimate individualized predicted probabilities of vaginal delivery with elective induction of labor.ResultsOf 6,106 women enrolled in the trial, 4,661 met criteria for this analysis. Vaginal delivery occurred in 80.6% of the 2,153 women in the elective induction of labor group and 77.2% of the 2,508 women in the expectant management group (P=.005). The final elective induction of labor model included age, height, weight, and modified Bishop score (area under the receiver operating characteristic curve [AUROC] 0.72, 95% CI 0.70-0.75). The same variables were included in the final expectant management model (AUROC 0.70, 95% CI 0.67-0.72). Across the range of predicted probability deciles derived from the elective induction of labor model, almost all women who underwent elective induction of labor at 39 weeks of gestation had a higher observed chance of vaginal delivery than expectant management.ConclusionIrrespective of the individual predicted chance of vaginal delivery from elective induction of labor at 39 weeks of gestation, vaginal delivery is generally more frequent if elective induction of labor is undertaken rather than expectant management. These data can be used to counsel nulliparous women regarding their "customized" chances of vaginal delivery as they choose between elective induction of labor or expectant management at 39 weeks of gestation.Clinical trial registrationClinicalTrials.gov, NCT01990612.
| S-EPMC7899015 | biostudies-literature
Project description:ObjectiveTo test the hypothesis that a longer length of time between diagnosis of hypertensive disorders of pregnancy and delivery is associated with increased risk of cardiovascular morbidity in the years after delivery.MethodsThis is a retrospective cohort study based in the New York State Inpatient Database. The first delivery for all patients from 2005 to 2014 who delivered preterm with an International Classification of Diseases, 9th Revision, Clinical Modification code for hypertensive disorders of pregnancy (excluding isolated chronic hypertension) was included. The duration between diagnosis and delivery was divided into 7 days or less or more than 7 days. The primary outcome was admission for a composite of cardiovascular disease, stroke, or death after the index delivery through December 31, 2014.ResultsThere were 22,594 patients with a median follow-up period of 5.2 years: 19,750 (87.4%) were delivered within 7 days of diagnosis and 2,844 (12.6%) were delivered more than 7 days from diagnosis. The primary outcome occurred in 216 (1.1%) patients in the 0-7 days group (21 events/10,000 person-years) and 67 (2.4%) patients in the more than 7 days group (46 events/10,000 person-years), adjusted hazard ratio 1.45 (95% CI 1.09 to 1.93). The findings were robust in a number of sensitivity analyses.ConclusionsProlonged expectant management of preterm hypertensive disorders of pregnancy is associated with an increased risk of maternal cardiac disease in the ensuing years.
| S-EPMC6923587 | biostudies-literature
Project description:BackgroundAt present, there is insufficient evidence to guide appropriate management of women with preterm prelabor rupture of membranes (PPROM) near term.Methods and findingsWe conducted an open-label randomized controlled trial in 60 hospitals in The Netherlands, which included non-laboring women with >24 h of PPROM between 34(+0) and 37(+0) wk of gestation. Participants were randomly allocated in a 1:1 ratio to induction of labor (IoL) or expectant management (EM) using block randomization. The main outcome was neonatal sepsis. Secondary outcomes included mode of delivery, respiratory distress syndrome (RDS), and chorioamnionitis. Patients and caregivers were not blinded to randomization status. We updated a prior meta-analysis on the effect of both interventions on neonatal sepsis, RDS, and cesarean section rate. From 1 January 2007 to 9 September 2009, 776 patients in 60 hospitals were eligible for the study, of which 536 patients were randomized. Four patients were excluded after randomization. We allocated 266 women (268 neonates) to IoL and 266 women (270 neonates) to EM. Neonatal sepsis occurred in seven (2.6%) newborns of women in the IoL group and in 11 (4.1%) neonates in the EM group (relative risk [RR] 0.64; 95% confidence interval [CI] 0.25 to 1.6). RDS was seen in 21 (7.8%, IoL) versus 17 neonates (6.3%, EM) (RR 1.3; 95% CI 0.67 to 2.3), and a cesarean section was performed in 36 (13%, IoL) versus 37 (14%, EM) women (RR 0.98; 95% CI 0.64 to 1.50). The risk for chorioamnionitis was reduced in the IoL group. No serious adverse events were reported. Updating an existing meta-analysis with our trial results (the only eligible trial for the update) indicated RRs of 1.06 (95% CI 0.64 to 1.76) for neonatal sepsis (eight trials, 1,230 neonates) and 1.27 (95% CI 0.98 to 1.65) for cesarean section (eight trials, 1,222 women) for IoL compared with EM.ConclusionsIn women whose pregnancy is complicated by late PPROM, neither our trial nor the updated meta-analysis indicates that IoL substantially improves pregnancy outcomes compared with EM.Trial registrationCurrent Controlled Trials ISRCTN29313500
| S-EPMC3335867 | biostudies-literature
Project description:Preterm premature rupture of membranes (PPROM) is associated with an increased risk of serious maternal, fetal, and neonatal morbidities. We compared neonatal outcomes of women with PPROM before 34+0 weeks of gestation according to inpatient or outpatient management policy. 587 women with PPROM >48 hours, 246 (41.9%) in the group with an inpatient care policy (ICP) and 341 (58.1%) in the group with an outpatient care policy (OCP), were identified in France, from 2009 to 2012. Neonatal outcomes were compared between the two groups using logistic regression. A second analysis was performed to compare inpatient care and effective outpatient care (discharge from hospital) through propensity score matching. The outcome was a neonatal composite variable including one or more of the neonatal morbidity complications. The perinatal composite outcome was 14.6% with the ICP and 15.5% with the OCP (p = 0.76). After using the 1:1 ratio propensity score matching, effective outpatient care was not associated with a significantly higher risk of the perinatal composite outcome (OR 0.88, CI 0.35 to 2.25; p = 0.80) compared with inpatient care. Outpatient care is not associated with an increased rate of obstetric or neonatal complications and can be an alternative to hospital care for women with uncomplicated PPROM.
| S-EPMC6414533 | biostudies-literature
Project description:ObjectiveThe present study evaluated maternal plasma protein profiles before the onset of hypertensive disorders of pregnancy (HDP) to assess the relationship between maternal plasma tumor necrosis factor-related apoptosis-inducing ligand (TRAIL) and HDP before 20 weeks gestation and to evaluate the discriminatory performance of plasma TRAIL levels for HDP.MethodsA 2-phase discovery/validation study was designed. In the discovery phase, a nested case-controlled study was performed using plasma sampled at 8 to 20 weeks gestation from 20 women who later developed HDP and from 20 age- and gestational week-matched controls. Plasma was analyzed using a human protein microarray technology designed to simultaneously detect 507 proteins. The functional annotation and clustering of the differentially expressed proteins were performed using DAVID and the GO database. TRAIL levels were further validated in an independent study using plasma obtained at 8 to 20 weeks gestation from 53 women who later developed HDP and from 106 matched controls, and 62 clinical risk factors were investigated.ResultsIn the protein microarray analysis, 23 proteins were differentially expressed between the two groups. The ELISA showed that women who later developed HDP had significantly lower TRAIL levels compared to women with uncomplicated pregnancies. The multivariable Cox regression analysis identified the following three factors that were entered into the final Cox regression model: gravidity (OR = 2.02, 95% CI 1.00-4.09), pre-pregnancy BMI (OR = 1.46, 95% CI 1.21-1.76) and TRAIL levels (OR = 0.97, 95% CI 0.94-0.99). The model had a significantly better discriminatory power (AUC = 0.83, 95% CI 0.75-0.88) compared to TRAIL alone as an independent predictor of HDP (AUC = 0.59, 95% CI 0.51-0.67).ConclusionTwenty-three differentially expressed proteins before 20 weeks gestation might be associated with the pathogenesis of HDP. Plasma TRAIL levels were associated with the development of HDP, and the combination of plasma TRAIL levels with pre-pregnancy BMI and gravidity had a good discriminatory performance for HDP before 20 weeks gestation.
| S-EPMC4451764 | biostudies-literature
Project description:BackgroundPlanned birth by induction of labour in low-risk, nulliparous women at 39+0-39+6 weeks gestation is associated with fewer caesarean sections, adverse maternal and neonatal outcomes and perinatal deaths compared with expectant management. However, the consequences of scheduled caesarean section in these women at this gestation are unclear. We compared outcomes following planned birth at 39+0-39+6 weeks gestation (either by induction of labour or scheduled caesarean section) to expectant management.MethodsThe population included low-risk, singleton pregnancies between 2000 and 2021 in Queensland, Australia. Study outcomes were perinatal mortality (antepartum or intrapartum stillbirth and neonatal death), severe neonatal neurological morbidity and non-neurological morbidity, severe maternal outcome, maternal-infant separation, perineal trauma, shoulder dystocia, and caesarean birth. Multivariable models were built to determine risks of adverse outcomes for planned birth compared to expectant management. Subgroup analyses according to parity and birthweight were also performed. We calculated the number of planned births required that were associated with one less adverse outcome.FindingsIn 472,520 low-risk pregnancies, planned birth at 39+0-39+6 weeks occurred in 97,438 (20.6%) women, of whom 39,697 (40.7%) underwent induction of labour and 57,741 (59.3%) had scheduled caesarean delivery. Planned birth was associated with 52% lower odds of perinatal mortality (adjusted Odds Ratio (aOR) 0.48; 95% CI 0.30, 0.76, p = 0.002), 62% lower odds of antepartum stillbirth (aOR 0.38; 95% CI 0.15, 0.97, p = 0.04), and 84% lower odds of intrapartum stillbirth by (aOR 0.16; 95% CI 0.04, 0.66, p = 0.01). It was also associated with reduction in the odds of severe neurological morbidity (aOR 0.46; 95% CI 0.39, 0.53, p = 0.00004), severe non-neurological morbidity (aOR 0.65; 95% CI 0.62, 0.68, p = 0.00004), and severe maternal outcome (aOR 0.95; 95% CI 0.92, 0.99, p = 0.008) but not maternal-infant separation (aOR 1.04; 95% CI 1.00, 1.08, p = 0.08). The reduction in odds for perinatal mortality, severe neurological, and non-neurological morbidity was greatest for birth by scheduled caesarean section. Compared to expectant management, planned birth by induction of labour was associated with reduced odds of caesarean delivery (aOR 0.54; 95% CI 0.51, 0.58, p = 0.00004), severe perineal trauma (aOR 0.53; 95% CI 0.45, 0.63, p = 0.00004), and shoulder dystocia (aOR 0.73; 95% CI 0.64, 0.84, p = 0.00004). Planned delivery of 2278 (95% CI 1760, 3231) women is associated with a reduction in one case of perinatal death, however significantly lower numbers are required for the other outcomes.InterpretationPlanned birth at 39+0-39+6 weeks in low-risk women was associated with lower odds of perinatal mortality and other adverse outcomes. Reductions in odds of adverse outcome were greater following scheduled caesarean section than induction of labour. Compared to expectant management, induction of labour was associated with lower odds of severe perineal trauma, shoulder dystocia, and caesarean birth. These findings generate further hypotheses that need to be tested in adequately powered randomised controlled trials.FundingThis study was supported by funds from the National Health and Medical Research Council and Mater Foundation.
| S-EPMC11803212 | biostudies-literature
Project description:ObjectiveTo compare induction of labour at 41 weeks with expectant management until 42 weeks in low risk women.DesignOpen label, randomised controlled non-inferiority trial.Setting123 primary care midwifery practices and 45 hospitals (secondary care) in the Netherlands, 2012-16.Participants1801 low risk women with an uncomplicated singleton pregnancy: randomised to induction (n=900) or to expectant management until 42 weeks (n=901).InterventionsInduction at 41 weeks or expectant management until 42 weeks with induction if necessary.Primary outcome measuresPrimary outcome was a composite of perinatal mortality and neonatal morbidity (Apgar score <7 at five minutes, arterial pH <7.05, meconium aspiration syndrome, plexus brachialis injury, intracranial haemorrhage, and admission to a neonatal intensive care unit (NICU). Secondary outcomes included maternal outcomes and mode of delivery. The null hypothesis that expectant management is inferior to induction was tested with a non-inferiority margin of 2%.ResultsMedian gestational age at delivery was 41 weeks+0 days (interquartile range 41 weeks+0 days-41 weeks+1 day) for the induction group and 41 weeks+2 days (41 weeks+0 days-41 weeks+5 days) for the expectant management group. The primary outcome was analysed for both the intention-to-treat population and the per protocol population. In the induction group, 15/900 (1.7%) women had an adverse perinatal outcome versus 28/901 (3.1%) in the expectant management group (absolute risk difference -1.4%, 95% confidence interval -2.9% to 0.0%, P=0.22 for non-inferiority). 11 (1.2%) infants in the induction group and 23 (2.6%) in the expectant management group had an Apgar score <7 at five minutes (relative risk (RR) 0.48, 95% CI 0.23 to 0.98). No infants in the induction group and three (0.3%) in the expectant management group had an Apgar score <4 at five minutes. One fetal death (0.1%) occurred in the induction group and two (0.2%) in the expectant management group. No neonatal deaths occurred. 3 (0.3%) neonates in the induction group versus 8 (0.9%) in the expectant management group were admitted to an NICU (RR 0.38, 95% CI 0.10 to 1.41). No significant difference was found in composite adverse maternal outcomes (induction n=122 (13.6%) v expectant management n=102 (11.3%)) or in caesarean section rate (both groups n=97 (10.8%)).ConclusionsThis study could not show non-inferiority of expectant management compared with induction of labour in women with uncomplicated pregnancies at 41 weeks; instead a significant difference of 1.4% was found for risk of adverse perinatal outcomes in favour of induction, although the chances of a good perinatal outcome were high with both strategies and the incidence of perinatal mortality, Apgar score <4 at five minutes, and NICU admission low.Trial registrationNetherlands Trial Register NTR3431.
| S-EPMC6598648 | biostudies-literature
Project description:BackgroundIn women with late preterm pre-eclampsia, the optimal time to initiate delivery is unclear because limitation of maternal disease progression needs to be balanced against infant complications. The aim of this trial was to determine whether planned earlier initiation of delivery reduces maternal adverse outcomes without substantial worsening of neonatal or infant outcomes, compared with expectant management (usual care) in women with late preterm pre-eclampsia.MethodsIn this parallel-group, non-masked, multicentre, randomised controlled trial done in 46 maternity units across England and Wales, we compared planned delivery versus expectant management (usual care) with individual randomisation in women with late preterm pre-eclampsia from 34 to less than 37 weeks' gestation and a singleton or dichorionic diamniotic twin pregnancy. The co-primary maternal outcome was a composite of maternal morbidity or recorded systolic blood pressure of at least 160 mm Hg with a superiority hypothesis. The co-primary perinatal outcome was a composite of perinatal deaths or neonatal unit admission up to infant hospital discharge with a non-inferiority hypothesis (non-inferiority margin of 10% difference in incidence). Analyses were by intention to treat, together with a per-protocol analysis for the perinatal outcome. The trial was prospectively registered with the ISRCTN registry, ISRCTN01879376. The trial is closed to recruitment but follow-up is ongoing.FindingsBetween Sept 29, 2014, and Dec 10, 2018, 901 women were recruited. 450 women (448 women and 471 infants analysed) were allocated to planned delivery and 451 women (451 women and 475 infants analysed) to expectant management. The incidence of the co-primary maternal outcome was significantly lower in the planned delivery group (289 [65%] women) compared with the expectant management group (338 [75%] women; adjusted relative risk 0·86, 95% CI 0·79-0·94; p=0·0005). The incidence of the co-primary perinatal outcome by intention to treat was significantly higher in the planned delivery group (196 [42%] infants) compared with the expectant management group (159 [34%] infants; 1·26, 1·08-1·47; p=0·0034). The results from the per-protocol analysis were similar. There were nine serious adverse events in the planned delivery group and 12 in the expectant management group.InterpretationThere is strong evidence to suggest that planned delivery reduces maternal morbidity and severe hypertension compared with expectant management, with more neonatal unit admissions related to prematurity but no indicators of greater neonatal morbidity. This trade-off should be discussed with women with late preterm pre-eclampsia to allow shared decision making on timing of delivery.FundingNational Institute for Health Research Health Technology Assessment Programme.
| S-EPMC6892281 | biostudies-literature
Project description:AimThere is currently limited evidence on the costs associated with late preterm pre-eclampsia beyond antenatal care and post-natal discharge from hospital. The aim of this analysis is to evaluate the 24-month cost-utility of planned delivery for women with late preterm pre-eclampsia at 34+0-36+6 weeks' gestation compared to expectant management from an English National Health Service perspective using participant-level data from the PHOENIX trial.MethodsWomen between 34+0 and 36+6 weeks' gestation in 46 maternity units in England and Wales were individually randomised to planned delivery or expectant management. Resource use was collected from hospital records between randomisation and primary hospital discharge following birth. Women were followed up at 6 months and 24 months following birth and self-reported resource use for themselves and their infant(s) covering the previous 6 months. Women completed the EQ-5D 5L at randomisation and follow-up.ResultsA total of 450 women were randomised to planned delivery, 451 to expectant management: 187 and 170 women, respectively, had complete data at 24 months. Planned delivery resulted in a significantly lower mean cost per woman and infant(s) over 24 months (- £2711, 95% confidence interval (CI) - 4840 to - 637), with a mean incremental difference in QALYs of 0.019 (95% CI - 0.039 to 0.063). Short-term and 24-month infant costs were not significantly different between the intervention arms. There is a 99% probability that planned delivery is cost-effective at all thresholds below £37,000 per QALY gained.ConclusionThere is a high probability that planned delivery is cost-effective compared to expectant management. These results need to be considered alongside clinical outcomes and in the wider context of maternity care.Trial registrationISRCTN registry ISRCTN01879376. Registered 25 November 2013.
| S-EPMC9440173 | biostudies-literature