Dataset Information

Hypertension in pregnancy and adverse outcomes among low-risk nulliparous women expectantly managed at or after 39 weeks: a secondary analysis of a randomised controlled trial.

ABSTRACT:

Objective

To evaluate whether hypertensive disorders of pregnancy (HDP) among low-risk nulliparous women expectantly managed at or after 39 weeks of gestation are associated with adverse outcomes.

Design

Secondary analysis of a randomised trial.

Setting

Multicentre, USA.

Population

Individuals in the expectantly managed group who delivered on or after 39 weeks.

Methods

Multivariable analysis to estimate adjusted relative risks (aRR) for binomial outcomes, adjusted odds ratios (aOR) for multinomial outcomes and 95% CI.

Main outcome measures

Composite adverse maternal outcome including placental abruption, pulmonary oedema, postpartum haemorrhage, postpartum infection, venous thromboembolism or intensive care unit admission. Secondary outcomes included a composite of perinatal death or severe neonatal complications, mode of delivery, small and large for gestational age and neonatal intermediate or intensive unit length of stay.

Results

Of the 3044 women randomised to expectant management in the original trial, 2718 (89.3%) were eligible for this analysis, of whom 373 (13.7%) developed HDP. Compared with participants who remained normotensive, those who developed HDP were more likely to experience the maternal composite (12% versus 6%, aRR 1.84, 95% CI 1.33-2.54) and caesarean delivery (29% versus 23%, aOR 1.32, 95% CI 1.01-1.71). Differences between the two groups were not significantly different for the adverse perinatal composite (7% versus 5%, aRR 1.38, 95% CI 0.92-2.07) or for other secondary outcomes.

Conclusion

Almost 14% of low-risk nulliparous individuals expectantly managed at 39 weeks developed HDP, and were more likely to experience adverse maternal outcomes compared with those who did not develop HDP.

Tweetable abstract

Almost 14% of low-risk nulliparous individuals expectantly managed at 39 weeks developed hypertensive disorders of pregnancy, and were more likely to experience adverse maternal outcomes compared with those who did not develop hypertensive disorders.

SUBMITTER: Fishel Bartal M

PROVIDER: S-EPMC9207156 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature

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Publications

Hypertension in pregnancy and adverse outcomes among low-risk nulliparous women expectantly managed at or after 39 weeks: a secondary analysis of a randomised controlled trial.

Fishel Bartal Michal M Premkumar Ashish A Murguia Rice Madeline M Reddy Uma M UM Tita Alan T N ATN Silver Robert M RM El-Sayed Yasser Y YY Wapner Ronald J RJ Rouse Dwight J DJ Saade George R GR Thorp John M JM Costantine Maged M MM Chien Edward K EK Casey Brian M BM Srinivas Sindhu K SK Swamy Geeta K GK Simhan Hyagriv N HN

BJOG : an international journal of obstetrics and gynaecology 20220106 8

<h4>Objective</h4>To evaluate whether hypertensive disorders of pregnancy (HDP) among low-risk nulliparous women expectantly managed at or after 39 weeks of gestation are associated with adverse outcomes.<h4>Design</h4>Secondary analysis of a randomised trial.<h4>Setting</h4>Multicentre, USA.<h4>Population</h4>Individuals in the expectantly managed group who delivered on or after 39 weeks.<h4>Methods</h4>Multivariable analysis to estimate adjusted relative risks (aRR) for binomial outcomes, adju ...[more]

PMID: 34927787

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Project description:ObjectiveTo estimate whether the frequency of adverse maternal and neonatal outcomes differs between low-risk nulliparous and multiparous women at 39-41 weeks of gestation.MethodsThis is a secondary analysis of an observational obstetrics cohort of maternal-neonatal dyads at 25 hospitals. Low-risk women with nonanomalous singletons who delivered between 39 0/7 and 41 6/7 weeks of gestation were included. The composite neonatal adverse outcome included 5-minute Apgar score less than five, ventilator support or cardiopulmonary resuscitation, seizure, hypoxic ischemic encephalopathy, sepsis, bronchopulmonary dysplasia, persistent pulmonary hypertension, necrotizing enterocolitis, birth injury or perinatal death. The composite maternal adverse outcome included infection, third- or fourth-degree perineal laceration, thromboembolism, transfusion of blood products, or maternal death. Small for gestational age (SGA), large for gestational age (LGA), and shoulder dystocia requiring maneuvers were also evaluated. Multivariable regression was used to estimate adjusted relative risks (aRRs) and adjusted odds ratios (aORs) with 95% CIs.ResultsOf the 115,502 women in the overall cohort, 39,870 (34.5%) met eligibility criteria for this analysis; 18,245 (45.8%) were nulliparous. The risk of the composite neonatal adverse outcome (1.5% vs 1.0%, aRR 1.80, 95% CI 1.48-2.19), composite maternal adverse outcome (15.1% vs 3.3%, aRR 5.04, 95% CI 4.62-5.49), and SGA (8.9% vs 5.8%, aOR 1.45, 95% CI 1.33-1.57) was significantly higher in nulliparous than multiparous patients. The risk of LGA (aOR 0.65, 95% CI 0.60-0.71) and shoulder dystocia with maneuvers (aRR 0.68, 95% CI 0.60-0.77) was significantly lower in nulliparous rather than multiparous patients.ConclusionThe risk of composite adverse outcomes and SGA among low-risk nulliparous women at 39-41 weeks of gestation is significantly higher than among multiparous counterparts. However, nulliparous women had a lower risk of shoulder dystocia with maneuvers and LGA.

Project description:ObjectiveTo evaluate characteristics associated with adverse outcomes in low-risk nulliparous women randomized to elective labor induction at 39 weeks of gestation or expectant management.MethodsWe conducted a secondary analysis of women randomized during the 38th week to induction at 39 weeks of gestation or expectant management. Deliveries before 39 weeks of gestation and those not adherent to study protocol or with fetal anomalies were excluded. A composite of adverse outcomes (perinatal death or severe neonatal complications), third- or fourth-degree lacerations, and postpartum hemorrhage were evaluated. Log binomial regression models estimated relative risks and 95% CIs for associations of outcomes with patient characteristics including randomly assigned treatment group. Interactions between patient characteristics and treatment group were tested.ResultsOf 6,096 women with outcome data, 5,007 (82.1%) met criteria for inclusion in this analysis. Frequency of the perinatal composite was 252 (5.0%), 166 (3.3%) for third- or fourth-degree perineal laceration, and 237 (4.7%) for postpartum hemorrhage. In multivariable analysis, intended labor induction at 39 weeks of gestation was associated with a reduced perinatal composite outcome (4.1% vs 6.0%; adjusted relative risk [aRR] 0.71; 95% CI 0.55-0.90), whereas increasing body mass index (BMI) was associated with an increased perinatal composite outcome (aRR 1.04/unit increase; 95% CI 1.02-1.05). Decreased risk of third- or fourth-degree perineal laceration was observed with increasing BMI (aRR 0.96/unit increase; 95% CI 0.93-0.98) and in Black women compared with White women (1.2% vs 3.9%; aRR 0.34; 95% CI 0.19-0.60). Increased risk of postpartum hemorrhage was observed in Hispanic women compared with White women (6.3% vs 4.0%; aRR 1.64; 95% CI 1.18-2.29). Patient characteristics associated with adverse outcomes were similar between treatment groups (P for interaction >.05).ConclusionCompared with expectant management, intended induction at 39 weeks of gestation was associated with reduced risk of adverse perinatal outcome. Patient characteristics associated with adverse outcomes were few and similar between groups.Clinical trial registrationClinicalTrials.gov, NCT01990612.

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: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.

Project description:BackgroundObesity increases the risk for developing gestational diabetes mellitus (GDM) and preeclampsia (PE), which both associate with increased risk for type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD) in women in later life. In the general population, metabolic syndrome (MetS) associates with T2DM and CVD. The impact of maternal MetS on pregnancy outcomes, in nulliparous pregnant women, has not been investigated.Methods and findingsLow-risk, nulliparous women were recruited to the multi-centre, international prospective Screening for Pregnancy Endpoints (SCOPE) cohort between 11 November 2004 and 28 February 2011. Women were assessed for a range of demographic, lifestyle, and metabolic health variables at 15 ± 1 weeks' gestation. MetS was defined according to International Diabetes Federation (IDF) criteria for adults: waist circumference ≥80 cm, along with any 2 of the following: raised trigycerides (≥1.70 mmol/l [≥150 mg/dl]), reduced high-density lipoprotein cholesterol (<1.29 mmol/l [<50 mg/dl]), raised blood pressure (BP) (i.e., systolic BP ≥130 mm Hg or diastolic BP ≥85 mm Hg), or raised plasma glucose (≥5.6 mmol/l). Log-binomial regression analyses were used to examine the risk for each pregnancy outcome (GDM, PE, large for gestational age [LGA], small for gestational age [SGA], and spontaneous preterm birth [sPTB]) with each of the 5 individual components for MetS and as a composite measure (i.e., MetS, as defined by the IDF). The relative risks, adjusted for maternal BMI, age, study centre, ethnicity, socioeconomic index, physical activity, smoking status, depression status, and fetal sex, are reported. A total of 5,530 women were included, and 12.3% (n = 684) had MetS. Women with MetS were at an increased risk for PE by a factor of 1.63 (95% CI 1.23 to 2.15) and for GDM by 3.71 (95% CI 2.42 to 5.67). In absolute terms, for PE, women with MetS had an adjusted excess risk of 2.52% (95% CI 1.51% to 4.11%) and, for GDM, had an adjusted excess risk of 8.66% (95% CI 5.38% to 13.94%). Diagnosis of MetS was not associated with increased risk for LGA, SGA, or sPTB. Increasing BMI in combination with MetS increased the estimated probability for GDM and decreased the probability of an uncomplicated pregnancy. Limitations of this study are that there are several different definitions for MetS in the adult population, and as there are none for pregnancy, we cannot be sure that the IDF criteria are the most appropriate definition for pregnancy. Furthermore, MetS was assessed in the first trimester and may not reflect pre-pregnancy metabolic health status.ConclusionsWe did not compare the impact of individual metabolic components with that of MetS as a composite, and therefore cannot conclude that MetS is better at identifying women at risk. However, more than half of the women who had MetS in early pregnancy developed a pregnancy complication compared with just over a third of women who did not have MetS. Furthermore, while increasing BMI increases the probability of GDM, the addition of MetS exacerbates this probability. Further studies are required to determine if individual MetS components act synergistically or independently.

Project description:BackgroundIn 2017, the American College of Cardiology and American Heart Association (ACC/AHA) lowered blood pressure (BP) thresholds to define hypertension in adults outside pregnancy. If used in pregnancy, these lower thresholds may identify women at increased risk of adverse outcomes, which would be particularly useful to risk-stratify nulliparous women. In this secondary analysis of the SCOPE cohort, we asked whether, among standard-risk nulliparous women, the ACC/AHA BP categories could identify women at increased risk for adverse outcomes.Methods and findingsIncluded were pregnancies in the international SCOPE cohort with birth at ≥20 weeks' gestation, 2004 to 2008. Women were mostly of white ethnicity, in their 20s, and of normal-to-overweight body mass index (BMI). Excluded were pregnancies ending in fetal loss at <20 weeks' gestation, and those terminated at any point in pregnancy. Women were categorized by highest BP during pregnancy, using ACC/AHA criteria: normal (BP <120/80 mmHg), "Elevated BP" (BP 120 to 129 mmHg/<80 mmHg), "Stage-1 hypertension" (systolic BP [sBP] 130 to 139 mmHg or diastolic BP [dBP] 80 to 89 mmHg), and "Stage-2 hypertension" that was non-severe (sBP 140 to 159 mmHg or dBP 90 to 109 mmHg) or severe (sBP ≥160 mmHg or dBP ≥110 mmHg). Primary outcomes were preterm birth (PTB), low birthweight, postpartum hemorrhage, and neonatal care admission. Adjusted relative risks (aRRs) and diagnostic test properties were calculated for each outcome, according to: each BP category (versus "normal"), and using the lower limit of each BP category as a cut-off. RRs were adjusted for maternal age, BMI, smoking, ethnicity, and alcohol use. Of 5,628 women in SCOPE, 5,597 were included in this analysis. When compared with normotension, severe "Stage 2 hypertension" was associated with PTB (24.0% versus 5.3%; aRR 4.88, 95% confidence interval, CI [3.46 to 6.88]), birthweight <10th centile (24.4% versus 8.8%; aRR 2.70 [2.00 to 3.65]), and neonatal unit admission (32.9% versus 8.9%; aRR 3.40 [2.59 to 4.46]). When compared with normotension, non-severe "Stage 2 hypertension" was associated with birthweight <10th centile (16.1% versus 8.8%; aRR 1.82 [1.45 to 2.29]) and neonatal unit admission (15.4% versus 8.9%; aRR 1.65 [1.31 to 2.07]), but no association with adverse outcomes was seen with BP categories below "Stage 2 hypertension." When each BP category was assessed as a threshold for diagnosis of abnormal BP (compared with BP values below), only severe "Stage 2 hypertension" had a useful (good) likelihood ratio (LR) of 5.09 (95% CI [3.84 to 6.75]) for PTB. No BP threshold could rule-out adverse outcomes (i.e., had a negative LR <0.2). Limitations of our analysis include lack of ethnic diversity and use of values from clinical notes for BP within 2 weeks before birth. This study was limited by: its retrospective nature, not all women having BP recorded at all visits, and the lack of detail about some outcomes.ConclusionsIn this study, we observed that 2017 ACC/AHA BP categories demonstrated a similar pattern of association and diagnostic test properties in nulliparous women, as seen in the general obstetric population. BP thresholds below the currently used "Stage 2 hypertension" were not associated with PTB, low birthweight, postpartum hemorrhage, or neonatal unit admission. This study does not support implementation of lower BP values as abnormal in nulliparous pregnant women.

Project description:ObjectivesThe aim of the study was to identify the characteristics associated with spontaneous labor onset in pregnant patients undergoing expectant management at greater than 39 weeks' gestation and delineate perinatal outcomes associated with spontaneous labor compared with labor induction.Study designThis was a retrospective cohort study of singleton pregnancies at ≥390/7 weeks' gestation delivered at a single center in 2013. The exclusion criteria were elective induction, cesarean delivery or presence of a medical indication for delivery at 39 weeks, more than one prior cesarean delivery, and fetal anomaly or demise. We evaluated prenatally available maternal characteristics as potential predictors of the primary outcome-spontaneous labor onset. Multivariable logistic regression was used to generate two parsimonious models: one with and one without third trimester cervical dilation. We also performed sensitivity analysis by parity and timing of cervical examination, and compared the mode of delivery and other secondary outcomes between patients who went into spontaneous labor and those who did not.ResultsOf 707 eligible patients, 536 (75.8%) attained spontaneous labor and 171 (24.2%) did not. In the first model, maternal body mass index (BMI), parity, and substance use were identified as the most predictive factors. Overall, the model did not predict spontaneous labor (area under the curve [AUC]: 0.65; 95% confidence interval [CI]: 0.61-0.70) with high accuracy. The addition of third trimester cervical dilation in the second model did not significantly improve labor prediction (AUC: 0.66; 95% CI: 0.61-0.70; p = 0.76). These results did not differ by timing of cervical examination or parity. Patients admitted in spontaneous labor had lower odds of cesarean delivery (odds ratio [OR]: 0.33; 95% CI: 0.21-0.53) and neonatal intensive care unit (NICU) admission (OR: 0.38; 95% CI: 0.15-0.94). Other perinatal outcomes were similar between the groups.ConclusionMaternal characteristics did not predict spontaneous labor onset at ≥39 weeks' gestation with high accuracy. Patients should be counseled on the challenges of labor prediction regardless of parity and cervical examination, outcomes if spontaneous labor does not occur, and benefits of labor induction.Key points· Majority of patients will attain spontaneous labor at ≥39 weeks.. · Maternal characteristics do not predict labor at ≥39 weeks.. · Spontaneous labor has associated lower perinatal risks.. · A shared decision model should be utilized in counseling patients who may choose expectant management..

Dataset Information

Hypertension in pregnancy and adverse outcomes among low-risk nulliparous women expectantly managed at or after 39 weeks: a secondary analysis of a randomised controlled trial.

Objective

Design

Setting

Population

Methods

Main outcome measures

Results

Conclusion

Tweetable abstract

Publications

Hypertension in pregnancy and adverse outcomes among low-risk nulliparous women expectantly managed at or after 39 weeks: a secondary analysis of a randomised controlled trial.

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