Composite Maternal Outcome Research Articles

Covid‐19 vaccination during the third trimester of pregnancy: rate of vaccination and maternal and neonatal outcomes, a multicentre retrospective cohort study

ObjectiveTo evaluate the impact of Covid‐19 vaccination (Pfizer–BioNTech BNT162b2) during the third trimester of pregnancy on maternal and neonatal outcomes.DesignA multicentre, retrospective computerised database.PopulationWomen who gave birth at >24 weeks of gestation in Israel, between January and April 2021, with full records of Covid‐19 disease and vaccination status.MethodsWomen who received two doses of the vaccine were compared with unvaccinated women. Women who were recorded as having disease or a positive Covid‐19 polymerase chain reaction (PCR) swab during pregnancy or delivery were excluded from both study groups. Univariate analysis was followed by multivariate logistic regression.Main outcome measuresComposite adverse maternal outcomes. Secondary outcomes were vaccination rate and composite adverse neonatal outcomes.ResultsThe overall uptake of one or both vaccines was 40.2%; 712 women who received two doses of the Covid‐19 vaccine were compared with 1063 unvaccinated women. Maternal composite outcomes were comparable between the groups; however, women who received the vaccine had higher rates of elective caesarean deliveries (CDs) and lower rates of vacuum deliveries. An adjusted multivariable logistic regression analysis demonstrated that Covid‐19 vaccination was not associated with maternal composite adverse outcome (aOR 0.8, 95% CI 0.61–1.03); a significant reduction in the risk for neonatal composite adverse outcomes was observed (aOR 0.5, 95% CI 0.36–0.74).ConclusionsIn a motivated population covered by a National Health Insurance Plan, we found a 40.2% rate of vaccination for the Covid‐19 vaccine during the third trimester of pregnancy, which was not associated with adverse maternal outcomes and, moreover, decreased the risk for neonatal adverse outcomes.Tweetable abstractCovid‐19 vaccine during pregnancy is safe for both mother and fetus.

Use of metformin to prolong gestation in preterm pre-eclampsia: randomised, double blind, placebo controlled trial

ObjectiveTo evaluate whether extended release metformin could be used to prolong gestation in women being expectantly managed for preterm pre-eclampsia.DesignRandomised, double blind, placebo controlled trial.SettingReferral hospital in Cape Town, South...

Vacuum-assisted vaginal deliveries among parturients with congenital uterine anomalies; risk factors and outcomes

ObjectiveTo evaluate the maternal and neonatal outcomes associated with vacuum-assisted vaginal delivery (VAVD) in a subset of parturients with congenital uterine anomalies. Study DesignA retrospective database study was conducted at a single tertiary center between 2005 and 2019. Parturients with known congenital uterine anomalies who had vaginal deliveries were enrolled, whereas parturients with failed VAVD, didelphic uterus, and delivery after intrauterine fetal death were excluded. Various maternal and neonatal outcomes were compared between parturients who achieved spontaneous vaginal delivery (SVD) and those who delivered via VAVD. The maternal composite outcome was calculated for each group and included one or more of the following: post-partum hemorrhage, hemoglobin drop ≥ 4 gr/dL, blood transfusions, retained placental products, and obstetric anal sphincter injuries. Univariate analysis was performed followed by multivariate logistic regression analysis controlling for potential confounders. Adjusted odds ratios (aORs) and 95% confidence intervals (CIs) were calculated. ResultsAfter the application of the exclusion criteria, 332 parturients were found eligible. Of those, 289 (87%) had SVD and 43 (13%) had VAVD. VAVD was more common among primiparous parturients and epidural analgesia users. Parturients with VAVD had higher rates of third-degree perineal tear, postpartum hemorrhage, and blood transfusions. The maternal composite outcome was significantly more prevalent in the VAVD group (44.2% vs. 20.8%, p < 0.01). After controlling for potential confounders, the maternal composite outcome was found to be independently associated with VAVD (aOR 2.3, 95% CI 1.10–4.60). The neonatal results were overall comparable, except for scalp trauma and Erb’s palsy/clavicular fracture, which were more prevalent in the VAVD group. ConclusionIn a special population of parturients with congenital uterine anomalies, VAVD was found to be associated with significantly higher rates of adverse maternal outcomes and perinatal birth trauma. These findings should be presented to parturients during consultations about modes of delivery.

Maternal anemia and severe maternal morbidity in a US cohort

Maternal anemia is a common pregnancy complication and often leads to a requirement for additional treatments and interventions. Identifying the frequency at which women with antenatally diagnosed anemia experience severe morbidity at the time of admission to the labor and delivery unit will guide future recommendations regarding screening and interventions for anemia during pregnancy. The objective of this study was to evaluate the association between antenatally diagnosed anemia and severe maternal morbidity as defined by the Centers for Disease Control and Prevention in a large, contemporary, US cohort. Neonatal outcomes were also examined. This was a secondary analysis of the Consortium on Safe Labor database from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, which collected data on 228,438 deliveries in 19 United States hospitals from 2002 to 2008. This analysis included women with viable, singleton gestations and excluded stillbirths and gestations with severe congenital anomalies. Women with a diagnosis of antenatal anemia were compared with those without. Identification of diagnoses of antenatal anemia was obtained via electronic medical record abstraction and International Classification of Diseases coding according to each hospital protocol within the Consortium on Safe Labor. The primary maternal outcome consisted of a composite of severe maternal morbidity as defined by the Centers for Disease Control and Prevention and included maternal death, eclampsia, thrombosis, transfusion, hysterectomy, and maternal intensive care unit admission. The primary neonatal outcome was a composite that included a 5-minute Apgar score of <7, hypoxic ischemic encephalopathy, respiratory distress syndrome, necrotizing enterocolitis, seizures, intracranial hemorrhage, periventricular or intraventricular hemorrhage, neonatal sepsis, neonatal intensive care unit admission, and neonatal death. Each outcome within the composites was assessed individually along with other additional secondary outcomes, including a composite of severe maternal morbidity not including transfusion morbidity. All statistical analyses were performed with Stata version 14.2 (StataCorp LLC, College Station, TX) using Student's t test, chi-square test, Fisher's exact test, and Wilcoxon rank-sum (Mann-Whitney U) test, as appropriate. A multivariable logistic regression was performed with potential confounding variables entered into the regression equation if they differed between groups at a significance level of P<.05. A total of 166,566 women met the inclusion criteria. From the original cohort, 56,734 women could not be included because of an unknown diagnosis of anemia. Of those included, 10,217 (6.1%) were diagnosed with anemia during the pregnancy. Women with anemia were more likely to be younger, non-Hispanic Black, single, multiparous, and have a higher prepregnancy body mass index than those without anemia. The frequency of the primary maternal composite outcome, the neonatal composite outcome, and other secondary outcomes including the severe maternal morbidity composite not including transfusion, maternal death, transfusion during labor and the postpartum period, hysterectomy, postpartum hemorrhage, infectious morbidity, cesarean delivery, and preterm delivery were more common in women with anemia (P<.05). After multivariable logistic regression analysis adjusting for confounders, higher rates of severe maternal morbidity remained persistently associated with anemia (adjusted odds ratio, 2.04; 95% confidence interval, 1.86-2.23) in addition to the association of anemia with the severe maternal morbidity composite not including transfusion, maternal death, thrombosis, transfusion, hysterectomy, intensive care unit admission, postpartum hemorrhage, hypertensive disorders of pregnancy, cesarean delivery, and infectious morbidity. The composite neonatal outcome also remained associated with anemia after adjusting for confounders (adjusted odds ratio, 1.14; 95% confidence interval, 1.06-1.23). Women with antepartum anemia experienced increased rates of severe maternal morbidity and other serious adverse outcomes. Diagnosis and treatment of anemia during the antepartum period may lead to the identification and treatment of women at higher risk for maternal morbidity and mortality.

Efficacy and safety of oral misoprostol vs transvaginal balloon catheter for labor induction: An observational study within the SWEdish Postterm Induction Study (SWEPIS).

Induction of labor is increasing. A common indication for induction of labor is late term and postterm pregnancy at 41 weeks or more. We aimed to evaluate if there are any differences regarding efficacy, safety, and women's childbirth experience between oral misoprostol and transvaginal balloon catheter for cervical ripening in women with a low-risk singleton pregnancy and induction of labor at 41+0 to 42+0 to 1 weeks of gestation. In this observational study, based on data from the Swedish Postterm Induction Study (SWEPIS), a multicenter randomized controlled trial, a total of 1213 women with a low-risk singleton pregnancy at 41 to 42 weeks of gestation were induced with oral misoprostol (n=744) or transvaginal balloon catheter (n=469) at 15 Swedish delivery hospitals. The primary efficacy outcome was vaginal delivery within 24h and primary safety outcomes were neonatal and maternal composite adverse outcomes. Secondary outcomes included time to vaginal delivery and mode of delivery. Women's childbirth experience was assessed with the Childbirth Experience Questionnaire (CEQ 2.0) and visual analog scale. We present crude and adjusted mean differences and relative risks (RR) with 95% CI. Adjustment was performed for a propensity score based on delivery hospital and baseline characteristics including Bishop score. Vaginal delivery within 24h was significantly lower in the misoprostol group compared with the balloon catheter group (46.5% [346/744] vs 62.7% [294/469]; adjusted RR 0.76 95% CI 0.640.89]). Primary neonatal and maternal safety outcomes did not differ between groups (neonatal composite 3.5% [36/744] vs 3.2% [15/469]; adjusted RR 0.77 [95% CI 0.31-1.89]; maternal composite 2.3% [17/744] vs 1.9% [9/469]; adjusted RR 1.70 [95% CI 0.58-4.97]). Adjusted mean time to vaginal delivery was increased by 3.8h (95% CI 1.3-6.2h) in the misoprostol group. Non-operative vaginal delivery and cesarean delivery rates did not differ. Women's childbirth experience was positive overall and similar in both groups. Induction of labor with oral misoprostol compared with a transvaginal balloon catheter was associated with a lower probability of vaginal delivery within 24h and a longer time to vaginal delivery. However, primary safety outcomes, non-operative vaginal delivery, and women's childbirth experience were similar in both groups. Therefore, both methods can be recommended in women with low-risk postdate pregnancies.

Association between the number of pulls and adverse neonatal/maternal outcomes in vacuum-assisted delivery.

To determine the association between the number of pulls during vacuum-assisted deliver and neonatal and maternal complications. This was a single-center observational study using a cohort of pregnancies who underwent vacuum-assisted delivery from 2013 to 2020. We excluded pregnancies transitioning to cesarean section after a failed attempt at vacuum-assisted delivery. The number of pulls to deliver the neonate was categorized into 1, 2, 3, and≥4 pulls. We used logistic regression models to investigate the association between the number of pulls and neonatal intensive care unit (NICU) admission and maternal composite outcome (severe perineal laceration, cervical laceration, transfusion, and postpartum hemorrhage≥500mL). We extracted 480 vacuum-assisted deliveries among 7,321 vaginal deliveries. The proportion of pregnancies receiving 1, 2, 3, or≥4 pulls were 51.9, 28.3, 10.8, and 9.0%, respectively. The crude prevalence of NICU admission with 1, 2, 3, and≥4 pulls were 10.8, 16.2, 15.4, and 27.9%, respectively. The prevalence of NICU admission, amount of postpartum hemorrhage, and postpartum hemorrhage≥500mL were significantly different between the four groups. Multivariable logistic regression analysis found the prevalence of NICU admission in the≥4 pulls group was significantly higher compared with the 1 pull group (adjusted odds ratio, 3.3; 95% confidence interval, 1.4-7.8). In contrast, maternal complications were not significantly associated with the number of pulls. Vacuum-assisted delivery with four or more pulls was significantly associated with an increased risk of NICU admission. However, the number of pulls was not associated with maternal complications.

378 Age, parity and interval from previous delivery – influence on perinatal outcome

To investigate the effect of parity and interpregnancy interval (IPI) on perinatal outcomes in advanced maternal age parturients (>40 years). A population-based retrospective cohort study of all women older than 40 years old, who had a singleton live birth after 24 weeks in the US in 2017 (http://data.nber.org/data/vital-statistics-natality-data.html). Women were categorized to three groups by parity and interval from last delivery: primiparas, multiparas with IPI<5 years, and multiparas with IPI>5 years. Primary outcome was composite neonatal outcome (preterm delivery <34 weeks, birthweight <2000 grams, neonatal seizures, neonatal intensive care unit admission, Apgar score less than 7 at 5 minutes or neonatal assisted ventilation for more than 6 hours). Secondary outcome was maternal composite (uterine rupture, unplanned hysterectomy, maternal intensive care unit admission or maternal blood transfusion) and other adverse perinatal outcomes. Univariate analysis followed by multivariate analysis was used to compare between groups. During 2017, 3,864,754 deliveries were recorded into the database. Following exclusion, 109,564 elderly gravidas entered analysis. Of them, 24,769(22.6%) were nulliparas, 39,933(36.4%) were multiparas with IPI< 5 years and 44,862(40.9%) were multiparas with IPI>5 years. Composite neonatal outcome was higher in nulliparas and in multiparas with IPI > 5 years, in comparison to multiparas with IPI lower than 5 years (16% vs. 13% vs. 10%, respectively, p<0.05). Nulliparas had higher rates of hypertensive disorders, induction of labor, cesarean deliveries and postpartum blood transfusions. However, maternal composite outcome was similar between groups (Table 1). In the multivariable analysis, relative to nulliparas, only multiparity with IPI<5 years had a protective effect against the composite neonatal outcome (aOR 0.97, 95% CI 0.95-0.99, p<0.001), Table 2. Among elderly gravidas, multiparity with IPI≤5 years has a significant protective effect against adverse neonatal outcomes. Multiparity with IPI>5 years is no longer protective.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

446 Risk factors and outcomes of vacuum assisted vaginal deliveries among parturients with congenital uterine anomalies

To evaluate the maternal and neonatal outcomes associated with vacuum-assisted vaginal delivery (VAVD) in a subset of parturients with congenital uterine anomalies. A retrospective cohort study was conducted at a single tertiary center between 2005 and 2019. Parturients with known congenital uterine anomalies who had vaginal deliveries were included; we excluded parturients with failed VAVD, didelphic uterus, and delivery after intrauterine fetal death. Maternal and neonatal outcomes were compared between parturients who achieved spontaneous vaginal delivery (SVD) and those delivered via VAVD. A maternal adverse composite outcome was calculated for each group and included one or more of the following: hemoglobin drop > 3 gr/Dl, blood transfusions, retained placental products, and obstetric anal sphincter injuries. Univariate analysis was performed followed by multivariate logistic regression analysis controlling for potential confounders. Adjusted odds ratios (aORs) and 95% confidence intervals (CIs) were calculated. After the application of the exclusion criteria, 332 parturients were identified; of those, 289 (87%) had SVD and 43 (13%) had VAVD. VAVD was more common among primiparous parturients and epidural analgesia users. Parturients with VAVD had higher rates of third-degree perineal tear, postpartum hemorrhage, and blood transfusions. The maternal composite outcome was significantly more prevalent in the VAVD group (44.2% vs. 20.8%, p < 0.01). After controlling for potential confounders, the maternal adverse composite outcome was found to be independently associated with VAVD (aOR 2.3, 95% CI 1.10–4.60). The neonatal outcomes were comparable among groups, except for scalp trauma and Erb’s palsy/clavicular fracture, which were more prevalent in the VAVD group. In a population of parturients with known congenital uterine anomalies, VAVD was found to be associated with significantly higher rates of adverse maternal outcomes and perinatal birth trauma. These findings should be accounted for at consult sessions towards delivery plan.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

27 Metformin to treat Preterm Pre-eclampsia (PI-2): A randomised, double blind, placebo-controlled trial

Preterm preeclampsia has high rates of maternal and perinatal morbidity and mortality. No drugs have clearly shown a prolongation in gestation. Preclinical studies have identified metformin as a potential treatment. We performed a double-blind, randomised placebo-controlled trial at Tygerberg Hospital, South Africa. We randomly assigned women with preterm preeclampsia between 26+0 to 31+6 weeks gestation and undergoing expectant management to 3 grams of oral metformin XR (extended released) in divided doses, or placebo. The primary outcome was prolongation of pregnancy. Secondary outcomes included maternal and neonatal composite, and individual outcomes. Before the trial we performed metformin pharmacokinetic studies on 15 women with preterm preeclampsia. Between Feb 2018 and Mar 2020 we randomly allocated 180 participants to receive metformin (n=90) or placebo (n=90). Pharmacokinetic studies demonstrated oral metformin XR resulted in good circulating drug concentrations. The primary outcome analysis included 87 allocated to metformin and 84 assigned to placebo. The median time from randomization to delivery was 16.2 days (interquartile range (IQR), 5.2-28.8 days) in the metformin group and 9.5 days (IQR 3.4-22.7) days in the placebo group (difference of 6.7 days (95% Confidence Interval (CI) -0.17 to 13.64; P=0.056; Fig 1). In a pre-specified per protocol analysis that included only those who were compliant, the median prolongation was 16.2 (IQR 5.3-27.5; n=75) versus 7.4 (IQR 2.9-21.2; n=72) days, respectively (difference of 8.4 days, 95%CI 1.0-15.8; P=0.026). There were trends towards increased birthweight (1538g vs 1402g, difference of 136g, 95% CI-12 to 285;P=0.07) and a decreased length of stay (12 vs 18.0, difference of 6 days (95% CI-0.4 to 12.4;P=0.07) in the neonatal nursery among those in the metformin group (Table 1). There were no differences in composite maternal or neonatal outcomes or circulating concentrations of sFlt-1 or placental growth factor. In women with preterm preeclampsia, metformin prolongs gestation and may improve neonatal outcomes.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

370 The risk of failed operative delivery - impact on maternal and neonatal adverse outcome

Operative delivery (OP) is associated with adverse perinatal outcome, however, cesarean delivery (CD), especially at second stage of labor has also an impact on adverse outcome. We aimed to compare perinatal outcome between delivery routes at second stage of labor - CD, successful OP or CD following failed OP. A retrospective cohort study of all live, singleton deliveries in one medical center (2018-2019). Preterm deliveries <34 weeks, spontaneous vaginal deliveries and any CD before second stage of labor were excluded. Maternal demographics and perinatal outcomes were compared between 3 groups: CD, successful OP and CD after failed OP. Primary outcome was defined as neonatal composite outcome (including: pH<7.1, 5-minute Apgar score<8 and NICU admission). Secondary outcome included maternal composite outcome (including: DIC, relaparotomy, hysterectomy, readmission and ICU admission) and other separate adverse outcomes. Multivariable logistic regression analysis was used to adjust for potential confounders. P value< 0.05 was considered significant. Overall, 779 deliveries met inclusion criteria. Of them, 628 (80.6%) had successful OP ,128 (16.4%) had second stage CD, and 23 (2.9%) had CD after failed OP. Women that underwent CD after failed OP had lower BMI compared to OP and CD (26.4 vs 28 vs 30.6, Kg/m2 p=0.001). Rates of neonatal composite outcome, low PH (<7.1) and NICU admission were higher following CD after failed OP (p<0.05 for all). There was no difference in maternal outcome between groups, except for higher rates of readmission for the group who had CD (1.1% vs 7.8% vs 4.3%, p<0.001). After adjusting for potential confounders, neonatal composite outcome remained significantly worse for the group who had CD following failed OP (aOR 2.38, 95% CI 1.18-4.7, p=0.015). When intervention during second stage of labor is warranted, failed OP seems to be associated with less favorable neonatal outcome compared to CD or successful OP. Nevertheless, method of intervention chosen has minor impact on maternal outcome.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

535 Maternal and neonatal outcomes among women with and without SARS-CoV-2 infection during pregnancy

Objective: To examine maternal and neonatal outcomes in women with and without SARS-CoV-2 during pregnancy. Study Design: We conducted a multicenter retrospective cohort study of all pregnant women delivering at three hospitals in a large not-for-profit health care organization from March through July 2020. We compared outcomes between women with and without confirmed SARS-CoV-2 during pregnancy. Coarsened exact matching was performed to match women with and without SARS-CoV-2 using maternal age, body mass index, gestational age at delivery, parity and institution of delivery. The primary outcome was a composite of maternal complications including stillbirth, postpartum hemorrhage, intraamniotic infection, endometritis and ICU admission. Secondary outcomes of neonatal complications included Apgar score <7 at 5 minutes and low birth weight. Outcomes were examined by adjusted binomial logistic regression analysis incorporating matched weights. Result(s): Of 2,714 women who delivered at the three hospitals, a diagnosis of SARS-CoV-2 was made in 122 (4.5%) women during the pregnancy. After coarsened exact matching, the study cohort included 486 women, 91 (18.7%) with a diagnosis of SARS-CoV-2 during pregnancy and 395 (81.3%) without this diagnosis. Demographic data showed that more Hispanic women were diagnosed with SARS-CoV-2 infection compared to other races. Compared to uninfected women, women with SARS-CoV-2 infection had statistically significant higher odds of the composite maternal outcome (6.6% vs. 14.3%;aOR 2.35 [95% CI 1.16-4.78). No statistically significant differences were seen between the groups regarding neonatal outcomes. Conclusion(s): Hispanic women were more likely to be infected during pregnancy with SARS-CoV-2, illustrating the racial disparity that exists within virus infectivity. Our data illustrates increased maternal morbidity with SARS-CoV-2 infection, but no differences in neonatal outcomes. [Formula presented] [Formula presented]Copyright © 2020

Parity and Interval from Previous Delivery-Influence on Perinatal Outcome in Advanced Maternal Age Parturients.

Objective: To investigate the effect of parity and interpregnancy interval (IPI) on perinatal outcomes in advanced maternal age (AMA) parturients. Methods: A population-based retrospective cohort study of all women older than 40 years, who had a singleton live birth after 24 weeks in the United States in 2017 Women were categorized to three groups by parity and interval from last delivery: primiparas, multiparas with IPI ≤ 5 years, and multiparas with IPI > 5 years. Primary outcome was composite adverse neonatal outcome (preterm delivery <34 weeks, birthweight <2000 g, neonatal seizure, neonatal intensive care unit admission, Apgar score <7 at 5 min, or assisted ventilation >6 h). Secondary outcome was composite adverse maternal outcome and other adverse perinatal outcomes. Univariate and multivariate analysis were used to compare between groups. Results: During 2017, 3,864,754 deliveries were recorded into the database. Following exclusion, 109,564 AMA gravidas entered analysis. Of them, 24,769 (22.6%) were nulliparas, 39,933 (36.4%) were multiparas with IPI ≤ 5 years, and 44,862 (40.9%) were multiparas with IPI > 5 years. Composite neonatal outcome was higher in nulliparas and in multiparas with IPI > 5 years, in comparison to multiparas with IPI ≤ 5 years (16% vs. 13% vs. 10%, respectively, p < 0.05). Maternal composite outcome was similar between groups. In the multivariable analysis, relative to nulliparas, only multiparity with IPI ≤ 5 years had a protective effect against the composite neonatal outcome (aOR 0.97, 95% CI 0.95–0.99, p < 0.001). Conclusion: Among AMA gravidas, multiparity with IPI ≤ 5 years has a significant protective effect against adverse neonatal outcomes when compared to nulliparas. Multiparity with IPI > 5 years is no longer protective.

Cesarean delivery or induction of labor in pre-labor twin gestations: a secondary analysis of the twin birth study

BackgroundIn the Twin Birth Study, women at 320/7–386/7 weeks of gestation, in whom the first twin was in cephalic presentation, were randomized to planned vaginal delivery or cesarean section. The study found no significant differences in neonatal or maternal outcomes in the two planned mode of delivery groups. We aimed to compare neonatal and maternal outcomes of twin gestations without spontaneous onset of labor, who underwent induction of labor or pre-labor cesarean section as the intervention of induction may affect outcomes.MethodsIn this secondary analysis of the Twin Birth Study we compared those who had an induction of labor with those who had a pre-labor cesarean section. The primary outcome was a composite of fetal or neonatal death or serious neonatal morbidity. Secondary outcome was a composite of maternal morbidity and mortality. Trial Registration: NCT00187369.ResultsOf the 2804 women included in the Twin Birth Study, a total of 1347 (48%) women required a delivery before a spontaneous onset of labor occurred: 568 (42%) in the planned vaginal delivery arm and 779 (58%) in the planned cesarean arm. Induction of labor was attempted in 409 (30%), and 938 (70%) had a pre-labor cesarean section. The rate of intrapartum cesarean section in the induction of labor group was 41.3%. The rate of the primary outcome was comparable between the pre-labor cesarean section group and induction of labor group (1.65% vs. 1.97%; p = 0.61; OR 0.83; 95% CI 0.43–1.62). The maternal composite outcome was found to be lower with pre-labor cesarean section compared to induction of labor (7.25% vs. 11.25%; p = 0.01; OR 0.61; 95% CI 0.41–0.91).ConclusionIn women with twin gestation between 320/7–386/7 weeks of gestation, induction of labor and pre-labor cesarean section have similar neonatal outcomes. Pre-labor cesarean section is associated with favorable maternal outcomes which differs from the overall Twin Birth Study results. These data may be used to better counsel women with twin gestation who are faced with the decision of interventional delivery.

Duration of labor induction in nulliparous women with hypertensive disorders of pregnancy and maternal and neonatal outcomes

Objective The objective of this study was to quantify the association between duration of labor induction in nulliparous women with hypertensive disorders of pregnancy and maternal and neonatal morbidity. Methods This was a secondary analysis of a multicenter cohort study of 228,438 deliveries in 19 U.S. hospitals. The analysis included nulliparous women ≥18 years old with singleton gestation diagnosed with hypertensive disorders of pregnancy and undergoing induction of labor for that indication. Duration of labor induction, defined as time from admission to delivery, was examined by 4 h intervals from <12 h to ≥24 h in relation to maternal and neonatal composite outcomes. Maternal composite outcome included operative vaginal delivery, chorioamnionitis, blood transfusion, intensive care unit admission, placental abruption, 3rd or 4th degree perineal laceration, endometritis, postpartum hemorrhage, or venous thromboembolism. Neonatal composite outcome included neonatal intensive care unit (NICU) admission, respiratory distress syndrome, 5-minute Apgar score ≤7, seizure, infection, intrapartum meconium aspiration, intracranial hemorrhage, shoulder dystocia, and neonatal death. The trends in proportions of outcomes that occurred at different intervals were examined by Cochran-Armitage trend test. Relative risks were calculated with <12 h as the reference category and potential confounders adjusted by log-binomial or Poisson regression. Possible correlations within centers were taken into account using generalized estimating equations. Results A total of 3,990 women met inclusion criteria. The median labor duration was 19.8 h (interquartile range 12.9 h-27.9h), with 849 (21.3%) lasting <12 h and 1,426 (35.7%) >24 h. The frequency of composite maternal outcome was not associated with labor duration; however, the rates of chorioamnionitis (p < .001) and postpartum hemorrhage (p < .001) increased as labor duration increased. The frequency of composite neonatal outcome was greater with increasing labor duration (p < .001). After multivariable adjustment, duration of labor induction was associated with increased risks of maternal composite outcome after 24 h (aRR 1.39, 95% CI 1.20–1.62) and neonatal composite outcome after 24 h (aRR 1.32, 95% CI 1.11–1.56). Conclusions In nulliparous women with hypertensive disorders of pregnancy, duration of labor induction was associated with increased risks for maternal and neonatal morbidity after 24 h.

OC04.02: Maternal outcomes of pregnant women with COVID‐19: a multinational study

To evaluate maternal outcomes of pregnant women affected by COVID-19. This was a multinational cohort study including women with laboratory-confirmed COVID-19 from 73 centres from 22 different countries in Europe, USA, South America, Asia and Australia. Confirmed COVID-19 infection was defined as a positive result on real-time reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay of nasal and pharyngeal swab specimens. The primary outcome was a composite measure of maternal mortality and morbidity including admission to intensive care unit (ICU), use of mechanical ventilation, or death. Logistic regression analysis was performed to evaluate parameters independently associated with the primary outcome. Logistic regression was reported as odds ratio (OR) with 95% confidence interval (CI). 388 singleton pregnancies tested positive to COVID-19 at RT-PCR nasal and pharyngeal swab in were included in the study. The mean gestational age at infection was 30.6 ± 9.5 weeks. Included women were symptomatic in 75.8% of the cases. The most common symptom at the time of triage was cough (52.1%), while shortness of breath was present in 60 women (15.5%). Adverse composite maternal outcome was reported in 47/388 (12.1%) women, with 11.1% of women admitted to ICU, and 9.3% requiring mechanical ventilation. Three cases of maternal deaths occurred (mortality rate 0.8%). At logistic regression analysis, gestational age at infection (OR: 0.93, 95% CI 0.87 to 0.99 per week increase, p = 0.039), shortness of breath (OR: 3.32, 95% CI 1.07 to 9.21, p = 0.037), bilateral CT abnormalities (OR: 3.14, 95% CI 1.18 to 10.94, p = 0.025) and increased LDH levels (OR: 4.07, 95% CI 1.30 to 12.75, p = 0.016) were the only parameters independently associated with composite adverse maternal outcome. This is the largest study on COVID-19 infection during pregnancy. COVID-19 in pregnant women is associated with low rate of maternal mortality, but 11.1% rate of admission to ICU.

Obstetric Hemorrhage Risk Associated with Novel COVID-19 Diagnosis from a Single-Institution Cohort in the United States.

The study aimed to compare the quantitative blood loss (QBL) and hemorrhage-related outcomes of pregnant women with and without a coronavirus disease 2019 (COVID-19) diagnosis. This retrospective cohort study of all live deliveries at Boston Medical Center between April 1, 2020 and July 22, 2020 compares the outcomes of pregnant women with a laboratory-confirmed COVID-19 positive diagnosis and pregnant women without COVID-19. The primary outcomes are QBL and obstetric hemorrhage. The secondary outcomes analyzed were a maternal composite outcome that consisted of obstetric hemorrhage, telemetry-level (intermediate care unit) or intensive care unit, transfusion, length of stay greater than 5 days, or intraamniotic infection, and individual components of the maternal composite outcome. Groups were compared using Student's t-test, Chi-squared tests, or Fisher's exact. Logistic regression was used to adjust for confounding variables. Of 813 women who delivered a live infant between April 1 and July 22, 2020, 53 women were diagnosed with COVID-19 on admission to the hospital. Women with a COVID-19 diagnosis at their time of delivery were significantly more likely to identify as a race other than white (p = 0.01), to deliver preterm (p = 0.05), to be diagnosed with preeclampsia with severe features (p < 0.01), and to require general anesthesia (p < 0.01). Women diagnosed with COVID-19 did not have a significantly higher QBL (p = 0.64). COVID-19 positive pregnant patients had no increased adjusted odds of obstetric hemorrhage (adjusted odds ratio [aOR]: 0.41, 95% confidence interval [CI]: 0.17-1.04) and no increased adjusted odds of the maternal morbidity composite (aOR: 0.98, 95% CI: 0.50-1.93) when compared with those without a diagnosis of COVID-19. Pregnant women with COVID-19 diagnosis do not have increased risk for obstetric hemorrhage, increased QBL or risk of maternal morbidity compared with pregnant women without a COVID-19 diagnosis. Further research is needed to describe the impact of a COVID-19 diagnosis on maternal hematologic physiology and pregnancy outcomes. · Information about blood loss associated with peripartum COVID-19 is limited.. · COVID-19 diagnosis is not associated with increase in obstetric hemorrhage.. · COVID-19 diagnosis is not associated with increase in blood loss..

Association between Number of Prior Cesareans and Early Preterm Delivery in Women with Abnormal Placentation.

Delivery timing at 34 to 36 weeks is nationally recommended for pregnancies complicated by placenta accreta spectrum (PAS). However, it has recently been suggested that those with ≥2 prior cesarean deliveries (CD) and PAS should be delivered earlier than 34 weeks because of a higher risk of unscheduled delivery and complications. We sought to evaluate whether the number of prior CD in women with PAS is associated with early preterm delivery (PTD) (<34 weeks). We also evaluated the same relationship in women with placenta previa alone (without PAS). This is a secondary analysis of a multicenter and observational study that included women with prior CD (maternal-fetal medicine unit cesarean registry). Women with a diagnosis of PAS (regardless of placenta previa) were included for our primary analysis, and women with known placenta previa (without a component of PAS) were independently analyzed in a second analysis. Two groups of patients from the registry were studied: patients with PAS (regardless of placenta previa) and patients with placenta previa without PAS. The exposure of interest was the number of prior CD: ≥2 CD compared with <2 CD. The primary outcome was PTD <34 weeks. Secondary outcomes included preterm labor requiring hospitalization or tocolysis, transfusion of blood products, composites of maternal and neonatal morbidities, and NICU admission. Outcomes by prior CD number groups were compared in both cohorts. Backward selection was used to identify parsimonious logistic regression models. There were 194 women with PAS, 97 (50%) of whom had <2 prior CD and 97 (50%) of whom had ≥2 prior CD. The rate of PTD <34 weeks in women with ≥2 prior CD compared with <2 in the setting of PAS was 23.7 versus 29.9%, p = 0.27; preterm labor requiring hospitalization was 24.7 versus 13.5%; p = 0.05. The rates of plasma transfusion were increased with ≥2 prior CD (29.9 vs. 17.5%, p = 0.04), but there were no differences in transfusion of other products or in composite maternal or neonatal morbidities. After multivariable adjustments, having ≥2 CDs was not associated with PTD <34 weeks in women with PAS (adjusted odds ratio (aOR): 0.73, 95% confidence interval [CI]: 0.39-13.8) despite an association with preterm labor requiring hospitalization (aOR: 2.69; 95% CI: 1.15-6.32). In our second analysis, there were 687 women with placenta previa, 633 (92%) with <2 prior CD, and 54 (8%) with ≥2 prior CD. The rate of PTD <34 weeks with ≥2 CD in the setting of placenta previa was not significantly increased (27.8 vs. 22.1%, aOR: 1.49; 95% CI: 0.77-2.90, p = 0.08); the maternal composite outcome (aOR: 4.85; 95% CI: 2.43-9.67) and transfusion of blood products (aOR: 6.41; 95% CI: 2.30-17.82) were noted to be higher in the group with ≥2 prior CD. Women with PAS who have had ≥2 prior CD as compared with women with <2 prior CD did not appear to have a higher risk of complications leading to delivery prior to 34 weeks. As such, considering the associated morbidity with early preterm birth, we would not recommend scheduled delivery prior to 34 weeks in this population. · We do not recommend delivery prior to 34 weeks of gestational age in PAS.. · PTD was not significantly increased in PAS with ≥2 CDs.. · PTD < 34 weeks of gestational age was not increased in placenta previa with ≥2 prior CDs..

Epidemiology of coronavirus disease 2019 in pregnancy: risk factors and associations with adverse maternal and neonatal outcomes

BackgroundCoronavirus disease 2019 may be associated with adverse maternal and neonatal outcomes in pregnancy, but there are few controlled data to quantify the magnitude of these risks or to characterize the epidemiology and risk factors.ObjectiveThis study aimed to quantify the associations of coronavirus disease 2019 with adverse maternal and neonatal outcomes in pregnancy and to characterize the epidemiology and risk factors.Study DesignWe performed a matched case-control study of pregnant patients with confirmed coronavirus disease 2019 cases who delivered between 16 and 41 weeks’ gestation from March 11 to June 11, 2020. Uninfected pregnant women (controls) were matched to coronavirus disease 2019 cases on a 2:1 ratio based on delivery date. Maternal demographic characteristics, coronavirus disease 2019 symptoms, laboratory evaluations, obstetrical and neonatal outcomes, and clinical management were chart abstracted. The primary outcomes included (1) a composite of adverse maternal outcome, defined as preeclampsia, venous thromboembolism, antepartum admission, maternal intensive care unit admission, need for mechanical ventilation, supplemental oxygen, or maternal death, and (2) a composite of adverse neonatal outcome, defined as respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, 5-minute Apgar score of <5, persistent category 2 fetal heart rate tracing despite intrauterine resuscitation, or neonatal death. To quantify the associations between exposure to mild and severe or critical coronavirus disease 2019 and adverse maternal and neonatal outcomes, unadjusted and adjusted analyses were performed using conditional logistic regression (to account for matching), with matched-pair odds ratio and 95% confidence interval based on 1000 bias-corrected bootstrap resampling as the effect measure. Associations were adjusted for potential confounders.ResultsA total of 61 confirmed coronavirus disease 2019 cases were enrolled during the study period (mild disease, n=54 [88.5%]; severe disease, n=6 [9.8%]; critical disease, n=1 [1.6%]). The odds of adverse composite maternal outcome were 3.4 times higher among cases than controls (18.0% vs 8.2%; adjusted odds ratio, 3.4; 95% confidence interval, 1.2–13.4). The odds of adverse composite neonatal outcome were 1.7 times higher in the case group than to the control group (18.0% vs 13.9%; adjusted odds ratio, 1.7; 95% confidence interval, 0.8–4.8). Stratified analyses by disease severity indicated that the morbidity associated with coronavirus disease 2019 in pregnancy was largely driven by the severe or critical disease phenotype. Major risk factors for associated morbidity were black and Hispanic race, advanced maternal age, medical comorbidities, and antepartum admissions related to coronavirus disease 2019.ConclusionCoronavirus disease 2019 during pregnancy is associated with an increased risk of adverse maternal and neonatal outcomes, an association that is primarily driven by morbidity associated with severe or critical coronavirus disease 2019. Black and Hispanic race, obesity, advanced maternal age, medical comorbidities, and antepartum admissions related to coronavirus disease 2019 are risk factors for associated morbidity.

Considering delay of cholecystectomy in the third trimester of pregnancy.

Current guidelines support laparoscopic cholecystectomy as the treatment of choice for pregnant women with symptomatic gallbladder disease, regardless of the trimester. Early intervention has remained the standard of care, but recent evidence has challenged this practice in pregnant women. We sought to compare surgical and maternal-fetal outcomes of antepartum versus postpartum cholecystectomy in New York State. Between 2005 and 2014, the New York Statewide Planning and Research Cooperative System (SPARCS) database was queried for patients who underwent cholecystectomy within 3 months before (antepartum cholecystectomy, APCCY: n = 82) and after (postpartum cholecystectomy, PPCCY: n = 5040) childbirth to approximate third-trimester operations. All patients who underwent cholecystectomy during pregnancy (n = 971) were extracted to evaluate inter-trimester differences. Subgroup analysis compared APCCY patients who were not hospitalized within 1 year before APCCY (n = 80) and PPCCY patients who were hospitalized within 1 year before childbirth (n = 29) for symptomatic biliary disease. Multivariable generalized linear regression models were used to characterize the association between timing of cholecystectomy and several primary outcomes: length of stay (LOS), 30-day non-pregnancy, non-delivery readmission (NPND), bile duct injury (BDI), composite maternal outcome (antepartum hemorrhage, preterm delivery, cesarean section), any complications, and fetal demise. Third-trimester APCCY women had longer LOS (Ratio: 1.44, 95% CI [1.26-1.66], p < 0.0001) and greater incidence of preterm delivery (OR 2.54, 95% CI [1.37-4.43], p = 0.0019). Cholecystectomy timing was not independently associated with differences in composite maternal outcome (p = 0.1480), BDI (p = 0.2578), 30-day NPND readmission (p = 0.7579), any complications (p = 0.2506), and fetal demise (2.44% versus 0.44%, p = 0.0545). Subgroup analysis revealed no differences in any of the seven outcomes. New York Statewide data suggest that although laparoscopic cholecystectomy is safe in pregnancy, delay of cholecystectomy should be discussed in the third trimester due to an increased risk for preterm delivery.

Kielland’s rotational forceps delivery: A comparison of maternal and neonatal outcomes with rotational ventouse or second stage caesarean section deliveries

ObjectivesThe objective of our study was to derive accurate estimates of risks of maternal and neonatal complications associated with Kielland’s rotational forceps delivery (KRFD) compared to rotational ventouse delivery (RVD) or 2nd stage caesarean section (CS). MethodsThis was a retrospective cohort study undertaken at a large tertiary maternity and neonatal unit in the United Kingdom between January 2010 and June 2018. Pregnancies with fetal demise, major fetal defects, those lost to follow-up, those delivering by elective or emergency CS in the first stage of labour and non-rotational instrumental deliveries were excluded. The study population included singleton pregnancies delivering by Kielland’s forceps, rotational ventouse, 2nd stage CS or spontaneous unassisted cephalic vaginal delivery; the latter forming the control group. The maternal outcomes examined included post-partum haemorrhage (PPH) and obstetric anal sphincter injury (OASIS). The neonatal outcomes included admission to neonatal intensive care unit (NICU), 5-minute Apgar scores <7, hypoxic ischaemic encephalopathy (HIE), jaundice, shoulder dystocia and birth trauma. Absolute risks with 95 % confidence intervals (CI) were calculated in the study groups. Univariate and multivariate logistic regression analysis was carried out to estimate crude and adjusted odds ratio (OR) with 95 % CI. ResultsThe study population of 23,786 pregnancies included: 491 (2.1 %) requiring KRFD, 344 (1.4 %) requiring RVD, 840 (3.5 %) that had a 2nd stage CS and 22,111 (93.0 %) spontaneous cephalic vaginal deliveries. With regard to maternal adverse outcomes, in pregnancies that had a KRFD compared to RVD, there was no significant difference in the incidence of OASIS (p = 0.599) or PPH (p = 0.982). In contrast, the risk of PPH was significantly higher in those delivering by a 2nd stage CS compared to KRFD (27.5 % vs. 12.4 %; p < 0.0001). With regard to neonatal adverse outcomes, in those delivering by KRFD compared to RVD and 2nd stage CS, there was no significant difference in the incidence of admission to NICU (p = 0.912; p = 0.746, respectively), 5-minute Apgar score<7 (p = 0.335; p = 0.150, respectively), jaundice (p = 0.810; p = 0.332, respectively), mild shoulder dystocia (p = 0.077), severe shoulder dystocia (p = 0.603) or birth trauma (p = 0.265; p = 0.323, respectively). The risk of maternal composite adverse outcome was highest after 2nd stage CS (OR 7.68; 95 %CI: 6.52−9.04) and lowest after KRFD (OR 3.82; 95 %CI: 2.98−4.91). The risk of composite neonatal adverse outcome was higher in those delivering by RVD (OR 2.87; 95 %CI: 2.10−3.91), compared to KRFD (OR 2.23; 95 %CI: 1.67−2.97) or 2nd stage CS (OR 2.02; 95 %CI: 1.60−2.54). ConclusionOur study demonstrates that KRFD is a safer management option when compared to RVD or 2nd stage CS for the management of persistent fetal malposition in labour.