Primary Maternal Outcomes Research Articles

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.

Maternal and Fetal Outcome in Intrahepatic Cholestasis of Pregnancy in a Multicultural Society Conducted at a Tertiary Care Hospital in Dubai

Introduction: Intrahepatic cholestasis of pregnancy (ICP) has been sparsely studied especially in the Middle East. The incidence and outcome of ICP varies worldwide. Its incidence in the Middle East and primary maternal and fetal outcome must be evaluated to ascertain the burden so that appropriate preventive and intervention measures can be formulated and implemented. Objective: To assess the incidence, associations, and maternal-fetal outcomes in ICP. Design: Case-control study. Settings: tertiary care hospital settings affiliated with the academic center in the UAE. Patients and methods: a total of 150 patients were included from October 2016 to September 2018 in the study with 75 cases of ICP and 75 controls matched according to age and date of delivery. The maternal risk factors attributable to ICP were recorded. Biochemical profile of mothers was monitored. Maternal and fetal outcomes were compared in 2 groups. Main outcomes measured: incidence and associations of ICP were evaluated. Maternal and fetal outcomes were compared in cases and controls. Sample size: 150. Result: The incidence of ICP in our study in the UAE was 1.0%. ICP has significant association with past obstetric cholestasis history (p value <0.01, odds ratio [OR] 9.3, 95% CI: 2.1–41.8), gestational diabetes (p value <0.05, OR 2.0, 95% CI: 1.0–3.8), pre-eclampsia (p value <0.05, OR 7.2, 95% CI: 1.6–33.1), and undergoing induction of labor (p value <0.01, OR 8.1, 95% CI: 3.7–17.8). The maternal bile acid level above 40 μmol/L is ­associated with higher chances of preterm delivery (p value <0.01, OR 8.2, 95% CI: 3.0–22.5), intrauterine fetal demise (p value <0.01), low birth weight (p value <0.01, OR 13.6, 95% CI: 4.2–43.5), respiratory distress (p value <0.05, OR 15.5, 95% CI: 1.8–132.7), poor Apgar score (p value <0.05, OR 12.720, 95% CI: 1.5–111.4), and NICU admissions (p value <0.01, OR 9.0, 95% CI: 1.8–45.9). Conclusion: ICP mothers have low incidence in the UAE and significant association with gestational diabetes and pre-eclampsia. High maternal bile acids above 40 μmol/L have poor fetal outcomes.

257 Impact of mode of delivery on maternal and neonatal outcomes at the cusp of viability

To assess the maternal, obstetric, and neonatal complications of periviable birth by route of delivery A retrospective cohort study of periviable deliveries (22w0d-25w6d) from 2013-2019 at a single institution was conducted. Deliveries were grouped by mode of delivery (vaginal or cesarean). Deliveries were excluded if neonatal resuscitation was not desired. The primary maternal outcome consisted of a composite of maternal death, ICU admission, sepsis, wound infection, unplanned operation, or readmission. The primary neonatal outcome was survival to discharge. Secondary outcomes included maternal interventions, blood loss, maternal and neonatal length of stay, neonatal outcomes at the time of discharge. Outcomes were compared using the Mann-Whitney U and chi-square tests where appropriate After exclusion, 198 deliveries of 230 neonates were included in the cohort (64 vaginal deliveries and 134 cesarean deliveries). Baseline characteristics were similar between the cesarean and vaginal delivery cohorts. For the primary composite outcome, cesarean delivery was associated with an increased rate of maternal morbidity (22.4% vs 10.9%, p-value 0.05) driven by increased rates of readmission, sepsis, ICU admission, and wound infection. The primary neonatal outcome, survival to hospital discharge, was not different between the groups (47/71, 66.2% vs 97/159, 61.0%, p-value 0.45). Maternal administration of magnesium sulfate, antenatal corticosteroids, and tocolytics were the same between cohorts. Delivery room chest compressions, epinephrine use, intubation, surfactant use, and survival to NICU did not differ between cohorts. Among the 144 neonates that survived to discharge (47 after vaginal delivery, 97 after cesarean delivery), there was no difference in CLD, IVH, NEC, PDA, ROP, tracheostomy placement, or gastrostomy placement This small cohort of pregnancies from 22w0d-25w6d shows increased maternal morbidity in women undergoing cesarean delivery when compared to vaginal delivery without improving neonatal outcomes. These risks should be included in shared decision makingView Large Image Figure ViewerDownload Hi-res image Download (PPT)

Ramadan Fasting: Perception and maternal outcomes during Pregnancy

Objectives:To see perception and knowledge of women about Ramadan fasting and maternal effects of fasting.Methods:The study design was prospective, case-controlled. This study was conducted at Holy Family Hospital from 1st May 2020 to July 2020. Pregnant women with spontaneous conception and singleton pregnancies, who fasted for seven or more days, were cases, and those who did not fast were taken as controls. Questionnaire was filled regarding perception of women about maternal fasting. Primary maternal outcomes included preterm delivery, pregnancy induced hypertension, and gestational diabetes mellitus. The analysis was conducted using Statistical Package for Social Sciences version 16.0.Results:A total of 215 women were included in the study, 123 women fasted, and 92 women did not fast. Only 2.8% of women knew that fasting is forbidden in pregnancy. Sixty five percent of women reported weakness as the main reason for not fasting. The rate of gestational diabetes, pregnancy induced hypertension and preterm delivery was higher among women who fasted (17% vs 14%, 7% vs 2%, 9% vs 9%) respectively, compared to non-fasting women, but were not found statistically significant. There was no difference in anthropometric measurements of newborn, among both groups.Conclusion:Ramadan fasting does not affect maternal outcomes during pregnancy.

Primary Postpartum Hemorrhage and Maternal Health-Effects and Outcome

Objective: To assess outcome of different management strategies in women presenting with primary postpartum hemorrhage (PPH). Study Design: Observational, prospective. Settings: Department of Obstetrics &amp; Gynecology Unit-III, Liaquat University of Medical and Health Sciences, Jamshoro Pakistan. Duration: From May 2016 to November 2017. Methodology: Total 50 delivered women fulfilling the inclusion criteria were included in study. All relevant variable like a detailed demographic characteristics, details about labour, symptomatology, general conditions of patient, amount of blood loss, clinical examination, finding such as condition of the uterus, genital tract trauma, retained placenta, uterine inversion. Investigation like complete blood picture blood group, blood sugar, coagulation profile, serum electrolytes, virology status, liver function test, renal function test, ultrasound examination, maternal effects and outcome were recorded on proforma and analyzed by using SPSS. Results: Among 50 women (with primary PPH) included in this study, all were managed medically, in 24 patients medical treatment was unsuccessful so surgical treatment offered. Most common cause identified was uterine atony, however anemia 50(100%).&nbsp; Hypovolemic shock 5(10%), puerperal sepsis 8(16%), complication of anesthesia 4(8%), blood reactions 6 (12%) were the morbidities observed in present study, 2 patients (4%) died inspite of all measures. Conclusion: It was concluded that best results were obtained with use of AMTSL, combination of more than on medical option and surgical management were equally effective in treating the PPH.

An Elevated Fasting GTT Doesn't Increase Adverse Outcomes Compared With Other GTT Elevations [03D

INTRODUCTION: To determine if an isolated elevated fasting blood sugar (FBS) has an increased risk for adverse maternal and neonatal outcomes compared to isolated elevated values at 1, 2, or 3 hours on the glucose tolerance test (GTT). METHODS: A retrospective cohort study of pregnant women who completed a GTT between 23–32 weeks, had an isolated elevation of one of the GTT results and delivered from 7/12–6/18 was performed. The composite primary maternal outcome included preeclampsia, cesarean, operative vaginal delivery, and perineal lacerations. Composite neonatal outcome was calculated as a secondary outcome. Sensitivity analyses of obese patients were performed. RESULTS: Nine hundred and nine women met inclusion criteria: 252 had an elevated FBS and 657 had a non-fasting isolated GTT elevation. There were clinically non-significant differences in race, age, BMI and nulliparity between the groups; outcomes were adjusted for these variables. The primary outcome did not differ between groups. APGAR &lt;7 was higher with an elevated FBS (9.1% vs 2.6%, P&lt;.01); there were no differences in other neonatal outcomes. In obese patients, there were no differences in composite maternal or neonatal outcomes. APGAR &lt;7 was higher in those with an elevated FBS (13.4% vs 3.3%, P&lt;.01) as was neonatal hyperbilirubinemia (10.6% vs 5.6%, P=.01). CONCLUSION: There are no significant differences in maternal/neonatal composite outcomes between isolated abnormal FBS on GTT compared to other isolated elevations, regardless of obesity status. In obese women, there was a higher incidence of APGAR &lt;7 and neonatal hyperbilirubinemia in the group with elevated FBS on GTT.

Association between maternal anemia at admission for delivery and adverse perinatal outcomes

Maternal anemia is a risk factor for poor pregnancy outcomes and threatens maternal or fetal life. Anemia increases the risk of low birth weight and preterm birth. We aimed to determine the cutoff level of hemoglobin and risk factors for maternal anemia at admission for delivery and investigate the association between maternal anemia and adverse perinatal outcomes in contemporary Taiwanese women. About 32,234 women admitted to the Taipei Chang Gung Memorial Hospital from 2001 to 2016 were enrolled in this retrospective observational cohort study. The prevalence of pre-delivery maternal anemia in Taiwan and the maternal demographic and perinatal outcomes associated with maternal anemia was assessed. The 10th and 5th percentile hemoglobin levels of the test cohort (2001-2008, n = 15,602) were 10.8 g/dL and 9.9 g/dL, respectively. In the study cohort (2009-2016, n = 13,026), women who were multiparous, who were aged >34 years, with history of cesarean delivery, and with history of uterine fibroids had higher prevalence of anemia. Anemic women were at increased risk of cesarean delivery, primary cesarean delivery, premature rupture of membranes, early preterm birth <34 weeks, having very low birth weight infants (<1,500 g), having large for gestational age infants, and neonatal intensive care center transfer, but at lower risk of having small for gestational age infants. Maternal anemia at delivery is a risk factor for primary cesarean delivery and adverse maternal and neonatal outcomes. Furthermore, we hypothesize that maternal anemia might increase fetoplacental vasculogenesis and angiogenesis as an adaptive response.

Perinatal Outcomes with Longer Second Stage of Labor: A Risk Analysis Comparing Expectant Management to Operative Intervention.

The aim of this study is to assess the impact of a prolonged second stage of labor on maternal and neonatal outcomes by comparing women who had expectant management versus operative intervention beyond specified timeframes in the second stage of labor. Retrospective cohort including live singletons at ≥36 weeks who reached the second stage of labor. Expectant management (second stage >3, 2, 2, and 1 hour in nulliparas with an epidural, nulliparas without an epidural, multiparas with an epidural, and multiparas without an epidural, respectively) was compared with those who had an operative delivery (vaginal or cesarean) prior to these timeframes. The primary maternal outcome was a composite of postpartum hemorrhage, chorioamnionitis, operative complications, postpartum infections, and intensive care unit admission. The primary neonatal outcome was a composite of cord blood acidemia, 5-minute Apgar's score <5, chest compressions or intubation at birth, sepsis, seizures, birth injury, death, transfer to a long-term care facility, and respiratory support for >1 day. Among 218 women, 115 (52.8%) had expectant management. Expectant management was associated with a significantly increased risk of the maternal composite (adjusted odds ratio [aOR]: 1.99, 95% confidence interval [CI]: 1.09-3.64) but not the neonatal composite (aOR: 1.54, 95% CI: 0.71-3.35). Expectant management of a prolonged second stage was associated with a higher rate of adverse maternal outcomes, but the rate of adverse neonatal outcomes was not significantly increased.

Pregnancy outcomes in women with significant valve disease: a systematic review and meta-analysis

ObjectiveTo perform a systematic review and meta-analysis of maternal/fetal outcomes in pregnant women with moderate/severe native valvular heart disease (VHD) from medium/higher Human Development Index (HDI) countries.MethodsOvidSP platform databases were...

The pre-gestational triglycerides and high-density lipoprotein cholesterol ratio is associated with adverse perinatal outcomes: A retrospective cohort analysis.

To investigate associations between pre-gestational dyslipidemia, expressed as the ratio between triglycerides (TG) and high-density lipoprotein cholesterol (HDL), and adverse maternal and neonatal outcomes. A retrospective cohort analysis included women with TG and HDL measurements available up to 52weeks before conception who delivered a singleton, non-anomalous infant. The study population was stratified according to a TG/HDL ratio cutoff of 3. Primary maternal outcomes included gestational diabetes or hypertensive disorders of pregnancy and neonatal outcomes after delivery before 37weeks. Among 5226 women included, 4446 (85.1%) had TG/HDL <3 and 780 (14.9%) ≥3. TG/HDL ratio ≥3 vs <3 was associated with higher rates of gestational diabetes (13.1% vs 5.2%, P<0.0001) and hypertensive disorders of pregnancy (5.3% vs 2.2%, P<0.0001). Larger babies (3229.7±520.7g vs 3181.7±504.4g, P=0.015) with higher birth weight percentile (59.0±26.4 vs 55.1±26.6, P<0.0001) and increased rates of large-for-gestational-age (14.5% vs 10.8%, P=0.007) and macrosomia (5.6% vs 3.9%, P=0.026) were found. In multivariate analysis, TG/HDL ≥3 remained an independent risk-factor for gestational diabetes (adjusted odds ratio [aOR] 1.56, 95% confidence interval [CI] 1.02-2.39) and pre-eclampsia (aOR 3.02, 95% CI 1.82-5.01). An increase in adverse pregnancy outcomes was reported, mainly gestational diabetes and pre-eclampsia, when TG/HDL ratio up to 1year before pregnancy was ≥3.

Interventions to reduce the cesarean delivery rate in a tertiary hospital in China

Introduction High cesarean delivery rate has been a global public health concern. This study assesses the effect of medical interventions and societal changes on cesarean delivery rates in a Chinese tertiary hospital. Material and methods A retrospective study including all live births ≥34-week gestation between 2008 and 2016 from Guangzhou Women and Children’s Medical Center was divided into 5 stages: (1) no interventions; (2) patient-controlled epidural analgesia; (3) episiotomy restriction; (4) new labor management; (5) universal two-child policy. An interrupted time series design was used to measure the effect of interventions on overall cesarean rate, primary cesarean rate, maternal and neonatal outcomes. Results There were 126,609 deliveries including 49,092 cesarean deliveries and 77,517 vaginal deliveries in this period. Overall cesarean delivery rate declined after implementing patient-controlled epidural analgesia, episiotomy restriction and universal two-child policy. Primary cesarean rate decreased after implementing episiotomy restriction. Cesarean rate with previous cesarean dramatically increased, and maternal request cesarean rate decreased gradually. Low Apgar rate (score ≤7 at 5 min) increased after episiotomy restriction and maternal postpartum hemorrhage rate increased after new labor management. Conclusions Patient-controlled epidural analgesia, episiotomy restriction and the universal two-child policy showed the most significant effects to reducing the cesarean rate.

Safety and effectiveness of intravenous iron sucrose versus standard oral iron therapy in pregnant women with moderate-to-severe anaemia in India: a multicentre, open-label, phase 3, randomised, controlled trial

Intravenous iron sucrose is a promising therapy for increasing haemoglobin concentration; however, its effect on clinical outcomes in pregnancy is not yet established. We aimed to assess the safety and clinical effectiveness of intravenous iron sucrose (intervention) versus standard oral iron (control) therapy in the treatment of women with moderate-to-severe iron deficiency anaemia in pregnancy. We did a multicentre, open-label, phase 3, randomised, controlled trial at four government medical colleges in India. Pregnant women, aged 18 years or older, at 20-28 weeks of gestation with a haemoglobin concentration of 5-8 g/dL, or at 29-32 weeks of gestation with a haemoglobin concentration of 5-9 g/dL, were randomly assigned (1:1) to receive intravenous iron sucrose (dose was calculated using a formula based on bodyweight and haemoglobin deficit) or standard oral iron therapy (100 mg elemental iron twice daily). Logistic regression was used to compare the primary maternal composite outcome consisting of potentially life-threatening conditions during peripartum and postpartum periods (postpartum haemorrhage, the need for blood transfusion during and after delivery, puerperal sepsis, shock, prolonged hospital stay [>3 days following vaginal delivery and >7 days after lower segment caesarean section], and intensive care unit admission or referral to higher centres) adjusted for site and severity of anaemia. The primary outcome was analysed in a modified intention-to-treat population, which excluded participants who refused to participate after randomisation, those who were lost to follow-up, and those whose outcome data were missing. Safety was assessed in both modified intention-to-treat and as-treated populations. The data safety monitoring board recommended stopping the trial after the first interim analysis because of futility (conditional power 1·14% under the null effects, 3·0% under the continued effects, and 44·83% under hypothesised effects). This trial is registered with the Clinical Trial Registry of India, CTRI/2012/05/002626. Between Jan 31, 2014, and July 31, 2017, 2018 women were enrolled, and 999 were randomly assigned to the intravenous iron sucrose group and 1019 to the standard therapy group. The primary maternal composite outcome was reported in 89 (9%) of 958 patients in the intravenous iron sucrose group and in 95 (10%) of 976 patients in the standard therapy group (adjusted odds ratio 0·95, 95% CI 0·70-1·29). 16 (2%) of 958 women in the intravenous iron sucrose group and 13 (1%) of 976 women in the standard therapy group had serious maternal adverse events. Serious fetal and neonatal adverse events were reported by 39 (4%) of 961 women in the intravenous iron sucrose group and 45 (5%) of 982 women in the standard therapy group. At 6 weeks post-randomisation, minor side-effects were reported by 117 (16%) of 737 women in the intravenous iron sucrose group versus 155 (21%) of 721 women in the standard therapy group. None of the serious adverse events was found to be related to the trial procedures or the interventions as per the causality assessment made by the trial investigators, ethics committees, and regulatory body. The study was stopped due to futility. There is insufficient evidence to show the effectiveness of intravenous iron sucrose in reducing clinical outcomes compared with standard oral iron therapy in pregnant women with moderate-to-severe anaemia. WHO, India.

Regimens of vitamin D supplementation for women during pregnancy.

Vitamin D deficiency during pregnancy increases the risk of pre-eclampsia, gestational diabetes, preterm birth, and low birthweight. In a previous Cochrane Review we found that supplementing pregnant women with vitamin D alone compared to no vitamin D supplementation may reduce the risk of pre-eclampsia, gestational diabetes, and low birthweight and may increase the risk of preterm births if it is combined with calcium. However the effects of different vitamin D regimens are not yet clear. To assess the effects and safety of different regimens of vitamin D supplementation alone or in combination with calcium or other vitamins, minerals or nutrients during pregnancy, specifically doses of 601 international units per day (IU/d) or more versus 600 IU/d or less; and 4000 IU/d or more versus 3999 IU/d or less. We searched the Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (12 July 2018), and the reference lists of retrieved studies. Randomised trials evaluating the effect of different vitamin D regimens (dose, frequency, duration, and time of commencement of supplementation during pregnancy), alone or in combination with other nutrients on pregnancy and neonatal health outcomes. We only included trials that compared 601 IU/d or more versus 600 IU/d or less and 4000 IU/d or more versus 3999 IU/d or less. We did not include in the analysis groups that received no vitamin D, as that comparison is assessed in another Cochrane Review. Two review authors independently: i) assessed the eligibility of studies against the inclusion criteria; ii) extracted data from included studies, and iii) assessed the risk of bias of the included studies. Our primary maternal outcomes were: pre-eclampsia, gestational diabetes, and any adverse effects; our primary infant outcomes were preterm birth and low birthweight. Data were checked for accuracy. The certainty of the evidence was assessed using the GRADE approach. In this review, we included data from 30 trials involving 7289 women. We excluded 11 trials, identified 16 ongoing/unpublished trials and two trials are awaiting classification. Overall risk of bias for the trials was mixed.Comparison 1. 601 IU/d or more versus 600 IU/d or less of vitamin D alone or with any other nutrient (19 trials; 5214 participants)Supplementation with 601 IU/d or more of vitamin D during pregnancy may make little or no difference to the risk of pre-eclampsia (risk ratio (RR) 0.96, 95% confidence interval (CI) 0.65 to 1.42); 5 trials; 1553 participants,low-certainty evidence), may reduce the risk of gestational diabetes (RR 0.54, 95% CI 0.34 to 0.86; 5 trials; 1846 participants; moderate-certainty evidence), may make little or no difference to the risk of preterm birth (RR 1.25, 95% CI 0.92 to 1.69; 4 trials; 2294 participants; low-certainty evidence); and may make little or no difference to the risk of low birthweight (RR 0.90, 95% CI 0.66 to 1.24; 4 trials; 1550 participants; very low-certainty evidence) compared to women receiving 600 IU/d or less.Comparison 2. 4000 IU or more versus 3999 IU or less of vitamin D alone (15 trials; 4763 participants)Supplementation with 4000 IU/d or more of vitamin D during pregnancy may make little or no difference to the risk of: pre-eclampsia (RR 0.87, 95% CI 0.62 to 1.22; 4 trials, 1903 participants, low-certainty evidence); gestational diabetes (RR 0.89, 95% CI 0.56 to 1.42; 5 trials, 2276 participants; low-certainty evidence); preterm birth (RR 0.85, 95% CI 0.64 to 1.12; 6 trials, 2948 participants, low-certainty evidence); and low birthweight (RR 0.92, 95% CI 0.49 to 1.70; 2 trials; 1099 participants; low-certainty evidence) compared to women receiving 3999 IU/d or less.Adverse events (such as hypercalcaemia, hypocalcaemia, hypercalciuria, and hypovitaminosis D) were reported differently in most trials; however, in general, there was little to no side effects reported or similar cases between groups. Supplementing pregnant women with more than the current vitamin D recommendation may reduce the risk of gestational diabetes; however, it may make little or no difference to the risk of pre-eclampsia, preterm birth and low birthweight. Supplementing pregnant women with more than the current upper limit for vitamin D seems not to increase the risk of the outcomes evaluated. In general, the GRADE was considered low certainty for most of the primary outcomes due to serious risk of bias and imprecision of results. With respect to safety, it appears that vitamin D supplementation is a safe intervention during pregnancy, although the parameters used to determine this were either not reported or not consistent between trials. Future trials should be consistent in their reports of adverse events. There are 16 ongoing trials that when published, will increase the body of knowledge.

Influence of Estimated Fetal Weight on Labor Management.

Prior studies suggest knowledge of estimated fetal weight (EFW), particularly by ultrasound (US), increases the risk for cesarean delivery. These same studies suggest that concern for macrosomia potentially alters labor management leading to increased rates of cesarean delivery. We aimed to assess if shortened labor management, as a result of suspected macrosomia (≥4,000 g), leads to an increased rate of cesarean delivery. This is a secondary analysis of a retrospective cohort study at a single tertiary center in 2015 of women with singleton pregnancies ≥36 weeks with documented EFW by US within 3 weeks or physical exam on admission. Women were excluded if an initial cervical exam was ≥6 cm or no attempt was made to labor. In addition, patients were excluded for the diagnosis of hypertension, diabetes, or prior cesarean delivery, as these comorbidities influence the use of US, labor management, and cesarean delivery independent of fetal weight. Patients were classified as EFW of ≥4,000 and <4,000 g. Secondary analysis examined the impact of US within 3 weeks of admission when compared with physical exam at the time of admission. The primary maternal outcomes were duration of labor and cesarean delivery. Duration of labor was evaluated as total time from 4 cm to delivery (with 4-cm dilation being a surrogate marker for active labor), length of time allowed from 4 cm until the first documented cervical change (or delivery), and time in second stage of labor (complete dilation to delivery). Cesarean delivery for arrest of labor was a secondary outcome. Student's t-test, Mann-Whitney U-test, chi-squared test, and Fisher's exact test were used for univariate data analysis as appropriate. Of 1,506 patients included, 54 (3.5%) had EFW of ≥4,000 g. Women with EFW of ≥4,000 g had a larger body mass index, higher fetal birth weight, were more likely to be undergoing induction of labor, had a more advanced gestational age, and were more likely to have had an US within 3 weeks of delivery. They were more likely to undergo cesarean delivery (29.6 vs. 9.3%, adjusted odds ratio [AOR]: 2.7, 95% confidence interval [CI]: 1.3-5.5) despite not having shortened labor times. When analyzing this population by method of obtaining EFW, those with EFW based on US rather than external palpation were more likely to undergo cesarean delivery (13.1 vs. 7.9%, AOR: 1.5, 95% CI: 1.01-2.12), again without having shortened labor times. EFW of ≥4,000 g and use of US to estimate fetal weight do not appear to shorten labor management despite being associated with an increased risk of cesarean delivery.

Methods of Glycemic Control and Neonatal Outcomes after Antenatal Corticosteroid Administration among Women with Pregestational Diabetes.

The objective of this study was to evaluate the association between the method of maternal glycemic control after antenatal corticosteroid, administration and maternal hyperglycemia and neonatal morbidity among women with diabetes. This was a retrospective cohort study of women with pregestational diabetes who received antenatal corticosteroids and delivered in <34 weeks. The primary maternal outcome was adequate glycemic control, defined as <50% of glucose values above goal (fasting <100 mg/dL, 2-hour postprandial <120 mg/dL, or <115 mg/dL on insulin infusion). The primary neonatal outcome was composite morbidity (continuous positive airway pressure, mechanical ventilation, intraventricular hemorrhage, or death). Demographic characteristics and outcomes were compared by the method of glycemic control and neonatal morbidity using chi-square test, Fisher's exact test, Mann-Whitney U-test, and Student's t-test, as appropriate. Of 52 eligible women, only 1 (1.9%) had adequate maternal glycemic control. There was no significant association between the method of glycemic control and maternal hyperglycemia or neonatal morbidity. There was no association between maternal glucose and neonatal morbidity; however, neonates with composite morbidity were more likely to be born to women who received less insulin. Maternal glycemic control among women with diabetes was poor after the antenatal corticosteroid administration, regardless of glycemic control method. Neither the method of maternal glycemic control nor the degree of control was associated with neonatal morbidity.

Delivery or expectant management for prevention of adverse maternal and neonatal outcomes in hypertensive disorders of pregnancy: an individual participant data meta-analysis.

ABSTRACTObjectiveHypertensive disorders affect 3–10% of pregnancies. Delayed delivery carries maternal risks, while early delivery increases fetal risk, so appropriate timing is important. The aim of this study was to compare immediate delivery with expectant management for prevention of adverse maternal and neonatal outcomes in women with hypertensive disease in pregnancy.MethodsCENTRAL, PubMed, MEDLINE and ClinicalTrials.gov were searched for randomized controlled trials comparing immediate delivery to expectant management in women presenting with gestational hypertension or pre‐eclampsia without severe features from 34 weeks of gestation. The primary neonatal outcome was respiratory distress syndrome (RDS) and the primary maternal outcome was a composite of HELLP syndrome and eclampsia. The PRISMA‐IPD guideline was followed and a two‐stage meta‐analysis approach was used. Relative risks (RR) and numbers needed to treat or harm (NNT/NNH) with 95% CI were calculated to evaluate the effect of the intervention.ResultsMain outcomes were available for 1724 eligible women. Compared with expectant management, immediate delivery reduced the composite risk of HELLP syndrome and eclampsia in all women (0.8% vs 2.8%; RR, 0.33 (95% CI, 0.15–0.73); I 2 = 0%; NNT, 51 (95% CI, 31.1–139.3)) as well as in the pre‐eclampsia subgroup (1.1% vs 3.5%; RR, 0.39 (95% CI, 0.15–0.98); I 2 = 0%). Immediate delivery increased RDS risk (3.4% vs 1.6%; RR, 1.94 (95% CI 1.05–3.6); I 2 = 24%; NNH, 58 (95% CI, 31.1–363.1)), but depended upon gestational age. Immediate delivery in the 35th week of gestation increased RDS risk (5.1% vs 0.6%; RR, 5.5 (95% CI, 1.0–29.6); I 2 = 0%), but immediate delivery in the 36th week did not (1.5% vs 0.4%; RR, 3.4 (95% CI, 0.4–30.3); I 2 not applicable).ConclusionIn women with hypertension in pregnancy, immediate delivery reduces the risk of maternal complications, whilst the effect on the neonate depends on gestational age. Specifically, women with a‐priori higher risk of progression to HELLP, such as those already presenting with pre‐eclampsia instead of gestational hypertension, were shown to benefit from earlier delivery. © 2019 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of the International Society of Ultrasound in Obstetrics and Gynecology.

Maternal anaemia and maternal, fetal, and neonatal outcomes in a prospective cohort study in India and Pakistan.

To describe the association of maternal anaemia with maternal, fetal, and neonatal outcomes. Prospective cohort study. Rural India and Pakistan. Pregnant women residing in the study catchment area. We performed an analysis of a prospective pregnancy registry in which haemoglobin is commonly obtained as well as maternal, fetal, and neonatal outcomes for 42days post-delivery. Women 40years or older who delivered before 20weeks or had a haemoglobin level of <3.0g/dl were excluded. Our primary exposure was maternal anaemia, which was categorised in keeping with World Health Organization criteria based on a normal (≥11g/dl), mild (>10-10.9g/dl), moderate (7-9.9g/dl) or severe (<7g/dl). haemoglobin level. The primary maternal outcome was maternal death, the primary fetal outcome was stillbirth, and the primary neonatal outcome was neonatal mortality <28days. A total of 92247 deliveries and 93107 infants were included, of which 87.8% were born to mothers who were anaemic (mild 37.9%, moderate 49.1%, and severe 0.7%). Maternal mortality (number per 100000) was not associated with anaemia: normal 124, mild 106, moderate 135, and severe 325 (P=0.64). Fetal and neonatal mortality was associated with severe anaemia: stillbirth rate (n/1000)-normal 27.7, mild 25.8, moderate 30.1, and severe 90.9; P<0.0001; 28-day neonatal mortality (n/1000)-normal 24.7, mild 22.9, moderate 28.1, and severe 72.6 (P<0.0001). Severe maternal anaemia was also associated with low birthweight (<2500and <1500g), preterm birth, and postpartum haemorrhage. Severe maternal anaemia is associated with higher risks of poor maternal, fetal, and neonatal outcomes but otherdegrees of anaemia are not. Interventions directed at preventing severe anaemia in pregnant women should be considered. Severe maternal anaemia is associated with adverse fetal and neonatal outcomes in low/middle-income countries.

749: Impact of distance traveled to prenatal care on outcomes of pregnancies complicated by pregestational diabetes

The concentration of high-risk pregnancy care in urban centers and rural hospital closures have caused concern about the distances patients travel for care and its impact on outcomes. We aimed to assess the impact of distance traveled to site of prenatal care (PNC) on perinatal outcomes in women with pregestational diabetes (DM). Retrospective cohort of all women with DM delivering at a single academic center from 2007-2013. Women were excluded for major medical problems (not hypertension), fetal anomalies, and entry to PNC ≥26 weeks. Exposure was classified into residing <30 miles, 30-60 miles, and >60 miles from the site of PNC. The primary maternal outcome was cesarean delivery (CD). Secondary maternal outcomes were primary CD, markers of glycemic control, and preeclampsia. The primary neonatal outcome was macrosomia (>4000g) and secondary neonatal outcomes were shoulder dystocia, neonatal hypoglycemia (<40 mg/dL), and hyperbilirubinemia. Chi square, Fisher exact, and ANOVA were used as appropriate. A multivariable logistic regression model was performed controlling for important confounding variables using <30 miles as the referent group. Impact of distance from the hospital was also evaluated as a continuous variable. Of 475 women, 341 (71.8%) lived <30 miles, 72 (15.2%) 30-60 miles, and 62 (13.1%) >60 miles from the site of PNC. Women living closest to the site of PNC were more likely to be black and less likely to use diabetic medications prior to or use insulin during pregnancy. Odds of CD and primary CD increased with distance from the hospital (Table). For each 1 mile over 30 miles lived from the site of PNC, the odds of primary CD increased by 1% (95% CI 1.003-1.030). Glycemic control, macrosomia, shoulder dystocia and hyperbilirubinemia did not differ between groups. Odds of neonatal hypoglycemia doubled with increased distance from PNC (Table). Per mile over 30 miles, the odds increased 1% (95% CI 1.004-1.021). Traveling further for prenatal care was associated with increased odds of cesarean and neonatal hypoglycemia, in spite of no detectable differences in glycemic control. When access to care and maternal morbidity are explored, distance from site of care should be considered as a contributing factor to patient and public health outcomes.

455: American College of Cardiology/American Heart Association Stage 1 Hypertension Before Delivery and Adverse Pregnancy Outcomes

The American College of Cardiology/American Heart Association (ACA/AHA) recently revised their definitions of hypertension (HTN) with the addition of stage 1 HTN (either systolic (SBP) 130-139 or diastolic (DBP) 80-89 mmHg). Because the implications of this new definition in pregnancy are not known, we aimed to determine the frequency of adverse maternal and neonatal outcomes in stage 1 HTN at the last clinic visit before delivery. Secondary analysis of a multicenter randomized trial of antioxidants to prevent preeclampsia (PE) in singleton nulliparous low-risk women. BP was measured by trained staff and outcomes were adjudicated. For this analysis, we included women who delivered ≥ 36 weeks gestation and abstracted their most recent BP in clinic, within 30 days prior to delivery. The higher of systolic (SBP) and diastolic (DBP) was used for classification into: Group 1, those who were never diagnosed with pregnancy associated hypertension (PAH, defined as either SBP >140 or DBP >90 mmHg on two occasions at least 4 hours apart) and their last clinic BP was <130/80 mmHg; Group 2, women without PAH but last clinic BP was consistent with stage 1 HTN by the new classification; and Group 3, those later diagnosed with PAH or had SBP at least 140 or DBP at least 90 mm Hg at their last clinic visit (stage 2 HTN). The primary outcome was a composite of adverse neonatal outcomes. Univariable and multivariable analyses were performed. 8,778 women were included in the analysis with 1,114 (12.7%) who would have been re-labeled as stage I hypertension by the recent guideline (Group 2). Groups differed on baseline and demographic characteristics (table 1). After adjusting for these differences, women in Group 2 did not have higher primary composite maternal (aOR 0.86, 95% CI 0.69-1.07) or neonatal (aOR 0.94, 95% CI 0.74-1.18) adverse outcomes, or other outcomes compared with Group 1 (Table 2). As expected, women in Group 3 had higher odds of developing the composite maternal outcome (aOR 1.35, 95% CI 1.17-1.56) and various adverse maternal outcomes and their infants had higher odds of developing the primary (aOR 1.47, 95% CI 1.26-1.72) and various secondary outcomes, compared with those from Group 1 (Table 2). Stage 1 HTN as defined by the new ACC/AHA at the last visit before delivery is not associated with adverse maternal or neonatal outcomes. Findings do not justify reclassifying PAH to include stage 1 BP levels.View Large Image Figure ViewerDownload Hi-res image Download (PPT)