Infant Outcomes In Women Research Articles

Maternal and infant outcomes in women with sickle cell disease: a matched cohort study

ObjectiveWomen with sickle cell disease (SCD) have adverse maternal and infant outcomes. Our aim was to determine whether the outcomes of SCD mothers and their infants differed from African or...

The Impact of Delivery Methods on the Delivery Outcomes of Women with a Prolonged Second Stage and a Fetus in the Occipital Posterior Position

Background: The objective was to explore the impact of different delivery methods on maternal and infant outcomes in women with a prolonged second stage of labor and a fetus with a persistent occipital posterior position. Methods: 60 women with a fetus in the occipital posterior position who underwent obstetric low forceps-assisted delivery were selected as the study group according to the order of delivery, and 40 women who underwent cesarean section during the same period were selected as study group 1 according to the order of delivery. We compared the maternal-related indicators and neonatal outcome-related indicators of the two groups. Then, we selected women in chronological order during the same period to be included in control group 2 (60 primiparous women with a fetus in the occipital anterior position who underwent low forceps-assisted delivery during the same period) for comparison with the study group. Results: The time of fetal head delivery, postpartum hemorrhage rate, hospitalization time, average hospitalization cost, and number of cases of postpartum infection in the group with a fetus in the occipital posterior position and low forceps-assisted delivery were significantly lower than those in the cesarean section group (p < 0.05). There was no statistically significant difference in the 1-minute Apgar score, umbilical artery blood gas pH value, or number of neonatal injuries between the cesarean section group and the group with a fetus in the occipital posterior position with forceps-assisted delivery (p > 0.05). There were also no statistically significant differences in the complication-related indicators between the group with a fetus in the occipital posterior position with forceps-assisted delivery and the group with a fetus in the occipital anterior position with forceps-assisted delivery. The two groups had second-degree lacerations, cervical lacerations, vaginal wall lacerations, and vaginal wall hematomas. There was no statistically significant difference in the comparison of urinary retention (p > 0.05), and there was no statistically significant difference between the group with a fetus in the occipital posterior position and forceps-assisted delivery and the group with a fetus in the occipital anterior position and forceps-assisted delivery in the comparison of related indicators of neonatal outcomes and pelvic floor reexamination at the Aa and Ap points 42 days after delivery (p > 0.05). Conclusions: The use of low forceps for women with a prolonged second stage of labor and a fetus in a persistent occipital posterior position can effectively shorten the time of fetal head delivery, reduce postpartum bleeding, reduce the incidence of postpartum infection, shorten the hospitalization time, and reduce average hospitalization costs and does not increase adverse neonatal outcomes.

Serum Taurocholic Acid Levels Have Predictive Value for Adverse Maternal and Infant Outcomes in Pregnant Women with Intrahepatic Cholestasis of Pregnancy: A Prospective Cohort Study

Background: Intrahepatic cholestasis of pregnancy (ICP) is a common liver disorder specific to pregnancy. Taurocholic acid (TCA) has been implicated in the pathogenesis of ICP. This study aimed to investigate the association between serum TCA levels and adverse maternal and infant outcomes in women with ICP. Methods: Pregnant women diagnosed with ICP were categorized into normal or adverse groups based on their pregnancy outcomes. Baseline data, including age, pre-pregnancy body mass index (BMI), systolic blood pressure (SBP), diastolic blood pressure (DBP), and fasting blood sample (5 mL), were collected at 28 weeks of gestation. Serum levels of total bile acid (TBA), alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin (TBIL), and TCA were measured using a fully automatic biochemical analyzer. The predictive value of serum TCA levels for adverse outcomes in ICP was analyzed using receiver operating characteristic (ROC) curve analysis. Subsequently, ICP patients were divided into high and low TCA expression groups, and the changes in baseline data and adverse outcomes were compared between the groups. The relationship between serum TCA levels and adverse outcomes was evaluated using adverse maternal and infant outcome curves. Logistic regression analysis was performed to identify independent risk factors for adverse outcomes in ICP patients. Results: The adverse outcome group showed significant differences in gestational age at delivery (median value of 37 years old, p = 0.0001), levels of TBA (mean ± standard deviation 47.05 ± 6.43 µmol/L, p < 0.0001), ICP severity (proportion of severe ICP patients was 85.14%, p < 0.0001), ALT (mean ± standard deviation 82.59 ± 6.29 U/L, p < 0.0001), AST (median value of 67.50 U/L, p < 0.0001), and TBIL (mean ± standard deviation 47.05 ± 6.99 µmol/L, p < 0.0001), compared to the normal outcome group. Serum TCA levels were higher in the adverse outcome group (mean ± standard deviation 17.79 ± 4.56 µmol/L) than in the normal outcome group (mean ± standard deviation 11.72 ± 3.68 µmol/L) (p < 0.001). Serum taurocholic acid (TCA) levels demonstrated predictive value for adverse outcomes in ICP patients, and the areas under the ROC curve/sensitivity/specificity/cutoff value were 0.8430, 66.22%, 91.03%, and 16.17, respectively. The high TCA expression group had higher levels of TBA (median value of 43.40 µmol/L, p < 0.0001), ALT (median value of 79.89 µmol/L, p < 0.0001), AST (median value of 63.87 µmol/L, p < 0.0001), and TBIL (median value of 43.79 µmol/L, p < 0.0001), a higher proportion of severe ICP cases (71.43%, p < 0.0001). There were a remarkably increased number of adverse pregnancy outcomes (postpartum hemorrhage, premature birth, neonatal asphyxia, fetal distress, amniotic fluid fecal staining, and low birth weight) in the high TCA expression group (n = 49) compared to the low TCA expression group (n = 25) (p < 0.0001). The Kaplan-Meier (KM) curve of patients with high TCA expression shifted to the left compared with patients with low TCA expression (p < 0.0001). The cumulative survival rate of patients with high serum TCA expression (22.22%) was prominently reduced compared to patients with low serum TCA expression (85.03%), indicating that high serum TCA levels increased the risk of maternal and infant adverse outcomes in ICP patients. TBAs, AST, and TCA were identified as independent risk factors for adverse maternal and fetal outcomes in ICP patients. Conclusion: Serum TCA is an independent risk factor for adverse outcomes in ICP patients. Serum TCA levels have predictive values for adverse maternal and infant outcomes in pregnant women with ICP, but there are still some false positives. In clinical diagnosis, it is essential to combine other clinical data to increase the diagnostic accuracy.

Pregnancy and Infant Outcomes in Women Receiving Ocrelizumab for the Treatment of Multiple Sclerosis: Analysis of the Largest Available Outcomes Database

Pregnancy and Infant Outcomes in Women Receiving Ocrelizumab for the Treatment of Multiple Sclerosis: Analysis of the Largest Available Outcomes Database

Association between very advanced maternal age women with gestational diabetes mellitus and the risks of adverse infant outcomes: a cohort study from the NVSS 2014–2019

BackgroundTo evaluate the association between gestational diabetes mellitus (GDM) and infant outcomes in women of very advanced maternal age (vAMA) (≥45 years).MethodsThis cohort study utilized data from the National Vital Statistics System (NVSS) database (2014–2019) in the United States. Preterm birth was the primary outcome, which was subdivided into extremely preterm, very preterm, and moderate or late preterm. The secondary outcomes were neonatal intensive care unit (NICU) admission, low birthweight and small for gestational age. Univariate and multivariate logistic regression analyses were used to explore the association between GDM and infant outcomes among vAMA women. Subgroup analyses were performed based on race and use of infertility treatment. Odds ratios (ORs) and 95% confidence intervals (CIs) were estimated.ResultsA total of 52,544 vAMA pregnant women were included. All analysis made comparisons between women with vAMA and GDM and women with vAMA and no GDM. Women with GDM had a significantly higher risk of preterm birth than those without GDM (OR = 1.26, 95%CI = 1.18–1.36, P < 0.001). Compared with women without GDM, those with GDM had a significantly increased risk of moderate or late preterm birth (OR = 1.27, 95%CI = 1.18–1.37, P < 0.001); no significant association of GDM with extremely preterm birth and very preterm birth was observed. Women with GDM had a significantly greater risk of NICU admission than those without (OR = 1.33, 95%CI = 1.23–1.43, P < 0.001). GDM was associated with a significantly lower risk of low birthweight (OR = 0.91, 95%CI = 0.84–0.98, P = 0.010), and no significant association was found between GDM and small for gestational age (OR = 0.95, 95%CI = 0.87–1.03, P = 0.200) in vAMA women.ConclusionvAMA women with GDM had an increased risk of preterm birth, especially moderate or late preterm birth. NICU admission and low birthweight were also associated with GDM among vAMA women.

Adverse Maternal and Infant Outcomes in Women With Chronic Hypertension in France (2010-2018): The Nationwide CONCEPTION Study.

Background It has been suggested that chronic hypertension is a risk factor for negative maternal and fetal outcomes during pregnancy and postpartum. We aimed to estimate the association of chronic hypertension on adverse maternal and infant outcomes and assess the impact of antihypertensive treatment and these outcomes. Methods and Results Using data from the French national health data system, we identified and included in the CONCEPTION cohort all women in France who delivered their first child between 2010 and 2018. Chronic hypertension before pregnancy was identified through antihypertensive medication purchases and by diagnosis during hospitalization. We assessed the incidence risk ratios (IRRs) of maternofetal outcomes using Poisson models. A total of 2 822 616 women were included, and 42 349 (1.5%) had chronic hypertension and 22 816 were treated during pregnancy. In Poisson models, the adjusted IRR (95% CI) of maternofetal outcomes for women with hypertension were as follows: 1.76 (1.54-2.01) for infant death, 1.73 (1.60-1.87) for small gestational age, 2.14 (1.89-2.43) for preterm birth, 4.58 (4.41-4.75) for preeclampsia, 1.33 (1.27-1.39) for cesarean delivery, 1.84 (1.47-2.31) for venous thromboembolism, 2.62 (1.71-4.01) for stroke or acute coronary syndrome, and 3.54 (2.11-5.93) for maternal death postpartum. In women with chronic hypertension, being treated with an antihypertensive drug during pregnancy was associated with a significantly lower risk of obstetric hemorrhage, stroke, and acute coronary syndrome during pregnancy and postpartum. Conclusions Chronic hypertension is a major risk factor of infant and maternal negative outcomes. In women with chronic hypertension, the risk of pregnancy and postpartum cardiovascular events may be decreased by antihypertensive treatment during pregnancy.

JAHA Go Red for Women Spotlight 2023.

JAHA Go Red for Women Spotlight 2023.

Maternal and infant outcomes in women with and without gestational diabetes mellitus in the COVID-19 era in China: Lessons learned.

The global COVID-19 pandemic has required a drastic transformation of prenatal care services. Whether the reformulation of the antenatal care systems affects maternal and infant outcomes remains unknown. Particularly, women with gestational diabetes mellitus (GDM) are among those who bear the greatest brunt. Thus, this study aimed to evaluate the impact of COVID-19 lockdown during late pregnancy on maternal and infant outcomes in women stratified by the GDM status in China. The participants were women who experienced the COVID-19 lockdown during late pregnancy (3185 in the 2020 cohort) or not (2540 in the 2019 cohort) that were derived from the Beijing Birth Cohort Study. Maternal metabolic indicators, neonatal outcomes, and infant anthropometrics at 12 months of age were compared between the two cohorts, stratified by the GDM status. Participants who experienced COVID-19 lockdown in late pregnancy showed lower gestational weight gain than those in the control cohort. Nevertheless, they displayed a worse metabolic profile. COVID-19 lockdown during pregnancy was associated with higher glycosylated hemoglobin (HbA1c) (β= 0.11, 95% CI = 0.05-0.16, q-value = 0.002) and lower high density lipoprotein cholesterol level (HDL-C) level (β=-0.09, 95% CI = -0.14 to -0.04, q-value = 0.004) in women with GDM, adjusted for potential confounders. In normoglycemic women, COVID-19 lockdown in late pregnancy was associated with higher fasting glucose level (β= 0.10, 95% CI = 0.08-0.12, q-value <0.0001), lower HDL-C level (β=-0.07, 95% CI = -0.08 to -0.04, q-value <0.0001), and increased risk of pregnancy-induced hypertension (adjusted OR=1.80, 95%CI=1.30-2.50, q-value=0.001). The fasting glucose level decreased less from early to late pregnancy in women who experienced COVID-19 lockdown than in the controls, regardless of the GDM status. The HDL-C has risen less with COVID-19 lockdown in the normoglycemic subgroup. In contrast, no significant differences regarding neonatal outcomes or infant weight were found between the two cohorts. Experiencing the COVID-19 lockdown in pregnancy was associated with worse maternal metabolic status but similar neonatal outcomes and infant weight.

Brief Report: Impact of Antiretroviral Regimen on Pregnancy and Infant Outcomes in Women With HIV/ HBV Coinfection.

There are limited data on the impact of antenatal antiretroviral regimens (ARV) on pregnancy and infant outcomes in HIV/HBV coinfection. We compared outcomes among 3 antenatal antiretroviral regimens for pregnant women with HIV/HBV. The PROMISE study enrolled ARV-naive pregnant women with HIV. Women with HBV were randomized to (no anti-HBV)-zidovudine (ZDV) + intrapartum nevirapine and 1 week of tenofovir disoproxil fumarate and emtricitabine (TDF-FTC); (3TC)-3TC + ZDV + LPV/r; or (FTC-TDF)-FTC + TDF + LPV/r. Pairwise group comparisons were performed with Fisher exact, t , or log rank tests. Adverse pregnancy outcome (APO) was a composite of low birth weight, preterm delivery, spontaneous abortion, stillbirth, or congenital anomaly. Of 138 women with HIV/HBV, 42, 48, and 48 were analyzed in the no anti-HBV, 3TC, and FTC-TDF arms. Median age was 27 years. APOs trended lower in the no anti-HBV (26%) vs 3TC (38%), and FTC-TDF arms (35%), P ≥ 0.25). More infant deaths occurred among the FTC-TDF [6 (13%)] vs no anti-HBV [2 (5%)] and 3TC [3 (7%)] arms. There were no differences in time-to-death, HIV-free survival, birth or one-year WHO Z-score length-for-age, and head circumference. Hepatitis B e antigen (HBeAg) was associated with an increased risk of APO, 48% vs 27% (odds ratio 2.79, 95% confidence interval: 1.19 to 6.67, post hoc ). With HBV/HIV coinfection, the risk of an APO was increased with maternal ARV compared with ZDV alone, although the differences were not statistically significant. Maternal HBeAg was associated with a significantly increased risk of APO. Infant mortality was highest with FTC + TDF + LPV/r. Early assessment of HBeAg could assist in identifying high-risk pregnancies for close monitoring.

Adverse Maternal and Infant Outcomes in Women with Chronic Hypertension in France (2010-2018): The Nationwide CONCEPTION Study

Adverse Maternal and Infant Outcomes in Women with Chronic Hypertension in France (2010-2018): The Nationwide CONCEPTION Study

Analysis of the Clinical Effects of Sodium Valproate and Levetiracetam in the Treatment of Women with Epilepsy during Pregnancy.

Objective To explore the clinical effects of sodium valproate and levetiracetam in the treatment of women with epilepsy during pregnancy. Methods The clinical data of 124 women with epilepsy during pregnancy who received monotherapy with antiepileptic drugs (AEDs) in our hospital from September 2017 to January 2020 were retrospectively analyzed. According to the type of medication taken by the patients, they were recorded as the sodium valproate group (the VPA group, n = 56) and the levetiracetam group (the LEV group, n = 68 cases). The effects and the maternal and infant outcomes after treatment were compared between the two groups. The neuron-specific enolase (NSE), cognitive function-related parameters (brain-derived neurotrophic factor (BDNF) and myelin basic protein (MBP)), and related inflammatory factors (tumor necrosis factor- (TNF-) α and interleukin- (IL-) 6) levels were compared between the two groups before and after treatment. Results After treatment, the total clinical effective rate of the LEV group was 91.18% higher than that of the VPA group 73.21%, and the frequency and duration of seizures were lower than those of the VPA group (P < 0.05). After treatment, the probability of gestational hypertension, depression during pregnancy, low-weight infants, and neonatal deformities in the LEV group was lower than that in the VPA group (P < 0.05). After treatment, the levels of NSE, MBP, TNF-α, and IL-6 in the two groups decreased, and the levels of BDNF increased, and the LEV group changed significantly compared with the VPA group (P < 0.05). Conclusion Compared with sodium valproate monotherapy, levetiracetam is more effective in controlling seizures and improving maternal and infant outcomes in women with epilepsy during pregnancy and can effectively regulate their neurological and cognitive functions and reduce the serum inflammation factor level.

Comparison of Pregnancy Outcomes of Women with and Without Hypertension at the Latent Phase of Labor Who Were Under Medical Care for Preeclampsia

OBJECTIVE: We explored the association between hypertension (&gt;140/90) at the latent phase of labor (resistant hypertension) and the subsequent development of major maternal complications or adverse infant outcomes in women with preeclampsia under medical care. STUDY DESIGN: We drew data from 824 women who were under follow-up at the Department of Perinatology of Health Sciences University Zeynep Kamil Women and Children’s Health Training and Research Hospital with a diagnosis of preeclampsia. Women with and without resistant hypertension were compared in terms of major maternal complications and adverse infant outcomes. RESULTS: Mean age and body mass index were similar between the two groups (p&gt;0.05). The rate of preeclamptic complaints was significantly higher in groups with resistant hypertension (90.1% vs. 67.2%, p&lt;0.05). Proteinuria was more frequent in the resistant hypertension group (78.7% vs. 66.8%, p&lt;0.001). The newborn intensive care unit admission rate was significantly higher in the group with resistant hypertension (65.6% vs. 45.9%, p&lt;0.001). Gestational age at delivery was significantly lower in the group with resistant hypertension compared to the normotensive group (34.6 vs. 32.9 weeks, p&lt;0.001). There was a significant difference between the two groups in terms of the rate of preterm delivery (78.5% vs. 66.7%, p=0.04). CONCLUSION: Resistant hypertension is associated with a higher rate of preeclamptic symptoms during labor and newborn intensive care unit admission.

909 Obstetric outcomes among women who underwent TOLAC versus repeat cesarean

Women with a prior cesarean must make an informed choice between a repeat cesarean versus a trial of labor after cesarean (TOLAC). The objective of this study was to determine the differences in maternal and infant outcomes in women who underwent repeat cesarean delivery (CD) without TOLAC versus women who underwent TOLAC. This was a retrospective cohort study of women delivering in California between 2007-2011 who were delivering after a previous cesarean. The study included women with singleton, non-anomalous, multiparous live births between 37- and 41-weeks’ gestation. We examined rates of maternal and infant outcomes. Analyses were conducted using Pearson’s chi-squared test of significance with an alpha of 0.05. In this study, 345,308 women-infant dyads met the inclusion criteria. Of these, 296,457 (85.9%) had a repeat cesarean section without TOLAC and 48,851 (14.1%) underwent TOLAC. Maternal and infant outcomes were significantly different between groups. Rates of endometritis were lower in women with a repeat cesarean without TOLAC than those who had a trial of labor (0.4% vs. 0.6%, p<0.001). Women who did not undergo TOLAC experienced lower rates of postpartum hemorrhage compared to those who did (1.2% vs. 3.1%, p<0.001), though the experienced a higher rate of blood transfusion (1.0% vs. 0.9%, p<0.001). Infants of women in the TOLAC group had higher rates of neonatal intensive care unit admission (7.2% vs. 5.6%, p<0.001) and higher rates of APGAR scores under 7 at five minutes (0.5% vs. 0.3%, p <0.001). Infants of women in the TOLAC group were also more likely to have hypoxic-ischemic encephalopathy (0.1% vs. 0.02%, p<0.001). There was no significant difference in neonatal death. We found that, when comparing undergoing repeat cesarean with and without TOLAC, maternal and infant outcomes were significantly different. Future research should investigate characteristics and management factors contributing to these differences.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Maternal HBV Viremia and Association With Adverse Infant Outcomes in Women Living With HIV and HBV.

There is limited information on perinatal outcomes in HIV-hepatitis B virus (HBV) coinfection. HIV Prevention Trials Network (HPTN) 046 was a randomized double-blind placebo-controlled trial of perinatal transmission that evaluated 6 months of infant nevirapine versus placebo among breast-fed infants. Women living with HIV and their infants enrolled in sub-Saharan Africa from 2007 to 2010; 78% received antiretroviral therapy (ART). Maternal samples were tested for hepatitis B surface antigen (HBsAg). High and low HBV viral load (VL) was defined as ≥106 IU/mL and <106 IU/mL. The association between HIV-HBV coinfection and maternal and infant outcomes was assessed using multivariate (MV) logistic and Cox regression. Among 2025 women, 88 (4.3%) had HBV. HIV-HBV women with high HBV VL had lower median CD4, versus HIV alone or HIV-HBV women with low HBV VL [320, 490 and 434 cells/mm3, respectively (P < 0.007)]. In MV analysis, adjusted for maternal CD4, age and maternal ART, infants born to women with high HBV VL were more likely to be low birth weight (LBW), versus HIV+/HBV- and low HBV VL women: [30% (3/10) vs. 10% (194/1953) vs. 6% (5/78), respectively, P = 0.03). High HBV VL was associated with HIV perinatal transmission [(hazard ratio 6.75 (95% confidence interval (CI): 1.86 - 24.50)]. There was no impact on infant mortality or maternal outcomes at 18 months. In HIV-HBV women, high HBV viral loads increase the risk of LBW and potentially HIV perinatal transmission. Reduction of antepartum HBV viremia may have beneficial effects beyond the prevention of HBV perinatal transmission.

Infant and Maternal Outcomes for Women Who Experience Imprisonment in Ontario, Canada: A Retrospective Cohort Study.

To describe the population-level risk of infant and maternal outcomes for women who experience imprisonment and compare outcomes with the general population. We conducted a retrospective cohort study. We used linked correctional and health data for women released from provincial prisons in 2010. We defined three exposure groups for Ontario singleton deliveries from 2005-2015: deliveries to women who were in prison during pregnancy but not necessarily for delivery, prison pregnancies; deliveries to women who had been in prison but not while pregnant, prison controls; and general population deliveries. We compared groups using generalized estimating equations. Primary outcomes were preterm birth, low birth weight, and small for gestational age birth weight. Secondary outcomes included NICU admission, neonatal abstinence syndrome, placental abruption, and preterm prelabour rupture of membranes. In prison pregnancies (n = 544) and prison controls (n = 2156), respectively, preterm birth risk was 15.5% and 12.5%, low birth weight risk was 13.0% and 11.6%, and small for gestational age birth weight risk was 18.1% and 19.2%. Adjusted for maternal age and parity and compared with general population deliveries (N = 1 284 949), odds ratios were increased for prison pregnancies and prison controls, respectively, at 2.7 (95% CI 2.2-3.4) and 2.1 (95% CI 1.9-2.4) for preterm birth, 3.1 (95% CI 2.4-3.9) and 2.7 (95% CI 2.3-3.1) for low birth weight, and 1.6 (95% CI 1.3-2.1) and 1.8 (95% CI 1.6-2.0) for small for gestational age birth weight. There is an increased risk of adverse infant outcomes in women who experience imprisonment compared with the general population, whether they are in prison during pregnancy or not.

Design of a Multi-Source Post-Marketing Study to Evaluate Pregnancy and Infant Outcomes in Women With Multiple Sclerosis Who Were Exposed to Ocrelizumab During, or Within 6 Months Before, Pregnancy (P4.372)

Design of a Multi-Source Post-Marketing Study to Evaluate Pregnancy and Infant Outcomes in Women With Multiple Sclerosis Who Were Exposed to Ocrelizumab During, or Within 6 Months Before, Pregnancy (P4.372)

Design of the Ocrelizumab Pregnancy Registry to Assess Maternal, Fetal and Infant Outcomes in Women With Multiple Sclerosis Who Were Exposed to Ocrelizumab During, or Within 6 Months Before, Pregnancy (P4.367)

Design of the Ocrelizumab Pregnancy Registry to Assess Maternal, Fetal and Infant Outcomes in Women With Multiple Sclerosis Who Were Exposed to Ocrelizumab During, or Within 6 Months Before, Pregnancy (P4.367)

Randomized controlled trial of induction at 38 weeks versus 40 weeks gestation on maternal and infant outcomes in women with insulin-controlled gestational diabetes

To compare the impact of induction of labor at 38weeks of gestation with the induction of labor at 40weeks of gestation in women with insulin-treated gestational diabetes on maternal and fetal outcome. In this study 100pregnant women with insulin-treated gestational diabetes were randomized to either induction of labor at 38(groupI) or 40weeks (groupII) to evaluate the rate of large for gestational age newborns, neonatal hypoglycemia, success rate of deliveries within 48h and cesarean section rate after induction in both groups. The difference of large for gestational age newborns was not significant between the two groups (6.8% vs. 12.8%, p= 0.49), 16(36.4%) newborns in groupI and 8(17.0%) newborns in groupII developed hypoglycemia <35 mg/dl (p= 0.04). The success rate for deliveries within 48h after induction of labor for groupsI andII was 77.3% and 92.3%, respectively (p= 0.25). The cesarean section rate after induction of labor was not significantly different between the two groups (24.1% vs. 18.7%, p= 0.49). In acohort of women with insulin-treated gestational diabetes, induction of labor at 38weeks did not significantly reduce the rate of large for gestational age newborns compared to induction at 40weeks but seems to increase the rate of neonatal hypoglycemia.

Vaginal progesterone prophylaxis for preterm birth (the OPPTIMUM study): a multicentre, randomised, double-blind trial.

SummaryBackgroundProgesterone administration has been shown to reduce the risk of preterm birth and neonatal morbidity in women at high risk, but there is uncertainty about longer term effects on the child.MethodsWe did a double-blind, randomised, placebo-controlled trial of vaginal progesterone, 200 mg daily taken from 22–24 to 34 weeks of gestation, on pregnancy and infant outcomes in women at risk of preterm birth (because of previous spontaneous birth at ≤34 weeks and 0 days of gestation, or a cervical length ≤25 mm, or because of a positive fetal fibronectin test combined with other clinical risk factors for preterm birth [any one of a history in a previous pregnancy of preterm birth, second trimester loss, preterm premature fetal membrane rupture, or a history of a cervical procedure to treat abnormal smears]). The objective of the study was to determine whether vaginal progesterone prophylaxis given to reduce the risk of preterm birth affects neonatal and childhood outcomes. We defined three primary outcomes: fetal death or birth before 34 weeks and 0 days gestation (obstetric), a composite of death, brain injury, or bronchopulmonary dysplasia (neonatal), and a standardised cognitive score at 2 years of age (childhood), imputing values for deaths. Randomisation was done through a web portal, with participants, investigators, and others involved in giving the intervention, assessing outcomes, or analysing data masked to treatment allocation until the end of the study. Analysis was by intention to treat. This trial is registered at ISRCTN.com, number ISRCTN14568373.FindingsBetween Feb 2, 2009, and April 12, 2013, we randomly assigned 1228 women to the placebo group (n=610) and the progesterone group (n=618). In the placebo group, data from 597, 587, and 439 women or babies were available for analysis of obstetric, neonatal, and childhood outcomes, respectively; in the progesterone group the corresponding numbers were 600, 589, and 430. After correction for multiple outcomes, progesterone had no significant effect on the primary obstetric outcome (odds ratio adjusted for multiple comparisons [OR] 0·86, 95% CI 0·61–1·22) or neonatal outcome (OR 0·62, 0·38–1·03), nor on the childhood outcome (cognitive score, progesterone group vs placebo group, 97·3 [SD 17·9] vs 97·7 [17·5]; difference in means −0·48, 95% CI −2·77 to 1·81). Maternal or child serious adverse events were reported in 70 (11%) of 610 patients in the placebo group and 59 (10%) of 616 patients in the progesterone group (p=0·27).InterpretationVaginal progesterone was not associated with reduced risk of preterm birth or composite neonatal adverse outcomes, and had no long-term benefit or harm on outcomes in children at 2 years of age.FundingEfficacy and Mechanism Evaluation (EME) Programme, a Medical Research Council (MRC) and National Institute for Health Research (NIHR) partnership. The EME Programme is funded by the MRC and NIHR, with contributions from the Chief Scientist Office in Scotland and National Institute for Social Care and Research in Wales.

Belimumab Pregnancy Registry

INTRODUCTION: Systemic lupus erythematosus (SLE) is an autoimmune disorder typically affecting women of childbearing age, making it important to understand how underlying disease and treatments affect pregnancy outcomes. Belimumab, a biologic, received regulatory approval in 2011. Given that the agent has been used for a short time, there is little information about its use in pregnancy. Belimumab Pregnancy Registry objectives are to evaluate pregnancy and infant outcomes in women with SLE exposed to commercially supplied belimumab within the 4 months before or during pregnancy or both. METHODS: The registry is a multicenter, international, prospective cohort study with voluntary participation. Data collection consists of information documented in medical records. Primary reporters are physicians (belimumab prescriber, obstetric provider, and pediatrician). Primary outcome is birth defects and secondary outcomes include spontaneous miscarriage, live birth (preterm birth, small for gestational age), stillbirth, elective termination, and infant outcomes through age 1 year (serious, clinically significant infections, or both). RESULTS: As of May 31, 2013, two pregnancy outcomes had been reported in six enrolled participants. One participant, exposed to belimumab 6 weeks preconception, delivered a live-born neonate at 35-5/7 weeks of gestation by repeat cesarean delivery after uterine contractions with no cervical dilation. The second participant, exposed to belimumab approximately 1 week postconception, delivered a live-born neonate at 32-5/7 weeks of gestation after placental abruption. No birth defects were reported. CONCLUSIONS: Registry data will add to current clinical experience with belimumab and assist clinicians and patients in weighing potential risks and benefits of treatment for pregnant patients with SLE. WEUKBRE6076:GSK1550188; ClinicalTrials.gov NCT01532310.