Duration of double balloon catheter for patients with prior cesarean: a before and after study.

Background: Previous studies that suggest a shorter time from cervical ripening balloon placement to delivery with shorter total balloon placement time have excluded patients with prior cesarean deliveries. Objective: To evaluate, in patients with a prior history of cesarean delivery undergoing cervical ripening with a double-balloon catheter, whether planned removal of device after 6 vs 12 hours would result in shorter time to vaginal delivery. Study Design: A before-and-after study was performed after a practice change occurred November 2020, shortening the planned time of double-balloon catheter placement for cervical ripening from 12 to 6 hours. Data were collected via retrospective electronic chart review. Primary outcome was time from balloon placement to vaginal delivery. Secondary outcomes included rates of cesarean delivery, maternal intraamniotic infection, and uterine rupture. Kaplan-Meier curves compared median times to delivery between the groups. A Cox proportional-hazards model was used to adjust for time of balloon placement, number of previous vaginal deliveries, and co-medications used. Results: From November 2018 to November 2022, 189 analyzable patients with a prior history of cesarean delivery received a double-balloon catheter for cervical ripening during their trial of labor. Patients were separated into pre- and postpolicy change groups (n=91 and 98, respectively). The median time to vaginal delivery for the pregroup was 28 hours (95% CI: 26, 35) and 25 hours (95% CI: 23, 29) for those in the postgroup (P value .052). After adjusting for dilation at time of balloon placement, number of previous vaginal deliveries, and co-medication, the estimated hazard ratio for successful vaginal delivery postpolicy change was 1.89 (95% CI: 1.27, 2.81). There were no differences in rates of secondary outcomes. Conclusion: In patients with prior cesarean delivery undergoing mechanical cervical ripening with a double-balloon catheter, planned removal at 6 hours compared to 12 hours may result in higher chances of successful vaginal delivery and possibly a shorter time to delivery, without increasing rates of cesarean delivery and intraamniotic infection.

Intensive glycaemic targets in overweight and obese individuals with gestational diabetes mellitus: clinical trial protocol for the iGDM study.

INTRODUCTION: The prevalence of both obesity and gestational diabetes mellitus (GDM) has increased, and each is associated with adverse perinatal outcomes including fetal overgrowth, neonatal morbidity, hypertensive disorders of pregnancy and caesarean delivery. Women with GDM who are also overweight or obese have higher rates of pregnancy complications when compared with normal-weight women with GDM, which may occur in part due to suboptimal glycaemic control. The current recommendations for glycaemic targets in pregnant women with diabetes are based on limited evidence and exceed the mean fasting (70.9±7.8 mg/dL) and 1-hour postprandial (108.9±12.9 mg/dL) glucose values in pregnant individuals without diabetes. Our prior work demonstrated that the use of intensive (fasting <90 mg/dL and 1-hour postprandial <120 mg/dL) compared with standard (fasting <95 mg/dL and 1-hour postprandial <140 mg/dL) glycaemic targets resulted in improved glycaemic control without increasing the risk for hypoglycaemia in pregnant individuals with GDM, but the impact of intensive glycaemic targets on perinatal outcomes is unknown. METHODS AND ANALYSIS: The Intensive Glycemic Targets in Overweight and Obese Women with Gestational Diabetes Mellitus: A Multicenter Randomized Trial (iGDM Trial) is a large, pragmatic randomised clinical trial designed to investigate the impact of intensive versus standard glycaemic targets on perinatal outcomes in women with GDM who are overweight and obese. During the 5-year project period, a multidisciplinary team of investigators from five medical centres representing regions of the USA with high rates of obesity will randomise 828 overweight and obese women with GDM to either intensive or standard glycaemic targets. We will test the central hypothesis that intensive glycaemic targets will result in lower rates of neonatal composite morbidity including large for gestational age birth weight, neonatal hypoglycaemia, respiratory distress syndrome and need for phototherapy when compared with standard glycaemic targets using the intention-to-treat approach to analysis. ETHICS AND DISSEMINATION: The Institutional Review Board (IRB) at Indiana University School of Medicine approved this study (IRB# 11435; initial approval date 25 August 2021). We will submit the results of the trial for publication in peer-reviewed journals and presentations at international scientific meetings. TRIAL REGISTRATION NUMBER: NCT05124808.

New sensitive LC-MS/MS method for the simultaneous determination of 13 phenolic and carboxylic acid pesticide biomarkers in human urine, including dicamba.

The commercialization in 2016 of genetically engineered seeds tolerant to dicamba and/or 2,4-dichlorophenoxyacetic acid (2,4-D) has caused a rapid increase in the use of these herbicides. New questions about the reproductive and chronic health effects of long-term exposure to these herbicides have been raised. To assess exposure to dicamba and other pesticides of interest in the Heartland Study, a birth cohort study based in the United States, a new analytical method was needed. The present study describes the development and validation of this new solid phase extraction and liquid chromatography-tandem mass spectrometry method that detects simultaneously 13 pesticides or their metabolites in 250 µL of urine. More specifically, the method allows the analysis of dicamba, 2,4-D and 2,4,5-trichlorophenoxyacetic acid (2,4,5-T), which are herbicides, of malathion dicarboxylic acid (MDA), para-nitrophenol (PNP), 3,5,6-trichloro-2-pyridinol (TCPy), 2-diethylamino-6-methylpyrimidin-4-ol (DEAMPY) and 2-isopropyl-6-methyl-4-pyrimidinol (IMPY), which are metabolites of organophosphate insecticides, and finally of cis-3-(2,2-Dichlorovinyl)-2,2-dimethylcyclopropane carboxylic acid (cis-DCCA), trans-3-(2,2-Dichlorovinyl)-2,2-dimethylcyclopropane carboxylic acid (trans-DCCA), 3-Phenoxybenzoic acid (3-PBA), 4-Fluoro-3-phenoxybenzoic acid (4-F-3-PBA) and cis-3-(2,2-Dibromovinyl)-2,2-dimethylcyclopropane carboxylic acid (cis-DBCA), which are metabolites of synthetic pyrethroids insecticides. The method was validated under ISO/IEC 17025 guidance. The limit of detection (LOD) in urine samples was 0.10 µg/L for dicamba, while the LOD for other analytes ranged between 0.0038 µg/L and 0.091 µg/L. Accuracy was evaluated by analyzing samples from two External Quality Assessment Schemes, namely G-EQUAS and OSEQAS. Preliminary results obtained following the analysis of 91 urine samples taken from pregnant women enrolled in the Heartland Study are presented here. This method is suitable for human biomonitoring studies.

The Impact of Self-Reported Alcohol, Tobacco, and Recreational Drug Use during Pregnancy on Adverse Pregnancy Outcomes in First-Time Mothers.

OBJECTIVE: The objective of this study was to derive profiles of alcohol, tobacco, and recreational drug use during pregnancy for first-time mothers with latent class growth analysis (LCGA) and determine the association of these classes with the risk of adverse pregnancy outcomes (APO). STUDY DESIGN: A secondary analysis of a prospective cohort of Nulliparous Outcomes in Pregnancy: Monitoring Mothers-to-Be was conducted in eight medical centers across the United States from September 30, 2010, to September 23, 2013. Self-reported use of any alcohol, tobacco, or recreational drugs in the 1 month prior to the visit was assessed at up to four visits throughout pregnancy, and APOs included a composite of preterm birth, hypertensive disorder of pregnancy (HDP), small for gestational age (SGA) infant, or stillbirth, and each adverse outcome separately. RESULTS: Four latent classes were identified from the LCGA for 10,031 nulliparous pregnant women that were on average 26.9 years old (standard deviation [SD] = 5.7) and mostly non-Hispanic White (59.7%). Classes included consistent tobacco users (N = 517, 5.2%), nonusers (N = 8,945, 89.2%), alcohol users (N = 500, 5.0%), and a combination of alcohol/tobacco/drug users (N = 69, 0.7%). Logistic regression demonstrated that the class of tobacco users was more likely to have an APO (odds ratio [OR] = 1.48, 95% confidence interval [CI] = 1.22-1.81), preterm birth (OR = 1.53, 95% CI = 1.15-2.02), and SGA (OR = 1.79, 95% CI = 1.36-2.35) relative to the class of nonusers. The class of alcohol users was more likely to have HDP (OR = 1.37, 95% CI = 1.11-1.70) and less likely to have preterm birth (OR = 0.59, 95% CI = 0.38-0.90) and SGA (OR = 0.61, 95% CI = 0.40-0.93) compared to nonusers. CONCLUSION: Trajectories of substance use are associated with APOs; thus, interventions to mitigate the use when encountered early in pregnancy are warranted. KEY POINTS: · Four classes of substance use were identified.. · Tobacco users were at a higher risk of APO and alcohol users were at higher risk of HDP.. · Mitigation strategies are warranted to reduce APO..

Pharmacokinetics of vaginal versus buccal misoprostol for labor induction at term.

The IMPROVE study (NCT02408315) compared the efficacy and safety of vaginal and buccal administration of misoprostol for full-term, uncomplicated labor induction. This report compares the pharmacokinetics of misoprostol between vaginal and buccal routes. Women greater than or equal to 14 years of age undergoing induction of labor greater than or equal to 37 weeks gestation without significant complications were randomized to vaginal or buccal misoprostol 25 µg followed by 50 µg doses every 4 h. Misoprostol acid concentrations were determined using liquid chromatography-tandem mass spectrometry for the first 8 h in a subgroup of participants. A population pharmacokinetic model was developed using NONMEM. Plasma concentrations (n = 469) from 47 women were fit to a one-compartment nonlinear clearance model. The absorption rate constant (ka ) was dependent on both route and dose of administration: buccal 25 µg 0.724 (95% confidence interval, 0.54-0.92) h-1 ; 50 µg 0.531 (0.37-0.63) h-1 ; vaginal 25 µg 0.507 (0. 2-1. 4) h-1 ; and 50 µg 0.246 (0.103-0.453) h-1 . Relative bioavailability for vaginal compared to buccal route was 2.4 (1.63-4.77). There was no effect of body mass index or age on apparent clearance 705 (431-1099) L/h or apparent volume of distribution 632 (343-1008) L. The area under the concentration-time curve to 4 h following the first 25 µg dose of misoprostol was 16.5 (15.4-17.5) pg h/ml for buccal and 34.3 (32.5-36.1) pg h/ml for vaginal administration. The rate of buccal absorption was two times faster than that of vaginal, whereas bioavailability of vaginal administration was 2.4 times higher than that of buccal. Decreased time to delivery observed with vaginal dosing may be due to higher exposure to misoprostol acid compared to buccal.

Profile of Reported Alcohol, Tobacco, and Recreational Drug Use in Nulliparous Women.

OBJECTIVE: To estimate alcohol, tobacco, and recreational drug use during pregnancy among nulliparous women. METHODS: In a cohort of nulliparous women followed through pregnancy from the first-trimester nuMoM2b (Nulliparous Outcomes in Pregnancy: Monitoring Mothers to be) study, self-reported use of alcohol, tobacco, and drugs was chronicled longitudinally at four study visits in this secondary analysis. Rates of use before pregnancy, in each trimester (visit 1, visit 2, visit 3, approximating each trimester), and at the time of delivery (visit 4) were recorded. The amount of alcohol, tobacco, and drug exposure were recorded using validated measures, and trends across pregnancy were analyzed. RESULTS: Of the 10,038 study participants, 10,028 had information regarding alcohol, tobacco, and drug use at visit 1, 9,412 at visit 2, 9,217 at visit 3, and 7,167 at visit 4. The rates of drinking alcohol, which had been 64.6% in the 3 months before pregnancy, were lower in pregnancy (3.9% at visit 1, 5.6% at visit 2, 7.0% at visit 3, and 6.1% at visit 4, P<.001 for all). Rates later in pregnancy were all greater than in the first trimester (P<.01). The rate of smoking in the 3 months before pregnancy, which was 17.8%, also declined at visit 1 (5.9%), and continued to decline through pregnancy (5.3% at visit 2, 4.7% at visit 3, and 3.9% at visit 4, with all rates lower than that of visit 1 [P<.01]). Although recreational drug use was relatively common in the months before pregnancy (33.8%), it also declined during pregnancy (1.1% at visit 2, 0.7% at visit 3, 0.4% at visit 4). CONCLUSIONS: In this geographically and ethnically diverse cohort of nulliparous women, rates of self-reported alcohol, smoking, and recreational drug use were all significantly lower during than before pregnancy. Nonetheless, rates of alcohol use rose as pregnancy progressed, highlighting the need for continued counseling throughout all trimesters of pregnancy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01322529.

Psychosocial and Sociodemographic Contributors to Breastfeeding Intention in First-Time Mothers.

OBJECTIVE: Breastfeeding has multiple benefits for women and babies. Understanding factors contributing to intention to exclusively breastfeed may allow for improving the rates in first-time mothers. The study objective was to examine factors associated with a woman's intention to breastfeed her first child. METHODS: A secondary analysis of the prospective "Nulliparous Pregnancy Outcomes Study: monitoring mothers-to-be" (nuMoM2b) study of nulliparous women in the U.S. with singleton pregnancies was performed. Sociodemographic and psychosocial factors were analyzed for associations with breastfeeding intention. RESULTS: For the 6443 women with complete information about breastfeeding intention and all factors under consideration, women who intended to breastfeed (either exclusively or any breastfeeding) were more likely to be older, not black, have reached a higher level of education, have higher incomes, have a lower body mass index (BMI), and be nonsmokers. Reporting a planned pregnancy and several psychosocial measures were also associated with intention to breastfeed. In the multivariable analysis for exclusive breastfeeding, in addition to age, BMI, race, income, education, and smoking, of the psychosocial measures assessed, only women with higher hassle intensity ratios on the Pregnancy Experience Scale had lower odds of exclusive breastfeeding intention (OR 0.71, 95% CI 0.55-0.92). Other psychosocial measures were not associated with either exclusive breastfeeding or any breastfeeding after controlling for demographic characteristics. CONCLUSIONS FOR PRACTICE: Several sociodemographic factors, having a planned pregnancy, and fewer intense pregnancy hassles compared to uplifts are associated with intention to exclusively breastfeed. Identifying these factors may allow providers to identify women for focused, multilevel efforts to enhance breastfeeding rates.

Knowledge and Awareness Among Patients with Chronic Kidney Disease Stage 3.

Knowledge is a prerequisite for changing behavior, and is useful for improving outcomes and reducing mortality rates in patients diagnosed with chronic kidney disease (CKD). The purpose of this article is to describe baseline CKD knowledge and awareness obtained as part of a larger study testing the feasibility of a self-management intervention. Thirty patients were recruited who had CKD Stage 3 with coexisting diabetes and hypertension. Fifty-four percent of the sample were unaware of their CKD diagnosis. Participants had a moderate amount of CKD knowledge. This study suggests the need to increase knowledge in patients with CKD Stage 3 to aid in slowing disease progression.