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Background: Involving patients and consumers in research design helps ensure relevance for those affected by the problem being investigated and can optimize recruitment to clinical trials. This is particularly important when conducting research involving pregnant women. Aims: We investigated women's motivations to participate in a hypothetical randomized control trial (RCT) of a third-trimester screening test for intrapartum fetal compromise (IFC) and adverse perinatal outcomes. Materials and methods: Women attending for routine antenatal care at a tertiary center were invited to complete a short, anonymized patient acceptability survey. The survey was developed with the assistance of the Perinatal Society of Australia and New Zealand's Consumer Advisory Panel and consisted of Likert scales and open-ended questions. It was designed to ascertain women's responses to research issues, particularly the acceptability of being randomized to a non-revealed arm of a screening test RCT. Results: 100 pregnant women took part; 40% indicated that they would agree/strongly agree to participate in a hypothetical RCT regardless of whether they were given the result of a screening test and 31% were unsure. Randomization to either an intervention or control group was acceptable to 47%, 30% were unsure and 23% were not willing to be randomized. Reasons to participate included the desire to contribute to research and to improve pregnancy care. Conclusions: Participation in an RCT of a screening test for IFC involving non-disclosure of the test result was acceptable to a large minority of pregnant women. This finding supports the feasibility of conducting a large-scale study of this design. [ABSTRACT FROM AUTHOR]

Introduction This study aimed to assess satisfaction of patients affected by various fluid regimes during uncomplicated labor; to identify factors possibly associated with the level of satisfaction; to compare obstetrical and neonatal outcomes between the intervention groups. Methods Between October and December 2014, 40 women were included in the study set at the Poitiers University Hospital, France. Women were randomly allocated to two study arms: 20 to strict and 20 to liberal fluid regime group. Women’s satisfaction was assessed using visual analog scale. Categorical obstetrical and neonatal outcomes were analyzed using Chi-squared test and Fischer’s exact test. The between-group difference was assessed with Mann–Whitney U-test. Results Overall satisfaction was higher among women from the liberal fluid regime than from the strict fluid regime group (median score: 88, interquartile range [IQR]: 21 vs. 72, IQR: 21; p = 0.03). The active phase of the second stage of labor was shorter in the liberal fluid regime than in the strict fluid regime group (median 9 min, IQR: 7 vs. 17 min, IQR: 12; p = 0.02). The length of stay in the delivery room was significantly shorter in liberal fluid regime than in strict fluid regime group (median 190 min, IQR: 128 vs. 340 min, IQR: 195, p = 0.04). There were no significant differences in other obstetrical and neonatal outcomes. Conclusion Liberal fluid regime during labor was associated with significantly higher satisfaction of women. The active phase of the second stage of labor and the length of stay in the delivery room were significantly shorter in the liberal fluid regime group. [ABSTRACT FROM AUTHOR]

To compare maternal and perinatal outcomes between randomized trials and observational studies in which conservative management was performed for more than 48 h in patients with early-onset severe preeclampsia. We searched PubMed, LILACS, Cochrane and Google Scholar. The studies were divided in two groups: randomized and observational studies, from 1990 to 2018 that included patients with severe preeclampsia before 34 weeks of gestation with pregnancy prolongation ≥48 h but that did not include fetal growth restriction or HELLP syndrome at the beginning. The main variables recorded were maternal and perinatal complications. Forty-four studies met the inclusion criteria, and 5 of these were randomized. The average pregnancy prolongation was 9 days, with no difference between groups. Maternal complications were significantly more common in observational studies, RR = 0.71, 95% CI (0.54–0.93), p =.009. Perinatal complications were also significantly more common in observational studies (RR = 0.89, 95% CI (0.80–0.98), p =.01) at the expense of stillbirth and neonatal deaths. The percentages of cesarean sections were significantly higher in randomized studies, RR = 1.54, 95% CI (1.46–1.64). There were 2 maternal deaths, both in observational studies. Observational studies in which conservative management of early-onset preeclampsia is performed and do not include patients with fetal growth restriction or patients with HELLP syndrome and where at least 2 days of pregnancy prolongation is achieved are associated with significantly more maternal and perinatal complications. [ABSTRACT FROM AUTHOR]

Introduction: Although exclusive breastfeeding is very beneficial for children's and mothers' health, a limited number of infants are exclusively breastfed for 6 months.Aim: This randomized controlled intervention study aims to determine the effect of breastfeeding training on mothers' knowledge, behaviors, and exclusive breastfeeding for 6 months.Materials and Methods: The participants were selected randomly for training (n = 60) and control groups (n = 60) among the pregnant women admitted to the obstetrics and gynecology polyclinics of a baby-friendly hospital. The training group received breastfeeding training during the prenatal and postnatal periods. The data were collected using a questionnaire during admission and at the postpartum 1st and 24th weeks through face-to-face interviews. The study was completed with 34 and 30 mother-infant pairs in the training and control groups, respectively. Analyzed using the chi-square, Student t, Mann-Whitney U, and Wilcoxon t-tests.Results: The difference between the number of correct answers in pre- and posttest was higher in the training group (four questions) than in the control group (two questions) (p < .001). The number of mothers exclusively breastfeeding for 6 months was significantly higher in the training group (26.5%) than in the control group (3.3%) (p = .015). The median of the exclusive breastfeeding period was longer in the training group (5 months) than in the control group (4 months) (p = .013).Conclusion: Training and supporting pregnant women and breastfeeding mothers on breastfeeding increased their knowledge, the period of exclusive breastfeeding, and the rate of 6-month exclusive breastfeeding. [ABSTRACT FROM AUTHOR]

Background: Misoprostol has been shown to be effective in induction of labor (IOL) with different dosages and routes of administration. Objectives: This study compared the efficacy and safety of hourly titrated and 2-hourly static low dose oral misoprostol for IOL in Ekiti State University Teaching Hospital, Ado-Ekiti. Methods: One hundred fifty women with singleton pregnancy at term admitted for IOL were randomized into the two groups. Oxytocin augmentation was done as necessary. The primary outcome is rate of vaginal delivery within 24 hours. Data were analyzed using SPSS. Results: Vaginal delivery was achieved within 24 hours in 40 (67.8%) women who received hourly titrated-doses oral misoprostol and 42 (70.0%) women who received 2-hourly static-dose of oral misoprostol, p >.05. The rate of vaginal delivery, oxytocin augmentation, induction delivery time and cesarean section rate were similar in both groups, p >.05. Occurrence of uterine hyperactivity did not differ significantly among the women (p >.05) and no cases of uterine rupture were recorded. There were no adverse neonatal outcomes. Conclusions: The hourly titrated oral misoprostol is as effective and safe as the 2-hourly static oral misoprostol for IOL. Both can be utilized in IOL without the fear of adverse outcomes. [ABSTRACT FROM AUTHOR]

Objective: To examine whether in patients with CH and mild to moderate hypertension the level of control of blood pressure during pregnancy has a beneficial or adverse effect on the risk of PE or SGA. Methods: We performed a systematic review and meta-analysis of randomized controlled trials of patients with mild to moderate CH in pregnancy that reported the impact of different levels of control of blood pressure on the risk of PE or SGA. We completed a literature search through PubMed, Embase, Cinahl, Web of science, Cochrane CENTRAL Library Relative risks with random effect were calculated with their 95% confidence intervals (95%CI). Results: Six trials including 495 participants provided data on blood pressure (BP) after entry to the study. Four studies compared antihypertensive agents to no treatment and two studies compared antihypertensive agents to placebo. All trials were conducted between 1976 and 1990 and were considered to be at high risk of bias. There was high heterogeneity between studies for mean arterial pressure (MAP) after randomization (I2 = 87%) and SGA (I2 = 60%), but not for PE (I2 = 0%). There were large differences between studies in the inclusion criteria, antihypertensive regimens, targets of therapy, and gestational age range at entry to the trials. In women receiving antihypertensive therapy, compared to those receiving placebo or no treatment, the MAP after entry to the trial was significantly lower (mean difference −4.2 mmHg, 95%CI −6.6 to −1.8; p = .006). However, there was no significant reduction in the risk of PE (relative risks (RR) 1.03, 95%CI 0.63-1.68; p = .90) or SGA (RR 1.01, 95%CI 0.35-2.93; p = .99). Conclusions: The findings of the meta-analysis suggest that lowering the blood pressure by antihypertensive medication in women with mild to moderate hypertension in the context of CH has no significant effect on the risk of SGA or PE. [ABSTRACT FROM AUTHOR]

Objective: Threatened preterm labor (tPTL) is a complication of pregnancy. Identification of women and clinical definition differs between countries. This study investigated differences in tPTL and effectiveness of vaginal progesterone to prevent preterm birth (PTB) between two countries.Methods: Secondary analysis of a randomized controlled trial (RCT) from Argentina and Switzerland comparing vaginal progesterone to placebo in women with tPTL (n = 379). Cox proportional hazards analysis was performed to compare placebo groups of both countries and to compare progesterone to placebo within each country. We adjusted for baseline differences. Iatrogenic onset of labor or pregnancy beyond gestational age of interest was censored.Results: Swiss and Argentinian women were different on baseline. Risks for delivery <14 days and PTB < 34 and < 37 weeks were increased in Argentina compared to Switzerland, HR 3.3 (95% CI 0.62-18), 54 (95% CI 5.1-569) and 3.1 (95% CI 1.1-8.4). In Switzerland, progesterone increased the risk for delivery <14 days [HR 4.4 (95% CI 1.3-15.7)] and PTB <37 weeks [HR 2.5 (95% CI 1.4-4.8)], in Argentina there was no such effect.Conclusion: In women with tPTL, the effect of progesterone may vary due to population differences. Differences in populations should be considered in multicenter RCTs. [ABSTRACT FROM AUTHOR]

Objective: To identify characteristics of pregnant women potentially influencing the decision to participate in peripartum interventional research.Methods: Women screened as eligible to participate in two prospective interventional trials conducted in the labor and delivery unit at a single center were included. Characteristics of eligible women were compared based on their decision whether to participate or not. The best predictors of research participation were identified using multivariable logistic regression analyses.Results: Of the 605 subjects who screened as eligible to participate, 363 (60%) agreed to participate and 242 (40%) declined. Women using a private obstetric provider or who had prior obstetrical complications were less likely to participate [aOR 0.6 (95% CI: 0.4-0.8)] and [aOR 0.6 (95% CI: 0.4-0.9)], respectively. A history of a mental health condition and a higher body mass index (BMI) were marginally more likely to participate [aOR 1.5 (95% CI: 1.0-2.3)] and [aOR 1.03 (95% CI: 1.0-1.1)], respectively. Overall logistic regression model R(2) was 0.23.Conclusions: There are differences between eligible subjects who decide to participate or not participate in prospective peripartum interventional research. There is a need to better understand non-participation in order to improve recruitment of representative populations that allow more generalizable research results. [ABSTRACT FROM AUTHOR]

Objective. To evaluate the efficacy of acupuncture for labor stimulation. Methods. Nulliparous women at 38 weeks or greater were randomized to traditional Chinese medicine (TCM) acupuncture, sham acupuncture, or usual care only groups. Acupuncture points LI4, SP6, BL32, and BL54 were needled bilaterally. The primary outcome was time from enrollment to delivery. Secondary outcomes included rates of spontaneous labor and cesarean delivery. Medical records were abstracted for maternal demographic, medical, and delivery outcome data. ANOVA, Student's t-test, Chi-square, and Kaplan-Meier statistics were used to compare groups. Results. Eighty-nine women were enrolled and randomized. Maternal age, gestational age, prior acupuncture experience, tobacco, alcohol and drug use, gravida, and history of gynecological surgery were similar among the groups. There were no statistically significant differences among groups for time from enrollment to delivery (p = 0.20), rates of spontaneous labor (p = 0.66), or rates of cesarean delivery (p = 0.37). Rates of maternal and neonatal outcomes were not significantly different. Conclusion. TCM acupuncture was not effective in initiating spontaneous labor or reducing the rate of cesarean delivery compared with sham acupuncture or usual medical care. [ABSTRACT FROM AUTHOR]

Background . In a large Swedish multicenter randomized controlled trial (RCT) on intra partum fetal monitoring with automatic analysis of fetal ECG waveform (STAN) in combination with cardiotocography (CTG) (4966 parturients, 300 obstetricians and midwives managing the patients), interim analysis revealed protocol violations. By a post hoc analysis of the results over time, factors affecting the acceptance of the new technique were analyzed. Methods . The rates of primary and secondary outcome measures (fetal outcome, operative deliveries) were compared in the two study groups (CTG + ST and CTG only). Changes over time were statistically evaluated using a test for homogeneity between the two periods. Results . After retraining, the CTG + ST group showed the lowest rates of operative delivery for fetal distress, fetal blood sampling and admissions to neonatal intensive care unit. Operative deliveries ( p = 0.02) and the number of fetal blood sampling decreased significantly over time ( p = 0.001). Conclusions . Training and education probably predisposed the clinicians to a change and reinforced it when it occurred as a result of increased personal experience. The audit and feedback together with the influence of opinion leaders and inter-collegial interactions seem to have been of importance for the successively increasing acceptance of the new method during the RCT. [ABSTRACT FROM AUTHOR]

History-indicated cervical cerclage is offered to patients who are at risk of spontaneous preterm birth (SPTB), though the indications are controversial. A common practice of offering cerclage after three prior SPTBs or midtrimester losses (MTLs) is based on findings of the subgroup analysis of the 1993 Royal College of Obstetricians and Gynaecologists (RCOG) randomized trial of cervical cerclage. The subgroup analysis was performed by repeating the primary analysis within individual subgroups, which can lead to erroneous conclusions. We repeated the subgroup analysis by evaluating the interaction between the characteristic of interest and treatment allocation in a regression model. The interaction between cerclage and any prior PTB as a binary variable was non-significant. Among subjects delivering at <37 weeks, there was a significant interaction between cerclage and prior PTBs as a continuous variable or ≥ 3 ( p-values 0.04 and 0.03, respectively). There were no significant interactions between cerclage and the aforementioned outcomes among women who delivered at <33 weeks, though this may have been secondary to a smaller number of SPTB in this range. Our findings lend credence to the current recommendations regarding the use of history-indicated cerclage, though they remain subject to the inherent limitations of subgroup analyses. [ABSTRACT FROM AUTHOR]