Vaginal Progesterone for Pregnancy Prolongation After Arrested Preterm Labor: A Randomized Clinical Trial.

Importance: Women with arrested preterm labor (APTL) are at very high risk for spontaneous preterm delivery (SPTD), the leading cause of neonatal mortality and morbidity. To date, no maintenance therapy has been found to be effective for pregnancy prolongation. A few clinical trials with considerable methodological limitations have demonstrated some efficacy for 400 mg vaginal micronized progesterone (VMP) in women with APTL. Objective: To investigate the effectiveness of daily 400 mg VMP for the prolongation of pregnancy after APTL. Design, Setting, and Participants: This randomized clinical trial was conducted between December 19, 2018, and February 27, 2023, in 3 university-affiliated medical centers in Israel. Participants included women with singleton and twin pregnancies after APTL following tocolysis at 24 weeks 0 days to 34 weeks 0 days' gestation. Women with a history of preterm delivery or asymptomatic cervical shortening in the current pregnancy were excluded. Interventions: Participants were randomly allocated to receive VMP 200 mg twice a day or no treatment until 36 weeks 6 days' gestation. Main Outcomes and Measures: The primary end points were mean number of days from study enrollment to delivery and the rate of SPTD prior to 37 weeks' gestation. Results: A total of 129 participants were enrolled (65 in the VMP group and 64 in the no-treatment group). Mean (SD) age was 27.6 (5.1) years. Between the VMP and no-treatment groups, there was no difference in pregnancy prolongation (mean [SD], 40.0 [17.8] vs 37.4 [20.3] days; P = .44) and the rate of SPTD (16 [25%] vs 19 [30%]; relative risk, 0.8; 95% CI, 0.5-1.5; P = .52). In twin pregnancies, including 12 and 15 pairs in the VMP and no-treatment groups, respectively, VMP prolonged pregnancy (mean [SD], 43.7 [18.1] vs 26.1 [15.2] days; P = .02), postponed the delivery week (36.5 [1.4] vs 34.7 [2.2] weeks; P = .01), shortened the length of stay in the neonatal intensive care unit (4.9 [10.6] vs 13.2 [18.5] days; P = .03) and overall hospital stay (8.3 [9.6] vs 15.1 [17.2] days; P = .03), and was associated with a higher birth weight (2444 [528] vs 2018 [430] g; P = .01). Conclusions and Relevance: These findings show that VMP given in a dosage of 200 mg twice a day following APTL is not an effective treatment to prolong pregnancy or prevent SPTD. However, VMP demonstrated beneficial effects in twin pregnancies, warranting further investigation. Trial Registration: ClinicalTrials.gov Identifier: NCT02430233.

The effect of oral probiotics on glycemic control of women with gestational diabetes mellitus-a multicenter, randomized, double-blind, placebo-controlled trial.

BACKGROUND: Gestational diabetes mellitus should be treated adequately to avoid maternal hyperglycemia-related complications. Previously, probiotic supplements were suggested to improve fasting blood glucose in women with gestational diabetes mellitus. However, a major limitation of previous studies was that preprandial and especially postprandial glucose values, which are important predictors of pregnancy outcomes, were not studied. OBJECTIVE: This study aimed to examine the effect of a mixture of probiotic strains on maternal glycemic parameters, particularly preprandial and postprandial glucose values and pregnancy outcomes among women with gestational diabetes mellitus. STUDY DESIGN: A multicenter prospective randomized, double-blind, placebo-controlled trial was conducted. Women newly diagnosed with gestational diabetes mellitus were randomly allocated into a research group, receiving 2 capsules of oral probiotic formula containing Bifidobacterium bifidum, B lactis, Lactobacillus acidophilus, L paracasei, L rhamnosus, and Streptococcus thermophilus (>6 × 109/capsule), and a control group, receiving a placebo (2 capsules/day) until delivery. Glycemic control was evaluated by daily glucose charts. After 2 weeks, pharmacotherapy was started in case of poor glycemic control. The primary outcomes were the rate of women requiring medications for glycemic control and mean daily glucose charts after 2 weeks of treatment with the study products. RESULTS: Forty-one and 44 women were analyzed in the treatment and placebo cohorts, respectively. Mean daily glucose during the first 2 weeks in the probiotics and placebo groups was 99.7±7.9 and 98.0±9.3 mg/dL, respectively (P=.35). The rate of women needing pharmacotherapy because of poor glycemic control after 2 weeks of treatment in the probiotics and placebo groups was 24 (59%) and 18 (41%), respectively (P=.10). Mean preprandial and postprandial glucose levels throughout the study period were similar between the groups (P>.05). There were no differences in maternal and neonatal outcomes, including birthweight and adverse effect profile between the groups. CONCLUSION: The oral probiotic product tested in this study did not affect glycemic control of women with gestational diabetes mellitus.

What can European Principlism Teach about Public Funding of IVF? The Israeli Case.

Fertility treatments, which are part of "assisted reproductive technologies" (ART), mainly undertaken through in vitro fertilization (IVF), offer the opportunity to infertile couples to conceive. IVF treatments are undertaken in Israel in significantly higher numbers than in the rest of the world. As such, Israel provides an important case-in-point for examining the validity of the actual claims used to justify the more generous public funding of IVF treatments at the policy level. In this article, we utilize an analytical philosophy approach to conduct this examination. First, we highlight two fundamental concepts that were used at the Israeli public policy level in order to justify the generous public funding of IVF treatments. These concepts are "emotional vulnerability" and the "worthlessness of the childless," where the latter emphasizes the infinite value of children. Then, by applying the perspective of the European model of Bioethical Principlism, and focusing the attention to these two concepts we show that these justifications are invalid. Specifically, it is suggested that these concepts are on the one hand both relying on and expressing the principles of vulnerability, dignity, and integrity; yet on the other hand, these concepts are also undermining the very principles of bioethics they are supposed to express and rely on. Based on this suggested criticism, we offer two "take home" messages informed by our analysis of the Israeli case, but reaching beyond it.