Randomized control trial to compare effects of ultra-low dose (Ethinylestradiol 20 µg or 15 µg) with low dose (Ethinylestradiol 30 µg) hormonal pills on lipid discordance in non-obese PCOS women.

OBJECTIVE: Regular users of hormonal contraceptive pills show marked heterogeneity in metabolic effects with variations in compositions. This might be due to choice of outcome variables for comparison. Total cholesterol-high-density lipoprotein ratio (TC/HDL) discordance with low-density lipoprotein (LDL-C) has now become an established marker of future risk for atherosclerotic cardiovascular disease and stable to variations in user. METHODS: The present study was a randomized controlled trial to compare prevalence of TC/HDL and LDL discordance among non-obese women with polycystic ovarian syndrome (PCOS) treated with hormonal pills. Women were randomized into three arms, two arms received ultra-low dose pills (Ethinylestradiol [EE] 20 µg with drosperinone 3 mg or EE 15 µg with gestodene 60 µg) and one arm received low dose pill (EE 30 µg with desogestrel 150 µg). The role of baseline participant features and pill composition on discordance was determined. RESULTS: Discordance was observed in more than a quarter of the participants before intervention. After 1 year of treatment, less than a fifth of the participants were discordant. Ultralow-dose pill users had lower discordance, LDL, and TC than low-dose pill users after 1 year of treatment. The random forest, a non-linear classifier, showed the highest accuracy in predicting discordance. The baseline Parameters with the maximal impact on the occurrence of discordance were triglyceride, homeostatic model assessment for insulin resistance, body mass index, and high density lipoprotein. CONCLUSION: Non-obese PCOS women on ultra-low dose pill have a lower risk of acquiring future atherosclerotic cardiovascular disease.

Randomized controlled trial comparing efficacy of a combination regime containing two cervical sensitizers (mifepristone + Foley's catheter) versus single agent mifepristone or Foley's catheter for labor induction in women attempting TOLAC at late third trimester with a dead fetus in utero.

Randomized controlled trial comparing efficacy of a combination regime containing two cervical sensitizers (mifepristone + Foley's catheter) versus single agent mifepristone or Foley's catheter for labor induction in women attempting TOLAC at late third trimester with a dead fetus in utero. AIM: To compare efficacy and safety of a new combination regime comprising of two cervical sensitizers used simultaneously with single agents, for labor induction in women attempting TOLAC at ≥34 weeks' gestation with a dead fetus. METHOD: This was a multiarm randomized controlled trial (RCT) where participants received one of the three regimes-single agent oral Mifepristone 200 mg, intracervical Foley's catheter (16 Fr size, filled with 40 mL normal saline after intracervical instillation), and combination regime consisting of both used simultaneously. Number of women undergoing vaginal birth within 48 h of induction (VB48 ) was the primary outcome compared between groups. RESULTS: VB48 was higher in participants on combination regime in comparison to participants on Foley's catheter (54 vs. 42). Total vaginal births were higher in participants on combination regime compared to both single agents (58 vs. 48 and 44). Duration and dose of oxytocin augmentation was lower in participants on combination regime compared to both single agents. Induction birth interval was short in participants on combination regime compared to those on Foley's catheter. Maternal complications between groups were similar. CONCLUSION: Combination of cervical sensitizers for labor induction in late third trimester among women with dead fetus attempting TOLAC resulted in higher proportion of vaginal births and might reduce risk of scar dehiscence due to requirement of a lower dose of oxytocin for augmentation.