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Women treated with progesterone in early pregnancy had similar live birth rates after 34 weeks of gestation compared to women treated with placebo.
2. Subgroup badysis was generally inconclusive, although the risk ratio of many subgroups was close to the importance of progesterone use.
Level of Evidence: Level 1 (Excellent)
Summary of the study: Miscarriages are not uncommon during pregnancy and are badociated with a variety of adverse effects. The use of progesterone during pregnancy has been evaluated in various settings as a possible treatment to support the viability of pregnancy. The PRISM study (progesterone in spontaneous miscarriage) determined whether progesterone treatment in women with bleeding in early pregnancy resulted in a higher incidence of live births than placebo. Women treated with progesterone had similar live birth rates to those treated with placebo. The incidence of adverse events was similar between treatment groups.
This large, double-blind study provides further insight into the factual uses of progesterone treatment during pregnancy. Its strengths include its large sample size, randomized design, and in-depth subgroup badysis. The study was limited by the evaluation of a single lane and the routine administration of progesterone was not used beyond 16 weeks of gestation.
Click to read the study, published today in NEJM
Click to read an accompanying editorial in NEJM
Relevant reading: Bleeding in early pregnancy
In depth [randomized controlled trial]: This double-blind, placebo-controlled, randomized controlled trial included women between 2015 and 2017. Eligible participants were aged 16 to 39, completed 12 weeks or less of pregnancy, had badl bleeding, and had intra-uterine gestational sac visible. on ultrasound. Participants were randomized to a progesterone group (n = 2025) or a placebo group (n = 2013). Both groups received badl or rectal treatment twice daily from the start of the study until 16 weeks of gestation. The main criterion of live birth at 34 or more gestation weeks was observed in 75% and 72% of progesterone and placebo groups, with [RR]1.03; 95% CI, 1.00 to 1.07; P = 0.08). The imputation badysis to correct the missing data also revealed no significant difference in treatment outcomes. The incidence of miscarriage was 20% and 22% respectively in the progesterone and placebo groups (RR: 0.91, 95% CI, 0.81 to 1.01). The incidence of live births among women who had had three or more miscarriages was 72% and 57% respectively for the progesterone and placebo groups (RR, 1.28, 95% CI, 1.08 to 1, 51). Maternal or neonatal side effects did not differ significantly between treatment groups.
Picture: PD
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