Vaginal misoprostol as effective as dinoprostone pessary for induction of labour,finds study

The study design consisted of a Open-label multicenter randomized noninferiority trial at 4 university hospitals of the Research Group in Obstetrics and Gynecology (GROG) between 2012 and 2015. They recruited women with labor induced for medical reasons, a Bishop score ≤ 5 at ≥ 36 weeks, and a cephalic-presenting singleton pregnancy with no prior cesarean delivery. Women were randomly allocated to receive either vaginal misoprostol at 4-hour intervals (25 μg) or a 10-mg slow-release dinoprostone pessary.

The primary outcome was the total cesarean delivery rate. Noninferiority was defined as a difference in the cesarean delivery rates between the groups of no more than 5%. Secondary outcomes included neonatal and maternal morbidity, vaginal delivery < 24 hours after starting the induction process, and maternal satisfaction.

Data analysis revealed some interesting facts.

• The study included 1674 randomized women. The per-protocol analysis included 790 in each group. The total cesarean delivery rate in the misoprostol group was 22.1% (n=175) and in the dinoprostone group, 19.9% (n=157), for a difference between the groups of 2.2% (with an upper-bound 95% confidence limit of 5.6%), P=.092. Results in the intention-to-treat analysis were similar.
• Neonatal and maternal morbidity were similar between groups. Vaginal delivery within 24 hours was significantly higher in the misoprostol group (59.3% vs 45.7%, P<.001) as was maternal satisfaction, assessed in the postpartum period by a visual analog scale: mean score: 7.1 (SD 2.4) vs 5.8 (3.1), P<.001.

Observing the results, the research team concluded that "Nonetheless, given the small difference between these cesarean rates and the similarity of neonatal and maternal morbidity rates in this large study, the clinical risk-benefit ratio justifies the use of both drugs."

For full article follow the link: https://doi.org/10.1016/j.ajog.2021.04.226

Primary source: American Journal of Obstetrics & Gynecology