Danish study to compare Misodel and Angusta efficacy and safety for labor induction in primiparas

Prolonged pregnancy, defined as gestation beyond 41 weeks, affects a significant portion of births in Denmark and is associated with increased maternal morbidity, including emergency caesareans, perineal lesions, and postpartum hemorrhage. Fetal risks include oligohydramnios and meconium aspiration. While various methods exist for labor induction, the optimal approach balancing efficacy and safety remains debated. The Danish Regions' group (RADS) recently recommended oral prostaglandin tablets like Angusta® based on meta-analyses, but Misodel®, a vaginal prostaglandin insert with proven safety in other studies, was not included in their evaluation due to limited comparative data.

Investigators are conducting a prospective cohort study across three divisions in Region Zealand, Denmark, to compare two different labor induction regimes in primiparas. The study will evaluate women who primarily use Misodel® (dinoprostone vaginal insert) versus Angusta® (misoprostol oral tablet) as their primary induction method. Primary endpoints include the comparative efficacy and safety of these two prostaglandin formulations. Secondary outcomes will assess women's experience, the cost of medicine associated with each regime, and the overall consumption of resources within the maternity wards. This design aims to provide real-world comparative data.