Oral Nifedipine vs Vaginal Progesterone for Prolonging Pregnancy in Preterm Labor

Summary

The purpose of this randomized clinical trial is to compare oral nifedipine and vaginal progesterone for prolonging pregnancy in women who develop preterm labor. Preterm labor can lead to early birth and related complications for newborns. The study will examine whether vaginal progesterone can prolong pregnancy for more than one week after treatment is started compared with oral nifedipine. The main question this study aims to answer is: \- Is pregnancy prolonged for more than one week in a greater proportion of women receiving vaginal progesterone compared with women receiving oral nifedipine? The study will include 84 women with singleton pregnancies between 24 and 34 weeks of gestation who have preterm labor, have responded successfully to initial treatment to stop contractions for 48 hours, and have received corticosteroids to help mature the baby's lungs. Participants will be randomly assigned to one of two groups: * Group A: Oral nifedipine, given initially at 20 mg followed by 10-20 mg three times daily, up to a maximum of 60 mg per day. * Group B: Micronized progesterone 400 mg administered vaginally once daily. Treatment will continue until 36 weeks and 6 days of pregnancy or until delivery. Participants will be followed weekly after discharge until delivery. The researchers will record the gestational age at delivery and whether pregnancy was prolonged by more than one week from the time of randomization.

Timeline

Start

2025-08-01

Primary completion

2026-01-30

Completion

2026-01-30

Drugs

Indications

No indication recorded.