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Oral Nifedipine vs Vaginal Progesterone for Prolonging Pregnancy in Preterm Labor
Sponsor: Medicare Hospital (Pvt) Limited
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.
Official title: Comparison of Oral Nifedipine Versus Vaginal Progesterone in Prolongation of Pregnancy With Preterm Labor
Key Details
Gender
FEMALE
Age Range
18 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
84
Start Date
2025-08-01
Completion Date
2026-01-30
Last Updated
2026-10-08
Healthy Volunteers
No
Conditions
Interventions
Nifedipine 20 Mg
After successful tocolysis oral nifedipine will be administered at an initial dose of 20 mg, followed by 20 mg three times daily, with a maximum daily dose of 60 mg. Treatment will continue until 36 weeks and 6 days of gestation or delivery.
Vaginal micronized progesterone
After successful tocolysis micronized progesterone 400 mg will be administered vaginally once daily. Treatment will continue until 36 weeks and 6 days of gestation or delivery.
Locations (1)
Medicare Hospital (Pvt) Limited
Multan, Punjab Province, Pakistan