A Phase 4 interventional study of Nifedipine 20 Mg and Vaginal micronized progesterone in Preterm Labor, sponsored by Medicare Hospital (Pvt) Limited. Completed at 1 site in Pakistan. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Medicare Hospital (Pvt) Limited · Phase 4, Interventional, and Prevention
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:
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.
261 studies on the registry are indexed under Obstetric Labor, Premature; 38 are open to participants now.
This study's enrollment of 84 is below the median of 110 across 157 interventional studies indexed under Obstetric Labor, Premature.
Browse Obstetric Labor, Premature studies →Medicare Hospital (Pvt) Limited is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
After successful acute tocolysis women in this arm will be given oral nifedipine
Drug: Nifedipine 20 Mg
After successful tocolysis, women in this arm will get vaginal progesterone
Drug: Vaginal micronized progesterone
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.
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.
Pregnancy prolongation
Pregnancy will be considered prolonged when the duration of pregnancy increases by more than 1 week from the day of randomization.
Time frame: From the day of randomization until delivery or 36 weeks and 6 days of gestation, whichever occurs first.
Gestational Age at Delivery
Gestational age at the time of delivery, calculated in completed weeks and days from the first day of the last menstrual period or confirmed by early ultrasound when the last menstrual period is uncertain.
Time frame: From randomization through 42 weeks and 0 days of gestation, with gestational age recorded at delivery.
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2025 to primary completion in Jan 2026, 5 months.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Progesterone
Medicare Hospital (Pvt) Limited