A Phase 4 interventional study of Nifedipine 20 Mg and Dexamethasone in Preterm Labor With Intact Membranes and Preterm Birth, sponsored by Medicare Hospital (Pvt) Limited. Completed at 1 site in Pakistan. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Medicare Hospital (Pvt) Limited · Phase 4, Interventional, and Prevention
Preterm labor, which occurs when labor starts before 37 weeks of pregnancy, is a major cause of illness and death in newborns. Babies born too early are at higher risk of breathing problems, low birth weight, infections, and other complications. Treatments that safely delay delivery can improve outcomes for both the mother and the baby.
The purpose of this clinical study is to determine whether vaginal progesterone treatment can improve pregnancy and newborn outcomes in women who present with preterm labor. The study will compare vaginal progesterone supplementation with conventional care after the initial treatment of preterm labor.
The main questions this study aims to answer are:
This randomized controlled trial will be conducted in the Department of Obstetrics and Gynaecology at Medicare Hospital Multan. A total of 60 pregnant women with singleton pregnancies between 24 and 34 weeks of gestation who present with preterm labor will be enrolled in the study. All participants will first receive standard treatment for preterm labor, including medications to stop contractions (tocolysis with nifedipine for 48 hours) and steroid injections to help mature the baby's lungs.
Women whose contractions settle after the initial treatment will then be randomly assigned to one of two groups. One group will receive vaginal progesterone (400 mg daily), while the other group will receive conventional care, which includes counseling and routine pregnancy precautions without progesterone treatment.
Participants will continue their assigned management until 36 weeks and 6 days of pregnancy or until delivery occurs. After discharge from the hospital, all women will be followed every two weeks until delivery.
Researchers will record important pregnancy and newborn outcomes, including:
By comparing these outcomes between the two groups, the study aims to determine whether vaginal progesterone can safely prolong pregnancy and improve neonatal outcomes in women with preterm labor. The results of this study may help guide future treatment strategies to reduce complications associated with premature birth.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 60 is below the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Medicare Hospital (Pvt) Limited is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Participants after successful tocolysis will receive vaginal progesterone
Drug: Nifedipine 20 Mg · Drug: Dexamethasone · Drug: Progesterone 200 mg vaginal capsules
Participants after successful tocolysis will receive counseling and precautionary advice
Drug: Nifedipine 20 Mg · Drug: Dexamethasone · Behavioral: Counseling
Oral Nifedipine 20 mg every 30-minutes for two doses, then 20 mg every 6-hours for 48-hours
6 mg intramuscular every 12 hours for a total of four doses
two capsules (200 mg each) applied to the vagina daily till 36-weeks + 6 days or delivery
Standard counseling and precautionary advice provided after successful tocolysis
Latency Period
Time from randomization to delivery, measured in days, among women presenting with preterm labor after successful tocolysis.
Time frame: From randomization until delivery (up to approximately 13 weeks, depending on gestational age at enrollment).
Preterm Birth
Delivery occurring before 37 completed weeks of gestation, determined using the last menstrual period (LMP) method.
Time frame: At delivery (up to approximately 13 weeks after randomization).
Low birth Weight
Birth weight less than 2500 grams measured using a digital weighing scale at the time of delivery.
Time frame: At birth (up to approximately 13 weeks after randomization).
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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