Oral Nifedipine vs Vaginal Progesterone for Prolonging Pregnancy in Preterm Labor

NCT07865949 | Completed Phase 4

• 1 other identifier: U1111-1347-7628
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Preterm Labor

Keywords

Preterm Labor; Preterm Birth; Pregnancy Prolongation; Nifedipine; Progesterone; Tocolysis; Preterm Delivery; Oral Nifedipine; Gestational Age; Vaginal Progesterone

Outcome Measures

Primary Outcomes (1)

• Pregnancy prolongation

  Pregnancy will be considered prolonged when the duration of pregnancy increases by more than 1 week from the day of randomization.

  From the day of randomization until delivery or 36 weeks and 6 days of gestation, whichever occurs first.

Other Outcomes (1)

• Gestational Age at Delivery

  From randomization through 42 weeks and 0 days of gestation, with gestational age recorded at delivery.

Study Arms (2)

Oral Nifedipine

ACTIVE COMPARATOR

After successful acute tocolysis women in this arm will be given oral nifedipine

Drug: Nifedipine 20 Mg

Vaginal Progesterone

EXPERIMENTAL

After successful tocolysis, women in this arm will get vaginal progesterone

Drug: Vaginal micronized progesterone

Interventions

Nifedipine 20 Mg DRUG

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.

Oral Nifedipine

Vaginal micronized progesterone DRUG

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.

Vaginal Progesterone

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with singleton pregnancies (on antenatal scan)
• Presenting with preterm labor between 24 - 34 weeks of gestation
• Successful acute tocolysis for 48 hours
• and Received steroids

You may not qualify if:

• Multiple pregnancy
• Preterm premature rupture of membranes
• Congenital anomalies
• Cervical dilatation \>3 cm (clinical examination)
• and who refuse to participate

Sponsors & Collaborators

• Medicare Hospital (Pvt) Limited: lead

Study Sites (1)

Medicare Hospital (Pvt) Limited

Multan, Punjab Province, 60000, Pakistan

Location

MeSH Terms

Conditions

Obstetric Labor, Premature; Premature Birth

Interventions

Nifedipine

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Shahid I Professor, FCPS

  Medicare Hospital (Pvt) Limited

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 3, 2026
• First Posted: October 8, 2026
• Study Start: August 1, 2025
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: October 8, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)