Effect of Vaginal Progesterone Treatment on Pregnancy and Newborn Outcomes in Women With Preterm Labor

Perinatal and Neonatal Outcomes of Vaginal Progesterone Supplementation in Women With Preterm Labor

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:

• Does vaginal progesterone increase the latency period (the time from treatment to delivery) in women with preterm labor?
• Does vaginal progesterone reduce the chances of preterm birth and low birth weight compared with conventional treatment?

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:

• Latency period (time from treatment to delivery)
• Preterm birth (delivery before 37 weeks of pregnancy)
• Birth weight of the newborn

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.

Study Overview

• Status: Completed
• Conditions: Preterm Birth; Preterm Labor With Intact Membranes
• Intervention / Treatment: Drug: Nifedipine 20 Mg; Drug: Dexamethasone; Drug: Progesterone 200 mg vaginal capsules; Behavioral: Counseling

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Multan, Punjab Province, Pakistan, 60000
      • Medicare Hospital (Pvt) Limited

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women with singleton pregnancies (on antenatal scan)
• Presenting with pr-term labor
• Between 24 - 34 weeks of gestation
• Treated successfully with acute tocolysis for 48 hours and received steroids

Exclusion Criteria:

• Women with multiple pregnancy
• Preterm premature rupture of membranes
• Cervical dilatation >3 cm (clinical examination)
• Congenital fetal anomalies
• Refuse to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vaginal Progesterone; Participants after successful tocolysis will receive vaginal progesterone	Drug: Nifedipine 20 Mg; Oral Nifedipine 20 mg every 30-minutes for two doses, then 20 mg every 6-hours for 48-hours; Drug: Dexamethasone; 6 mg intramuscular every 12 hours for a total of four doses; Drug: Progesterone 200 mg vaginal capsules; two capsules (200 mg each) applied to the vagina daily till 36-weeks + 6 days or delivery
Active Comparator: Conventional Care Group; Participants after successful tocolysis will receive counseling and precautionary advice	Drug: Nifedipine 20 Mg; Oral Nifedipine 20 mg every 30-minutes for two doses, then 20 mg every 6-hours for 48-hours; Drug: Dexamethasone; 6 mg intramuscular every 12 hours for a total of four doses; Behavioral: Counseling; Standard counseling and precautionary advice provided after successful tocolysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Latency Period	Time from randomization to delivery, measured in days, among women presenting with preterm labor after successful tocolysis.	From randomization until delivery (up to approximately 13 weeks, depending on gestational age at enrollment).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preterm Birth	Delivery occurring before 37 completed weeks of gestation, determined using the last menstrual period (LMP) method.	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.	At birth (up to approximately 13 weeks after randomization).

Collaborators and Investigators

• Sponsor: Medicare Hospital (Pvt) Limited
• Investigators: Study Chair: Muhammad S Akhtar, FRCOG, Medicare Hospital (Pvt) Limited

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2025
• Primary Completion (Actual): November 5, 2025
• Study Completion (Actual): November 5, 2025

Study Registration Dates

• First Submitted: April 4, 2026
• First Submitted That Met QC Criteria: April 4, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 4, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Dexamethasone; Preterm birth; low birth weight; Vaginal progesterone; nifedipine
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Health Services; Health Care Facilities Workforce and Services; Community Health Services; Behavioral Disciplines and Activities; Pregnadienetriols; Mental Health Services; Gonadal Steroid Hormones; Gonadal Hormones; Pregnenediones; Pregnenes; Corpus Luteum Hormones; Progesterone Congeners; Dihydropyridines; Dexamethasone; Nifedipine; Progesterone; Counseling
• Other Study ID Numbers: U1111-1338-4965

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No