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

NCT07523295 | Completed Phase 4

• 1 other identifier: U1111-1338-4965
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preterm Labor With Intact Membranes; Preterm Birth

Keywords

low birth weight; Preterm birth; Vaginal progesterone; Dexamethasone; nifedipine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Preterm Birth

  At delivery (up to approximately 13 weeks after randomization).

• Low birth Weight

  At birth (up to approximately 13 weeks after randomization).

Study Arms (2)

Vaginal Progesterone

EXPERIMENTAL

Participants after successful tocolysis will receive vaginal progesterone

Drug: Nifedipine 20 Mg; Drug: Dexamethasone; Drug: Progesterone 200 mg vaginal capsules

Conventional Care Group

ACTIVE COMPARATOR

Participants after successful tocolysis will receive counseling and precautionary advice

Drug: Nifedipine 20 Mg; Drug: Dexamethasone; Behavioral: Counseling

Interventions

Nifedipine 20 Mg DRUG

Oral Nifedipine 20 mg every 30-minutes for two doses, then 20 mg every 6-hours for 48-hours

Conventional Care Group; Vaginal Progesterone

Dexamethasone DRUG

6 mg intramuscular every 12 hours for a total of four doses

Conventional Care Group; Vaginal Progesterone

Progesterone 200 mg vaginal capsules DRUG

two capsules (200 mg each) applied to the vagina daily till 36-weeks + 6 days or delivery

Vaginal Progesterone

Counseling BEHAVIORAL

Standard counseling and precautionary advice provided after successful tocolysis

Conventional Care Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Medicare Hospital (Pvt) Limited: lead

Study Sites (1)

Medicare Hospital (Pvt) Limited

Multan, Punjab Province, 60000, Pakistan

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Nifedipine; Dexamethasone; Progesterone; Counseling

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Pregnenediones; Pregnenes; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Muhammad S Akhtar, FRCOG

  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: April 4, 2026
• First Posted: April 13, 2026
• Study Start: May 6, 2025
• Primary Completion: November 5, 2025
• Study Completion: November 5, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)