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

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

Interventions

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

BEHAVIORAL

Counseling

Standard counseling and precautionary advice provided after successful tocolysis

Sponsors & Collaborators

• Medicare Hospital (Pvt) Limited

  lead OTHER

Principal Investigators

• Muhammad S Akhtar, FRCOG · Medicare Hospital (Pvt) Limited

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-06

Primary Completion

2025-11-05

Completion

2025-11-05

Countries

• Pakistan

Study Locations