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Completed

NCT Number: NCT07523295

Effect of Vaginal Progesterone Treatment on Pregnancy and Newborn Outcomes 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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Medicare Hospital (Pvt) Limited

Multan, Punjab Province, 60000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nifedipine 20 Mg

Drug

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

Dexamethasone

Drug

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

Progesterone 200 mg vaginal capsules

Drug

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

Counseling

Behavioral

Standard counseling and precautionary advice provided after successful tocolysis

Primary outcomes

  1. Latency Period

    Time frame: From randomization until delivery (up to approximately 13 weeks, depending on gestational age at enrollment).

    Time from randomization to delivery, measured in days, among women presenting with preterm labor after successful tocolysis.

Other outcomes

  1. Preterm Birth

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

    Delivery occurring before 37 completed weeks of gestation, determined using the last menstrual period (LMP) method.

  2. Low birth Weight

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

    Birth weight less than 2500 grams measured using a digital weighing scale at the time of delivery.

Sponsors and collaborators

Lead sponsor

Medicare Hospital (Pvt) Limited

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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