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临床试验/NCT07523295
NCT07523295已完成4 期

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

Medicare Hospital (Pvt) Limited1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年5月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Latency Period

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

Vaginal Progesterone

Experimental

Participants after successful tocolysis will receive vaginal progesterone

干预措施: Progesterone 200 mg vaginal capsules (Drug)

Conventional Care Group

Active Comparator

Participants after successful tocolysis will receive counseling and precautionary advice

干预措施: Counseling (Behavioral)

Conventional Care Group

Active Comparator

Participants after successful tocolysis will receive counseling and precautionary advice

干预措施: Dexamethasone (Drug)

Vaginal Progesterone

Experimental

Participants after successful tocolysis will receive vaginal progesterone

干预措施: Nifedipine 20 Mg (Drug)

Conventional Care Group

Active Comparator

Participants after successful tocolysis will receive counseling and precautionary advice

干预措施: Nifedipine 20 Mg (Drug)

Vaginal Progesterone

Experimental

Participants after successful tocolysis will receive vaginal progesterone

干预措施: Dexamethasone (Drug)

结局指标

主要结局

Latency Period

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Medicare Hospital (Pvt) Limited
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Bushra Mukhtiar

Principal Investigator

Medicare Hospital (Pvt) Limited

研究点 (1)

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