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临床试验/NCT07649668
NCT07649668已完成4 期

Efficacy of Vaginal Progesterone and Nifedipine in Inhibiting Threatened Preterm Labour

Dr Mudassar Saeed Pansota1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2025年11月30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
160
试验地点
1
主要终点
Percentage of efficacy

研究概览

简要总结

So, a number of studies have been conducted worldwide to find a suitable agent for arresting threatened preterm labor. The current study is planned to examine the effectiveness of nifedipine and progesterone in the treatment of threatened preterm labor (TPL). The result of this study will be used to recommend the best treatment modality in our population to reduce the risk of preterm labor

详细描述

Preterm birth is defined as any birth before 37 completed weeks of gestation, or fewer than 259 days of gestation. It is estimated that annually, 13 million preterm infants are born. The worldwide rates of preterm birth vary with an estimated prevalence of 5-25%. Approximately 60% of preterm infants are born in south Asia and sub-Saharan Africa.

Progesterone and nifedipine were tested as tocolytic medications in women who were at risk of preterm birth to see whether they had any influence on efficacy, success, and the effects on the mother and foetus. Nifedipine is a drug which was reported for stopping uterine contractions in preterm labour. It is calcium channel blockers have some qualities that make them a better choice as compared to others. They decrease calcium entry through cell membranes, so controlling muscle contractility in various tissues like uterus. However; its use for maintenance tocolysis has yielded conflicting results.

Various interventions have been attempted to reduce the risk of preterm birth in women at increased risk, including progesterone, cervical cerclage, and cervical pessary. Progesterone plays a role in the maintenance of pregnancy by suppression of the calcium-calmodulin-myosin light chain kinase system. Additionally, progesterone has recognized anti-inflammatory properties, raising a possible link between inflammatory processes, alterations in progesterone receptor expression and the onset of preterm labor.

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 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • All the females aged 18-35 year
  • Singleton pregnancy
  • With gestational age of 24 weeks to 36 weeks
  • With presentation of the threatened preterm labor

排除标准

  • Pregnant women with presentation cervical dilation (>3 cm),
  • Patients with known contraindications to receiving either vaginal progesterone or oral nifedipine
  • Patients with co morbidities such as GDP, gestational hypertension, preeclampsia
  • Multiple pregnancy

研究组 & 干预措施

Vaginal Progesterone

Experimental

干预措施: Vaginal progesterone 200mg daily (Drug)

Nifedipine

Placebo Comparator

干预措施: Nifedipine 20 Mg (Drug)

结局指标

主要结局

Percentage of efficacy

时间窗: 48 hours

Efficacy will be labeled in terms of delaying the delivery beyond 48 hours from the initiation of therapy or absence of preterm birth

次要结局

未报告次要终点

研究者

发起方
Dr Mudassar Saeed Pansota
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr Mudassar Saeed Pansota

Associate Professor

Shahida Islam Medical Complex

研究点 (1)

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