Efficacy of Vaginal Progesterone and Nifedipine in Inhibiting Threatened Preterm Labour
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
- 否
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
干预措施: Vaginal progesterone 200mg daily (Drug)
Nifedipine
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
Dr Mudassar Saeed Pansota
Associate Professor
Shahida Islam Medical Complex
