Threatened Preterm Labour: Vaginal Progesterone Versus Nifedipine
Efficacy of Vaginal Progesterone and Nifedipine in Inhibiting Threatened Preterm Labour
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
-
-
Punjab Province
-
Faisalabad、Punjab Province、巴基斯坦、60000
- Hilal-e-ahmar Hospital
-
-
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Vaginal Progesterone
|
In Group B, participants will be instructed to use vaginal micronized progesterone tablets at a dosage of 200mg once daily or until reaching 37 weeks of gestational age or until cervical dilation exceeded 4cm (for a duration of 48 hours)
|
|
安慰剂比较:Nifedipine
|
In Group A, participants will receive oral nifedipine at a dose of 20mg every 30 minutes for three doses initially, followed by long-acting nifedipine SR 20mg every 12 hours until reaching 37 weeks of gestational age or until cervical dilation exceeded 4cm (for a duration of 48 hours).
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of efficacy
大体时间: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
|
48 hours
|
合作者和调查者
调查人员
- 首席研究员:Aqdas Aziz, MBBS、Hilal-e-Ahmar Hospital, Faisalabad
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.