Comparison of Intramuscular Progesterone and Rectal Progesterone in the Prevention of Preterm Labour in Patients Undergoing Cervical Cerclage: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 820
- 试验地点
- 1
- 主要终点
- Frequency of Preterm Birth (<37 Weeks)
研究概览
简要总结
Preterm labour is a major cause of neonatal morbidity and mortality worldwide. Progesterone supplementation is known to help reduce the risk of preterm birth in high-risk women. This randomized controlled trial compared the effectiveness of intramuscular progesterone and rectal progesterone in preventing preterm labour among pregnant women who had undergone cervical cerclage. The study aimed to determine which route of progesterone administration provides better pregnancy prolongation and improved neonatal outcomes.
详细描述
Background:
Preterm labour remains one of the leading causes of perinatal mortality and long-term neonatal complications. Cervical insufficiency, often managed by cervical cerclage, is a recognized risk factor for preterm birth. Progesterone supplementation helps maintain uterine quiescence and cervical integrity, but the optimal route of administration after cerclage is not well established.
Objective:
To compare the efficacy of intramuscular progesterone versus rectal progesterone in preventing preterm labour among women who underwent cervical cerclage.
Methods:
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
- 否
入选标准
- •Pregnant women aged 18-45 years
- •Singleton pregnancy
- •Gestational age between 16 and 24 weeks at enrollment
- •Diagnosed with cervical insufficiency and scheduled for or recently undergone cervical cerclage
- •Willing to receive progesterone therapy and provide written informed consent
排除标准
- •Multiple pregnancy
- •Known fetal anomalies
- •Severe maternal comorbidities (e.g., hypertension, diabetes, cardiac disease)
- •History of allergy or hypersensitivity to progesterone or related compounds
- •Contraindications to progesterone use
- •Women who declined to participate or were non-compliant with follow-upInclusion Criteria:
- •Exclusion Criteria:
研究组 & 干预措施
Intramuscular Progesterone Group
Participants in this group received intramuscular progesterone (hydroxyprogesterone caproate) 250 mg once weekly, starting from 16 weeks until 36 weeks of gestation, following cervical cerclage. The injections were administered in the gluteal region under aseptic conditions. The purpose of this intervention was to maintain uterine quiescence and reduce the risk of preterm labour in high-risk pregnancies after cerclage.
干预措施: Intramuscular Progesterone (Drug)
Intramuscular Progesterone Group
Participants in this group received intramuscular progesterone (hydroxyprogesterone caproate) 250 mg once weekly, starting from 16 weeks until 36 weeks of gestation, following cervical cerclage. The injections were administered in the gluteal region under aseptic conditions. The purpose of this intervention was to maintain uterine quiescence and reduce the risk of preterm labour in high-risk pregnancies after cerclage.
干预措施: Rectal Progesterone (Drug)
Rectal Progesterone Group
Participants in this group received rectal progesterone suppositories 400 mg once daily, starting from 16 weeks until 36 weeks of gestation, following cervical cerclage. The suppositories were self-administered at bedtime. The aim of this intervention was to provide sustained progesterone support for maintaining uterine relaxation and reducing the risk of preterm labour after cerclage.
干预措施: Intramuscular Progesterone (Drug)
Rectal Progesterone Group
Participants in this group received rectal progesterone suppositories 400 mg once daily, starting from 16 weeks until 36 weeks of gestation, following cervical cerclage. The suppositories were self-administered at bedtime. The aim of this intervention was to provide sustained progesterone support for maintaining uterine relaxation and reducing the risk of preterm labour after cerclage.
干预措施: Rectal Progesterone (Drug)
结局指标
主要结局
Frequency of Preterm Birth (<37 Weeks)
时间窗: 16-36 weeks until delivery
次要结局
- Neonatal Birth Weight(At birth)
- Apgar Scores at 1 and 5 Minutes(Immediately post-delivery)
- Maternal Adverse Effects(During treatment period (16-36 weeks))
- Gestational Age at Delivery(At delivery)
- NICU Admission Rate(Within 24 hours of birth)
研究者
Hina Mukhtar
DR
Combined Military Hospital (CMH) institute of Medical Sciences Bahawalpur Pakistan