CTRI/2024/09/073383尚未招募Unknown
Comparison of Intracervical Foleys catheter, buccal misoprostol and their combination for induction of labor
Director Principal, Government Medical College and Hospital, Sector-32, Chandigarh1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2024年9月30日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- The induction to active phase interval, induction-to-delivery interval.
研究概览
简要总结
This study is aimed to compare the effectiveness of buccal misoprostol, Intracervical Foleys catheter and the combination of both for induction of labor
A total of 132 of antenatal patients will be recruited by computerized generated randomization , each will be induced with one of the above method of induction of labor after taking proper consent.
Each group will be compared for induction to delivery intervel, rate of vaginal and cesarean deliveries
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 19.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women with Cephalic singleton pregnancy from 34 to 41 weeks with a specific indication for induction of labor such as Abruptio placenta , chorioamnionitis, gestational hypertension, preeclampsia, eclampsia, Prelabor rupture of membrane, postterm pregnancy, Diabetes mellitus, chronic hypertension, Fetal growth restriction, Oligohydraminos.
排除标准
- •Estimated fetal weight ≤1.500 kg to ≥3.5 kg.
- •â€¢ Multifetal gestation • Non-reassuring fetal heart rate tracing • Poor biophysical profile • Congenital anomalies of the fetus • Intrauterine death of the fetus • Previous caesarean delivery or other uterine surgery (myomectomy, hysterotomy) • History of ante partum hemorrhage including placenta previa, vasa previa • Cephalopelvic disproportion • Any contraindication of vaginal delivery • Cervical cancer • History of cervical tear or any surgery • Contraindications & hypersensitivity to prostaglandins • Parity≥5.
结局指标
主要结局
The induction to active phase interval, induction-to-delivery interval.
时间窗: baseline
• Rate of successful vaginal birth within 24 hours.
时间窗: baseline
• Rate of caesarean section and operative vaginal deliveries.
时间窗: baseline
次要结局
- Maternal outcome:(• Uterine hyperstimulation (defined as either tachysystole or hypertonus with a nonreassuring fetal heart-rate pattern on cardiotocography).)
研究者
Arshed Ali
Government medical college and hospital, Chandigarh
研究点 (1)
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