CTRI/2024/06/069578已完成2 期
Comparative study of mifepristone followed by misoprostol alone or combined with intracervical Foley’s catheter for second-trimester medical abortion
Dr Lakshyaa Chawla1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2024年7月24日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Comparison of the Induction- abortion interval (IAI) – Time period from initiation of induction
研究概览
简要总结
we plan to administer two sequential doses of mifepristone followed by misoprostol alone or combined with intracervical foley’s catheter for second trimester medical abortion and see if we can further reduce the IAI. A shortened IAI will be beneficial by reducing hospital admission time and also have a favourable psychosocial impact on the women undergoing MTP.
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
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant women seeking MTP between 16 to 24 weeks of gestation including women with previous one LSCS
- •Age ≥18 years
- •Single intrauterine viable pregnancy
- •Women fulfilling the pre-requisites of MTP amendment act, 2021 (India).
排除标准
- •1.Prior 2 or more uterine surgeries 2.Contraindications to mifepristone or misoprostol: ectopic pregnancy, inherited porphyria, chronic adrenal failure, on immunosuppressants (on corticosteroids), coagulation disorders 3.Chorioamnionitis or vaginal infections 4.Any medical or surgical disorders like heart disease , uncontrolled hypertension (≥160/100 mm Hg) or diabetes, bronchial asthma or any other medical illness 5.Haemoglobin ≤8 Gm/dl.
结局指标
主要结局
Comparison of the Induction- abortion interval (IAI) – Time period from initiation of induction
时间窗: 11 months
(misoprostol only i.e group A or foley’s + misoprostol i.e group B) to expulsion of fetus between above mentioned 2 groups.
时间窗: 11 months
次要结局
- 1.Comparison of completion of abortion within 24 hours between two groups.(2.To compare the need for curettage for retained placental tissue after abortion between two groups)
研究者
Dr Lakshyaa Chawla
Postgraduate institute of medical education & research, Chandigarh
研究点 (1)
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