CTRI/2025/09/094475尚未招募4 期
Randomized controlled trial comparing letrozole versus mifepristone for pretreatment in medical management of first trimester missed abortion
Dr Vandana Devi1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2025年9月20日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- 9.To determine the efficacy of letrozole versus mifepristone as a pretreatment in management of first trimester missed abortion in terms of
研究概览
简要总结
Recent studies suggest that letrozole may enhance effectiveness of misoprostol in medical abortion the exploration of letrozole as a pretreatment agent before misoprostol administration present a promising alternative in medical management of first trimester missed abortion especially setting where mifepristone is contraindicated moreover letrozole can be cheaper than mifepristone
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
- •1.Hemodynamically stable patient 2.Gestational age up to 12 complete weeks of gestation by LMP and missed.
- •abortion confirmed by following USG criteria [USG findings CRL more than 7mm and no heartbeat or mean sac diameter (MSD) more than 25 mm no embryo visualized] Hb 9 g/dl,.
排除标准
- •1.Known hypersensitivity to letrozole or misoprostol, mifepristone 2.Known case of heart, liver, kidney disease and adrenal insufficiency 3.History of bleeding disorder or intake of anticoagulant drug 4.History of previous 2 LSCS or more, history of myomectomy or other uterine surgery 5.Diagnosed case of uterine fibroid, uterine anomalies.
结局指标
主要结局
9.To determine the efficacy of letrozole versus mifepristone as a pretreatment in management of first trimester missed abortion in terms of
时间窗: baseline follow by 2 week
Induction to expulsion interval
时间窗: baseline follow by 2 week
need for surgical interventions
时间窗: baseline follow by 2 week
次要结局
- 1. To evaluate and compare the following complications and side effects in both the groups(a Abnormal uterine bleeding)
研究者
DR VANDANA DEVI
Baba Saheb Ambedkar hospital Rohini new Delhi
研究点 (1)
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