CTRI/2024/06/068990尚未招募不适用
A cross-sectional analysis to assess the safety and Utilization of dydrogesterone in Patients with bad obstetRIc hiStory or habitual abortion in rEal world outpatients of India
Torrent Pharmaceuticals Ltd1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2024年6月26日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Ongoing pregnancy rate (fetal viability confirmed with ultrasound)
研究概览
简要总结
- This study is planned to evaluate the safety and effectiveness of dydrogesterone in Indian patients with bad obstetric history.
- Study design**:**Post Approval Observational Studies (PAOS).
- Duration of Observation**:**12 weeks (At least)
- Study drug and dose: Dydrogesterone 10 mg
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant women up to 12 weeks of gestation
- •Women with a history of miscarriage with suspect luteal phase insufficiency
- •Patients willing for follow-up at scheduled visit as per protocol at same center.
排除标准
- •Known hypersensitivity or contraindication to study drug
- •Heavy vaginal bleeding requiring surgical intervention.
- •Any uterine anomalies.
- •Any associated medical and surgical illness.
结局指标
主要结局
Ongoing pregnancy rate (fetal viability confirmed with ultrasound)
时间窗: At 12 weeks
次要结局
- Patient acceptability to treatment(At 4 weeks)
- Safety assessment for Common Adverse events(At 4 weeks)
研究者
Dr Krupa Shah
Ayuh Fertility Centre
研究点 (1)
Loading locations...
相似试验
尚未招募
2/3 期
A Clinical Study Comparing a Traditional Herbal Remedy (Vishwa-Eladi Yog) with Norethisterone for Managing Heavy Menstrual Bleeding (Asrigdara)CTRI/2025/07/091249Tilak ayurvedic mahavidyalaya rasta peth Pune60
尚未招募
3 期
Effect of D-Co-D for the management of type 2 diabetesCTRI/2025/01/079791Dr.JRKs Research and Pharmaceuticals Pvt Ltd300
尚未招募
2/3 期
Oral gargling with medicated ayurveda preparation in treating throat infectionCTRI/2025/09/094453Dr Dombale Kiran Shashikant60
尚未招募
不适用
To Study the Safety and Efficacy of A Novel Intrauterine Estrogen-Releasing System in Induced AbortionNCT07381569Peking Union Medical College Hospital200
尚未招募
2/3 期
To evaluate the analgesic effect of patha nirgundi ghrita suppository in post operative pain in ano rectal surgeriesCTRI/2025/01/078922Dr Omkar Tukaram Khatkar60