NCT03492034已完成不适用
Insertion of Intrauterine Contraceptive Device During Cesarean Section: Randomized Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- IUD expulsion rate
研究概览
简要总结
Insertion of Intrauterine Contraceptive Device during Cesarean Section: Randomized Clinical Trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant woman aged between 18 to 40 years old.
- •Scheduled for elective cesarean section at gestational age between 37 to 42 weeks.
- •Body mass index between 19-30 kg/m2
- •Seeking contraception after delivery.
排除标准
- •History of menorrhagia or severe dysmenorrhea.
- •History of pelvic inflammatory disease or current pelvic infection (ex: puerperal sepsis, purulent cervicitis).
- •Patients who have bleeding disorders.
- •Anemia (Hb < 9 g %).
- •Chronic depilating diseases reducing immunity such as Diabetes.
- •Structural uterine anomaly or large uterine fibroids distorting anatomy.
- •History of previous IUD expulsion or removal for complications.
- •Unexplained uterine bleeding.
- •Copper allergy or Wilson disease.
- •Gestational trophoblastic disease with persistently elevated Beta HCG.
- •Predisposing factor to postoperative infection (e.g. rupture of membranes prior to admission or delivery of a stillborn baby at cesarean section).
- •Complications during cesarean section e.g. postpartum hemorrhage.
- •Cesarean section during placenta previa.
结局指标
主要结局
IUD expulsion rate
时间窗: 6 weeks
次要结局
- Bleeding(6 weeks)
- Degree of Pain(6 weeks)
- dyspareunia(6 weeks)
- patient satisfaction(6 weeks)
研究者
Mohamed S Sweed, MD
Principal Investigator
Ain Shams University
研究点 (1)
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