Visibility of strings after post placental insertion of Cu T 380 A and Cu 375 intra uterine contraceptive device: A randomized comparative study.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Visibility of strings at follow up visits
研究概览
简要总结
Postplacental insertion of Cu375 and CuT380A intra uterine contraceptive device will be done transcesarean within10 minutes after delivery of placenta. Cu T will be inserted using Kelly’sforcep at fundus of uterus and strings will be directed towards the internalos. The women will be observed in post operative ward for 72 hours postinsertion.
Thesubject will be advised to return for scheduled follow up visit at 1 week and 6 weeks post Cu T insertion. At follow upvisit, women will be interviewed in a pre structured proforma about any complaints, menstrualhistory, general physical , pelvic examination will be done, availability ofthread will be noted, requirement of ultrasound or invasive procedure and their findings or anycomplications will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women fulfilling following criteria will be eligible for study.
- •1.Women desirous of postpartum contraception for less than or upto 5 years.
- •2.Women posted for elective / emergency caesarean section 3.Women willing to come for follow up.
排除标准
- •1.More than 18 hours of rupture of membranes before delivery.
- •2.Any evidence of chorioamnionitis 3.Antepartum hemorrhage or postpartum hemorrhage 4.Fever in recent antepartum period 5.Women in Medical eligibility criteria category 3 or 4 of Copper T insertion.
结局指标
主要结局
Visibility of strings at follow up visits
时间窗: Visibility of strings at 1 week, 6 weeks post cesarean
次要结局
- 1.Clinical outcome including pain, bleeding, pelvic infection, expulsion.(2.Requirement of Ultrasound , X- ray, invasive procedure)