Comparative of Two Devices (Conventional Intrauterine Devices (Cu T380 A)/Frameless Intrauterine Devices (GyneFix)) for Postpartum Immediate Contraception in Cesarean Deliveries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- expulsion rates
研究概览
简要总结
To compare two intrauterine systems in order to avoid complications originating from short pregnancy interval and undesired pregnancies in the early postpartum period.
详细描述
The patients admitting to Zeynep Kamil Research and Training Hospital for caesarean delivery will be included in the study. There will be two computer based randomized groups. The investigators expect that both groups will have 100 cases. First group will be treated with conventional intrauterine devices (Cu T380 A) while the second group will be treated with frameless intrauterine devices (GyneFix). The participants will be informed about postpartum unplanned pregnancies and the complications of short pregnancy interval. Participants will also be informed about possible complications of having an intrauterine device and that there may be a possibility of failure.The participants who choose to participate in the study will be divided into two groups by computer based randomization and one of the systems will be applied. After the participants read and sign the informed consent form, the intrauterine device will be applied postplacental up to 10 minutes.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The patients who read and sign the informed consent form.
排除标准
- •The patient who has more than 6 cm dilatation, prolonged premature rupture of the membranes (more than 12 hours), chorioamnionitis, and kongenital or acquired haemorragic diathesis will be excluded from the study.
研究组 & 干预措施
Gynefix
The GyneFix® 200 IUD(frameless iud) is only 2 cm long. Its small surface area is 1/3 of that of the conventional T-shaped IUDs such as TCu380A
干预措施: GyneFix (Device)
Cu T380a
conventional T-shaped IUDs (TCu380A)which has a frame will be placed into the uterus after placental extraction
干预措施: Cu T380 A (Device)
结局指标
主要结局
expulsion rates
时间窗: The patients will be seen postoperative 6th week
expulsion is the major obstacle for intrauterin devices when using immediate postpartum.
次要结局
- Number of participants with treatment-related adverse events as assessed by conventional intrauterine devices (Cu T380 A) and frameless intrauterine devices (GyneFix)(The patients will be seen postoperative 6th week)
研究者
Ahmet Eser
medical doctor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital