Acceptability and Technical Feasibility of Insertion of a Copper IUD at Time of Elective C-section: A Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Successful Retention of IUD
研究概览
简要总结
This is a pilot study of up to 10 women, which will test the hypothesis that the placement of copper IUDs through the uterine incision at the time of uncomplicated elective C-section is technically feasible and acceptable to women seeking long-term contraception.
详细描述
Women will be enrolled in this study during late prenatal care. Consent for placement of the IUD will be verified prior to elective C-section. After removal of the placenta, the copper IUD will be placed through the incision at the fundus and the tail strings will be delivered through the cervix. Data will be collected about patient bleeding and possible infection during the immediate postoperative period. The visibility of the strings will be verified at discharge and at 2 and 6 weeks postpartum. Fundal placement of the IUD will be verified by ultrasound at the patient's last visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Pregnant woman
- •Requires elective C-section
- •Desires long-term contraception
排除标准
- •Contraindications to copper IUD
研究组 & 干预措施
Copper IUD
Copper IUD
干预措施: Copper IUD ( ParaGard Intrauterine Contraceptive Device) (Device)
结局指标
主要结局
Successful Retention of IUD
时间窗: 6 weeks
次要结局
- Visibility Within the Vagina of IUD Strings at All Times.(At 3 days, 2 weeks and 6 weeks postpartum)