Clinical Outcomes of Post-placental Insertion of Cupper T380A and Multiload 375 Contraceptive Devices During Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The expulsion rate of Multiload IUCD versus CopperT380A after post-placental insertion
研究概览
简要总结
Clinical outcomes of post-placental insertion of Cupper T380A and Multiload 375 contraceptive devices during cesarean section
详细描述
An intrauterine device (IUD) is considered one of the most effective, highly convenient and cheap methods of contraception[1]. IUD has been endorsed as a first-line contraceptive choice by the American College of Obstetricians and Gynecologists [2]. However, many complications have been reported with its use, such as irregular bleeding, expulsion, pelvic pain, and unexpected pregnancy.
Furthermore, extrauterine migration of IUD may result in damage to adjacent organs, bowel injury or even death [3]. Well-designed studies have elucidated that uterine perforation is expected in 0.2 to 3.6 per 1000 IUD insertions [4]. In addition, some case reports have shown IUD displacement into the sigmoid colon and lower urinary tract [5-8].
Nearly, fifty percent of malpositioned IUDs are asymptomatic and usually undetected for many years. Taking into consideration the possible risk of extrauterine migration and its dangerous sequelas, follow-up examinations are advised for all women after IUD insertion [9].
One of the safe, trusted and most convenient strategies to avoid new unwanted pregnancies is immediate postpartum IUD placement, within 10 minutes of delivery of the placenta [10]. However, expulsion rates are higher after immediate postpartum IUD insertions in comparison to delayed postpartum insertions (4-6 weeks postpartum)[11-13] Ultrasonographic assessment is considered the standard tool for confirming the position of an IUD.
- Aim of the study The aim of the current study is to compare two types of intrauterine devices, namely Cu T380A IUD and Multiload 375 IUD, inserted immediately post placental, as regard to expulsion rates, safety, efficacy, side effects, and complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •(1) All patients admitted for delivery at our department who requested postpartum contraception, were invited to participate in the study.
- •(2) Age (18-45)
排除标准
- •(1) Intrauterine infection at time of delivery (chorioamnionitis) (2) postpartum hemorrhage (3) Uterine anomalies (distorted uterine cavity) (4) History of previous IUD expulsion (5) Anemic patients with hemoglobin< 10gm/dl (6) pre-labor rupture of membranes for more than 18 hours (7) Placenta previa.
结局指标
主要结局
The expulsion rate of Multiload IUCD versus CopperT380A after post-placental insertion
时间窗: 6 weeks
The expulsion rate of Multiload IUCD versus CopperT380A after post-placental insertion
次要结局
- pregnancy on top of IUCD(6 weeks)
- Uterine bleeding(6 weeks)
- perforation(6 weeks)
- PID(6 weeks)
研究者
Mahmoud Ahmed Abdelmawgoud
principal investigator
Sohag University
