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临床试验/NCT05624411
NCT05624411进行中(未招募)不适用

Clinical Outcomes of Post-placental Insertion of Cupper T380A and Multiload 375 Contraceptive Devices During Cesarean Section

Sohag University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年10月22日最近更新:
适应症

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.

  1. 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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahmoud Ahmed Abdelmawgoud

principal investigator

Sohag University

研究点 (1)

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