跳至主要内容
临床试验/NCT06023849
NCT06023849招募中不适用

Trans Caesarean Intra Uterine Contraceptive Device Insertion Versus Conventional Postpartum 6 Weeks Insertion

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
1-Patient satisfaction and complication.

研究概览

简要总结

To compare immediate post-placental intrauterine contraceptive device insertion versus conventional placement at 6 weeks interval (often referred to as delayed or interval insertion) as regard to:-

  1. Patient satisfaction.
  2. Expulsion rate.
  3. Complications

详细描述

Until the 1960s, Intrauterine devices (IUCDs) and condoms were the only artificial methods for the control of fertility. Nowadays ,despite the presence of 12 contraceptive methods which include 9 modern methods (pill, IUD, injectable, implant, vaginal methods (diaphragm and contraceptive foam or jelly), male condom, female sterilization, male sterilization, and emergency contraception) and 3 traditional methods (periodic abstinence, withdrawal, and prolonged breastfeeding , the insertion of an IUCD still the second most prevalent method of family planning used worldwide (13.6%), after female sterilization (20.5%), among women of reproductive age who are married or cohabiting.

In Egypt, Egypt Demographic and Health Survey 2014 findings revealed that 59 percent of currently married women in Egypt are currently using a contraceptive method. The most widely used method is the IUD, followed by the pill and injectables. Thirty percent of currently married women are using the IUD, 16 percent are relying on the pill, and 9 percent are employing injectables. Relatively small proportions of women are using other modern methods, e.g., 1 percent reported currently using female sterilization. Two percent of women report use of traditional methods.

There are two ways used in IUD insertion, in the postpartum period or immediate post-placental IUD insertion, in which the insertion of IUD occurs within ten minutes after placenta delivery and after the puerperium (after puerperal or interval period). Intrauterine device insertion during cesarean section was first introduced in 1967 by Zerzavy by suturing the IUD to the posterior uterine fundus. Research in China and Belgium introduced post-placental IUD insertion technique during cesarean delivery with placed an IUD as high as possible in the fundus without suturing the fundus wall.

Intrauterine device insertion during early postpartum period is the most effective reversible contraceptive methods for many mothers because the contraception motivation is high, and it doesn't interfere with breast feeding. On the other hand, without an effective contraception in the first six weeks, woman may be accidentally pregnant. Hence, the mother prefers to insert IUD during cesarean delivery.

As cesarean section (CS) rates are rising in all countries, IUD insertion at the time of CS creates an opportunity to increase access to long-acting reversible contraception methods. Conversely, a previous CS scar may deter access to interval insertion of an IUD if a previous CS may result in difficulty with insertion and/or future IUD problems.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age: 18-40years.
  • Full term pregnancies delivered by cesarean section.
  • Desire to have intrauterine contraceptive device (Cu T) as a contraceptive option.
  • Agree to participate in the study.

排除标准

  • Allergy to copper.
  • Ante- or intra-partum hemorrhage.
  • Ruptured of membranes for more than 18 h prior to delivery or Chorioamnionitis.
  • Known uterine abnormalities e.g., Bicornuate/septate Uterus, uterine myoma.
  • History of ectopic pregnancy.
  • Desire for pregnancy within 1 year of delivery.
  • Intrapartum fever >38 c.
  • Sever thrombocytopenia.

结局指标

主要结局

1-Patient satisfaction and complication.

时间窗: 6 months

assessment of patient satisfaction using a questionnaire as follow: * Will you use the same method of contraception after the next delivery? * Will you recommend the same method to your fellows? * Are you happy or not with this procedure? give score from 1 to 10, 1 mean you are very unhappy while 10 mean you are very happy. * have you developed any complication?

次要结局

未报告次要终点

研究者

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

Ahmed M.Osman

doctor

Al-Azhar University

研究点 (1)

Loading locations...

相似试验

Trans Caesarean Intra Uterine Contraceptive Device... | 临床试验