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临床试验/NCT04718337
NCT04718337Unknown不适用

Postpartum Intra-caesarean Intrauterine Device Insertion Using a Novel Technique

Assiut University0 个研究点目标入组 75 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
75
主要终点
Efficacy of postpartum intra-caesaren IUD insertion

研究概览

简要总结

The assessment of efficacy and patient safety of immediate postpartum IUD insertion using a novel technique.

详细描述

The postpartum period is so critical time for both the mother and newborn that needs special health care because there are high morbidity and mortality rates during it (1).

The World Health Organization (WHO) recommends that a woman should wait at least 24 months after delivery before the next pregnancy to decrease the adverse maternal, perinatal ,and infant outcomes (2, 3).

A woman's fertility may begin to return rapidly and ovulate within 4:6 weeks postpartum particularly if she is not exclusively breastfeeding. In addition , more than 50% of women become sexually active by 6 weeks postpartum (4, 5).

So, it is important to provide highly effective contraception immediately after delivery before leaving the delivery setting especially in communities where women cannot return easily for follow up visits due to financial and social barriers or who have limited access to medical service (6, 7).

The use of effective postpartum contraception particularly longـacting reversible contraception (LARC) methods like the intrauterine device (IUD) has been shown to decrease the risk of unintended pregnancy and its complications and avoid repeated caesarean sections with higher continuation rates of use than other methods 6 months after delivery (8-10).

研究设计

研究类型
Observational
观察模型
Other
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

  • Women admitted to undergo CS.
  • Singleton pregnancy.
  • Delivery of a liveـborn infant with gestational age < 36 weeks.
  • Informed and written consent to participate in the study.

排除标准

  • History of dysmenorrhea, menorrhagia or coagulopathies.
  • Uterine anomalies or fibroids.
  • Antepartum or intrapartum hemorrhage.
  • Prolonged rupture of membranes <24 hours with or without chorioamnionitis.
  • Intrapartum fever.
  • History of current, recent (within previous 3 months) or recurrent pelvic infilammatory diseases (PID).
  • History of ectopic pregnancy.
  • Multiple pregnancy.
  • Active cervicitis, vaginitis or sexual transmitted diseases (STD) on gyaecological examination.
  • Allergy to any component of the IUD or Wilson's disease.

结局指标

主要结局

Efficacy of postpartum intra-caesaren IUD insertion

时间窗: 6 months

the evaluation of efficacy of this novel technique to decrease the rates of expulsion, missing threads and failure.

次要结局

  • Patient safety of postpartum intra-caesarean IUD insertion(6 months)

研究者

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

Christine Tamer Laisha

Doctor

Assiut University

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