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临床试验/NCT05283798
NCT05283798Unknown不适用

Postpartum Intra-caesarean Section Insertion of Copper T380 Versus Multiload 375 IUD in a Randomized Controlled Trial.

Mahmoud Abdelhameed Hussien Soliman0 个研究点目标入组 300 人开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
主要终点
expulsion rate after 6 weeks of insertion

研究概览

简要总结

To compare efficacy safety & side effects of multiload 375 IUD versus copper T 380 IUD when inserted during elective CS

详细描述

Insertion of an intrauterine device (IUD) immediately after delivery is appealing for several reasons. The woman is known not to be pregnant, her motivation for contraception may be high, and the setting may be convenient for both the woman and her provider 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.

Compared with other contraceptive methods, early post-partum IUD insertion has several advantages. It provides immediate contraception without interfering with breast feeding, and it may avoid discomfort related to insertion. Inserting an IUD immediately after placental removal has not been associated with increased infection, uterine perforation, postpartum bleeding, or uterine subinvolution . The expulsion rate is higher (approximately 12% in the first postpartum year) after immediate postpartum insertion compared to insertion 4 to 8 weeks later. Continuation rates are relatively high (87.6% and 76.3%, at 6 and 12 months, respectively Studies have shown that with effective provider training, the immediate postpartum IUD insertion (IPPIUD) complications such as expulsion, pelvic infection, bleeding, pain, missing threads ,and failure rates are not significantly different from those of interval PPIUD insertion (4:6 weeks) after delivery

研究设计

研究类型
Interventional
分配方式
Randomized
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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women delivered by elective CS ≥ 36 wks

排除标准

  • Patients with PROM Patients on corticosteroids therapy Patients on anticoagulant patients who refuse participate in the study with written consent

结局指标

主要结局

expulsion rate after 6 weeks of insertion

时间窗: 6 weeks

compare expulsion rates between the two types after 6 weeks by ultrasoud

次要结局

  • compare bleedind dayes and shift to anthor methoud(6 weeks)

研究者

发起方
Mahmoud Abdelhameed Hussien Soliman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mahmoud Abdelhameed Hussien Soliman

resident

Assiut University

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