跳至主要内容
临床试验/NCT03600064
NCT03600064已完成不适用

Misoprostol for Cervical Ripening Before Copper Intrauterine Device Removal in Women Delivered Only by Elective Cesarean Section

Assiut University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
The degree of pain perception immediate after intrauterine device removal measured by Visual analogue scale

研究概览

简要总结

Intrauterine devices are the most common used method of contraception in the world, mostly in developing countries, because they offer long-term, reversible and relatively safe contraception. At present, 50% of intrauterine devices users are women of reproductive age and most of them are requesting Intrauterine device removal to regain their fertility. In general, an intrauterine device should be removed during menses or preferably immediate after menses because intrauterine device removal is usually easy because the cervix is still soft.

The intrauterine device is usually removed by firmly grasping the threads at the external os; traction should be applied away from the cervix. If resistance is present, the removal should be stopped until it is determined why the intrauterine device is not moving. Some deeply embedded intrauterine device may need to be removed by hysteroscope [4].

In practice, many women, however, have an intolerable pain during intrauterine device removal and some of them requesting painkiller or even anesthesia to allow the physician to remove it. Cervical hardening and adhesions are the major factors making IUD removal difficult especially in post-menopausal women.

Insertion and removal of IUD in nulliparous women is possible but it may carry more pain, more difficulty than in parous women. We think that this problem is also present in women has no vagina delivery before. So, the intrauterine device removal actually has some difficulty or pain in the nulliparous women, women delivered by elective caesarian section or postmenopausal women.

Many medical agents for cervical ripening prior to the removal have been emerged like misoprostol. Misoprostol is commonly used for cervical ripening in the first and second trimester miscarriage and prior intrauterine devices insertion. The use of vaginal misoprostol before intrauterine device insertion in women who had never delivered vaginally before may increase the ease and success of insertion with pain felt during the procedure .

However and up to our knowledge; no studies had been reported the effect of misoprostol on removal pain in women delivered only by elective cesarean section.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

  • Aged 18-45 years
  • Menstruating women
  • Nonpregnant women
  • Delivered before only by elective cesarean section
  • Women who did not receive any analgesics in the 24 h prior to Intrauterine device removal.
  • Using copper 380 A Intrauterine device for contraception only
  • Requesting Intrauterine device removal for returning of fertility

排除标准

  • Women with allergy to misoprostol or any medical disease that contraindicates its use
  • Ultrasonographic evidence of displaced Intrauterine device.
  • Women who will refuse to participate in the study.
  • Women who had any other type of Intrauterine device.

研究组 & 干预措施

Misoprostol group

Other

干预措施: Misoprostol (Drug)

结局指标

主要结局

The degree of pain perception immediate after intrauterine device removal measured by Visual analogue scale

时间窗: 1 minute

visual analogue scale from 0 to 10 score (0 means no pain, 10 means maximum pain)

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

Mohammed Khairy Ali

Lecturer

Assiut University

研究点 (1)

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