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临床试验/NCT05001061
NCT05001061Unknown早期 1 期

Sublingual vs Vaginal Misoprostol for Termination of First Trimesteric Missed Abortion

Cairo University0 个研究点目标入组 288 人开始时间: 2021年8月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
入组人数
288
主要终点
The occurance of complete abortion within 24 hours with Misoprostol drug

研究概览

简要总结

Efficacy of sublingual versus vaginal misoprostol in termination of first trimester missed abortion

详细描述

study will be made on female patients with first trimester missed abortion confirmed by ultrasound . Participants will be divided into 2 groups one group (A) will receive sublingual Misoprostol and the other group(B) will receive vaginal Misoprostol as a 800 micro grams every 4 hours in both groups up to five doses the aim of the study is to compare efficay of sublingual and vaginal Misoprostol in complete termination of first trimester missed abortion and which route is the best will less side effects.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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 with an ultrasound diagnosis of missed abortion < 13 weeks gestation without any clinical criteria of Inevitable abortion.

排除标准

  • Patients refused the medical treatment.
  • Patients have contraindications of the drug (Misoprostol).
  • Missed abortion associated with any signs of sepsis

研究组 & 干预措施

Sublingual Misoprostol for termination of first trimester missed abortion

Active Comparator

Patients diagnosed as first trimester missed abortion will receive sublingual Misoprostol 800 micrograms every 4 hours up to five doses

干预措施: Misoprostol Pill (Drug)

Vaginal Misoprostol for termination of first trimester missed abortion

Active Comparator

Patients diagnosed as first trimester missed abortion will receive vaginal Misoprostol 800 micrograms every 4 hours up to five doses

干预措施: Misoprostol Pill (Drug)

结局指标

主要结局

The occurance of complete abortion within 24 hours with Misoprostol drug

时间窗: Within 24 hours

Efficacy of sublingual and vaginal Misoprostol in complete termination of first trimester missed abortion

Which route is the best and less side effects in complete termination of first trimester missed abortion by Misoprostol drug

时间窗: within 24 hours

Vaginal versus sublingual route of administration of Misoprostol for complete termination of first trimester missed abortion

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 Mahmoud Emam Ahmed

Resident in obstetrics and gynecology

Cairo University

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