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临床试验/CTRI/2025/09/095303
CTRI/2025/09/095303尚未招募不适用

Comparative Efficacy of Expectant Management, Oral Contraceptive Pills and Misoprostol for Management of Retained Products of Conception following Miscarriage: A Randomized Controlled Trial

DR BR AMBEDKAR STATE INSTITUTE OF MEDICAL SCIENCES MOHALI1 个研究点 分布在 1 个国家目标入组 159 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
159
试验地点
1
主要终点
To compare the successful clearance of RPOCs with use of expectant management or OCPs use compared with misoprostol managed following spontaneous or induced miscarriage.( failure being defined as the need for surgical management)

研究概览

简要总结

Recent evidence supports improved outcomes with expectant/alternative medically treated clearance of retained products of conception (RPOCs) in post-miscarriage pregnancy when compared with misoprostol management.  There are few retrospectives, randomized controlled trials where the rates of the clearance of RPOCs were low or unchanged among expectantly managed or with oral contraceptive (OCP) use and managed with misoprostol group, whereas few trials showed an increase in the rate the clearance of RPOCs. Hence, there is a critical uncertainty about the effect of expectant management or OCP use on expulsion of RPOCs. In our study, 159  subjects with post-miscarriage retained products of conception of size 1-2.5 cm(measured in longest dimension) will be randomized into three groups: expectant management, medical management with oral contraceptive pills and medical management with misoprostol where expectantly managed and OCP used group will be compared with misoprostol group .

Expectant management is the clearance of retained products of conception post miscarriage pregnancy in the absence of any pharmacologic or mechanical initiation. Medical management is any pharmacological intervention required for attaining the desired clearance of RPOCs here by using synthetic prostaglandin E1 (Misoprostol) Or by using oral hormone containing contraceptive pills constituting ethinylestradiol, levonorgestral and ferrous fumarate.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • PREGNANT WOMEN OF AGE 18 TO 45 YEARS Spontaneous/Induced Miscarriage of Intrauterine pregnancy at Gestation Age LESS THAN 20 weeks RPOCs Size 1 Cm To 2.5 Cm.

排除标准

  • Hemodynamically unstable patients requiring surgical interventions who are actively bleeding.
  • Patient with sepsis( Fever or raised TLC less than or equal to 15k OR Foul smelling discharge) Patients with any coagulopathy disorders Any contraindications of oral contraceptives Any contraindications of Misoprostol Any uncontrolled medical disorder in the patient Any evidence of post molar RPOCs Any scar RPOCs.

结局指标

主要结局

To compare the successful clearance of RPOCs with use of expectant management or OCPs use compared with misoprostol managed following spontaneous or induced miscarriage.( failure being defined as the need for surgical management)

时间窗: within 4-6 weeks of enrolement

次要结局

  • 1)1. To Compare the side effects of expectant management or OCPs use with misoprostol for clearance of retained products of conception(2)2. To Compare patient perception regarding use of expectant management or OCPs use with misoprostol for clearance of retained products of conception)

研究者

发起方
DR BR AMBEDKAR STATE INSTITUTE OF MEDICAL SCIENCES MOHALI
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

DR JAPLEEN KAUR

Department of Obstetrics and Gynaecology

研究点 (1)

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