Vaginal Misoprostol In Management Of First Trimester Missed Abortion.

Phase 2

Completed

• Conditions: Abortion, Missed
• Interventions: Drug: buccal/sublingual misoprostol; Drug: vaginal misoprostol

• Registration Number: NCT03148314
• Lead Sponsor: Assiut University

Brief Summary

The world health organization defined abortion or miscarriage as : the expulsion or extraction from its mother of a fetus or an embryo weighting 500 grams or less ,or any other wise product of gestation of any weight irrespective of gestational age and weather or not there is evidence of life and weather or not the abortion was spontaneous or induced Miscarriage is the most common complication of pregnancy occurring in 10-20% of clinically recognized pregnancies (Bag. It is estimated that around 40% of early pregnancies result in miscarriage. A large majority of those are lost before the menstrual period is missed. More than 80%of abortions occur in first 12 weeks of pregnancy, and the rate decrease there after For clinical purposes: abortion is subdivided into: threatened abortion, inevitable abortion, incomplete abortion ,missed abortion ,septic abortion ,and recurrent abortion

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-05-08
• Study First Submitted QC: 2017-05-08
• Study First Posted: 2017-05-11
• Study Start: 2017-07-01
• Primary Completion: 2018-06-01
• Study Completion: 2018-06-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

Inclusion Criteria

• single dead fetus up-to 12 weeks.
• no low lying placenta
• no scarred uterus
• no or mild bleeding
• no evidence of infection
• accepting to participate in the study.

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Exclusion Criteria

• Advanced hepatic diseases .
• Suspected molar pregnancy
• Ectopic pregnancy or pregnancy of unknown location
• Haemodynamically unstable with significant anaemia ie Hb<10
• Uncontrolled severe asthma
• Chronic adrenal failure
• Known or suspected heart disease
• Glaucoma
• Haemoglobinopathies
• Haemorrhagic disorders and anti-coagulation therapy (aspirin accepted)
• Adrenal suppression and long term glucocorticoid therapy (may require corticosteroid)
• Patient living in remote areas with difficulty in accessing hospital

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
extended low dose oral misoprostol	buccal/sublingual misoprostol	extended low dose oral misoprostol
hospital- based vaginal misoprostol	vaginal misoprostol	hospital- based vaginal misoprostol

Primary Outcome Measures

Name	Time	Method
Percentage of patients with complete abortion (success rate).	1 week

Secondary Outcome Measures

Name	Time	Method
Number of misoprostol doses	1 week
induction-abortion time	1 week

Trial Locations

Locations (1)

Women Health Hospital - Assiut university; 🇪🇬 Assiut, Egypt