Comparitive Study of Two Misoprostol Regimen in Early Pregnancy Termination

Not Applicable

Completed

• Conditions: Termination
• Interventions: Drug: Misoprostol 400 micrograms; Drug: Misoprostol 800 micrograms

• Registration Number: NCT01508143
• Lead Sponsor: Hormozgan University of Medical Sciences

Brief Summary

The aim of this study is to compare two misoprostol regimen in pregnancy termination.

Detailed Description

Studies on determining the optimal dosage for misoprostol in pregnancy termination are continuing and still there is no evidence for ideal misoprostol regimen for pregnancy termination. The aim of this study is to compare two misoprostol regimen in pregnancy termination.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-09
• Study First Submitted QC: 2012-01-09
• Study First Posted: 2012-01-11
• Status Verified: 2012-09
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Last Update Submitted: 2012-09-30
• Last Update Posted: 2012-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 41

Inclusion Criteria

• All women who were candidates for early pregnancy termination because of fetal death or other medical conditions
• Before 14th week of gestation calculated according LMP or first trimester sonography

Exclusion Criteria

• Chorioamnionitis
• Hypersensitivity to prosstaglandins
• Past medical history of cardiovascular, kidney or liver or lung diseases
• Positive history for uterus pathologies
• suspicious to extra-uterus pregnancy
• sign and symptoms of uterus infection
• Molar pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
400 microgram misoprostol	Misoprostol 400 micrograms	400 micrograms misoprostol each 6 hours for 8 dose
800 micrograms misoprostol	Misoprostol 800 micrograms	800 micrograms misoprostol each 12 hours for 4 dose

Primary Outcome Measures

Name	Time	Method
Abortion	48 hours after treatment	After 48 hours after treatment each patient is assessed for abortion. Patients are devided into three groups including complete, partial or no abortion.

Secondary Outcome Measures

Name	Time	Method
Duration of abortion	Form the begining of treatment to complete abortion	Duration of abortion Form the begining of treatment to complete abortion
Adverse Effects	48 hours after treatment	including nausea, vomiting, fever and chill, diarhea, abdominal cramp, skin rash
Need for surgery	48 hours after treatment	Dilatation \& cartage

Trial Locations

Locations (1)

Hormozgan University of Medical Sciences; 🇮🇷 Bandar Abbas, Hormozgan, Iran, Islamic Republic of