Comparitive Study of Two Misoprostol Regimen in Early Pregnancy Termination

Study Overview
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Brief Summary
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The aim of this study is to compare two misoprostol regimen in pregnancy termination.

Detailed Description
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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.

Official Title
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A Comparative Study of Vaginal Misoprostol Two Dosing Regimen for First Trimester Pregnancy Termination in Patients Admitted at Bandarabbas in Shariati Hospital in 2009

Conditions
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Termination

Intervention / Treatment
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* Drug: Misoprostol 400 micrograms
* Drug: Misoprostol 800 micrograms


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 400 microgram misoprostol<br>400 micrograms misoprostol each 6 hours for 8 dose | Drug: Misoprostol 400 micrograms<br>* Misoprostol 400 micrograms each 6 hours for 8 dose<br>* Other names: Cytotec;|
| Active Comparator: 800 micrograms misoprostol<br>800 micrograms misoprostol each 12 hours for 4 dose | Drug: Misoprostol 800 micrograms<br>* Misoprostol 800 micrograms each 12 hours for 4 doses<br>* Other names: Cytotec;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abortion | After 48 hours after treatment each patient is assessed for abortion. Patients are devided into three groups including complete, partial or no abortion. | 48 hours after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of abortion | Duration of abortion Form the begining of treatment to complete abortion | Form the begining of treatment to complete abortion | 
| Adverse Effects | including nausea, vomiting, fever and chill, diarhea, abdominal cramp, skin rash | 48 hours after treatment | 
| Need for surgery | Dilatation & cartage | 48 hours after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abortion, Pregnancy, Termination, Misoprostol