Dry vs Wet Misoprostol for Cervical Dilation in First Trimester Abortion

Study Overview
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Brief Summary
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This study aims to verify whether the moisture of 400 µg of misoprostol pre uterine evacuation increases the dilatation of uterine cervix compared to dry misoprostol

Detailed Description
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Misoprostol is the most widely used drug for abortion due to its low cost, stability and easy to use regimen. Nevertheless, there is a debate whether the administration of dry misoprostol has similar effects compared to wet pill. It would be necessary to undertake a clinical trial to evaluate which regimen (dry or wet) offers a better cervical dilation pre uterine evacuation. The primary objective of this study is to compare the degree of cervical dilatation pre-uterine evacuation in subject that received 400 µg of dry or wet misoprostol 3 or more hours before the procedure. Secondary objective is to verify whether there is a correlation between vaginal pH (<5 / ≥5) and the degree of cervical dilation (≥8mm / <8mm) with the use of wet or dry misoprostol. Women will be randomized to one of the two groups: dry or wet misoprostol.

Official Title
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Dry vs Wet Misoprostol for Cervical Dilation in First Trimester Abortion - A Clinical Trial

Conditions
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Abortion Early

Intervention / Treatment
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* Drug: dry misoprostol
* Drug: wet misoprostol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with abortion (less than 12 weeks of pregnancy) Exclusion Criteria: congestive heart failure chronic pulmonary disease hypovolemic shock twins Marfan syndrome septic abortion (fever, pus , leukocytosis >14,000) known allergies to misoprostol blood dyscrasia open cervical (≥ 1cm) use of intrauterine device

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 50 Years

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 |
| --- | --- |
| Active Comparator: Dry Misoprostol<br>400 µg of dry misoprostol | Drug: dry misoprostol<br>* 400 µg of dry misoprostol will be introduced into the vaginal fornices 3 or more hours before uterine evacuation<br>|
| Experimental: Wet misoprostol<br>400 µg of wet misoprostol | Drug: wet misoprostol<br>* 400 µg of wet misoprostol will be introduced into the vaginal fornices 3 or more hours before uterine evacuation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cervical dilation | Cervical dilation will be measure with Karman cannulas | 3 to 4 hours after putting misoprostol into the vagina | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal acidity - hydrogen ion concentration | at the moment of the introduction of misoprostol into the vagina | within 2 min before putting the misoprostol into the vagina | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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misoprostol, abortion