NCT02522078

Dry vs Wet Misoprostol for Cervical Dilation in First Trimester Abortion

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: Female
• Age: 14 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Abortion Early

Interventions

Type	Name	Description
DRUG	dry misoprostol	400 µg of dry misoprostol will be introduced into the vaginal fornices 3 or more hours before uterine evacuation
DRUG	wet misoprostol	400 µg of wet misoprostol will be introduced into the vaginal fornices 3 or more hours before uterine evacuation

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2015-08-13
• Last updated: 2016-03-25

Locations

1 site across 1 country: Brazil