Dry vs Wet Misoprostol for Cervical Dilation in First Trimester Abortion (MisoWet)

March 24, 2016 updated by: Hospital de Clinicas de Porto Alegre

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90035903
        • Hospital de Clinicas de Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dry Misoprostol
400 µg of dry misoprostol
Drug: dry misoprostol
400 µg of dry misoprostol will be introduced into the vaginal fornices 3 or more hours before uterine evacuation
Experimental: Wet misoprostol
400 µg of wet misoprostol
Drug: wet misoprostol
400 µg of wet misoprostol will be introduced into the vaginal fornices 3 or more hours before uterine evacuation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cervical dilation
Time Frame: 3 to 4 hours after putting misoprostol into the vagina
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
Time Frame: within 2 min before putting the misoprostol into the vagina
at the moment of the introduction of misoprostol into the vagina
within 2 min before putting the misoprostol into the vagina

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Ricardo F Savaris, MD, PhD, Hospital de Clinicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

August 4, 2015

First Submitted That Met QC Criteria

August 11, 2015

First Posted (Estimate)

August 13, 2015

Study Record Updates

Last Update Posted (Estimate)

March 25, 2016

Last Update Submitted That Met QC Criteria

March 24, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-0115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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