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Completed

NCT Number: NCT02522078

Dry vs Wet Misoprostol for Cervical Dilation in First Trimester Abortion

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

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Key information

Conditions

Abortion Early

Age range

14 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dry misoprostol

Drug

400 µg of dry misoprostol will be introduced into the vaginal fornices 3 or more hours before uterine evacuation

wet misoprostol

Drug

400 µg of wet misoprostol will be introduced into the vaginal fornices 3 or more hours before uterine evacuation

Primary outcomes

  1. Cervical dilation

    Time frame: 3 to 4 hours after putting misoprostol into the vagina

    Cervical dilation will be measure with Karman cannulas

Secondary outcomes

  1. 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

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

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

Acronym: MisoWet

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 13, 2015
Registry last updated
Mar 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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