Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion in Nigeria

Women diagnosed with incomplete abortion in this health facility will be randomized to receive one of the following regimens: 400 mcg sublingual misoprostol in one dose or standard surgical treatment (MVA). The investigators hypothesize that treatment of incomplete abortion with misoprostol using 400 mcg administered sublingually will be as effective as surgical evacuation.

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Key information

Conditions

Incomplete Abortion Abortion, Incomplete Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Adeoyo Maternity Hospital, Ibadan, Nigeria

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

no contraindications to misoprostol
uterine size was not larger than 12 weeks
there were no signs of severe infection
haemodynamically stable
in general good health
willing to provide contact information

Exclusion criteria

an IUD in place
ectopic pregnancy
aged below 18 years and had no accompanying adult to provide informed consent

Treatment and study plan

Misoprostol

Drug

single dose of 400 mcg misoprostol administered sublingually

surgery Manual vacuum aspiration (MVA)

Procedure

standard surgical treatment

Primary outcomes

Complete abortion without recourse to surgical intervention

Time frame: follow up visit 7 days after initial treatment

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Registry information

Official study title

Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Feb 27, 2012
Registry last updated: Feb 27, 2012

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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