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Completed

NCT Number: NCT00466999

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

In this study, we will compare the safety and efficacy of 400 mcg sublingually administered misoprostol alone to standard surgical care for the treatment of incomplete abortion. This study will provide important data on the role of misoprostol in health services offering an array of treatments for incomplete abortion. Women could significantly benefit from a non-invasive treatment option for incomplete abortion. While safe surgical services are becoming more widespread, there is still a serious risk of complications from these procedures. Especially in developing countries, infection, hemorrhage and uterine damage are still too common. Medical treatment of incomplete abortion using misoprostol would be a tremendous step to reducing morbidity and mortality due to abortion complications.

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Key information

Conditions

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

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dandé District Hospital/Ziniaré District Hospital, Dande/Ziniare, Burkina Faso

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Uterine size no larger than 12 weeks LMP at time of presentation for care.
  • Past or present history of vaginal bleeding during pregnancy.
  • Open cervical os.
  • If ultrasound used evidence of incomplete abortion with substantial debris in the uterus.
  • All women would have been advised to have surgical evacuation of the uterus if misoprostol was not available.
  • General good health.
  • Willing to provide contact information for purposes of follow-up.
  • Also in Egypt: 21 years of age or over or parental permission (there is no minimum age requirement in Niger, Mauritania and Senegal).

Exclusion criteria

  • Contraindications to study drug
  • Signs of severe infection, defined as at least one of the following: 1) foul smelling discharge, 2) fever > 38 degrees C , 3) uterine tenderness
  • Hemodynamic disturbances (pulse >110/min and systolic bp <100)
  • Have an IUD in place; (the IUD may be removed making the woman eligible)
  • Suspected ectopic pregnancy

Treatment and study plan

Misoprostol

Drug

single dose of 400 mcg misoprostol administered sublingually

Surgery

Procedure

standard surgical treatment (dilation and curettage or manual vacuum aspiration)

Primary outcomes

  1. 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Apr 27, 2007
Registry last updated
Mar 30, 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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