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Completed

NCT Number: NCT00670761

Misoprostol for the Treatment of Incomplete Abortion

This randomized study will examine the efficacy, safety and acceptability of misoprostol for treatment of incomplete abortion.

Women diagnosed with incomplete abortion will be randomized to receive one of the following regimens:

In Tanzania and Mozambique:

1. 600 mcg of oral misoprostol in one dose, or 2. Standard surgical treatment (MVA)

In Moldova and Madagascar:

1. 600 mcg of oral misoprostol in one dose, or 2. 400 mcg of sublingual misoprostol in one dose.

In Burkina Faso and Vietnam:

1. 400 mcg of sublingual misoprostol in one dose.

We hypothesize that treatment of incomplete abortion with either 400 mcg sublingual misoprostol, 600 mcg oral misoprostol or MVA are equally effective in evacuating the uterus.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital de District Sanitaire Dandé, Bobo-Dioulasso, Burkina Faso

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • If no ultrasound used:
  • Past or present history of vaginal bleeding during pregnancy; and
  • Open cervical os.
  • If ultrasound used:
  • Past or present history of vaginal bleeding during pregnancy; and
  • 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.

  • Willing to provide contact information for purposes of follow-up.
  • In Tanzania: 18 years of age or over or parental permission
  • In Mozambique: 21 years of age or over or parental permission
  • In Moldova: 18 years of age or over
  • In Madagascar: 18 years of age or parental permission
  • In Vietnam: reproductive age

Exclusion criteria

  • Contraindications to the study drug;
  • Uterine size larger than 12 weeks L.M.P. at time of presentation for care.
  • Signs of severe infection, defined as at least one of the following of:
  • foul smelling discharge,
  • fever > 39 degrees C ,
  • pulse >110/min;

Treatment and study plan

Misoprostol

Drug

comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)

Other names: Cytotec

MVA

Procedure

comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)

Primary outcomes

  1. complete resolution of signs/symptoms of incomplete abortion without recourse to surgery at any point for any reason

    Time frame: one week after initial treatment with the option of an additional week

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

  • Befelatanana Maternity Centre
  • Cuchi General District hospital
  • Hôpital de District Sanitaire Dandé
  • Hôpital de District Sanitaire de Ziniaré
  • Jose Macamo Hospital
  • Kagera Regional Hospital
  • Municipal Clinical Hospital No. 1
  • National OBGYN hospital
  • Tudu hospital

Registry information

Official study title

Misoprostol for the Treatment of Incomplete Abortion: Comparison of Treatment Options

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
May 2, 2008
Registry last updated
Jul 27, 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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