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

Gynuity Health Projects

Status: Completed

Conditions: Incomplete Abortion

Treatments: Procedure: surgery; Drug: misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT00466999

2.2.2

Details and patient eligibility

About

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.

Enrollment: 1,000 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

surgery

Active Comparator group

Description:

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

Treatment:

Procedure: surgery

misoprostol

Active Comparator group

Description:

400 mcg misoprostol

Treatment:

Drug: misoprostol