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

Incomplete Abortion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00466999
• Other study ID #: 2.2.2
• Status: Completed
• Phase: N/A
• First received: April 25, 2007
• Last updated: March 28, 2012
• Start date: February 2007
• Est. completion date: November 2009

Study information

• Verified date: March 2012
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Local Ethical CommitteeMauritania: Allendale Investigational Review BoardNiger: Local Ethical CommitteeSenegal: Local Ethical CommitteeBurkina Faso: Local Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion, Incomplete
• Incomplete Abortion

Intervention

Drug:
• misoprostol
single dose of 400 mcg misoprostol administered sublingually

Procedure:
• surgery
standard surgical treatment (dilation and curettage or manual vacuum aspiration)

Locations

Country	Name	City	State
Burkina Faso	Dandé District Hospital/Ziniaré District Hospital	Dande/Ziniare
Egypt	El-Galaa Teaching Hospital	Cairo
Egypt	Shatby Maternity Hospital/Alexandria University	Shatby, Alexandria
Mauritania	Cheikh Zayed Hospital	Nouakchott
Niger	Maternite Issaka Gazobi	Niamey
Senegal	Centre de Sante Le Roi Baudouin	Guediawaye

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Countries where clinical trial is conducted

Burkina Faso,  Egypt,  Mauritania,  Niger,  Senegal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete abortion without recourse to surgical intervention.		follow up visit 7 days after initial treatment	No

External Links

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