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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00466999
Other study ID # 2.2.2
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT01939457 - 400mcg Sublingual Misoprostol as First Line Treatment N/A
Recruiting NCT05342467 - Gemeprost Versus Dinoprostone in First Trimester Miscarriages Phase 2
Completed NCT00674232 - Treatment of Incomplete Abortion With 600 Mcg Oral Misoprostol Compared to Standard Surgical Treatment N/A
Completed NCT02707653 - Sublingual Misoprostol for the Treatment of Incomplete Abortion: Operations Research N/A
Not yet recruiting NCT05343546 - Ideal Timing of Intrauterine Contraception Insertion After Medical Management of First Trimester Incomplete Abortion N/A
Recruiting NCT01775917 - The Role of Uterine Artery Doppler Parameters in the Management of Retained Products of Conception. N/A
Completed NCT01539408 - Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion in Nigeria Phase 1
Completed NCT03622073 - Misoprostol Treatment of Mid Trimester Incomplete Abortion by Midwives and Doctors in Uganda. N/A
Completed NCT01743508 - Misoprostol Treatment of Incomplete Abortion by Midwives and Physicians in Uganda N/A

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