Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion - Full Text View

Sponsor:	Gynuity Health Projects
Information provided by (Responsible Party):	Gynuity Health Projects
ClinicalTrials.gov Identifier:	NCT00466999

Purpose

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.

Condition	Intervention
Incomplete Abortion	Drug: misoprostol Procedure: surgery

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion

Resource links provided by NLM:

Drug Information available for: Misoprostol

U.S. FDA Resources

Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:

Complete abortion without recourse to surgical intervention. [ Time Frame: follow up visit 7 days after initial treatment ] [ Designated as safety issue: No ]

Enrollment:	1000
Study Start Date:	February 2007
Study Completion Date:	November 2009
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: surgery standard surgical treatment (either dilation and curettage or manual vacuum aspiration)	Procedure: surgery standard surgical treatment (dilation and curettage or manual vacuum aspiration)
Active Comparator: misoprostol 400 mcg misoprostol	Drug: misoprostol single dose of 400 mcg misoprostol administered sublingually

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466999

Locations

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

Sponsors and Collaborators

Gynuity Health Projects

Investigators

Principal Investigator:	Beverly Winikoff, MD, MPH	Gynuity Health Projects
Study Director:	Rasha Dabash, MPH	Gynuity Health Projects
Study Director:	Ayisha Diop, MPH	Gynuity Health Projects

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by Gynuity Health Projects

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Dabash R, Ramadan MC, Darwish E, Hassanein N, Blum J, Winikoff B. A randomized controlled trial of 400-?g sublingual misoprostol versus manual vacuum aspiration for the treatment of incomplete abortion in two Egyptian hospitals. Int J Gynaecol Obstet. 2010 Nov;111(2):131-5.

Responsible Party:	Gynuity Health Projects
ClinicalTrials.gov Identifier:	NCT00466999 History of Changes
Other Study ID Numbers:	2.2.2
Study First Received:	April 25, 2007
Last Updated:	March 28, 2012
Health Authority:	Egypt: Local Ethical Committee Mauritania: Allendale Investigational Review Board Niger: Local Ethical Committee Senegal: Local Ethical Committee Burkina Faso: Local Ethical Committee

Keywords provided by Gynuity Health Projects:

misoprostol
incomplete abortion
PAC

Additional relevant MeSH terms:

Abortion, Incomplete
Abortion, Spontaneous
Pregnancy Complications
Misoprostol
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

Pharmacologic Actions
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on May 22, 2012