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

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

MedlinePlus related topics:

Abortion Pregnancy Loss

ChemIDplus related topics:

Misoprostol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

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 ]

Estimated Enrollment:	1000
Study Start Date:	May 2007
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
surgery: Active Comparator standard surgical treatment (either dilation and curettage or manual vacuum aspiration)	Procedure: surgery standard surgical treatment (dilation and curettage or manual vacuum aspiration)
misoprostol: Active Comparator 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 and Mauritania).

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

Contacts


Contact: Beverly Winikoff, MD, MPH	1-212-448-1230	bwinikoff@gynuity.org

Locations


Egypt
	El-Galaa Teaching Hospital	Recruiting
	Cairo, Egypt
	Contact: Mohamed Cherine Ramadan, MD 20 12 21 58 631
	Principal Investigator: Mohamed Cherine Ramadan, MD
	Shatby Maternity Hospital/Alexandria University	Recruiting
	Shatby, Alexandria, Egypt
	Contact: Emad Darwish, MD 20 12 21 64 100
	Principal Investigator: Emad Darwish, MD

Mauritania
	Cheikh Zayed Hospital	Recruiting
	Nouakchott, Mauritania
	Contact: Aissata Bal Sall, MD 222 641 15 89
	Principal Investigator: Aissata Bal Sall, MD

Niger
	Maternite Issaka Gazobi	Recruiting
	Niamey, Niger
	Contact: Madi Nayama 227 73 35 50
	Principal Investigator: Madi Nayama, MD

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

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Gynuity Health Projects ( Dr. Beverly Winikoff )
Study ID Numbers:	2.2.2
First Received:	April 25, 2007
Last Updated:	May 5, 2008
ClinicalTrials.gov Identifier:	NCT00466999
Health Authority:	Egypt: Local Ethical Committee; Mauritania: Allendale Investigational Review Board; Niger: Local Ethical Committee

Keywords provided by Gynuity Health Projects:

misoprostol

incomplete abortion

PAC

Study placed in the following topic categories:

Pregnancy Complications

Misoprostol

Abortion, Spontaneous

Abortion, Incomplete

Additional relevant MeSH terms:

Oxytocics

Therapeutic Uses

Anti-Ulcer Agents

Physiological Effects of Drugs

Abortifacient Agents

Gastrointestinal Agents

Reproductive Control Agents

Abortifacient Agents, Nonsteroidal

Pharmacologic Actions

ClinicalTrials.gov processed this record on August 29, 2008

Sponsored by:	Gynuity Health Projects
Information provided by:	Gynuity Health Projects
ClinicalTrials.gov Identifier:	NCT00466999