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

Sponsor:	Gynuity Health Projects
Information provided by:	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 Control: Active Control Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Surgery

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 ]

Estimated Enrollment:	1000
Study Start Date:	May 2007
Estimated Primary Completion Date:	May 2010 (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

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Gynuity Health Projects ( Dr. Beverly Winikoff )
Study ID Numbers:	2.2.2
Study First Received:	April 25, 2007
Last Updated:	October 1, 2009
ClinicalTrials.gov Identifier:	NCT00466999 History of Changes
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

Additional relevant MeSH terms:

Pregnancy Complications
Oxytocics
Misoprostol
Physiological Effects of Drugs
Gastrointestinal Agents
Reproductive Control Agents
Abortion, Incomplete

Abortifacient Agents, Nonsteroidal
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Anti-Ulcer Agents
Abortion, Spontaneous

ClinicalTrials.gov processed this record on March 18, 2010