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Sponsored by: |
Gynuity Health Projects |
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Information provided by: | Gynuity Health Projects |
ClinicalTrials.gov Identifier: | NCT00466999 |
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 |
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Incomplete Abortion |
Drug: misoprostol Procedure: surgery |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
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 |
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surgery: Active Comparator
standard surgical treatment (either dilation and curettage or manual vacuum aspiration)
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Procedure: surgery
standard surgical treatment (dilation and curettage or manual vacuum aspiration)
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misoprostol: Active Comparator
400 mcg misoprostol
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Drug: misoprostol
single dose of 400 mcg misoprostol administered sublingually
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Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Beverly Winikoff, MD, MPH | 1-212-448-1230 | bwinikoff@gynuity.org |
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 |
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 |
Responsible Party: | Gynuity Health Projects ( Dr. Beverly Winikoff ) |
Study ID Numbers: | 2.2.2 |
Study 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 |
misoprostol incomplete abortion PAC |
Pregnancy Complications Misoprostol Abortion, Spontaneous Abortion, Incomplete |
Oxytocics Therapeutic Uses Anti-Ulcer Agents Physiological Effects of Drugs Abortifacient Agents |
Gastrointestinal Agents Reproductive Control Agents Abortifacient Agents, Nonsteroidal Pharmacologic Actions |