Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion
This study has been completed.
Sponsor:
Gynuity Health Projects
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT00466999
First received: April 25, 2007
Last updated: March 28, 2012
Last verified: March 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
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:
No publications provided by Gynuity Health Projects
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 21, 2013