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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00466999 |
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Date of registration:
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25/04/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion
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Scientific title:
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Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion |
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Date of first enrolment:
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February 2007 |
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Target sample size:
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1000 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00466999 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Burkina Faso
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Egypt
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Mauritania
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Niger
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Senegal
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Contacts
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Name:
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Rasha Dabash, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gynuity Health Projects |
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Name:
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Beverly Winikoff, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gynuity Health Projects |
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Name:
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Ayisha Diop, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gynuity Health Projects |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Incomplete Abortion
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Intervention(s)
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Procedure: surgery
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Drug: misoprostol
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Primary Outcome(s)
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Complete abortion without recourse to surgical intervention.
[Time Frame: follow up visit 7 days after initial treatment]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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