Induced Abortion Clinical Trial
Official title:
A Randomized Study of Sublingual Versus Oral Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation
Verified date | February 2014 |
Source | Gynuity Health Projects |
Contact | n/a |
Is FDA regulated | No |
Health authority | Moldova: Hospital Ethical Review Committee |
Study type | Interventional |
This open-label, randomized study is being conducted to determine whether a dose of 400 mcg
of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration
of mifepristone 200 mg is effective and acceptable at inducing an abortion compared with
misoprostol taken orally.
The goal of this study is to provide answers to the following four questions:
1. Is a regimen of medical abortion with mifepristone using sublingual misoprostol at
least as effective as using oral misoprostol up to 63 days since the last menstrual
period (LMP)?
2. Are the side effects with sublingual use tolerable for women?
3. Is sublingual administration of misoprostol acceptable to women?
4. Is one of the regimens (sublingual or oral) superior in terms of efficacy, safety
(side-effects) or acceptability?
Status | Completed |
Enrollment | 1443 |
Est. completion date | January 2008 |
Est. primary completion date | January 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Women presenting for medical abortion who consent to participate - Possibility of final gestational age of less than or equal to 63 days - General good health - Willing to provide contact information for purposes of follow-up Exclusion Criteria: - Conditions which contraindicate the use of mifepristone or misoprostol - Women presenting for medical abortion who do not consent to participate |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Moldova, Republic of | State University of Medicine and Pharmacy | Chisinau | |
Tunisia | Centre de Planification Familiale de l'Ariana | Ariana | |
Tunisia | Centre de Planification Familiale la Bardo | Tunis | |
Tunisia | Maternité de La Rabta | Tunis | |
Tunisia | Private clinic | Tunis | |
Turkey | Dr. Zekai Tahir Burak Women's Health Training and Research Hospital | Ankara | |
Turkey | MoH Ankara Etlik Maternity and Gyneacological Training Hospital | Ankara | |
Turkey | Haydarpasa Numune Training and Research Hospital Family Planning Clinic | Istanbul | |
Turkey | Ege Maternity and Gyneacological Training and Research Hospital | Izmir |
Lead Sponsor | Collaborator |
---|---|
Gynuity Health Projects |
Moldova, Republic of, Tunisia, Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Need for surgical completion for incomplete abortions or ongoing viable pregnancies at follow up visit Study day 15. | 2 weeks after mifepristone administration | No | |
Secondary | Side effects | 48 hours | No | |
Secondary | Acceptability for women | 2 weeks | No |
Status | Clinical Trial | Phase | |
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