Clinical trial NCT00286208: Study of Sublingual Versus Oral Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation
Official title: A Randomized Study of Sublingual Versus Oral Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Induced Abortion
Keywords: Medical abortion
mifepristone
misoprostol
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2006-02-03
Enrollment: 1443
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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?


Eligibility criteria: 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

Primary outcomes:
measure: Need for surgical completion for incomplete abortions or ongoing viable pregnancies at follow up visit Study day 15.
timeFrame: 2 weeks after mifepristone administration
Secondary outcomes:
measure: Side effects
timeFrame: 48 hours
measure: Acceptability for women
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Chisinau
country: Moldova, Republic of
facility: State University of Medicine and Pharmacy
city: Ariana
country: Tunisia
facility: Centre de Planification Familiale de l'Ariana
city: Tunis
country: Tunisia
facility: Centre de Planification Familiale la Bardo
city: Tunis
country: Tunisia
facility: Maternité de La Rabta
city: Tunis
country: Tunisia
facility: Private clinic
city: Ankara
country: Turkey
facility: Dr. Zekai Tahir Burak Women's Health Training and Research Hospital
city: Ankara
country: Turkey
facility: MoH Ankara Etlik Maternity and Gyneacological Training Hospital
city: Istanbul
country: Turkey
facility: Haydarpaşa Numune Training and Research Hospital Family Planning Clinic
city: Izmir
country: Turkey
facility: Ege Maternity and Gyneacological Training and Research Hospital
Study officials:
affiliation: Gynuity Health Projects
name: Sheila Raghavan, M.Sc.
role: STUDY_DIRECTOR
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Rasha Dabash, MPH
role: STUDY_DIRECTOR
affiliation: Reproductive Health Consultant
name: Selma Hajri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baskent University
name: Ayse Akin, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Ilana Dzuba, MHS
role: STUDY_DIRECTOR
References: