Clinical trial NCT00386282: Acceptability and Feasibility of Medical Abortion Using Mifepristone and Buccal Misoprostol
Official title: Acceptability and Feasibility of Medical Abortion in Mexico, Puerto Rico, Armenia and Azerbaijan: A Study of Buccal Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days' Gestation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion, First Trimester
Keywords: Mifepristone
Misoprostol
Buccal administration
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2006-10-11
Enrollment: 1250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study examined the acceptability and feasibility of introducing a mifepristone-misoprostol regimen of medical abortion into abortion services in two private clinics in Puerto Rico; 2 clinics in Baku, Azerbaijan; 3 clinics in Yerevan, Armenia; and 4 clinics in Mexico City. It was hypothesized that the study regimen would be both acceptable and efficacious.

Detailed description: The study recruited women with pregnancies up to 63 days gestation. Eligible women took 200 mg mifepristone, followed by 800 buccal misoprostol. They later underwent clinic follow-up to determine if their medical abortions were complete. The study assessed the acceptability and feasibility of the above regimen and sought to determine the efficacy and acceptability of buccal administration of misoprostol as well as the acceptability of side effects experienced by women.

Eligibility criteria: Inclusion Criteria:

* Gestation up to 63 days
* General good health
* Willingness to provide contact information for follow-up
* Absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination

Exclusion Criteria:

* Ectopic pregnancy
* Intrauterine device (IUD) in place

Primary outcomes:
measure: efficacy
timeFrame: 15 days
Secondary outcomes:
measure: acceptability
timeFrame: 15 days
Other outcomes:
Locations:
city: Yerevan
country: Armenia
facility: Center for Family Planning and Sexual Health
city: Yerevan
country: Armenia
facility: Institute of Perinatology, Obstetrics and Gynecology
city: Yerevan
country: Armenia
facility: State Medical University
city: Baku
country: Azerbaijan
facility: Family Planning Center
city: Baku
country: Azerbaijan
facility: Scientific Research Institute of Obstetrics and Gynecology
city: Mexico City
country: Mexico
facility: C.S. Beatriz Velasco Aleman
state: Federal District
city: Mexico City
country: Mexico
facility: C.S. Santa Catarina
state: Federal District
city: Mexico City
country: Mexico
facility: H.G. Enrique Cabrera
state: Federal District
city: Mexico City
country: Mexico
facility: H.M.I Inguaran
state: Federal District
city: Lomas Verdes, Bayamon
country: Puerto Rico
facility: Clinica de Planificacion Familiar
city: San Juan
country: Puerto Rico
facility: Woman's Metropolitan Center
Study officials:
affiliation: Clinica de Planificacion Familiar
name: Hector Diaz Martinez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Woman's Metropolitan Center
name: Angela Arredondo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Scientific Research Institute of Obstetrics & Gynecology
name: Gulnara Rzaeva, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Family Planning Center
name: Besti Muradova, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Perinatology, Obstetrics and Gynecology
name: Susanna Fildjyan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Family Planning and Sexual Health
name: Armine Harutyunyan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: State Medical University
name: Anna Aghajanyan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: H G Enrique Cabrera
name: Ranulfo Rios, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: H.M.I Inguaran
name: Laura Garcia Martinez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: C S Beatriz Velasco Aleman
name: Antonio E Flores, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: C S Santa Catarina
name: Elba Margarita Lugo Hernandez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pena M, Dzuba IG, Smith PS, Mendoza LJ, Bousieguez M, Martinez ML, Polanco RR, Villalon AE, Winikoff B. Efficacy and acceptability of a mifepristone-misoprostol combined regimen for early induced abortion among women in Mexico City. Int J Gynaecol Obstet. 2014 Oct;127(1):82-5. doi: 10.1016/j.ijgo.2014.04.012. Epub 2014 Jun 4.