Acceptability and Feasibility of Medical Abortion Using Mifepristone and Buccal Misoprostol

NCT ID: NCT00386282

Last Updated: 2014-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2011-03-31

Brief Summary

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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

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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.

Conditions

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Abortion, First Trimester

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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mifepristone-misoprostol treatment

200 mg mifepristone followed by 800 mcg buccal misoprostol 24-48 hours after the mifepristone

Group Type OTHER

mifepristone-misoprostol treatment

Intervention Type DRUG

200 mg mifepristone followed by 800 mcg buccal misoprostol 24-48 hours after the mifepristone.

Interventions

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mifepristone-misoprostol treatment

200 mg mifepristone followed by 800 mcg buccal misoprostol 24-48 hours after the mifepristone.

Intervention Type DRUG

Other Intervention Names

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medical abortion

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Gynuity Health Projects

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hector Diaz Martinez, MD

Role: PRINCIPAL_INVESTIGATOR

Clinica de Planificacion Familiar

Angela Arredondo, MD

Role: PRINCIPAL_INVESTIGATOR

Woman's Metropolitan Center

Beverly Winikoff, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Gynuity Health Projects

Gulnara Rzaeva, MD

Role: PRINCIPAL_INVESTIGATOR

Scientific Research Institute of Obstetrics & Gynecology

Besti Muradova, MD

Role: PRINCIPAL_INVESTIGATOR

Family Planning Center

Susanna Fildjyan, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Perinatology, Obstetrics and Gynecology

Armine Harutyunyan, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Family Planning and Sexual Health

Anna Aghajanyan, MD

Role: PRINCIPAL_INVESTIGATOR

State Medical University

Ranulfo Rios, MD

Role: PRINCIPAL_INVESTIGATOR

H G Enrique Cabrera

Laura Garcia Martinez, MD

Role: PRINCIPAL_INVESTIGATOR

H.M.I Inguaran

Antonio E Flores, MD

Role: PRINCIPAL_INVESTIGATOR

C S Beatriz Velasco Aleman

Elba Margarita Lugo Hernandez, MD

Role: PRINCIPAL_INVESTIGATOR

C S Santa Catarina

Locations

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Center for Family Planning and Sexual Health

Yerevan, , Armenia

Site Status

Institute of Perinatology, Obstetrics and Gynecology

Yerevan, , Armenia

Site Status

State Medical University

Yerevan, , Armenia

Site Status

Family Planning Center

Baku, , Azerbaijan

Site Status

Scientific Research Institute of Obstetrics and Gynecology

Baku, , Azerbaijan

Site Status

C.S. Beatriz Velasco Aleman

Mexico City, Federal District, Mexico

Site Status

C.S. Santa Catarina

Mexico City, Federal District, Mexico

Site Status

H.G. Enrique Cabrera

Mexico City, Federal District, Mexico

Site Status

H.M.I Inguaran

Mexico City, Federal District, Mexico

Site Status

Clinica de Planificacion Familiar

Lomas Verdes, Bayamon, , Puerto Rico

Site Status

Woman's Metropolitan Center

San Juan, , Puerto Rico

Site Status

Countries

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Armenia Azerbaijan Mexico Puerto Rico

References

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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.

Reference Type DERIVED
PMID: 24957534 (View on PubMed)

Other Identifiers

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1.1.4

Identifier Type: -

Identifier Source: org_study_id

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