Acceptability and Feasibility of Medical Abortion Using Mifepristone and Buccal Misoprostol

Abortion, First Trimester Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00386282
• Other study ID #: 1.1.4
• Status: Completed
• Phase: N/A
• First received: October 9, 2006
• Last updated: July 29, 2014
• Start date: September 2006
• Est. completion date: March 2011

Study information

• Verified date: July 2014
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1250
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion, First Trimester

Intervention

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

Locations

Country	Name	City	State
Armenia	Center for Family Planning and Sexual Health	Yerevan
Armenia	Institute of Perinatology, Obstetrics and Gynecology	Yerevan
Armenia	State Medical University	Yerevan
Azerbaijan	Family Planning Center	Baku
Azerbaijan	Scientific Research Institute of Obstetrics and Gynecology	Baku
Mexico	C.S. Beatriz Velasco Aleman	Mexico City	Federal District
Mexico	C.S. Santa Catarina	Mexico City	Federal District
Mexico	H.G. Enrique Cabrera	Mexico City	Federal District
Mexico	H.M.I Inguaran	Mexico City	Federal District
Puerto Rico	Clinica de Planificacion Familiar	Lomas Verdes, Bayamon
Puerto Rico	Woman's Metropolitan Center	San Juan

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Countries where clinical trial is conducted

Armenia,  Azerbaijan,  Mexico,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy		15 days	No
Secondary	acceptability		15 days	No