Acceptability and Feasibility of a Demedicalized Medical Abortion Regimen in the Caucasus

NCT02219100 | Completed

• 1 other identifier: 1.2.3.1
• Study Type: interventional
• Target: 613
• Locations: 2 countries
• Sites: 5

Brief Summary

This study examined the acceptability and feasibility of using a simplified regimen of medical abortion in Armenia and Azerbaijan. It was hypothesized that home use of mifepristone and misoprostol, and buccal administration of misoprostol, would be both acceptable to women and efficacious.

Conditions

Abortion, First Trimester

Outcome Measures

Primary Outcomes (1)

• Proportion of abortions that are complete without surgical intervention (unit: percent).

  Percentage of women with complete abortion without the need of a surgical intervention.

  15 days

Secondary Outcomes (1)

• Proportion of women satisfied with procedure (unit: percent) and with side effects (unit: percent).

  15 days

Other Outcomes (2)

• Proportion of Women Who Select Home-use of Mifepristone

  1 week

• Proportion of Women Who Select Home-use of Misoprostol

  1 week

Study Arms (2)

Home administration of mifepristone

EXPERIMENTAL

This arm consisted of women who chose home administration of 200 mg mifepristone.

Drug: Home administration of 200 mg mifepristone

Clinic administration of mifepristone

NO INTERVENTION

This arm consisted of women who underwent clinic administration of 200 mg mifepristone.

Interventions

Home administration of 200 mg mifepristone DRUG

Home administration of 200 mg mifepristone

Home administration of mifepristone

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years or older
• Good general health
• Living or working close to the study site
• Intrauterine pregnancy less than 64 days gestation
• Willing and able to sign consent forms
• Eligible for medical abortion according to the clinician's assessment
• Ready access to a telephone and emergency transportation
• Willing to provide an address and/or telephone number for purposes of follow-up
• Agree to comply with the study procedures and visit schedule

You may not qualify if:

• Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass
• IUD in place (IUD must be removed first)
• Chronic renal failure
• Concurrent long-term corticosteroid therapy
• History of allergy to mifepristone, misoprostol or other prostaglandin
• Hemorrhagic disorders or concurrent anticoagulant therapy
• Inherited porphyrias
• Other serious physical or mental health conditions

Sponsors & Collaborators

• Gynuity Health Projects: lead

Study Sites (5)

Gyumri Maternity Hospital

Gyumri, Armenia

Location

Vanadzor Hospital #1

Vanadzor, Armenia

Location

Antenatal Clinic

Ganja, Azerbaijan

Location

Family Planning Center

Ganja, Azerbaijan

Location

Gynecology Department of the Central Regional Hospital

Zaqatala, Azerbaijan

Location

MeSH Terms

Interventions

Mifepristone

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Beverly Winikoff, MD, MPH

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

• Rena Bagirova, MD

  Antenatal Clinic

  PRINCIPAL INVESTIGATOR

• Mehriban Huseynova, MD

  Gynecology Department of the Central Regional Hospital

  PRINCIPAL INVESTIGATOR

• Aram Avalyan, MD

  Vanadzor Hospital #1

  PRINCIPAL INVESTIGATOR

• Alla Minasyan, MD

  Gyumri Maternity Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2014
• First Posted: August 18, 2014
• Study Start: November 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: August 19, 2014

Record last verified: 2014-08

Locations

AR (2); AZ (3)