Study of 400mcg Versus 800mcg Buccal Misoprostol Following Mifepristone 200mg for Abortion up to 63 Days Gestation

NCT00482209 | Completed

• 1 other identifier: 1.1.6
• Study Type: interventional
• Target: 1,220
• Locations: 2 countries
• Sites: 4

Brief Summary

This double-blind, randomized study will compare the efficacy and acceptability of mifepristone 200mg followed in 36-48 hours by 400mcg or 800mcg of buccal misoprostol (i.e., in the cheeks) for termination of pregnancy in women up to 63 days LMP.

Conditions

Induced Abortion

Keywords

mifepristone, misoprostol, medical abortion

Outcome Measures

Primary Outcomes (1)

• Need for surgical completion for ongoing viable pregnancies at follow up visit (Study day 12-15) or for incomplete abortion at extended follow up visit (Study day (19-22).

  Study day 12-15 for ongoing viable pregnancies or Study day 19-22 for incomplete abortion at extended follow up visit

Secondary Outcomes (1)

• Side-effects, acceptability for women

  side effects and acceptability recorded at exit interview

Study Arms (2)

1

ACTIVE COMPARATOR

200mg mifepristone followed by 400mcg misoprostol

Drug: Mifepristone, misoprostol

2

ACTIVE COMPARATOR

200mg mifepristone followed by 800mcg misoprostol

Drug: mifepristone, misoprostol

Interventions

mifepristone, misoprostol DRUG

200mg mifepristone followed by 400mcg misoprostol 36-48 hours later

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women 18 years or over presenting for abortion services who consent to participate
• good general health
• assessed by a clinician to have an intrauterine pregnancy less than 64 days LMP on Study Day 1 and to be eligible for medical abortion
• Have ready access to a telephone and emergency transportation;
• Be willing to provide an address and/or telephone number for purposes of follow-up

You may not qualify if:

• Conditions which contraindicate the use of mifepristone or misoprostol
• Women presenting for medical abortion who do not consent to participate

Sponsors & Collaborators

• Gynuity Health Projects: lead

Study Sites (4)

Maternity House #2

Tbilisi, Georgia

Location

Maternity House #4

Tbilisi, Georgia

Location

Zhordania Institute of Human Reproduction

Tbilisi, Georgia

Location

Hocmon Hospital

Ho Chi Minh City, Vietnam

Location

Related Links

• Related Info

MeSH Terms

Interventions

Mifepristone; Misoprostol

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Beverly Winikoff, MD, MPH

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

• Erica Chong, MPH

  Gynuity Health Projects

  STUDY DIRECTOR

• Tamuna Tsereteli, MD, MSc, PhD

  Gynuity Health Projects

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 4, 2007
• First Posted: June 5, 2007
• Study Start: May 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: October 12, 2009

Record last verified: 2009-10

Locations

GE (3); VN (1)