Acceptability of an Out-patient Regimen of Medical Abortion With Mifepristone and 800 Mcg Misoprostol Administered at 78-84 Days Gestation

NCT01856985 | Completed Phase 4

• 1 other identifier: 1010
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

These pilot studies are designed as open label studies to investigate the acceptability of 200 mg mifepristone followed 24-48 hours later by either 1) 800 µg misoprostol administered buccally or 2) 800 µg misoprostol administered sublingually for medical abortion in gestations 78-84 days' LMP. They will be done consecutively. Findings from the pilot studies will guide the development of a larger, multi-site study to investigate the efficacy of outpatient medical abortion regimens for women with gestations from 78 - 84 days LMP. In that end, the pilots seek to collect information on the acceptability of an outpatient medical abortion regimen of 200 mg oral mifepristone followed by either 800 mcg misoprostol delivered either buccally or sublingually safe acceptable? Women's rating of the tolerability of any side effects will also be documented.

Conditions

Medical Abortion

Keywords

Medical abortion; Misoprostol; Mifepristone

Outcome Measures

Primary Outcomes (1)

• Percentage of women who have undergone a successful abortion

  2 weeks

Secondary Outcomes (2)

• Women's acceptability of the assigned method.

  2 weeks

• Side effects

  48 hours

Study Arms (1)

Misoprostol at clinic

EXPERIMENTAL

Eligible women will receive 200 mg mifepristone to be administered at home or at the clinic and will receive either 800 µg misoprostol buccally (study 1) or 800 µg misoprostol sublingually (study 2) to self administer at home. Participants will be asked to return to the hospital 14 days later for a follow-up visit.

Drug: Misoprostol; Drug: Mifepristone

Interventions

Misoprostol DRUG

Misoprostol at clinic

Mifepristone DRUG

Misoprostol at clinic

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Seeking abortion services
• Have an intrauterine pregnancy 78 days through 84 days' LMP
• Be willing and able to sign consent forms
• Agree to comply with study procedures and visit schedule
• Be living with 30 minutes from the hospital

Sponsors & Collaborators

• Gynuity Health Projects: lead

Study Sites (1)

Hung Vuong Hospital

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Interventions

Misoprostol; Mifepristone

Intervention Hierarchy (Ancestors)

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

Study Officials

• Beverly Winikoff, MD, MPH

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

• Jennifer Blum, MPH

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

• Nguyen Thu Nhu Ngoc, MD

  Center for Research and Consultancy in Reproductive Health

  PRINCIPAL INVESTIGATOR

• Dina F Abbas

  Gynuity Health Projects

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2013
• First Posted: May 20, 2013
• Study Start: April 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: October 11, 2013

Record last verified: 2013-10

Locations

VN (1)