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

Medical Abortion Clinical Trial

Official title:

The Acceptability of an Out-patient Regimen of Medical Abortion With Mifepristone and 800 Mcg Misoprostol Administered Buccally or Sublingually at 78-84 Days Gestation: Two Pilot Studies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01856985
• Other study ID #: 1010
• Status: Completed
• Phase: Phase 4
• First received: April 30, 2013
• Last updated: October 9, 2013
• Start date: April 2013
• Est. completion date: September 2013

Study information

• Verified date: October 2013
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Hung Vuong Hospital
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Does not meet the inclusion criteria outlined above

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Medical Abortion

Intervention

Drug:
• Misoprostol

• Mifepristone

Locations

Country	Name	City	State
Vietnam	Hung Vuong Hospital	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of women who have undergone a successful abortion		2 weeks	No
Secondary	Women's acceptability of the assigned method.		2 weeks	No
Secondary	Side effects	Side effects include nausea, vomiting, pain, diarrhea, fever. Asked women to rank as none, mild, moderate, severe. Used an acceptability scale (Very Acceptable v. Acceptable v. Neutral v. Unacceptable v. Very unacceptable v. Don't know) to ascertain acceptability among women	48 hours	No