Comparing Two Regimens for Medical Abortion: Mifepristone + Misoprostol Versus Misoprostol Alone

NCT01387256 | Completed Phase 4

• 1 other identifier: 1.2.1
• Study Type: interventional
• Target: 441
• Locations: 2 countries
• Sites: 2

Brief Summary

This double blinded, placebo-controlled randomized trial will compare the safety, efficacy and acceptability of two medical abortion regimens up to 63 days since last Menstrual Period (LMP) in Tunisia and Vietnam. The first regimen will include a 200 mg oral dose of mifepristone followed by 800 mcg buccal misoprostol. The second regimen will include two 800 mcg doses of buccal misoprostol three hours apart. All drugs are administered AT home by the participant.

Conditions

Complete Abortion

Keywords

abortion; mifepristone; misoprostol; with gestations > 63 days LMP

Outcome Measures

Primary Outcomes (1)

• Number of women with a complete abortion using study drug alone without recourse to surgical intervention

  Number of participants with a complete abortion after treatment without recourse to surgical intervention as a measure of efficacy of the study regimens

  one week from initial treatment

Secondary Outcomes (4)

• Number of women who indicate that the side effects of buccal misoprostol, administered either alone or in combination with mifepristone, is acceptable in Tunisia and Vietnam

  one week from initial treatment

• Evaluate whether women administering buccal misoprostol have a complete abortion with study drug and experience any adverse events, at a rate that is similar to other routes of misoprostol administration

  one week from initial treatment

• Measuring the proportion of women who report their medical abortion procedure to be acceptable in Tunisia and Vietnam

  one week from initial treatment

• Determining whether women can take both the mifepristone and misoprostol at home on their own by assessing protocol compliance

  one week from initial treatment

Study Arms (2)

mifepristone+misoprostol

OTHER

200 mg mifepristone + 800 mcg buccal misoprostol

Drug: medical abortion

buccal misoprostol

EXPERIMENTAL

2 doses of 800 mcg buccal misoprostol

Drug: medical abortion

Interventions

medical abortion DRUG

pregnancy termination with drugs

buccal misoprostol; mifepristone+misoprostol

Eligibility Criteria

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

You may qualify if:

• Gestational age \< 63 days since LMP, confirmed by ultrasound or clinical assessment.
• General good health including absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination.
• Agrees to return for follow-up visit and willing to provide an address and/or telephone number for purposes of follow-up.
• Able to consent to study participation.

You may not qualify if:

• Gestational age \> 63 days LMP
• Confirmed or suspected ectopic or molar pregnancy
• Contraindications to medical abortion including intra-uterine device (IUD) in place (must be removed before procedure), chronic adrenal failure, concurrent long-term corticosteroid therapy, history of allergy to mifepristone, misoprostol or prostaglandin, hemorrhagic disorders or concurrent anticoagulant therapy, inherited porphyries.

Sponsors & Collaborators

• Gynuity Health Projects: lead

Study Sites (2)

La Rabta Maternity Hospital

Tunis, Tunisia

Location

Hung Vuong Hospital

Ho Chi Minh City, Vietnam

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 2, 2011
• First Posted: July 4, 2011
• Study Start: May 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: July 20, 2011

Record last verified: 2011-07

Locations

TU (1); VN (1)