Medical Abortion With Mifepristone + Misoprostol (13 - 22 Weeks)
1 other identifier
interventional
504
1 country
3
Brief Summary
A double-blind randomized controlled trial to compare a shorter interval between the administration of mifepristone and misoprostol (simultaneous administration compared to 24hours from administration of mifepristone to receipt of the first dose of misoprostol) for termination of pregnancy up to 13-22 weeks of gestation. The investigators hypothesize that a shortened interval may achieve comparable efficacy in terminating pregnancy, whilst reducing the duration of the procedure and in turn, the duration of hospitalization.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2013
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2013
CompletedFirst Posted
Study publicly available on registry
January 15, 2013
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedMay 14, 2014
May 1, 2014
1.2 years
January 11, 2013
May 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of women who have had a complete uterine evacuation within 24 hours using study drug without recourse to any additional intervention.
Defined as complete evacuation of fetus and placenta using study drug without recourse to any additional intervention.
Within 1 week
Secondary Outcomes (6)
Induction to abortion interval
Within 1 week
Women's acceptability of the assigned method.
Within 1 week
Rate of fetal expulsion
Within 1 week
Provision of additional interventions
Within 1 week
Time interval from the mifepristone dose to abortion
Within 1 week
- +1 more secondary outcomes
Study Arms (2)
Mifepristone at home 24 hours before miso dosing starts
EXPERIMENTALAll women will receive study packet one containing mifepristone to swallow at home on study day 1. They will be told to return to the hospital for induction and will be scheduled to return to the hospital 24 hours later. Upon their return, they will be hospitalized and receive another study packet containing a placebo. Simultaneously, they will receive one dose of 400 mcg buccal misoprostol. Women will remain hospitalized and receive repeated doses of 400 mcg buccal misoprostol every three hours. Participants will receive up to eight doses of misoprostol (e.g. 3200 mcg misoprostol) over 24 hours. Misoprostol dosing will stop when both the fetus and placenta are expelled.
Mifepristone and first dose of misoprostol simultaneously.
EXPERIMENTALWill receive study packet one containing placebo to swallow at home on study day 1. They will be told to return to the hospital for induction and will be scheduled to return to the hospital 24 hours later. Upon their return, they will be hospitalized and receive another study packet containing mifepristone. Simultaneously they will receive one dose of 400 mcg buccal misoprostol. Women will remain hospitalized and receive repeated doses of 400 mcg buccal misoprostol every three hours. Participants will receive up to eight doses of misoprostol (e.g. 3200 mcg misoprostol) over 24 hours. Misoprostol dosing will stop when both the fetus and placenta are expelled. The procedure will be considered complete once both the fetus and placenta are expelled.
Interventions
200 mg oral Mifepristone 24 hours before 400 mcg buccal misoprostol
200 mg oral Mifepristone simultaneously 400 mcg buccal misoprostol
Eligibility Criteria
You may qualify if:
- Closed cervical os and no vaginal bleeding
- Live fetus at time of presentation for service
- No contraindications to medical abortion and study procedures, according to provider
- Able to consent to participate in the study, either by reading consent document or by having consent document read to her and sign informed consent
- Willing to follow study procedures
You may not qualify if:
- Known previous transmural uterine incision
- \> 5 parity
- Signs and symptoms of infection
- Any contraindications to vaginal delivery, including placenta previa
- Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Binh duong Obstetrics and Newborn Hospital
Ho Chi Minh City, Binh Duong Province, Vietnam
National Ob-Gyn Hospital
Hanoi, Vietnam
Hung Vuong Hospital
Ho Chi Minh City, Vietnam
Related Publications (1)
Abbas DF, Blum J, Ngoc NT, Nga NT, Chi HT, Martin R, Winikoff B. Simultaneous Administration Compared With a 24-Hour Mifepristone-Misoprostol Interval in Second-Trimester Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2016 Nov;128(5):1077-1083. doi: 10.1097/AOG.0000000000001688.
PMID: 27741182DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Blum, MPH
Gynuity Health Projects
- PRINCIPAL INVESTIGATOR
Beverly Winikoff, MD, MPH
Gynuity Health Projects
- PRINCIPAL INVESTIGATOR
Dina Abbas, MPH
Gynuity Health Projects
- PRINCIPAL INVESTIGATOR
Nguyen thi Ngoc, MD
Hung Vuong Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2013
First Posted
January 15, 2013
Study Start
February 1, 2013
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
May 14, 2014
Record last verified: 2014-05