Clinical trial NCT01768299: Medical Abortion With Mifepristone + Misoprostol (13 - 22 Weeks)
Official title: Medical Abortion With Mifepristone + Misoprostol (13 - 22 Weeks): A Double-blind Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Complete Uterine Evacuation After Use of Study Drugs
Keywords: abortion
medical abortion
mifepristone
misoprostol
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2013-01-15
Enrollment: 504
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Proportion of women who have had a complete uterine evacuation within 24 hours using study drug without recourse to any additional intervention.
timeFrame: Within 1 week
Secondary outcomes:
measure: Induction to abortion interval
timeFrame: Within 1 week
measure: Women's acceptability of the assigned method.
timeFrame: Within 1 week
measure: Rate of fetal expulsion
timeFrame: Within 1 week
measure: Provision of additional interventions
timeFrame: Within 1 week
measure: Time interval from the mifepristone dose to abortion
timeFrame: Within 1 week
measure: Total dose of misoprostol administered
timeFrame: Within 1 week
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Binh duong Obstetrics and Newborn Hospital
state: Binh Duong Province
city: Hanoi
country: Vietnam
facility: National Ob-Gyn Hospital
city: Ho Chi Minh City
country: Vietnam
facility: Hung Vuong Hospital
Study officials:
affiliation: Gynuity Health Projects
name: Jennifer Blum, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Dina Abbas, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Hung Vuong Hospital
name: Nguyen thi Ngoc, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.