Clinical trial NCT02708446: A Comparison of Sublingual and Buccal Misoprostol Regimens After Mifepristone for Mid-trimester Abortion
Official title: A Randomized Controlled Trial to Compare Sublingual and Buccal Misoprostol Regimens After Mifepristone for Termination of Pregnancy 13 - 21 Weeks From Last Menstrual Period (LMP)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Legally Induced Abortion Without Mention of Complication
Keywords: Second Trimester
Abortion
Misoprostol
Sublingual
Buccal
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: La Rabta Maternity Hospital
name: Republican Institute of RH, Perinatology, and Ob/Gyn
name: Kathmandu Medical College and Teaching Hospital
name: Clinic No. 2 of Tashkent Medical Academy
First posted: 2016-03-15
Enrollment: 320
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary goal of this study is to directly compare repeat doses of sublingual and buccal routes of 400 mcg misoprostol following mifepristone for second trimester abortion in order to determine if sublingual route confers an advantage with respect to efficacy and median time to complete abortion.

Detailed description: Eligible women 13-21 weeks gestation who give informed consent will be randomized to receive buccal or sublingual misoprostol. Participants will take 200mg mifepristone and return to the hospital 24 hours later to begin induction with misoprostol. 400mcg misoprostol will be given every 3 hours until the expulsion of the fetus and placenta.

Eligibility criteria: Inclusion Criteria:

* Meet criteria to obtain abortion
* Present with closed cervical os and no vaginal bleeding
* Live fetus at time of presentation for service
* Have no contraindications to study procedures, according to provider
* Be able to consent to procedure, either by reading consent document or by having consent document read to her
* Be willing to follow study procedures

Exclusion Criteria:

* Known previous transmural uterine incision
* Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol
* Any contraindications to vaginal delivery
* Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)

Primary outcomes:
measure: Rate of successful abortion by 24 hours
timeFrame: 24 hours following the start of misoprostol
measure: Rate of successful abortion by 48 hours
timeFrame: 48hours following the start of misoprostol
Secondary outcomes:
measure: Median time from first dose of misoprostol to complete expulsion of complete expulsion (provider diagnosis of complete expulsion of fetus and placenta).
timeFrame: 48 hours
measure: Percentage of patients requiring provision of additional interventions.
timeFrame: from first drug dose to complete expulsion as documented on study forms, up to 72 hours
measure: Total number of doses of misoprostol.
timeFrame: from first drug dose to complete expulsion as documented on study forms, up to 72 hours
measure: Rates of heavy bleeding, uterine rupture, or infection requiring additional treatment
timeFrame: 1 month
measure: Pain scale (1-7) as reported by women on questionnaire
timeFrame: from first drug dose to complete expulsion as documented on study forms, up to 72 hours
measure: Women's acceptability of the assigned method based on 5 point acceptability scale in questionnaire
timeFrame: from first drug dose to complete expulsion as documented on study forms, up to 72 hours
Other outcomes:
Locations:
city: Yerevan
country: Armenia
facility: b. Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology (RIRHPOG)
city: Kathmandu
country: Nepal
facility: Kathmandu Medical College
city: Tunis
country: Tunisia
facility: La Rabta Maternity Hospital
city: Tashkent
country: Uzbekistan
facility: Clinic No. 2, Tashkent Medical Academy
Study officials:
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: