A Comparison of Sublingual and Buccal Misoprostol Regimens After Mifepristone for Mid-trimester Abortion

Legally Induced Abortion Without Mention of Complication Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02708446
• Other study ID #: 1013
• Status: Recruiting
• Phase: Phase 4
• First received: February 10, 2016
• Last updated: July 13, 2016
• Start date: May 2014
• Est. completion date: December 2016

Study information

• Verified date: July 2016
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: Nepal: Kathmandu Medical College Research Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Legally Induced Abortion Without Mention of Complication

Intervention

Drug:
• Mifepristone
200mg oral mifepristone to both study arms
• Buccal misoprostol
doses of buccal misoprostol every 3 hours beginning 24 hours after mifepristone
• Sublingual misoprostol
doses of sublingual misoprostol every 3 hours beginning 24 hours after mifepristone

Locations

Country	Name	City	State
Armenia	b. Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology (RIRHPOG)	Yerevan
Nepal	Kathmandu Medical College	Kathmandu
Tunisia	La Rabta Maternity Hospital	Tunis
Uzbekistan	Clinic No. 2, Tashkent Medical Academy	Tashkent

Sponsors (5)

Lead Sponsor	Collaborator
Gynuity Health Projects	Clinic No. 2 of Tashkent Medical Academy, Kathmandu Medical College and Teaching Hospital, La Rabta Maternity Hospital, Republican Institute of RH, Perinatology, and Ob/Gyn

Countries where clinical trial is conducted

Armenia,  Nepal,  Tunisia,  Uzbekistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of successful abortion by 24 hours	Defined as complete evacuation of uterus at 24 hours following start of misoprostol, using study drugs without recourse to any additional intervention.	24 hours following the start of misoprostol	No
Primary	Rate of successful abortion by 48 hours	Defined as complete evacuation of uterus at 48 hours following start of misoprostol, using study drugs without recourse to any additional intervention.	48hours following the start of misoprostol	No
Secondary	Median time from first dose of misoprostol to complete expulsion of complete expulsion (provider diagnosis of complete expulsion of fetus and placenta).		48 hours	No
Secondary	Percentage of patients requiring provision of additional interventions.		from first drug dose to complete expulsion as documented on study forms, up to 72 hours	No
Secondary	Total number of doses of misoprostol.		from first drug dose to complete expulsion as documented on study forms, up to 72 hours	No
Secondary	Rates of heavy bleeding, uterine rupture, or infection requiring additional treatment		1 month	No
Secondary	Pain scale (1-7) as reported by women on questionnaire		from first drug dose to complete expulsion as documented on study forms, up to 72 hours	No
Secondary	Women's acceptability of the assigned method based on 5 point acceptability scale in questionnaire		from first drug dose to complete expulsion as documented on study forms, up to 72 hours	No