Mifepristone Plus Misoprostol Versus Misoprostol Alone for 2nd Trimester Abortion (14 - 21 Weeks Last Menstrual Period (LMP))

Abortion, Induced Clinical Trial

Official title:

Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14 - 21 Weeks LMP): A Randomized-controlled Double-blinded Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00969982
• Other study ID #: 1.4.1
• Status: Completed
• Phase: N/A
• First received: August 31, 2009
• Last updated: February 18, 2014
• Start date: June 2009
• Est. completion date: June 2013

Study information

• Verified date: February 2014
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tunisia: Research Ethics Commitee of La Rabta Maternity Hospital, Tunis, TunisiaMoldova: Researc Ethics Commitee of Municipal Clinical Hospital, Chisinau, Moldova
• Study type: Interventional

Clinical Trial Summary

The primary goal of this study is to determine the clinical advantage of pre-treatment with mifepristone in second trimester misoprostol induction abortion. This will be a randomized controlled double-blinded trial of 120 women in each country comparing misoprostol alone to mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 14 to 21 weeks gestation, based on menstrual history and clinical exam (with or without ultrasound)

• Meet legal 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, including placenta previa

• 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: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion, Induced

Intervention

Drug:
• mifepristone+misoprostol
single dose of 200 mg mifepristone followed 24 hours later by 800 mcg misoprostol administered buccally and repeated every 3 hours for a maximum of 5 doses per 24 hours up to 48 hours.
• misoprostol+placebo
placebo resembling mifepristone followed 24 hours later by 800 mcg buccal misoprostol repeated every 3 hours for a maximum of 5 doses per 24 hours up to 48 hours.

Locations

Country	Name	City	State
Moldova, Republic of	Municipal Clinical Hospital	Chishinau
Tunisia	La Rabta Maternity Hospital	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Countries where clinical trial is conducted

Moldova, Republic of,  Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of successful abortion: defined as complete evacuation using study drug without recourse to any additional intervention.		48 hours	No
Primary	Induction-to-abortion interval: defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus.		48 hours	No
Secondary	Provision of additional interventions to manage excessive blood loss		from start of treatment until discharge	No
Secondary	Any heavy bleeding, uterine rupture, or infection requiring additional treatment		start of treatment until discharge	No
Secondary	Total dose of misoprostol.		Assessed at time of complete abortion with study drug alone or when total maximum dose given.	No
Secondary	Pain experienced by the woman as self-reported.		Assessed during exit interview.	No
Secondary	Women's acceptability of the assigned method		Assessed at exit interview	No