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

Purpose

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.

Condition	Intervention
Abortion, Induced	Drug: mifepristone+misoprostol Drug: misoprostol+placebo


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14 - 21 Weeks LMP): A Randomized-controlled Double-blinded Trial

Resource links provided by NLM:

Drug Information available for: Misoprostol Mifepristone

U.S. FDA Resources

Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:

Rate of successful abortion: defined as complete evacuation using study drug without recourse to any additional intervention. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Induction-to-abortion interval: defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Provision of additional interventions to manage excessive blood loss [ Time Frame: from start of treatment until discharge ] [ Designated as safety issue: No ]
Any heavy bleeding, uterine rupture, or infection requiring additional treatment [ Time Frame: start of treatment until discharge ] [ Designated as safety issue: No ]
Total dose of misoprostol. [ Time Frame: Assessed at time of complete abortion with study drug alone or when total maximum dose given. ] [ Designated as safety issue: No ]
Pain experienced by the woman as self-reported. [ Time Frame: Assessed during exit interview. ] [ Designated as safety issue: No ]
Women's acceptability of the assigned method [ Time Frame: Assessed at exit interview ] [ Designated as safety issue: No ]


Enrollment:	238
Study Start Date:	June 2009
Study Completion Date:	June 2013
Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: mifepristone+misoprostol 200 mg mifepristone followed by 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 10 doses within 48 hours (maximum 5 doses per 24 hours).	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.
Active Comparator: misoprostol Placebo resembling mifepristone followed 24 hours later by 800 mcg buccal misoprostol repeated every 3 hours until complete abortion up to a maximum of 10 doses within 48 hours (maximum 5 doses per 24 hours).	Drug: 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.

Eligibility


Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00969982

Locations


Moldova, Republic of
Municipal Clinical Hospital
Chishinau, Moldova, Republic of
Tunisia
La Rabta Maternity Hospital
Tunis, Tunisia

Sponsors and Collaborators

Gynuity Health Projects

Investigators


Principal Investigator:	Beverly Winikoff	Gynuity Health Projects

More Information

No publications provided


Responsible Party:	Gynuity Health Projects
ClinicalTrials.gov Identifier:	NCT00969982 History of Changes
Other Study ID Numbers:	1.4.1
Study First Received:	August 31, 2009
Last Updated:	February 18, 2014
Health Authority:	Tunisia: Research Ethics Commitee of La Rabta Maternity Hospital, Tunis, Tunisia Moldova: Researc Ethics Commitee of Municipal Clinical Hospital, Chisinau, Moldova

Keywords provided by Gynuity Health Projects:


Pregnancy termination abortion medical abortion	2nd trimester mifepristone misoprostol

Additional relevant MeSH terms:


Mifepristone Misoprostol Abortifacient Agents Abortifacient Agents, Nonsteroidal Abortifacient Agents, Steroidal Anti-Ulcer Agents Contraceptive Agents Contraceptive Agents, Female Contraceptives, Oral Contraceptives, Oral, Synthetic Contraceptives, Postcoital	Contraceptives, Postcoital, Synthetic Gastrointestinal Agents Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Luteolytic Agents Menstruation-Inducing Agents Oxytocics Pharmacologic Actions Physiological Effects of Drugs Reproductive Control Agents Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015