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 ]

Estimated Enrollment:	240
Study Start Date:	June 2009
Estimated Study Completion Date:	June 2013
Estimated 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

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

Locations

Moldova, Republic of
Municipal Clinical Hospital	Recruiting
Chishinau, Moldova, Republic of
Contact: Rodica Commendant, MD rcomendant@gynuity.org
Contact: Stelian Hodorojea, MD
Tunisia
La Rabta Maternity Hospital	Recruiting
Tunis, Tunisia
Contact: Hela Chelli, MD hela.chelli@laposte.net
Contact: Selma Hajri, MD selmahajri@gmail.com

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:	March 11, 2013
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
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Postcoital, Synthetic

Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Abortifacient Agents, Steroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Abortifacient Agents, Nonsteroidal

ClinicalTrials.gov processed this record on May 23, 2013