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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT00969982
First received: August 31, 2009
Last updated: February 18, 2014
Last verified: February 2014
  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:


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 November 27, 2014