Comparative Effectiveness of Pregnancy Failure Management Regimens

ID: NCT02012491
Status: Active, not recruiting
Phase: Phase 3
Start Date: January 01, 2014
First Submitted: December 10, 2013
Last Updated: February 06, 2018
Results: N/A
Sponsors & Collaborators: University of Pennsylvania, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Location: United States
Conditions: Spontaneous Abortion
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Study Description

Brief Summary

The purpose of the study is to compare the effectiveness of combination treatment (mifepristone premedication plus single-dose misoprostol) to single-dose misoprostol (standard of care) for the management of early pregnancy failure.

Detailed Description

Condition or disease Intervention/treatment Phase

Spontaneous Abortion

Drug: Misoprostol
Other Names
Cytotec
Drug: Mifepristone
Other Names
Mifeprex
Phase 3

Tracking Information

First Submitted DateDecember 10, 2013
Last Update Posted DateFebruary 06, 2018
Start DateJanuary 01, 2014
Anticipated Completion DateJune 15, 2019
Primary Completion DateMay 15, 2017
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Gestational sac expulsion with one treatment dose on day 3 (visit 2) and no need for additional medical or surgical intervention within 30 days of treatment. [Time Frame: 30 days]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Frequency of side effects between study arms. [Time Frame: 30 Days]

  • Frequency of serious adverse events between study arms. [Time Frame: 30 days]

  • Acceptability. [Time Frame: 30 Days]

    Excluding the emotional aspects of coping with the pregnancy loss, how would you describe the experience? (Positive/Negative/Neutral)

  • Percentage of participants who would recommend treatment to a friend. [Time Frame: 30 Days]

    Would you recommend this method of treatment to a friend? (Yes/No)

  • Percentage of participants who would choose medical management of miscarriage in the future. [Time Frame: 30 Days]

    If you had another miscarriage, what option would you choose? (Surgical / Medical / Expectant Management)

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleComparative Effectiveness of Pregnancy Failure Management Regimens
Official TitleComparative Effectiveness of Pregnancy Failure Management Regimens
Brief Summary

The purpose of the study is to compare the effectiveness of combination treatment (mifepristone premedication plus single-dose misoprostol) to single-dose misoprostol (standard of care) for the management of early pregnancy failure.

Detailed Description

Study TypeInterventional
Study PhasePhase 3
Estimated Enrollment
300
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Double
Primary Purpose
Treatment
Conditions
Spontaneous Abortion
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Misoprostol

Other Names
Cytotec
Drug: Mifepristone

Other Names
Mifeprex
Study Groups/Cohorts
misoprostol plus mifepristone
800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior

misoprostol
800 micrograms of vaginal misoprostol alone

Study Arms
Active Comparator misoprostol
800 micrograms of vaginal misoprostol alone
Drug : Misoprostol

Active Comparator misoprostol plus mifepristone
800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior
Drug : Mifepristone

Active Comparator misoprostol plus mifepristone
800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior
Drug : Misoprostol

Arm Intervention/Treatment
Active Comparator misoprostol
800 micrograms of vaginal misoprostol alone
Drug : Misoprostol
Active Comparator misoprostol plus mifepristone
800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior
Drug : Mifepristone
Active Comparator misoprostol plus mifepristone
800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior
Drug : Misoprostol

Recruitment Information

Recruitment Status:Active, not recruiting
Enrollment300
Completion DateJune 15, 2019
Eligibility Criteria: Inclusion Criteria:
- between 5 and 12 completed weeks gestation
- 18 years or older
- hemodynamically stable
- confirmed diagnosis of intrauterine embryonic/fetal demise or anembryonic gestation (ultrasound examination demonstrates a fetal pole without cardiac activity measuring between 5.3 and 40 mm or an abnormal growth pattern diagnostic of early pregnancy failure)
- willing and able to give informed consent

Exclusion Criteria:
- diagnosis of incomplete or inevitable abortion (absent gestational sac and/or active bleeding, open cervical os)
- contraindication to mifepristone (chronic corticosteroid administration, adrenal disease)
- contraindication to misoprostol (glaucoma, mitral stenosis, sickle cell anemia, or known allergy to prostaglandin)
- cardiovascular disease (angina, valvular disease, arrhythmia, or cardiac failure)
- most recent hemoglobin <9.5 g/dL
- diagnosis of porphyria
- known clotting defect or receiving anticoagulants
- pregnancy with an intrauterine device (IUD) in place
- breastfeeding during the first 7 days of study participation
- unwilling to comply with the study protocol and visit schedule
- any evidence of viable pregnancy
- possibility of ectopic pregnancy
- known or suspected pelvic infection
- concurrent participation in any other interventional trial
GenderFemale
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT02012491
Other Study ID Numbers
818434
1R01HD071920-01A1
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
University of Pennsylvania
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator
Courtney A Schreiber, MD, MPH
University of Pennsylvania
Principal Investigator
Mitchell Creinin, MD
University of California, Davis