Comparative Effectiveness of Pregnancy Failure Management Regimens (PreFaiR)

July 3, 2019 updated by: University of Pennsylvania
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • University of California, Davis Medical Center
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: misoprostol plus mifepristone
800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior
Drug: Misoprostol
Other Names:
  • Cytotec
Drug: Mifepristone
Other Names:
  • Mifeprex
Active Comparator: misoprostol
800 micrograms of vaginal misoprostol alone
Drug: Misoprostol
Other Names:
  • Cytotec

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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: Day 3 (visit 2) and up to 30 days following visit (to ensure surgical measures were not done
Day 3 (visit 2) and up to 30 days following visit (to ensure surgical measures were not done
Gestational Sac Expulsion by the Second Follow-up Visit at Day 8
Time Frame: Day 8 (visit 3) and up to 30 day to ensure additional measures were not done (surgical)
Day 8 (visit 3) and up to 30 day to ensure additional measures were not done (surgical)
Gestational Sac Expulsion by the 30-day Telephone Call
Time Frame: 30 Days
30 Days
Uterine Asperation
Time Frame: 30 Days
Surgical removal of the miscarriage.
30 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency of Serious Adverse Events Between Study Arms.
Time Frame: 30 days
30 days
Adverse Event Reported by Participants
Time Frame: 30 Days
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

May 15, 2017

Study Completion (Actual)

June 15, 2019

Study Registration Dates

First Submitted

December 10, 2013

First Submitted That Met QC Criteria

December 10, 2013

First Posted (Estimate)

December 16, 2013

Study Record Updates

Last Update Posted (Actual)

July 18, 2019

Last Update Submitted That Met QC Criteria

July 3, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 818434
  • 1R01HD071920-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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