ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparative Effectiveness of Pregnancy Failure Management Regimens (PreFaiR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02012491
Recruitment Status : Active, not recruiting
First Posted : December 16, 2013
Results First Posted : December 21, 2018
Last Update Posted : January 14, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Spontaneous Abortion Drug: Misoprostol Drug: Mifepristone Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Effectiveness of Pregnancy Failure Management Regimens
Study Start Date : January 2014
Actual Primary Completion Date : May 15, 2017
Estimated Study Completion Date : June 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Miscarriage

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: misoprostol plus mifepristone
800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior
 Drug: Misoprostol
Other Name: Cytotec

Drug: Mifepristone
Other Name: Mifeprex
Active Comparator: misoprostol
800 micrograms of vaginal misoprostol alone
 Drug: Misoprostol
Other Name: Cytotec


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]
  2. 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) ]
  3. Gestational Sac Expulsion by the 30-day Telephone Call [ Time Frame: 30 Days ]
  4. Uterine Asperation [ Time Frame: 30 Days ]
    Surgical removal of the miscarriage.


Secondary Outcome Measures :
  1. Frequency of Serious Adverse Events Between Study Arms. [ Time Frame: 30 days ]
  2. Adverse Event Reported by Participants [ Time Frame: 30 Days ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02012491


Locations
United States, California
University of California, Davis Medical Center
Sacramento, California, United States, 95817
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10461
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
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
  Study Documents (Full-Text)

Documents provided by University of Pennsylvania:
Study Protocol and Statistical Analysis Plan  [PDF] March 7, 2017

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02012491     History of Changes
Other Study ID Numbers: 818434
1R01HD071920-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 16, 2013    Key Record Dates
Results First Posted: December 21, 2018
Last Update Posted: January 14, 2019
Last Verified: November 2018

Keywords provided by University of Pennsylvania:
Spontaneous abortion
Early Pregnancy Failure
Mifepristone
Misoprostol

Additional relevant MeSH terms:
Abortion, Spontaneous
Pregnancy Complications
Misoprostol
Mifepristone
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
 Abortifacient Agents, Steroidal
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents