Comparative Effectiveness of Pregnancy Failure Management Regimens (PreFaiR)

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ClinicalTrials.gov Identifier: NCT02012491

Recruitment Status : Completed

First Posted : December 16, 2013

Results First Posted : December 21, 2018

Last Update Posted : July 18, 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

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

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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
Actual Study Completion Date :	June 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Miscarriage

Drug Information available for: Misoprostol Mifepristone

U.S. FDA Resources

Arms and Interventions

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

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: 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) ]
Gestational Sac Expulsion by the 30-day Telephone Call [ Time Frame: 30 Days ]
Uterine Asperation [ Time Frame: 30 Days ]
Surgical removal of the miscarriage.

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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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

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

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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

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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

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

Clement EG, Horvath S, McAllister A, Koelper NC, Sammel MD, Schreiber CA. The Language of First-Trimester Nonviable Pregnancy: Patient-Reported Preferences and Clarity. Obstet Gynecol. 2019 Jan;133(1):149-154. doi: 10.1097/AOG.0000000000002997.

Schreiber CA, Creinin MD, Atrio J, Sonalkar S, Ratcliffe SJ, Barnhart KT. Mifepristone Pretreatment for the Medical Management of Early Pregnancy Loss. N Engl J Med. 2018 Jun 7;378(23):2161-2170. doi: 10.1056/NEJMoa1715726.

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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:	July 18, 2019
Last Verified:	July 2019

Keywords provided by University of Pennsylvania:


Spontaneous abortion Early Pregnancy Failure Mifepristone Misoprostol

Additional relevant MeSH terms:

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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

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