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
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Condition or disease | Intervention/treatment | Phase |
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Spontaneous Abortion | Drug: Misoprostol Drug: Mifepristone | Phase 3 |
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 |
Arm | Intervention/treatment |
---|---|
Active Comparator: misoprostol plus mifepristone
800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior
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Drug: Misoprostol
Other Name: Cytotec Drug: Mifepristone Other Name: Mifeprex |
Active Comparator: misoprostol
800 micrograms of vaginal misoprostol alone
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Drug: Misoprostol
Other Name: Cytotec |
- 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.
- Frequency of Serious Adverse Events Between Study Arms. [ Time Frame: 30 days ]
- Adverse Event Reported by Participants [ Time Frame: 30 Days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

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
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 |
Principal Investigator: | Courtney A Schreiber, MD, MPH | University of Pennsylvania | |
Principal Investigator: | Mitchell Creinin, MD | University of California, Davis |
Documents provided by University of Pennsylvania:
Responsible Party: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT02012491 |
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 |
Spontaneous abortion Early Pregnancy Failure Mifepristone Misoprostol |
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 |