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Comparative Effectiveness of Pregnancy Failure Management Regimens (PreFaiR)

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ClinicalTrials.gov Identifier: NCT02012491
Recruitment Status : Active, not recruiting
First Posted : December 16, 2013
Last Update Posted : May 11, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of Pennsylvania

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 Type : Interventional  (Clinical Trial)
Estimated 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

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




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: 30 days ]

Secondary Outcome Measures :
  1. Frequency of side effects between study arms. [ Time Frame: 30 Days ]
  2. Frequency of serious adverse events between study arms. [ Time Frame: 30 days ]
  3. Acceptability. [ Time Frame: 30 Days ]
    Excluding the emotional aspects of coping with the pregnancy loss, how would you describe the experience? (Positive/Negative/Neutral)

  4. 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)

  5. 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)



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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

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

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
Last Update Posted: May 11, 2018
Last Verified: May 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