Comparative Effectiveness of Pregnancy Failure Management Regimens (PreFaiR)

• 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: University of Pennsylvania
• 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

• 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

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 :

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

• 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

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

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

Shorter JM, Koelper N, Sonalkar S, Oquendo MA, Sammel MD, Schreiber CA. Racial Disparities in Mental Health Outcomes Among Women With Early Pregnancy Loss. Obstet Gynecol. 2021 Jan 1;137(1):156-163. doi: 10.1097/AOG.0000000000004212.

Sonalkar S, Koelper N, Creinin MD, Atrio JM, Sammel MD, McAllister A, Schreiber CA. Management of early pregnancy loss with mifepristone and misoprostol: clinical predictors of treatment success from a randomized trial. Am J Obstet Gynecol. 2020 Oct;223(4):551.e1-551.e7. doi: 10.1016/j.ajog.2020.04.006. Epub 2020 Apr 17.

Nagendra D, Koelper N, Loza-Avalos SE, Sonalkar S, Chen M, Atrio J, Schreiber CA, Harvie HS. Cost-effectiveness of Mifepristone Pretreatment for the Medical Management of Nonviable Early Pregnancy: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2020 Mar 2;3(3):e201594. doi: 10.1001/jamanetworkopen.2020.1594.

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.

• 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
• 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:

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