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Comparative Effectiveness of Pregnancy Failure Management Regimens (PreFaiR)

Primary Purpose

Spontaneous Abortion

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Misoprostol
Mifepristone
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spontaneous Abortion focused on measuring Spontaneous abortion, Early Pregnancy Failure, Mifepristone, Misoprostol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, Davis Medical Center
  • Montefiore Medical Center
  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

misoprostol plus mifepristone

misoprostol

Arm Description

800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior

800 micrograms of vaginal misoprostol alone

Outcomes

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.
Gestational Sac Expulsion by the Second Follow-up Visit at Day 8
Gestational Sac Expulsion by the 30-day Telephone Call
Uterine Asperation
Surgical removal of the miscarriage.

Secondary Outcome Measures

Frequency of Serious Adverse Events Between Study Arms.
Adverse Event Reported by Participants

Full Information

First Posted
December 10, 2013
Last Updated
July 3, 2019
Sponsor
University of Pennsylvania
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT02012491
Brief Title
Comparative Effectiveness of Pregnancy Failure Management Regimens
Acronym
PreFaiR
Official Title
Comparative Effectiveness of Pregnancy Failure Management Regimens
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
May 15, 2017 (Actual)
Study Completion Date
June 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spontaneous Abortion
Keywords
Spontaneous abortion, Early Pregnancy Failure, Mifepristone, Misoprostol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
misoprostol plus mifepristone
Arm Type
Active Comparator
Arm Description
800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior
Arm Title
misoprostol
Arm Type
Active Comparator
Arm Description
800 micrograms of vaginal misoprostol alone
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Other Intervention Name(s)
Cytotec
Intervention Type
Drug
Intervention Name(s)
Mifepristone
Other Intervention Name(s)
Mifeprex
Primary Outcome Measure Information:
Title
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
Title
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)
Title
Gestational Sac Expulsion by the 30-day Telephone Call
Time Frame
30 Days
Title
Uterine Asperation
Description
Surgical removal of the miscarriage.
Time Frame
30 Days
Secondary Outcome Measure Information:
Title
Frequency of Serious Adverse Events Between Study Arms.
Time Frame
30 days
Title
Adverse Event Reported by Participants
Time Frame
30 Days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Courtney A Schreiber, MD, MPH
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mitchell Creinin, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33930380
Citation
Roe AH, McAllister A, Flynn AN, Martin B, Jiang E, Koelper N, Schreiber CA. The effect of mifepristone pretreatment on bleeding and pain during medical management of early pregnancy loss. Contraception. 2021 Oct;104(4):432-436. doi: 10.1016/j.contraception.2021.04.023. Epub 2021 Apr 28.
Results Reference
derived
PubMed Identifier
33278280
Citation
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.
Results Reference
derived
PubMed Identifier
32305259
Citation
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.
Results Reference
derived
PubMed Identifier
32215633
Citation
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.
Results Reference
derived
PubMed Identifier
30531561
Citation
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.
Results Reference
derived
PubMed Identifier
29874535
Citation
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.
Results Reference
derived

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Comparative Effectiveness of Pregnancy Failure Management Regimens

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