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Comparative Effectiveness of Pregnancy Failure Management Regimens (PreFaiR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Spontaneous Abortion
Interventions Drug: Misoprostol
Drug: Mifepristone
Enrollment 300
Recruitment Details We randomly assigned 300 women who had an anembryonic gestation or in whom embryonic or fetal death was confirmed to receive pretreatment with 200 mg of mifepristone, orally, followed by 800 μg of misoprostol, administered vaginally (mifepristone-pretreatment group), or 800 μg of misoprostol alone, administered vaginally (misoprostol-alone group).
Pre-assignment Details  
Arm/Group Title Misoprostol Misoprostol Plus Mifepristone
Hide Arm/Group Description

800 micrograms of vaginal misoprostol alone

Misoprostol

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

Misoprostol

Mifepristone

Period Title: Overall Study
Started 151 149
Completed 149 148
Not Completed 2 1
Reason Not Completed
Lost to Follow-up             1             0
Protocol Violation             0             1
Withdrawal by Subject             1             0
Arm/Group Title Misoprostol Misoprostol Plus Mifepristone Total
Hide Arm/Group Description

800 micrograms of vaginal misoprostol alone

Misoprostol

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

Misoprostol

Mifepristone

Total of all reporting groups
Overall Number of Baseline Participants 151 149 300
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Full Range)
Unit of measure:  Years
Participant's age Number Analyzed 151 participants 149 participants 300 participants
30.2
(18 to 46)
30.7
(18 to 46)
30.4
(18 to 46)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants 149 participants 300 participants
Female
151
 100.0%
149
 100.0%
300
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Only females where included in this study.
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants 149 participants 300 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
11
   7.3%
9
   6.0%
20
   6.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
67
  44.4%
65
  43.6%
132
  44.0%
White
52
  34.4%
57
  38.3%
109
  36.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
21
  13.9%
18
  12.1%
39
  13.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 151 participants 149 participants 300 participants
151 149 300
Diagnosis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants 149 participants 300 participants
Anembryonic gestation
37
  24.5%
40
  26.8%
77
  25.7%
Embryonic of fetal death
114
  75.5%
109
  73.2%
223
  74.3%
1.Primary Outcome
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.
Hide Description [Not Specified]
Time Frame Day 3 (visit 2) and up to 30 days following visit (to ensure surgical measures were not done
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Misoprostol Misoprostol Plus Mifepristone
Hide Arm/Group Description:

800 micrograms of vaginal misoprostol alone

Misoprostol

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

Misoprostol

Mifepristone

Overall Number of Participants Analyzed 149 148
Measure Type: Count of Participants
Unit of Measure: Participants
100
  67.1%
124
  83.8%
2.Primary Outcome
Title Gestational Sac Expulsion by the Second Follow-up Visit at Day 8
Hide Description [Not Specified]
Time Frame Day 8 (visit 3) and up to 30 day to ensure additional measures were not done (surgical)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Misoprostol Misoprostol Plus Mifepristone
Hide Arm/Group Description:

800 micrograms of vaginal misoprostol alone

Misoprostol

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

Misoprostol

Mifepristone

Overall Number of Participants Analyzed 149 148
Measure Type: Count of Participants
Unit of Measure: Participants
111
  74.5%
132
  89.2%
3.Primary Outcome
Title Gestational Sac Expulsion by the 30-day Telephone Call
Hide Description [Not Specified]
Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Misoprostol Misoprostol Plus Mifepristone
Hide Arm/Group Description:

800 micrograms of vaginal misoprostol alone

Misoprostol

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

Misoprostol

Mifepristone

Overall Number of Participants Analyzed 149 148
Measure Type: Count of Participants
Unit of Measure: Participants
113
  75.8%
135
  91.2%
4.Primary Outcome
Title Uterine Asperation
Hide Description Surgical removal of the miscarriage.
Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Misoprostol Misoprostol Plus Mifepristone
Hide Arm/Group Description:

800 micrograms of vaginal misoprostol alone

Misoprostol

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

Misoprostol

Mifepristone

Overall Number of Participants Analyzed 149 148
Measure Type: Count of Participants
Unit of Measure: Participants
35
  23.5%
13
   8.8%
5.Secondary Outcome
Title Frequency of Serious Adverse Events Between Study Arms.
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Misoprostol Misoprostol Plus Mifepristone
Hide Arm/Group Description:

800 micrograms of vaginal misoprostol alone

Misoprostol

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

Misoprostol

Mifepristone

Overall Number of Participants Analyzed 151 149
Measure Type: Count of Participants
Unit of Measure: Participants
3
   2.0%
5
   3.4%
6.Secondary Outcome
Title Adverse Event Reported by Participants
Hide Description [Not Specified]
Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Misoprostol Misoprostol Plus Mifepristone
Hide Arm/Group Description:

800 micrograms of vaginal misoprostol alone

Misoprostol

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

Misoprostol

Mifepristone

Overall Number of Participants Analyzed 151 149
Mean (Full Range)
Unit of Measure: adverse events
5.6
(0 to 843)
6.1
(0 to 904)
Time Frame Adverse events were collected over a 30 day time frame
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Misoprostol Misoprostol Plus Mifepristone
Hide Arm/Group Description

800 micrograms of vaginal misoprostol alone

Misoprostol

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

Misoprostol

Mifepristone

All-Cause Mortality
Misoprostol Misoprostol Plus Mifepristone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/151 (0.00%)      0/149 (0.00%)    
Hide Serious Adverse Events
Misoprostol Misoprostol Plus Mifepristone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/151 (1.99%)      5/149 (3.36%)    
Blood and lymphatic system disorders     
Bleeding resulting in blood transfusion   1/151 (0.66%)  1 3/149 (2.01%)  3
Reproductive system and breast disorders     
Pelvic Infection   2/151 (1.32%)  2 2/149 (1.34%)  2
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Misoprostol Misoprostol Plus Mifepristone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   115/151 (76.16%)      118/149 (79.19%)    
General disorders     
Fatigue   115/151 (76.16%)  118/149 (79.19%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Courtney Schreiber
Organization: University of Pennsylvania
Phone: 215-615-5234
EMail: Courtney.Schreiber@uphs.upenn.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02012491    
Other Study ID Numbers: 818434
1R01HD071920-01A1 ( U.S. NIH Grant/Contract )
First Submitted: December 10, 2013
First Posted: December 16, 2013
Results First Submitted: August 28, 2018
Results First Posted: December 21, 2018
Last Update Posted: July 18, 2019