Comparative Effectiveness of Pregnancy Failure Management Regimens

Spontaneous Abortion Clinical Trial

— PreFaiR  

Official title:

Comparative Effectiveness of Pregnancy Failure Management Regimens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02012491
• Other study ID #: 818434
• Secondary ID: 1R01HD071920-01A
• Status: Completed
• Phase: Phase 3
• Start date: January 2014
• Est. completion date: June 15, 2019

Study information

• Verified date: July 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 15, 2019
• Est. primary completion date: May 15, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Spontaneous Abortion

Intervention

Drug:
• Misoprostol

• Mifepristone

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of California, Davis Medical Center	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Day 3 (visit 2) and up to 30 days following visit (to ensure surgical measures were not done
Primary	Gestational Sac Expulsion by the Second Follow-up Visit at Day 8		Day 8 (visit 3) and up to 30 day to ensure additional measures were not done (surgical)
Primary	Gestational Sac Expulsion by the 30-day Telephone Call		30 Days
Primary	Uterine Asperation	Surgical removal of the miscarriage.	30 Days
Secondary	Frequency of Serious Adverse Events Between Study Arms.		30 days
Secondary	Adverse Event Reported by Participants		30 Days