Comparative Effectiveness of Pregnancy Failure Management Regimens

Phase 3

Completed

• Conditions: Spontaneous Abortion
• Interventions: Drug: Misoprostol; Drug: Mifepristone

• Registration Number: NCT02012491
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-10
• Study First Submitted QC: 2013-12-10
• Study First Posted: 2013-12-16
• Study Start: 2014-01
• Primary Completion: 2017-05-15
• Results First Submitted: 2018-08-28
• Results First Submitted QC: 2018-11-28
• Results First Posted: 2018-12-21
• Study Completion: 2019-06-15
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-03
• Last Update Posted: 2019-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
misoprostol plus mifepristone	Misoprostol	800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior
misoprostol plus mifepristone	Mifepristone	800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior
misoprostol	Misoprostol	800 micrograms of vaginal misoprostol alone

Primary Outcome Measures

Name	Time	Method
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
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)
Uterine Asperation	30 Days	Surgical removal of the miscarriage.
Gestational Sac Expulsion by the 30-day Telephone Call	30 Days

Secondary Outcome Measures

Name	Time	Method
Adverse Event Reported by Participants	30 Days
Frequency of Serious Adverse Events Between Study Arms.	30 days

Trial Locations

Locations (3)

University of California, Davis Medical Center; 🇺🇸 Sacramento, California, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States