Skip to main content
OpenTrials
Completed

NCT Number: NCT02012491

Comparative Effectiveness of Pregnancy Failure Management Regimens

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spontaneous Abortion Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University of California, Davis Medical Center, Sacramento, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol

Drug

Other names: Cytotec

Mifepristone

Drug

Other names: Mifeprex

Primary outcomes

  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 outcomes

  1. Frequency of Serious Adverse Events Between Study Arms.

    Time frame: 30 days

  2. Adverse Event Reported by Participants

    Time frame: 30 Days

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Acronym: PreFaiR

Important dates

Study start
2014
Primary completion
2017
Study completion
2019
First posted
Dec 16, 2013
Registry last updated
Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.