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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02012491
Other study ID # 818434
Secondary ID 1R01HD071920-01A
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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