Spontaneous Abortion Clinical Trial
— PreFaiROfficial title:
Comparative Effectiveness of Pregnancy Failure Management Regimens
Verified date | July 2019 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
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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