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.
Brief Title
Comparative Effectiveness of Pregnancy Failure Management Regimens
Categories
Completion Date
Completion Date Type
Actual
Conditions
Spontaneous Abortion
Eligibility Criteria
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
* 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
Inclusion Criteria
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
* 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
Gender
Female
Gender Based
false
Keywords
Spontaneous abortion
Early Pregnancy Failure
Mifepristone
Misoprostol
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02012491
Org Class
Other
Org Full Name
University of Pennsylvania
Org Study Id
818434
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Comparative Effectiveness of Pregnancy Failure Management Regimens
Primary Outcomes
Outcome Measure
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.
Outcome Time Frame
Day 3 (visit 2) and up to 30 days following visit (to ensure surgical measures were not done
Outcome Measure
Gestational Sac Expulsion by the Second Follow-up Visit at Day 8
Outcome Time Frame
Day 8 (visit 3) and up to 30 day to ensure additional measures were not done (surgical)
Outcome Measure
Gestational Sac Expulsion by the 30-day Telephone Call
Outcome Time Frame
30 Days
Outcome Description
Surgical removal of the miscarriage.
Outcome Measure
Uterine Asperation
Outcome Time Frame
30 Days
Secondary Ids
Secondary Id
1R01HD071920-01A1
Secondary Outcomes
Outcome Time Frame
30 days
Outcome Measure
Frequency of Serious Adverse Events Between Study Arms.
Outcome Time Frame
30 Days
Outcome Measure
Adverse Event Reported by Participants
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jessica Atrio
Investigator Email
jatrio@montefiore.org
Investigator Phone