Clinical trial NCT02012491: Comparative Effectiveness of Pregnancy Failure Management Regimens
Official title: Comparative Effectiveness of Pregnancy Failure Management Regimens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spontaneous Abortion
Keywords: Spontaneous abortion
Early Pregnancy Failure
Mifepristone
Misoprostol
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2013-12-16
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
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.
timeFrame: Day 3 (visit 2) and up to 30 days following visit (to ensure surgical measures were not done
measure: Gestational Sac Expulsion by the Second Follow-up Visit at Day 8
timeFrame: Day 8 (visit 3) and up to 30 day to ensure additional measures were not done (surgical)
measure: Gestational Sac Expulsion by the 30-day Telephone Call
timeFrame: 30 Days
measure: Uterine Asperation
timeFrame: 30 Days
Secondary outcomes:
measure: Frequency of Serious Adverse Events Between Study Arms.
timeFrame: 30 days
measure: Adverse Event Reported by Participants
timeFrame: 30 Days
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Courtney A Schreiber, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Davis
name: Mitchell Creinin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roe AH, McAllister A, Flynn AN, Martin B, Jiang E, Koelper N, Schreiber CA. The effect of mifepristone pretreatment on bleeding and pain during medical management of early pregnancy loss. Contraception. 2021 Oct;104(4):432-436. doi: 10.1016/j.contraception.2021.04.023. Epub 2021 Apr 28.
citation: Shorter JM, Koelper N, Sonalkar S, Oquendo MA, Sammel MD, Schreiber CA. Racial Disparities in Mental Health Outcomes Among Women With Early Pregnancy Loss. Obstet Gynecol. 2021 Jan 1;137(1):156-163. doi: 10.1097/AOG.0000000000004212.
citation: Sonalkar S, Koelper N, Creinin MD, Atrio JM, Sammel MD, McAllister A, Schreiber CA. Management of early pregnancy loss with mifepristone and misoprostol: clinical predictors of treatment success from a randomized trial. Am J Obstet Gynecol. 2020 Oct;223(4):551.e1-551.e7. doi: 10.1016/j.ajog.2020.04.006. Epub 2020 Apr 17.
citation: Nagendra D, Koelper N, Loza-Avalos SE, Sonalkar S, Chen M, Atrio J, Schreiber CA, Harvie HS. Cost-effectiveness of Mifepristone Pretreatment for the Medical Management of Nonviable Early Pregnancy: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2020 Mar 2;3(3):e201594. doi: 10.1001/jamanetworkopen.2020.1594.
citation: Clement EG, Horvath S, McAllister A, Koelper NC, Sammel MD, Schreiber CA. The Language of First-Trimester Nonviable Pregnancy: Patient-Reported Preferences and Clarity. Obstet Gynecol. 2019 Jan;133(1):149-154. doi: 10.1097/AOG.0000000000002997.
citation: Schreiber CA, Creinin MD, Atrio J, Sonalkar S, Ratcliffe SJ, Barnhart KT. Mifepristone Pretreatment for the Medical Management of Early Pregnancy Loss. N Engl J Med. 2018 Jun 7;378(23):2161-2170. doi: 10.1056/NEJMoa1715726.