Comparative Effectiveness of Pregnancy Failure Management Regimens

NCT02012491 | Completed Phase 3 Results

• 2 other identifiers: 8184341R01HD071920-01A1
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

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.

Conditions

Spontaneous Abortion

Keywords

Spontaneous abortion; Early Pregnancy Failure; Mifepristone; Misoprostol

Outcome Measures

Primary Outcomes (4)

• 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

• 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)

• Gestational Sac Expulsion by the 30-day Telephone Call

  30 Days

• Uterine Asperation

  Surgical removal of the miscarriage.

  30 Days

Secondary Outcomes (2)

• Frequency of Serious Adverse Events Between Study Arms.

  30 days

• Adverse Event Reported by Participants

  30 Days

Study Arms (2)

misoprostol plus mifepristone

ACTIVE COMPARATOR

800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior

Drug: Misoprostol; Drug: Mifepristone

misoprostol

ACTIVE COMPARATOR

800 micrograms of vaginal misoprostol alone

Drug: Misoprostol

Interventions

Misoprostol DRUG

Also known as: Cytotec

misoprostol; misoprostol plus mifepristone

Mifepristone DRUG

Also known as: Mifeprex

misoprostol plus mifepristone

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• between 5 and 12 completed weeks gestation
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (3)

University of California, Davis Medical Center

Sacramento, California, 95817, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (7)

• Nagendra D, Gutman SM, Koelper NC, Loza-Avalos SE, Sonalkar S, Schreiber CA, Harvie HS. Medical management of early pregnancy loss is cost-effective compared with office uterine aspiration. Am J Obstet Gynecol. 2022 Nov;227(5):737.e1-737.e11. doi: 10.1016/j.ajog.2022.06.054. Epub 2022 Jun 30.

  PMID: 35780811 DERIVED

• 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.

  PMID: 33930380 DERIVED

• 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.

  PMID: 33278280 DERIVED

• 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.

  PMID: 32305259 DERIVED

• 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.

  PMID: 32215633 DERIVED

• 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.

  PMID: 30531561 DERIVED

• 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.

  PMID: 29874535 DERIVED

MeSH Terms

Conditions

Abortion, Spontaneous

Interventions

Misoprostol; Mifepristone

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Courtney Schreiber
• Organization: University of Pennsylvania

Courtney.Schreiber@uphs.upenn.edu

215-615-5234

Study Officials

• Courtney A Schreiber, MD, MPH

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Mitchell Creinin, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: December 16, 2013
• Study Start: January 1, 2014
• Primary Completion: May 15, 2017
• Study Completion: June 15, 2019
• Last Updated: July 18, 2019
• Results First Posted: December 21, 2018

Record last verified: 2019-07

Locations

US (3)