Spontaneous AbortionPhase 3PreFaiRNCT02012491
Comparative Effectiveness of Pregnancy Failure Management Regimens
A Phase 3 study testing Misoprostol and Mifepristone in people with Spontaneous Abortion, run by University of Pennsylvania at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Spontaneous Abortion
- What is being tested?
- Misoprostol and Mifepristone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2014to 15 Jun 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of California, Davis Medical Center
Sacramento, California, 95817
Montefiore Medical Center
The Bronx, New York, 10461
About this study
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
- Being tested
- Misoprostol, Mifepristone
- Keywords
- Spontaneous abortion, Early Pregnancy Failure, Mifepristone, Misoprostol
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called Cytotec
MifepristoneDrug
Also called Mifeprex
| Study group | Role | What they receive |
|---|---|---|
| misoprostol plus mifepristone | Active comparator | 800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior Receives: Drug: Misoprostol; Drug: Mifepristone |
| misoprostol | Active comparator | 800 micrograms of vaginal misoprostol alone Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 30 Days
Uterine Asperation
Surgical removal of the miscarriage.
Measured: 30 Days
Secondary outcomes (2)
Frequency of Serious Adverse Events Between Study Arms.
Measured: 30 days
Adverse Event Reported by Participants
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startJan 2014
- Primary completion15 May 2017
- Study completion15 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Spontaneous AbortionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Courtney A Schreiber, MD, MPH, Principal investigator, University of PennsylvaniaMitchell Creinin, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012491
- Sponsor's protocol ID
- 818434
- Other IDs
- 1R01HD071920-01A1
- Acronym
- PreFaiR
- Status last verified
- Jul 2019
- First submitted
- 10 Dec 2013
- Last updated
- 18 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 35780811Roe 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.
PubMed 33930380Shorter 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.
PubMed 33278280Sonalkar 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.
PubMed 32305259Nagendra 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.
PubMed 32215633Clement 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.
PubMed 30531561Schreiber 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.
PubMed 29874535
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Pregnancy Failure Management Regimens
- ClinicalTrials.gov ID
- NCT02012491
- Acronym / sponsor ID
- PreFaiR / 818434
- Conditions
- Spontaneous Abortion
- Keywords
- Spontaneous abortion, Early Pregnancy Failure, Mifepristone, Misoprostol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jan 2014
- Primary completion
- 15 May 2017 (actual)
- Study completion
- 15 Jun 2019 (actual)
- First posted
- 16 Dec 2013 (estimated)
- Results
- Posted 21 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| misoprostol plus mifepristone | Active comparator | Drug: Misoprostol, Drug: Mifepristone800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior |
| misoprostol | Active comparator | Drug: Misoprostol800 micrograms of vaginal misoprostol alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MisoprostolAlso: Cytotec | Drug | misoprostol, misoprostol plus mifepristone |
| MifepristoneAlso: Mifeprex | Drug | misoprostol plus mifepristone |
Primary outcome
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.
Time frame: 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
Time frame: 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
Time frame: 30 Days
Uterine Asperation
Time frame: 30 Days
Surgical removal of the miscarriage.
2 secondary outcomes
Frequency of Serious Adverse Events Between Study Arms.
Time frame: 30 days
Adverse Event Reported by Participants
Time frame: 30 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35780811Nagendra 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.
- Derived from this study: PubMed 33930380Roe 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.
- Derived from this study: PubMed 33278280Shorter 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.
- Derived from this study: PubMed 32305259Sonalkar 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.
- Derived from this study: PubMed 32215633Nagendra 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.
- Derived from this study: PubMed 30531561Clement 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.
- Derived from this study: PubMed 29874535Schreiber 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Courtney A Schreiber, MD, MPH principal investigator
University of Pennsylvania
Mitchell Creinin, MD principal investigator
University of California, Davis
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Misoprostol and Mifepristone in people with Spontaneous Abortion, run by University of Pennsylvania at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. (time frame: Day 3 (visit 2) and up to 30 days following visit (to ensure surgical measures were not done). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02012491, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019.