Phase 3
N=300
Comparative Effectiveness of Pregnancy Failure Management Regimens
Spontaneous Abortion
Bottom Line
View on ClinicalTrials.gov: NCT02012491 ↗Enrolled (actual)
300
Serious AEs
2.7%
Results posted
Dec 2018
Primary outcome: 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. — 100; 124 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Misoprostol (Drug); Mifepristone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Pennsylvania
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
100; 124 | — |
| PRIMARY Gestational Sac Expulsion by the Second Follow-up Visit at Day 8 |
111; 132 | — |
| PRIMARY Gestational Sac Expulsion by the 30-day Telephone Call |
113; 135 | — |
| PRIMARY Uterine Asperation |
35; 13 | — |
| SECONDARY Frequency of Serious Adverse Events Between Study Arms. |
3; 5 | — |
| SECONDARY Adverse Event Reported by Participants |
5.6; 6.1 | — |
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
Data sourced from ClinicalTrials.gov (NCT02012491). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.