Blocking Mifepristone Action With Progesterone (NCT03774745) | Clinical Trial CompassTerminatedPhase 1/2
Blocking Mifepristone Action With Progesterone
United States12 participantsStarted 2019-02-11 Plain-language summary
Double-blind randomized trial to evaluate the potential impact of progesterone treatment on early pregnancies exposed to mifepristone.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
- ✓. Pregnant females 18 years and older at enrollment.
- ✓. Seeking surgical abortion at 44-63 days' gestation on Study day 1.
- ✓. Have received counseling and signed informed consent per UCD standard procedures for surgical abortion.
- ✓. Presence of embryonic gestational cardiac activity on transvaginal ultrasonography.
- ✓. English-speaking
- ✓. Willing to sign informed consent and follow study protocol.
- ✓. Willing to experience potential expulsion of the pregnancy with mifepristone treatment.
Exclusion criteria
- ✕. Medical contraindications to medical abortion.
- ✕. Poorly controlled hypertension (systolic BP \>160 or diastolic BP \>95)
- ✕. Significant anemia - known recent hemoglobin \<9.5 gm/dL
- ✕. Clinically significant cardiovascular disease (angina, valvular disease, arrhythmia, or congestive heart failure)
- ✕. Breastfeeding
- ✕. Coagulopathy or therapeutic coagulation
- ✕. Ultrasound evidence of molar or ectopic pregnancy
What they're measuring
1Continuing Pregnancy Based on Ultrasound Examination
Timeframe: at 14-16 days after mifepristone administration
Trial details
NCT IDNCT03774745
SponsorUniversity of California, Davis
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2019-07-29
Results submitted2019-12-30