Status:
TERMINATED
Blocking Mifepristone Action With Progesterone
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
Society of Family Planning
Conditions:
Pregnancy, Unwanted
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Double-blind randomized trial to evaluate the potential impact of progesterone treatment on early pregnancies exposed to mifepristone.
Detailed Description
Medical abortion commonly refers to early pregnancy termination (usually before 10 weeks' gestation) performed without primary surgical intervention and resulting from the use of abortion-inducing med...
Eligibility Criteria
Inclusion
- 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
- 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
- Chronic systemic corticosteroid use
- Adrenal disease
- Sickle cell anemia with frequent/recent crises
- Glaucoma
- IUD in place during conception, even if removed.
- Peanut allergy.
- Known intolerance of mifepristone or progesterone.
- Any other condition, that in the opinion of the clinician, would contraindicate mifepristone, progesterone or medical abortion.
Key Trial Info
Start Date :
February 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03774745
Start Date
February 11 2019
End Date
August 15 2019
Last Update
January 22 2020
Active Locations (3)
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1
Planned Parenthood Mar Monte
Sacramento, California, United States, 95816
2
University of California, Davis
Sacramento, California, United States, 95817
3
Family Planning Associates
Sacramento, California, United States, 95825