Status:
COMPLETED
Efficacy Study of Prophylactic Ibuprofen Versus Placebo on Pain Relief and Success Rates of Medical Abortion
Lead Sponsor:
Sheba Medical Center
Conditions:
Pain
Pregnancy
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
Brief Summary
In the current study, we want to evaluate the prophylactic use of ibuprofen versus a placebo for medical abortion by mifepristone and misoprostol, at a gestational age of up to 7 weeks, in regard to t...
Eligibility Criteria
Inclusion
- Good general health
- Pregnancy of up to 7 weeks gestation.
- Approval from the Ministry of Health committee for termination of pregnancy after an intrauterine pregnancy was demonstrated by an ultrasound exam.
- Subjects that provided informed consent and agree to comply with all study procedures.
Exclusion
- Known allergy to mifepristone, misoprostol, paracetamol or NSAIDs.
- Severe anemia.
- Drug or alcohol abuse
- Known abnormal liver function (liver function tests greater than 1.5 times upper range of normal).
- Known abnormal renal function (serum creatinine \> 1.5 mg/dl).
- Abnormal blood tests
- Exclusionary health problems contraindicating mifepristone included adrenal disease; sickle cell anemia; severe liver, respiratory, or renal disease; and blood clotting defect.
- Chronic disease
- Patient is participating currently in another clinical trial
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00997074
Start Date
October 1 2009
End Date
October 1 2010
Last Update
February 17 2012
Active Locations (1)
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1
Sheba Medical Center
Tel Aviv, Israel