Efficacy Study of Prophylactic Ibuprofen Versus Placebo on Pain Relief and Success Rates of Medical Abortion
Information source: Sheba Medical Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain; Pregnancy
Intervention: ibuprofen (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Sheba Medical Center Official(s) and/or principal investigator(s):
Daniel Seidman, Prof., Principal Investigator, Affiliation: Sheba Medical Center
Overall contact:
Daniel Seidman, MD, Phone: 972-52-6666437, Email: dseidman@post.tau.ac.il
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 the effect on pain relief and the overall procedure success.
expected results:
The prophylactic use of NSAIDs could offer significant pain relief and thereby a reduction
in the need for additional pain relievers compared to the placebo, without interfering with
the outcome of medical abortion
Clinical Details
Official title: The Effect of Prophylactic Ibuprofen Versus Placebo on Pain Relief and Success Rates of Medical Abortion: A Double-blind Randomized Placebo Controlled Study
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: • Decrease in pain as assessed using an 11-point numeric pain scale from 0 (= no pain) to 10 (=most severe pain).
Secondary outcome: • Success of medical abortion as assessed by follow-up ultrasound examination and the frequency of surgical intervention was recorded.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Daniel Seidman, MD, Phone: 972-52-6666437, Email: dseidman@post.tau.ac.il
Sheba Medical Center, Tel Aviv, Israel
Additional Information
Starting date: October 2009
Ending date: October 2010
Last updated: October 15, 2009
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