Efficacy Study of Prophylactic Ibuprofen Versus Placebo on Pain Relief and Success Rates of Medical Abortion

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”

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

Intervention(s) in this Clinical Trial

• Drug: ibuprofen
  • The most common side effect observed during medical abortion using mifepristone together with misoprostol is abdominal pain. The use of ibuprofen was not shown to interfere with the action of misoprostol to induce uterine contractions and pregnancy expulsion.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: ibuprofen
  • the group will receive 2 tablets of ibuprofen 400 mg at the time of misoprostol administration. The information about the effect of the analgesics on the pain, and on the course of medical abortion, will be prospectively gathered from questionnaires completed by the study participants
• No Intervention: placebo
  • this group will receive 2 placebo tablets together with the misoprostol

Primary Measures

• • Decrease in pain as assessed using an 11-point numeric pain scale from 0 (= no pain) to 10 (=most severe pain).
  • Time Frame: 2 weeks
    Safety Issue?: No

Secondary Measures

• • Success of medical abortion as assessed by follow-up ultrasound examination and the frequency of surgical intervention was recorded.
  • Time Frame: 2 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Sheba Medical Center Other

Overall Clinical Trial Officials and Contacts

Daniel Seidman, Prof. Principal Investigator Sheba Medical Center  

Overall Contact: Daniel Seidman, MD 972-52-6666437 dseidman@post.tau.ac.il

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00997074

Study ID Number: SHEBA-09-7253-DS-CTIL

ClinicalTrials.gov Identifier: NCT00997074

Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration