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

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sheba Medical Center
• Treatments: Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Ibuprofen; Misoprostol

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