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

Phase 3

Completed

• Conditions: Pain; Pregnancy
• Interventions: Drug: ibuprofen

• Registration Number: NCT00997074
• Lead Sponsor: Sheba Medical Center

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 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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-15
• Study First Submitted QC: 2009-10-15
• Study First Posted: 2009-10-16
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-15
• Last Update Posted: 2012-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ibuprofen	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

Primary Outcome Measures

Name	Time	Method
• Decrease in pain as assessed using an 11-point numeric pain scale from 0 (= no pain) to 10 (=most severe pain).	2 weeks

Secondary Outcome Measures

Name	Time	Method
• Success of medical abortion as assessed by follow-up ultrasound examination and the frequency of surgical intervention was recorded.	2 weeks

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Tel Aviv, Israel