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

Sheba Medical Center

Status and phase: Completed; Phase 3

Conditions: Pain; Pregnancy

Treatments: Drug: ibuprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT00997074

SHEBA-09-7253-DS-CTIL

Details and patient eligibility

About

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

Enrollment: 61 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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61 participants in 2 patient groups

ibuprofen

Experimental group

Description:

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

Treatment:

Drug: ibuprofen

placebo

No Intervention group

Description:

this group will receive 2 placebo tablets together with the misoprostol