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

Sheba Medical Center61 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Pain Pregnancy

Interventions

ibuprofenDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (1)

Sheba Medical Center

Tel Aviv, Israel

Outcomes

Primary Outcomes

• 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

Secondary Outcomes

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

Time frame: 2 weeks

Data from ClinicalTrials.gov

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