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

Study Overview
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Brief Summary
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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

Official Title
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The Effect of Prophylactic Ibuprofen Versus Placebo on Pain Relief and Success Rates of Medical Abortion: A Double-blind Randomized Placebo Controlled Study

Conditions
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Pain, Pregnancy

Intervention / Treatment
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* Drug: ibuprofen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ibuprofen<br>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 | Drug: ibuprofen<br>* 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.<br>* Other names: ibuprofen - Nonsteroidal anti-inflammatory drugs (NSAIDs);|
| No Intervention: placebo<br>this group will receive 2 placebo tablets together with the misoprostol | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Success of medical abortion as assessed by follow-up ultrasound examination and the frequency of surgical intervention was recorded. |  | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain after abortion, abortion