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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00997074
Recruitment Status : Completed
First Posted : October 16, 2009
Last Update Posted : February 17, 2012
Information provided by (Responsible Party):
Prof. Daniel Seidman, 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

Condition or disease Intervention/treatment Phase
Pain Pregnancy Drug: ibuprofen Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Prophylactic Ibuprofen Versus Placebo on Pain Relief and Success Rates of Medical Abortion: A Double-blind Randomized Placebo Controlled Study
Study Start Date : October 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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
Drug: ibuprofen
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.
Other Name: ibuprofen - Nonsteroidal anti-inflammatory drugs (NSAIDs)

No Intervention: placebo
this group will receive 2 placebo tablets together with the misoprostol

Primary Outcome Measures :
  1. • 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 Outcome Measures :
  1. • Success of medical abortion as assessed by follow-up ultrasound examination and the frequency of surgical intervention was recorded. [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00997074

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Sheba Medical Center
Tel Aviv, Israel
Sponsors and Collaborators
Sheba Medical Center
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Principal Investigator: Daniel Seidman, Prof. Sheba Medical Center
Publications of Results:
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Responsible Party: Prof. Daniel Seidman, Senior Physician, Sheba Medical Center Identifier: NCT00997074    
Other Study ID Numbers: SHEBA-09-7253-DS-CTIL
First Posted: October 16, 2009    Key Record Dates
Last Update Posted: February 17, 2012
Last Verified: February 2012
Keywords provided by Prof. Daniel Seidman, Sheba Medical Center:
pain after abortion
Additional relevant MeSH terms:
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Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action