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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Daniel Seidman, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00997074
First received: October 15, 2009
Last updated: February 15, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Pain
Pregnancy
Drug: ibuprofen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • Success of medical abortion as assessed by follow-up ultrasound examination and the frequency of surgical intervention was recorded. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: October 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00997074

Locations
Israel
Sheba Medical Center
Tel Aviv, Israel
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Daniel Seidman, Prof. Sheba Medical Center
  More Information

Publications:
Responsible Party: Prof. Daniel Seidman, Senior Physician, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00997074     History of Changes
Other Study ID Numbers: SHEBA-09-7253-DS-CTIL
Study First Received: October 15, 2009
Last Updated: February 15, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
pain after abortion
abortion

Additional relevant MeSH terms:
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014