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

October 15, 2009
February 15, 2012
October 2009
October 2010   (final data collection date for primary outcome measure)
• 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 ]
Same as current
Complete list of historical versions of study NCT00997074 on ClinicalTrials.gov Archive Site
• 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy Study of Prophylactic Ibuprofen Versus Placebo on Pain Relief and Success Rates of Medical Abortion
The Effect of Prophylactic Ibuprofen Versus Placebo on Pain Relief and Success Rates of Medical Abortion: A Double-blind Randomized Placebo Controlled Study

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Pain
  • Pregnancy
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)
  • 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
    Intervention: Drug: ibuprofen
  • No Intervention: placebo
    this group will receive 2 placebo tablets together with the misoprostol
Avraham S, Gat I, Duvdevani NR, Haas J, Frenkel Y, Seidman DS. Pre-emptive effect of ibuprofen versus placebo on pain relief and success rates of medical abortion: a double-blind, randomized, controlled study. Fertil Steril. 2012 Mar;97(3):612-5. doi: 10.1016/j.fertnstert.2011.12.041. Epub 2012 Jan 20. PubMed PMID: 22265034.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
October 2010
October 2010   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00997074
SHEBA-09-7253-DS-CTIL
No
Prof. Daniel Seidman, Sheba Medical Center
Sheba Medical Center
Not Provided
Principal Investigator: Daniel Seidman, Prof. Sheba Medical Center
Sheba Medical Center
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP