Efficacy Study of Prophylactic Ibuprofen Versus Placebo on Pain Relief and Success Rates of Medical Abortion - Full Text View

Sponsor:	Sheba Medical Center
Information provided by:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00997074

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Abortion

Drug Information available for: Ibuprofen

U.S. FDA Resources

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 ]

Estimated Enrollment:	120
Study Start Date:	October 2009
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ibuprofen: Experimental 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.
placebo: No Intervention 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

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

Contacts

Contact: Daniel Seidman, MD	972-52-6666437	dseidman@post.tau.ac.il
Contact: Sarit Avraham	972-52-2371126	saritav@gmail.com

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

No publications provided

Responsible Party:	gynecologic department ( Sheba Medical Center )
Study ID Numbers:	SHEBA-09-7253-DS-CTIL
Study First Received:	October 15, 2009
Last Updated:	October 15, 2009
ClinicalTrials.gov Identifier:	NCT00997074 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:

pain after abortion
abortion

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Ibuprofen
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010