Efficacy Study of Prophylactic Ibuprofen Versus Placebo on Pain Relief and Success Rates of Medical Abortion
This study has been completed.
Sponsor:
Sheba Medical Center
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
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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 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:
|
Anti-Inflammatory Agents Ibuprofen Anti-Inflammatory Agents, Non-Steroidal Misoprostol Therapeutic Uses Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents Anti-Ulcer Agents Gastrointestinal Agents Oxytocics Reproductive Control Agents Abortifacient Agents, Nonsteroidal Abortifacient Agents |
ClinicalTrials.gov processed this record on May 19, 2013