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

Information source: Sheba Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain; Pregnancy

Intervention: ibuprofen (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sheba Medical Center

Official(s) and/or principal investigator(s):
Daniel Seidman, Prof., Principal Investigator, Affiliation: Sheba Medical Center

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: • Decrease in pain as assessed using an 11-point numeric pain scale from 0 (= no pain) to 10 (=most severe pain).

Secondary outcome: • Success of medical abortion as assessed by follow-up ultrasound examination and the frequency of surgical intervention was recorded.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

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

Locations and Contacts

Sheba Medical Center, Tel Aviv, Israel
Additional Information

Starting date: October 2009
Last updated: February 15, 2012

Page last updated: August 23, 2015

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