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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00997074
• Other study ID #: SHEBA-09-7253-DS-CTIL
• Status: Completed
• Phase: Phase 3
• First received: October 15, 2009
• Last updated: February 15, 2012
• Start date: October 2009
• Est. completion date: October 2010

Study information

• Verified date: February 2012
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Pain
• Pregnancy

Intervention

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.

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• Decrease in pain as assessed using an 11-point numeric pain scale from 0 (= no pain) to 10 (=most severe pain).		2 weeks	No
Secondary	• Success of medical abortion as assessed by follow-up ultrasound examination and the frequency of surgical intervention was recorded.		2 weeks	No