Clinical trial NCT00997074: Efficacy Study of Prophylactic Ibuprofen Versus Placebo on Pain Relief and Success Rates of Medical Abortion
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Pregnancy
Keywords: pain after abortion
abortion
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-10-16
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility 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

Primary outcomes:
measure: • Decrease in pain as assessed using an 11-point numeric pain scale from 0 (= no pain) to 10 (=most severe pain).
timeFrame: 2 weeks
Secondary outcomes:
measure: • Success of medical abortion as assessed by follow-up ultrasound examination and the frequency of surgical intervention was recorded.
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Daniel Seidman, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Reynolds-Wright JJ, Woldetsadik MA, Morroni C, Cameron S. Pain management for medical abortion before 14 weeks' gestation. Cochrane Database Syst Rev. 2022 May 13;5(5):CD013525. doi: 10.1002/14651858.CD013525.pub2.