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Completed

NCT Number: NCT00997074

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

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

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Pregnancy Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Sheba Medical Center

Tel Aviv, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibuprofen

Drug

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 names: ibuprofen - Nonsteroidal anti-inflammatory drugs (NSAIDs)

Primary outcomes

  1. • 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

Secondary outcomes

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

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Official study title

The Effect of Prophylactic Ibuprofen Versus Placebo on Pain Relief and Success Rates of Medical Abortion: A Double-blind Randomized Placebo Controlled Study

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 16, 2009
Registry last updated
Feb 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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