Pain, Pregnancy
Conditions
Keywords
pain after abortion, abortion
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
Interventions
DRUGibuprofen
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.
Sponsors
Sheba Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Decrease in pain as assessed using an 11-point numeric pain scale from 0 (= no pain) to 10 (=most severe pain). | 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| • Success of medical abortion as assessed by follow-up ultrasound examination and the frequency of surgical intervention was recorded. | 2 weeks |
Countries
Israel
Outcome results
None listed