Safety of ibuprofen to manage pain after caesarean section for women who have hypertension in pregnancy - a randomised pilot study
Safety of non-steroidal anti-inflammatory drugs to manage postpartum pain following caesarean section in women with hypertensive disorders of pregnancy – a randomised pilot trial
Royal North Shore Hospital
80 participants
Aug 20, 2024
Interventional
Conditions
Summary
The primary purpose of this study is to demonstrate the safety of the use of non steroidal medication in women who have high blood pressure (hypertension) in pregnancy. Traditionally the use of non steroidal medication has been avoided due to theoretical concerns of exacerbating preexisting hypertension. The hypothesis is that there is no increase in events of severe hypertension that would occur in the postpartum population and actually it is an effective pain killer and avoids the need for stronger pain killers like endone.
Eligibility
Inclusion Criteria4
- a) Pregnant women with HDP (including essential hypertension, gestational hypertension and preeclampsia) at any gestation but prior to giving birth
- b) Participants who deliver via caesarean section
- c) Age >= 18 years
- d) Participants who are English-speaking and provide informed consent to enrol into the study
Exclusion Criteria8
- a) Fetal death in utero diagnosed prior to caesarean section
- b) Participants with eclampsia
- c) Participants with acute kidney injury (as defined by serum or plasma creatinine >90umol/L in accordance with the Society of Obstetric Medicine of Australia and New Zealand Guidelines)
- d) Known history of chronic kidney disease (CKD)
- e) Participants with significant liver impairment (as defined by treating physicians)
- f) Patients with a history of psychological illness or condition such as to interfere with the patient’s ability to understand the requirements of the study.
- g) Participants with a history of prior NSAID allergy
- h) Any participants in whom the treating physician feels that that the risks of NSAID use outweigh analgesic benefits
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Interventions
Use of non steroid anti inflammatory drug (ibuprofen) for pain relief following caesarean section in women who have hypertensive disorders of pregnancy (chronic hypertension, preeclampsia, gestational hypertension). a) Treatment arm Women in the treatment arm will receive paracetamol (1 g four times orally per day) and ibuprofen (400 mg three times orally per day) regularly. If additional analgesia is required due to increased pain requirements, women will receive opioids as required (preferably endone orally 5-10 mg or as determined by their treating physicians). On the other hand, if women are not experiencing pain, ibuprofen will be administered as required. The medications will be administered by a midwife. Both groups will receive treatment for 7 days duration or up to time of discharge. Analgesic requirements will depend upon the needs of the participant, and cumulative non steroidal anti inflammatory drug (NSAID) and opioid doses will be recorded for analysis.
Locations(1)
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ACTRN12624000883516