None listed
Conditions
Brief 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.
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 (prefer
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.
Sponsors
Royal North Shore Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria include: 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 criteria
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
Outcome results
None listed