RecruitingPhase 4ACTRN12624000883516

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


Sponsor

Royal North Shore Hospital

Enrollment

80 participants

Start Date

Aug 20, 2024

Study Type

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

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at whether a common pain reliever called ibuprofen (a non-steroidal anti-inflammatory drug, or NSAID) is safe to use after a caesarean section for women who had high blood pressure during pregnancy. Traditionally, doctors have avoided using these medications in this group out of concern that they might make high blood pressure worse, but researchers want to find out if this concern is actually justified. The study compares women who receive ibuprofen for pain relief after their caesarean to those who receive other types of pain relief. The main goal is to check whether ibuprofen causes any dangerous spikes in blood pressure after birth. Researchers also hope to show that ibuprofen works well as a painkiller and could reduce the need for stronger opioid medications like endone. You may be eligible if you are at least 18 years old, pregnant with high blood pressure (including gestational hypertension or pre-eclampsia), and planning or having a caesarean section. Women with kidney problems, severe liver disease, eclampsia, or a known allergy to NSAIDs are not eligible. The study is being run at Royal North Shore Hospital.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

Royal North Shore Hospital - St Leonards

NSW, Australia

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