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Trial registered on ANZCTR


Registration number
ACTRN12624000883516
Ethics application status
Approved
Date submitted
4/07/2024
Date registered
19/07/2024
Date last updated
19/07/2024
Date data sharing statement initially provided
19/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety of ibuprofen to manage pain after caesarean section for women who have hypertension in pregnancy - a randomised pilot study
Scientific title
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
Secondary ID [1] 312455 0
Nil known
Universal Trial Number (UTN)
U1111-1310-2749
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic hypertension
 334289 0
Preeclampsia 334290 0
gestational hypertension 334291 0
Condition category
Condition code
Reproductive Health and Childbirth 330943 330943 0 0
Childbirth and postnatal care
Anaesthesiology 331034 331034 0 0
Pain management
Cardiovascular 331035 331035 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 328960 0
Treatment: Drugs
Comparator / control treatment

Non-interventional arm
Women in the non-interventional arm will receive paracetamol (1 g four times orally per day) ± opioids as required. The opioid preferably endone orally 5-10 mg or as determined by their treating physicians.
Control group
Active

Outcomes
Primary outcome [1] 338715 0
Development of severe hypertension (defined as 170 / 110 )
Timepoint [1] 338715 0
Outcome will be assessed postpartum with regular BP assessments (four times daily) until discharge. After discharge will be assessed again between 7-14day ( 2 weeks postpartum).
Secondary outcome [1] 437098 0
Hospital length of stay after birth (days)
Timepoint [1] 437098 0
2 weeks postpartum
Secondary outcome [2] 437099 0
Number of participants screened (ie: number of women who have a diagnosis of hypertensive disorder of pregnancy (HDP) pre-birth)
Timepoint [2] 437099 0
At the conclusion of the study
Secondary outcome [3] 437100 0
Number of participants consented
Timepoint [3] 437100 0
At the conclusion of the study
Secondary outcome [4] 437101 0
Number of participants followed-up at day 7-14 postpartum.
Timepoint [4] 437101 0
At the conclusion of the study
Secondary outcome [5] 437102 0
Adherence to protocol- this will be assessed as a composite outcome
Timepoint [5] 437102 0
at the conclusion of the study
Secondary outcome [6] 437103 0
Total dose of ibuprofen used during admission
Timepoint [6] 437103 0
Baseline and at 2 weeks postpartum
Secondary outcome [7] 437105 0
Number of episodes of hypertension (defined as blood pressure >140mmHg systolic or >90mmHg diastolic)
Timepoint [7] 437105 0
Baseline and then daily as inpatient and then review 2 weeks (7-14 days) postpartum as outpatient.
Secondary outcome [8] 437497 0
Number of antihypertensive agents at discharge
Timepoint [8] 437497 0
Baseline and at 2 weeks postpartum
Secondary outcome [9] 437498 0
Acute Kidney Injury (AKI) defined as creatinine >90 or >26.4umol/L within 48 hours (Y/N)
Timepoint [9] 437498 0
Baseline and 2 weeks postpartum
Secondary outcome [10] 437499 0
Admission to Intensive care unit (ICU)
Timepoint [10] 437499 0
Baseline and 2 weeks postpartum
Secondary outcome [11] 437500 0
Eclampsia development
Timepoint [11] 437500 0
2 weeks postpartum
Secondary outcome [12] 437501 0
Opioid use in hospital (including morphine equivalents per day per patient and cumulative dose)
Timepoint [12] 437501 0
baseline and at 2 weeks postpartum
Secondary outcome [13] 437502 0
Need for alternate analgesia (ie: other than NSAIDs and/or paracetamol)
Timepoint [13] 437502 0
2 weeks postpartum
Secondary outcome [14] 437503 0
Maternal death
Timepoint [14] 437503 0
2 weeks postpartum

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation in blocks of 8
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety
Statistical methods / analysis
Data regarding groups (intervention vs non-interventional) will be compared using student’s t-test, chi-square testing and regression modelling where appropriate. Further analysis will be performed based on subgroups including type of HDP and presence of severe preeclampsia.
An intention to treat analysis will be utilised and missing data will be reported.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/08/2024
Actual
Date of last participant enrolment
Anticipated
28/07/2026
Actual
Date of last data collection
Anticipated
28/08/2026
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26752 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 42800 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 316870 0
Commercial sector/Industry
Name [1] 316870 0
Ramsay Healthcare- Ramsay Research and Education Grant
Country [1] 316870 0
Australia
Primary sponsor type
Hospital
Name
Royal North Shore Hospital
Address
Country
Australia
Secondary sponsor category [1] 319111 0
None
Name [1] 319111 0
Address [1] 319111 0
Country [1] 319111 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315629 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 315629 0
https://www.nslhd.health.nsw.gov.au/Research/ResearchOffice/Pages/HREC.aspx
Ethics committee country [1] 315629 0
Australia
Date submitted for ethics approval [1] 315629 0
08/08/2023
Approval date [1] 315629 0
02/02/2024
Ethics approval number [1] 315629 0
2023/ETH01715

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135314 0
Dr Amanda Mather
Address 135314 0
Royal North Shore Hospital Reserve Road St Leonards 2065 NSW
Country 135314 0
Australia
Phone 135314 0
+61402059233
Fax 135314 0
Email 135314 0
[email protected]
Contact person for public queries
Name 135315 0
Amanda Mather
Address 135315 0
Royal North Shore Hospital Reserve Rd St Leonards 2065 NSW
Country 135315 0
Australia
Phone 135315 0
+61402059233
Fax 135315 0
Email 135315 0
[email protected]
Contact person for scientific queries
Name 135316 0
Amanda Mather
Address 135316 0
Royal North Shore Hospital Reserve Rd St Leonards 2065 NSW
Country 135316 0
Australia
Phone 135316 0
+61402059233
Fax 135316 0
Email 135316 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a small trial to assess safety and feasibility of a larger trial that will be blinded.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.