Safety of ibuprofen to manage pain after caesarean section for women who have hypertension in pregnancy - a randomised pilot study

Phase 4

Conditions: chronic hypertension
Preeclampsia
gestational hypertension
Reproductive Health and Childbirth - Childbirth and postnatal care
Anaesthesiology - Pain management
Cardiovascular - Hypertension

Registration Number: ACTRN12624000883516

Lead Sponsor: Royal North Shore Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: Female

Target Recruitment: 80

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of severe hypertension (defined as 170 / 110 ) [Blood Pressure (BP) measurement with digital blood pressure monitor four times daily postpartum while inpatient 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 Measures