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Trial registered on ANZCTR
Registration number
ACTRN12618000216213
Ethics application status
Approved
Date submitted
1/02/2018
Date registered
9/02/2018
Date last updated
24/02/2023
Date data sharing statement initially provided
30/04/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Prolong: a double-blind randomised placebo-controlled trial of broccoli sprout extract in
women with early onset preeclampsia.
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Scientific title
Randomised controlled trial of broccoli sprout extract targeting gestational length in women with early onset preeclampsia
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Secondary ID [1]
293358
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None
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Universal Trial Number (UTN)
U1111-1205-0293
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
preeclampsia
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Condition category
Condition code
Reproductive Health and Childbirth
304819
304819
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0
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Fetal medicine and complications of pregnancy
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Cardiovascular
305559
305559
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0
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The oral consumption of 8 broccoli seed extract capsules (64mg) twice a day for the remainder of pregnancy once diagnosed with early onset preeclampsia.
Minimum duration is 48 hours with no maximum duration.
Adherence will be monitored via a self administered drug diary.
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Intervention code [1]
299673
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Treatment: Other
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Comparator / control treatment
The control will be a delayed release placebo capsule comprising of hydroxypropylmethylcellulose.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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The interval between enrolment and delivery, recorded in days.
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Assessment method [1]
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Timepoint [1]
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Primary timepoint will be measured from the initiation of treatment until delivery. Hospital records will be used to generate this information.
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Secondary outcome [1]
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Composite maternal outcome including maternal death, eclampsia, HELLP syndrome , pulmonary oedema , thromboembolic event (significant deep vein thrombosis or pulmonary embolus), placental abruption , major postpartum haemorrhage , severe renal impairment , liver haematoma or rupture.
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Assessment method [1]
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Timepoint [1]
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Will be measured from 24 hours prior to initiation of treatment, and then every 48 hours after treatment is initiated until delivery. Additional information regarding clinical outcomes of eclampsia, HELLP syndrome , pulmonary oedema , thromboembolic event (significant deep vein thrombosis or pulmonary embolus), placental abruption , major postpartum haemorrhage , severe renal impairment , liver haematoma or rupture will be sourced from medical records.
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Secondary outcome [2]
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Composite neonatal outcomes, including neonatal death before hospital discharge, 5 minute APGAR score <7, umbilical lactate >5.0 at birth, admission to the neonatal intensive care unit, diagnosis of respiratory distress syndrome, bronchopulmonary dysplasia , sepsis, necrotising enterocolitis, intraventricular haemorrhage (grade III or IV), stage 4 or 5 retinopathy of prematurity, as determined by the treating clinician.
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Assessment method [2]
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Timepoint [2]
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Will be measured on the day of delivery and information regarding routine markers will be sourced from the Neonatal Intensive Care Unit and Special Care Nursery records.
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Secondary outcome [3]
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Maternal serum and placental angiogenic markers sFlt-1, soluble endoglin, placental growth factor and activin A.
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Assessment method [3]
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Timepoint [3]
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Will be measured in the maternal blood 24 hours prior to initiation of treatment, and then every 48 hours after treatment is initiated until delivery.
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Secondary outcome [4]
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Maternal TSH and free and total T3/T4 (measured at baseline and after delivery).
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Assessment method [4]
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Timepoint [4]
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Maternal thyroid function assessed by measuring T3/T4 and TSH will be measured on enrolment and at delivery through routine pathology services from serum and/or plasma collected as part of this trial.
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Secondary outcome [5]
373606
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Preeclampsia severity, as assessed by: escalation of antihypertensive therapy, systolic and diastolic blood pressures, severe renal involvement (serum or plasma creatinine >90umol/L, oliguria <80mL/4hr), haematological involvement (haemolysis , platelets <104/uL, disseminated intravascular coagulation) liver transanimases >500IU.
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Assessment method [5]
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Timepoint [5]
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These features of preeclampsia will be measured throughout pregnancy as part of routine care. Information will be sourced from routine medical records after delivery.
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Secondary outcome [6]
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Indication for delivery (maternal or fetal compromise).
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Assessment method [6]
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Timepoint [6]
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This will be established from routine medical records after delivery.
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Secondary outcome [7]
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Mode of labour and birth (prelabour caesarean section, intrapartum caesarean section, induced or spontaneous labour, spontaneous vaginal birth, assisted vaginal birth).
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Assessment method [7]
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Timepoint [7]
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Information regarding mode of birth will be sourced from routine medical records after delivery
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Secondary outcome [8]
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Intrauterine fetal death (stillbirth).
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Assessment method [8]
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Timepoint [8]
373609
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Fetal wellbeing will be recorded throughout pregnancy in routine medical records. Information regarding fetal death will be sourced from medical records.
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Secondary outcome [9]
373610
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Changes in fetal surveillance (fetal Doppler studies – umbilical or middle cerebral artery PI or abnormal ductus venosus – amniotic fluid volume <5cm, abnormal fetal heart rate on CTG).
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Assessment method [9]
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Timepoint [9]
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Fetal surveillance will be conducted throughout pregnancy of women with early onset preeclampsia as part of routine care. Abnormalities in fetal surveillance will be determined from routine medical records.
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Secondary outcome [10]
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Gestation at birth.
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Assessment method [10]
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Timepoint [10]
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This will be sourced from routine medical records after delivery.
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Secondary outcome [11]
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Duration of NICU care (days)
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Assessment method [11]
373612
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Timepoint [11]
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Information regarding length of stay in NICU will be sourced from neonatal medical records after discharge from hospital.
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Secondary outcome [12]
374342
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Birthweight <5th percentile.
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Assessment method [12]
374342
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Timepoint [12]
374342
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Information regarding birthweight will be sourced from online records. This will be done after delivery.
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Eligibility
Key inclusion criteria
• Singleton pregnancy
• Diagnosis of early onset preeclampsia as defined by the according to the SOMANZ guidelines
• Gestation between 24+0 and 33+ 6 weeks.
• Viable fetus, as determined by the treating obstetrician
• Able to safely continue pregnancy for 48 hours, or longer, as determined by the treating obstetrician
• Normal mid-trimester morphology scan, with no detectable significant anomalies.
• Deemed capable of understanding the information provided and able to give written informed consent (with interpreter use as required).
• >18 years of age
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• Eclampsia
• Current use of broccoli sprout extract supplement
• Contraindications to use (eg, intolerance of broccoli)
• Significant uncertainty in ensuring gestational age is within limits
• Unwillingness or inability to follow the procedures outlined in the PI and CF
• Mentally, cognitively or legally incapacitated or ineligible to provide informed consent
• Co-recruitment/participation in another clinical trial where there is a pharmaceutical or herbal or nutritional intervention (such trial interventions would also include: multi-vitamins, minerals, complementary and alternative medicines)
• Preexisting inflammatory bowel disease (Ulcerative Colitis and Crohn’s disease)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be performed by a perinatal epidemiologist in our clinical unit who is not involved in the clinical trial. The randomisation sequence will then be provided to the pharmacist.
Prior to commencement of the trial, the broccoli sprout extract capsules or identical placebo capsules will be dispensed into bottles and sealed by the hospital clinical trials dedicated Pharmacist, who is not involved in the conduct of the trial. Thereafter, the bottles containing the trial capsules will be labelled as per the randomisation sequence. Ultimately, only the dedicated clinical trials pharmacist will have a record of each containers contents such that the participant, the researchers nor clinical staff attending the participant will know whether the participant has been administered broccoli sprout extract or placebo capsules.
Both Pharmacy and the third party involved in the randomisation process will retain the randomisation and associated dispensing information until all participants have completed the trial, all data entry and processing are complete and the database has been locked, at which point un-blinding will take place.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
All continuous measures will be assessed for normality of distribution and compared using non-parametric or parametric testing where appropriate. Continuous data will described using mean (SD) if normally distributed and median (IQR) when the distribution is skewed. Maternal and pregnancy characteristics will be analysed using t-test or Mann-Whitney U, to determine statistical difference between groups and to assess the randomisation. Primary and secondary analysis will be assessed with intention to treat analysis. The primary outcome measure of length to delivery will be presented as a mean time to delivery. A secondary time-to event analysis will be performed with adjustment for any significant differences between treatment groups. Data will be presented as hazard ratios and 95% Confidence intervals for difference between trial arms.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/06/2023
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
180
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
9903
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Monash Medical Centre - Clayton campus - Clayton
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Recruitment hospital [2]
9904
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Jessie McPherson Private Hospital - Clayton
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Recruitment postcode(s) [1]
18711
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3168 - Clayton
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Funding & Sponsors
Funding source category [1]
297982
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University
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Name [1]
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Monash University located at Monash Health
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Address [1]
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246 Clayton Road
Clayton
Victoria 3168
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Country [1]
297982
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Australia
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Primary sponsor type
Hospital
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Name
Monash Health
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Address
246 Clayton Road
Clayton
Victoria 3168
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Country
Australia
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Secondary sponsor category [1]
297682
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None
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Name [1]
297682
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Address [1]
297682
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Country [1]
297682
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
299023
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Monash Health Ethics Comittee
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Ethics committee address [1]
299023
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Monash Medical Centre
246 Clayton Road,
Clayton, Victoria, 3168
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Ethics committee country [1]
299023
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Australia
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Date submitted for ethics approval [1]
299023
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14/02/2018
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Approval date [1]
299023
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20/09/2018
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Ethics approval number [1]
299023
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Summary
Brief summary
Pre-eclampsia (PE) is a condition that occurs only in human pregnancy. The condition is a multi-system disorder and is typically recognised by the new onset of high blood pressure (‘hypertension’) after 20 weeks of pregnancy, which can also be accompanied by protein in the urine (‘proteinuria’). While the exact cause and mechanisms of PE have yet to be determined, we do know that the placenta (‘after birth’) plays an important part in development of the condition, and that once the baby has been born, and the placenta is then removed, a mother’s PE usually begins to get better. Consequently, the only effective treatment for PE at this time is to deliver the baby and unfortunately, for many mothers with PE, this will mean that their baby will need to be born early in their pregnancies i.e. preterm, between 24-36 weeks. As a result, PE has the potential to be a significant cause of problems, for both mothers and their babies, in the immediate and long term.
Evidence derived from both the laboratory and also human studies, involving people who are not pregnant, has shown that sulforaphane, a compound that can be found naturally in broccoli sprouts, protects against cardiovascular disease and improves the health of blood vessels. For this reason, we believe that the administration of a broccoli sprout extract supplement containing sulforaphane, may offer a new ‘low risk, potential treatment for PE. Such a treatment would be highly beneficial to both the mother and her baby, since it could help doctors (obstetricians) to stabilize a mother’s PE and as a result, prolong the pregnancy.
The aim of this project is to test whether a nutritional supplement containing broccoli sprout extract, which is high in sulforaphane, can prolong the time to delivery in pregnant women who have been diagnosed early onset preeclampsia.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
79022
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Prof A/Prof Kirsten Palmer
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Address
79022
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Department of Obstetrics and Gynaecology Monash University, Level 5 Monash Medical Centre, 246 Clayton Road, Clayton, Victoria, 3186,
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Country
79022
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Australia
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Phone
79022
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+61 3 9594 5145
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Fax
79022
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Email
79022
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[email protected]
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Contact person for public queries
Name
79023
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Dr Sarah Marshall
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Address
79023
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Monash University
Hudson Institute of Medical Research
27-31 Wright St
Clayton
Victoria 3168
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Country
79023
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Australia
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Phone
79023
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+61 3 9594 5145
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Fax
79023
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Email
79023
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[email protected]
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Contact person for scientific queries
Name
79024
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Dr Sarah Marshall
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Address
79024
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The Ritchie Centre, Monash University, 27-31 Wright Street, Clayton, Victoria 3168
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Country
79024
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Australia
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Phone
79024
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+61 3 9594 5145
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Fax
79024
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Email
79024
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Upon completion and publication of the trial results, de-identified trial data will be made available to others upon reasonable request.
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When will data be available (start and end dates)?
We anticipate that the study will conclude in May 2025 and we hope to have the main data available shortly after the conclusion of the study. No end date is currently determined.
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Available to whom?
1) The editors and peer reviewers of the final manuscript.
2) Interested parties who contact the senior author, requesting more information about the trial
3) Those individuals who read the journal where the manuscript has been accepted for publication are able to see the de-identified, aggregated data.
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Available for what types of analyses?
Upon completion and publication of the trial results, de-identified trial data will be made available to others upon reasonable request. Associated documents such as protocol, PI&CF may be available by contacting the senior author. The senior author will determine who has access to documentation and data associated with this trial.
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How or where can data be obtained?
Upon completion and publication of the trial results, de-identified trial data will be made available to others upon reasonable request. Such requests should be made to:
Professor Euan Wallace:
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
3847
Study protocol
[email protected]
3848
Informed consent form
[email protected]
3849
Statistical analysis plan
[email protected]
3850
Ethical approval
[email protected]
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Prolong: A double-blind randomised placebo-controlled trial of broccoli sprout extract in women with early onset preeclampsia. A clinical trial protocol.
2019
https://dx.doi.org/10.1136/bmjopen-2018-027493
N.B. These documents automatically identified may not have been verified by the study sponsor.
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