None listed
Conditions
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.
Interventions
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.
Sponsors
Monash Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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)
Outcome results
None listed