ACTRN12624000812594尚未招募Unknown
Assessing the effects of a broccoli sprout extract on endothelial function in healthy non-pregnant and pregnant women, and pregnant women with a hypertensive disorder of pregnancy
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Female
入选标准
- •Group 1: Healthy, non-pregnant women
- •Not pregnant.
- •Deemed capable of understanding the information provided and able to give written informed consent (with interpreter use as required).
- •Body mass index (BMI) between 18 – 35kg/m2.
- •18 years old and over
- •Group 2: Healthy, pregnant women
- •Singleton pregnancy
- •Gestation between 28+0 and 36+0 weeks pregnant.
- •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).
- •Booking body mass index (BMI) between 18 and 35kg/m2.
- •18 years old and over.
- •Group 3: Pregnant women with a hypertensive disorder of pregnancy
- •Singleton pregnancy
- •Gestation between 28+0 and 36+6 weeks pregnant.
- •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).
- •Booking body mass index (BMI) between 18 and 35kg/m2.
- •18 years old and over.
- •Diagnosis of preeclampsia or clinical hypertension as defined by the according to the Society of Obstetric Medicine of Australia and New Zealand (SOMANZ) guidelines.
排除标准
- •Group 1: Healthy, non-pregnant women
- •Younger than 18 years old
- •Body mass index (BMI) < 18 or > 35kg/m2.
- •Confirmed or suspected pregnancy.
- •Current use of broccoli sprout extract supplement.
- •Contraindications to use (e.g., intolerance of broccoli).
- •Significant uncertainty in ensuring gestational age is within limits.
- •Unwillingness or inability to follow the procedures outlined in the PICF.
- •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).
- •Group 2: Healthy, pregnant women
- •major complications of pregnancy including but not limited to:
- •oFetal growth restriction estimated fetal weight <10th centile or AC (abdominal circumference) <5th
- •oPreeclampsia/HELLP syndrome (haemolysis elevated liver enzymes low platelet syndrome)
- •oGestational diabetes on insulin on >20units insulin/day
- •oPPROM (preterm pre-labour rupture of membranes) within 7 days ago
- •oChorioamnionitis
- •oStillbirth or intrauterine fetal death
- •oSuspected or confirmed congenital infection of pregnancy (i.e. CMV, syphilis, rubella)
- •oUnstable major placenta praevia or vasa praevia
- •oHypertensive disorder of pregnancy on >1 regular anti-hypertensive treatment
- •oAbnormal umbilical artery doppler i.e. elevated umbilical artery doppler pulsatility index (UA PI >95th), absent end-diastolic flow or reversal of end-diastolic flow, or a reduced middle cerebral artery pulsatility index (MCA PI <5th) or abnormal ductus venosus (DV)
- •Renal or hepatic dysfunction.
- •Current use of broccoli sprout extract supplement.
- •Contraindications to use (e.g., intolerance of broccoli).
- •Significant uncertainty in ensuring gestational age is within limits.
- •Unwillingness or inability to follow the procedures outlined in the PICF.
- •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).
- •Group 3: Pregnant women with a hypertensive disorder of pregnancy
- •major complications of pregnancy including but not limited to:
- •oFetal growth restriction estimated fetal weight <10th centile or AC (abdominal circumference) <5th
- •oGestational diabetes on insulin on >20units insulin/day
- •oPPROM (preterm pre-labour rupture of membranes) within 7 days ago
- •oChorioamnionitis
- •oStillbirth or intrauterine fetal death
- •oSuspected or confirmed congenital infection of pregnancy (i.e. CMV, syphilis, rubella)
- •oUnstable major placenta praevia or vasa praevia
- •oAbnormal umbilical artery doppler i.e. elevated umbilical artery doppler pulsatility index (UA PI >95th), absent end-diastolic flow or reversal of end-diastolic flow, or a reduced middle cerebral artery pulsatility index (MCA PI <5th) or abnormal ductus venosus (DV)
- •Current use of broccoli sprout extract supplement.
- •Contraindications to use (e.g., intolerance of broccoli).
- •Significant uncertainty in ensuring gestational age is within limits.
- •Unwillingness or inability to follow the procedures outlined in the PICF.
研究者
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