<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02218931</url>
  </required_header>
  <id_info>
    <org_study_id>009337QM</org_study_id>
    <secondary_id>732/2029</secondary_id>
    <nct_id>NCT02218931</nct_id>
  </id_info>
  <brief_title>ESTEEM - Effect of Simple, Targeted Diet in Pregnant Women With Metabolic Risk Factors on Pregnancy Outcomes</brief_title>
  <acronym>ESTEEM</acronym>
  <official_title>Effect of Simple, Targeted Diet in Pregnant Women With Metabolic Risk Factors on Pregnancy Outcomes (ESTEEM): A Randomised Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Queen Mary University of London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Queen Mary University of London</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obesity is a growing problem in East London and every other woman who enters pregnancy is&#xD;
      obese or overweight. In addition to obesity, other metabolic risk factors such as raised&#xD;
      lipids, high blood pressure and diabetes increase pregnancy related complications such as&#xD;
      preeclampsia and long term problems such as heart diseases, stroke and death. Preeclampsia,&#xD;
      presenting as hypertension and proteinuria is a leading cause of maternal and fetal mortality&#xD;
      and morbidity. Interventions that reduce cardiovascular events by modifying risk factors also&#xD;
      have the potential to reduce the risk of preeclampsia. The investigators work funded by the&#xD;
      National Institute of Health Research (NIHR) in the UK showed that dietary interventions in&#xD;
      obese pregnant women may reduce the risk of preeclampsia. The investigators propose to show&#xD;
      that pregnant women with metabolic risk factors derive the most benefit from a simple,&#xD;
      targeted intervention based on Mediterranean dietary pattern to reduce the risk of maternal&#xD;
      and fetal complications . Women with the risk factors (1230 women) will be randomly allocated&#xD;
      to dietary intervention or usual antenatal dietary advice and the risk of maternal and fetal&#xD;
      complications will be evaluated. The remaining eligible women who are consented for lipid&#xD;
      tests, but do not have metabolic risk factors, will be followed up for outcome data only.&#xD;
      Diet based interventions, especially those based on a Mediterranean dietary pattern has a&#xD;
      potential to reduce the risk of preeclampsia. In the investigators study, pregnant mothers&#xD;
      with risk factors will be randomly allocated to either a dietary invention or usual antenatal&#xD;
      care and they will assess their composite maternal (pre-eclampsia or gestational diabetes)&#xD;
      and fetal (stillbirth, small for gestational age or admission to neonatal intensive care&#xD;
      unit) outcomes. The investigators will tailor the intervention to suit the individual needs&#xD;
      of the mother and provide nuts and olive oil to improve compliance. The study will be&#xD;
      undertaken across the three maternity units at Barts Health NHS Trust, which delivers 17,000&#xD;
      women/year and two other maternity units in England. The study is supported by the office of&#xD;
      the Mayor of Tower Hamlets which will facilitate the involvement of grassroots workers to&#xD;
      promote recruitment and uptake of the intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obesity is a growing problem in east London with a fifth of women entering pregnancy as&#xD;
      obese. In addition to obesity, other metabolic risk factors such as raised lipids, high blood&#xD;
      pressure and insulin resistance are increasingly prevalent. With a large proportion of ethnic&#xD;
      minority mothers in east London, dietary habits and underlying genetic predisposition are&#xD;
      major contributors to this phenomenon. Obesity and raised serum lipids, especially&#xD;
      triglycerides increase the risk of complications such as preeclampsia in pregnancy and&#xD;
      cardiovascular events such as myocardial infarction, stroke and death in the long term.&#xD;
      Preeclampsia, a condition in pregnancy, with raised blood pressure and increased protein in&#xD;
      the urine is a leading cause of maternal and fetal deaths. Its treatment gives rise to large&#xD;
      health care costs. Preeclampsia contributes to preterm birth, one of the leading causes of&#xD;
      perinatal deaths in east London. It accounts for 65% of neonatal deaths and 50% of&#xD;
      neurological disability in childhood. Around £900 million in extra costs for care of preterm&#xD;
      babies per year in the NHS are linked to neonatal care. Preeclampsia, characterised by&#xD;
      insulin resistance, widespread endothelial damage and dysfunction, coagulation defects and&#xD;
      increased systemic inflammatory response, shares metabolic risk factors with cardiovascular&#xD;
      disease. Obesity, dyslipidaemia and hypertension are independent risk factors for&#xD;
      pre-eclampsia. Interventions that reduce cardiovascular events by modifying metabolic risk&#xD;
      factors also have the potential to reduce the risk of pre-eclampsia.&#xD;
&#xD;
      Early identification of mothers at risk of preeclampsia will allow clinicians to deliver&#xD;
      these targeted interventions in pregnancy, with the potential to prevent preeclampsia and&#xD;
      modify cardiovascular risk in the long-term. Currently, low dose aspirin, recommended as a&#xD;
      prophylactic measure reduces preeclampsia risk by only 10%. Simple, low-cost and effective&#xD;
      acceptable interventions are required to reduce this risk further. Dietary interventions in&#xD;
      pregnant women with metabolic risk factors such as obesity and insulin resistance are shown&#xD;
      to reduce the risk of preeclampsia. But the existing studies are of poor quality and do not&#xD;
      evaluate preeclampsia as the primary outcome. Furthermore, they focus on specific components&#xD;
      of the diet, rather than modifying the overall dietary pattern. Mediterranean diet with high&#xD;
      consumption of vegetables and fruits, olive oil and nuts and low consumption of red meat and&#xD;
      processed food significantly reduces lipid levels and cardiovascular adverse events in&#xD;
      non-pregnant high risk population. In pregnancy, the beneficial effect of the Mediterranean&#xD;
      dietary pattern was observed in a large prospective study of nulliparous pregnant women with&#xD;
      a 28% reduction in the risk of preeclampsia (RR 0.72; 95% CI 0.62, 0.85). These results need&#xD;
      confirmation in a sound experimental study.&#xD;
&#xD;
      There is a need for an adequately powered randomised trial to evaluate the beneficial effect&#xD;
      of lipid modifying diet in pregnancy that is simple, accessible and acceptable. The&#xD;
      investigators hypothesis is that pregnant women with metabolic risk factors will derive&#xD;
      benefit from dietary intervention in preventing maternal and fetal complications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 12, 2014</start_date>
  <completion_date type="Actual">April 30, 2017</completion_date>
  <primary_completion_date type="Actual">November 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite maternal outcomes: pre-eclampsia or gestational diabetes</measure>
    <time_frame>At delivery</time_frame>
    <description>Diagnosis of pre-eclampsia defined as:&#xD;
new onset hypertension after 20 weeks gestation defined as systolic BP ≥ 140 mm Hg or diastolic BP ≥ 90 mmHg, in at least two readings AND New onset proteinuria defined as spot urine Protein/creatinine ratio (PCR) test greater than 30mg/mmol or &gt;24 hour urine 300mg/24 hours or 2+ or more on standard urinary dipstick tests after 20 weeks gestation&#xD;
superimposed pre-eclampsia in women with chronic hypertension or chronic proteinuria&#xD;
women with eclamptic seizures with no hypertension or proteinuria&#xD;
Diagnosis of gestational diabetes defined as:&#xD;
fasting venous glucose of 5·1 mmol/L or higher or&#xD;
2 h venous glucose of 8·5 mmol/L or higher or&#xD;
combination of these</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Composite fetal outcomes: stillbirth, small for gestational age or admission to neonatal intensive care unit</measure>
    <time_frame>At delivery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>To assess the effect of targeted dietary intervention vs. usual antenatal dietary advice on other maternal and fetal outcomes</measure>
    <time_frame>At delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of participants with a change in lipid profiles from early pregnancy to delivery in women a) with and without dietary interventions b) with and without pre-eclampsia on the composite maternal and fetal outcomes.</measure>
    <time_frame>At delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rates of composite maternal and fetal outcomes in the following subgroups of women in the intervention and control group: obese; raised triglycerides and with raised blood pressure.</measure>
    <time_frame>Baseline and 36 weeks or delivery depending on which is sooner</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Development of a cohort for medium and long term follow up of mothers and babies after birth through applications to other grant giving bodies.</measure>
    <time_frame>End of follow up, an average of 5 months</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">3442</enrollment>
  <condition>Pre-eclampsia</condition>
  <condition>Obesity</condition>
  <condition>Raised Lipids</condition>
  <condition>High Blood Pressure</condition>
  <condition>Insulin Resistance</condition>
  <condition>Gestational Diabetes</condition>
  <condition>Small for Gestational Age</condition>
  <condition>Stillbirth</condition>
  <arm_group>
    <arm_group_label>Targeted ESTEEM diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The ESTEEM dietary pattern is similar to that in a Mediterranean diet associated with reduced risk of pre-eclampsia.&#xD;
The intervention will include structured meal plans and grocery lists, recipes for healthy diet and appropriate choices at restaurants</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Current clinical practice</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will be provided the usual antenatal dietary advice. This includes advice on healthy and physical activity in women with normal weight and obesity and overweight. Folic acid and vit D supplementation are provided as per national recommendations. Participants will provide outcome data at point of delivery and food frequency questionnaire at baseline and 36 weeks or delivery depending on which is sooner.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-randomised cohort</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Non-randomised cohort of women with no metabolic risk factors will be followed up to delivery to collect outcome data</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Targeted ESTEEM diet</intervention_name>
    <description>The key components of the diet are:&#xD;
High intake of vegetables, nuts, non-refined grains, legumes and fruits;Moderate to high consumption of fish;Small to moderate intake of poultry and dairy products such as yoghurt and cheese;Low consumption of red meat and processed meat and avoidance of sugary drinks, fast food and high fat food;High fibre;Intake of nuts including walnuts and almonds that are rich sources of monounsaturated and polyunsaturated fatty acids (30 g/day);Olive oil to cook and dress salads as the main source of fat (0.5 l/week)&#xD;
The intervention will include structured meal plans and grocery lists, recipes for healthy diet and appropriate choices at restaurants</description>
    <arm_group_label>Targeted ESTEEM diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non-randomised cohort</intervention_name>
    <description>Non-randomised cohort of women with no metabolic risk factors will be followed up to delivery to collect outcome data</description>
    <arm_group_label>Non-randomised cohort</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Pregnant women less than 18 weeks of gestation with at least one of the&#xD;
        following:&#xD;
&#xD;
        i. BMI ≥30 Kg/m2 ii. Raised serum triglycerides ≥1.7 mmol/l iii. Raised blood pressure of&#xD;
        systole ≥140 mm Hg or diastole ≥90 mm Hg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        i. BMI &lt;18.5 Kg/m2or ≥40 Kg/m2 ii. Women on lipid altering drugs iii. History of diabetes&#xD;
        iv. Chronic renal disease v. Auto immune disease vi. Multiple pregnancy vii. Poor&#xD;
        understanding of written and spoken English viii. Not able to follow Mediterranean diet for&#xD;
        religious or other reasons ix. &lt;16 years of age x. Not able to consume nuts or extra virgin&#xD;
        olive oil&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shakila Thangaratinam</last_name>
    <role>Principal Investigator</role>
    <affiliation>Queen Mary University of London</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rehan Khan</last_name>
    <role>Principal Investigator</role>
    <affiliation>Barts &amp; The London NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Barts Health NHS Trust</name>
      <address>
        <city>London</city>
        <zip>E1 1BB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>November 15, 2017</last_update_submitted>
  <last_update_submitted_qc>November 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pre-eclampsia</keyword>
  <keyword>Gestational diabetes</keyword>
  <keyword>Stillbirth</keyword>
  <keyword>Small for gestational age</keyword>
  <keyword>Admission to neonatal intensive care unit</keyword>
  <keyword>Obesity</keyword>
  <keyword>Raised Lipids</keyword>
  <keyword>High Blood Pressure</keyword>
  <keyword>Cardiovascular risk</keyword>
  <keyword>Insulin resistance</keyword>
  <keyword>Mediterranean dietary pattern</keyword>
  <keyword>Dietary interventions</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</mesh_term>
    <mesh_term>Eclampsia</mesh_term>
    <mesh_term>Pre-Eclampsia</mesh_term>
    <mesh_term>Stillbirth</mesh_term>
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Insulin Resistance</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02218931
org study id: 009337QM
secondary id: 732/2029
nct id: NCT02218931
lead sponsor: 
has dmc: Yes
Obesity is a growing problem in East London and every other woman who enters pregnancy is
      obese or overweight. In addition to obesity, other metabolic risk factors such as raised
      lipids, high blood pressure and diabetes increase pregnancy related complications such as
      preeclampsia and long term problems such as heart diseases, stroke and death. Preeclampsia,
      presenting as hypertension and proteinuria is a leading cause of maternal and fetal mortality
      and morbidity. Interventions that reduce cardiovascular events by modifying risk factors also
      have the potential to reduce the risk of preeclampsia. The investigators work funded by the
      National Institute of Health Research (NIHR) in the UK showed that dietary interventions in
      obese pregnant women may reduce the risk of preeclampsia. The investigators propose to show
      that pregnant women with metabolic risk factors derive the most benefit from a simple,
      targeted intervention based on Mediterranean dietary pattern to reduce the risk of maternal
      and fetal complications . Women with the risk factors (1230 women) will be randomly allocated
      to dietary intervention or usual antenatal dietary advice and the risk of maternal and fetal
      complications will be evaluated. The remaining eligible women who are consented for lipid
      tests, but do not have metabolic risk factors, will be followed up for outcome data only.
      Diet based interventions, especially those based on a Mediterranean dietary pattern has a
      potential to reduce the risk of preeclampsia. In the investigators study, pregnant mothers
      with risk factors will be randomly allocated to either a dietary invention or usual antenatal
      care and they will assess their composite maternal (pre-eclampsia or gestational diabetes)
      and fetal (stillbirth, small for gestational age or admission to neonatal intensive care
      unit) outcomes. The investigators will tailor the intervention to suit the individual needs
      of the mother and provide nuts and olive oil to improve compliance. The study will be
      undertaken across the three maternity units at Barts Health NHS Trust, which delivers 17,000
      women/year and two other maternity units in England. The study is supported by the office of
      the Mayor of Tower Hamlets which will facilitate the involvement of grassroots workers to
      promote recruitment and uptake of the intervention.
Obesity is a growing problem in east London with a fifth of women entering pregnancy as
      obese. In addition to obesity, other metabolic risk factors such as raised lipids, high blood
      pressure and insulin resistance are increasingly prevalent. With a large proportion of ethnic
      minority mothers in east London, dietary habits and underlying genetic predisposition are
      major contributors to this phenomenon. Obesity and raised serum lipids, especially
      triglycerides increase the risk of complications such as preeclampsia in pregnancy and
      cardiovascular events such as myocardial infarction, stroke and death in the long term.
      Preeclampsia, a condition in pregnancy, with raised blood pressure and increased protein in
      the urine is a leading cause of maternal and fetal deaths. Its treatment gives rise to large
      health care costs. Preeclampsia contributes to preterm birth, one of the leading causes of
      perinatal deaths in east London. It accounts for 65% of neonatal deaths and 50% of
      neurological disability in childhood. Around £900 million in extra costs for care of preterm
      babies per year in the NHS are linked to neonatal care. Preeclampsia, characterised by
      insulin resistance, widespread endothelial damage and dysfunction, coagulation defects and
      increased systemic inflammatory response, shares metabolic risk factors with cardiovascular
      disease. Obesity, dyslipidaemia and hypertension are independent risk factors for
      pre-eclampsia. Interventions that reduce cardiovascular events by modifying metabolic risk
      factors also have the potential to reduce the risk of pre-eclampsia.

      Early identification of mothers at risk of preeclampsia will allow clinicians to deliver
      these targeted interventions in pregnancy, with the potential to prevent preeclampsia and
      modify cardiovascular risk in the long-term. Currently, low dose aspirin, recommended as a
      prophylactic measure reduces preeclampsia risk by only 10%. Simple, low-cost and effective
      acceptable interventions are required to reduce this risk further. Dietary interventions in
      pregnant women with metabolic risk factors such as obesity and insulin resistance are shown
      to reduce the risk of preeclampsia. But the existing studies are of poor quality and do not
      evaluate preeclampsia as the primary outcome. Furthermore, they focus on specific components
      of the diet, rather than modifying the overall dietary pattern. Mediterranean diet with high
      consumption of vegetables and fruits, olive oil and nuts and low consumption of red meat and
      processed food significantly reduces lipid levels and cardiovascular adverse events in
      non-pregnant high risk population. In pregnancy, the beneficial effect of the Mediterranean
      dietary pattern was observed in a large prospective study of nulliparous pregnant women with
      a 28% reduction in the risk of preeclampsia (RR 0.72; 95% CI 0.62, 0.85). These results need
      confirmation in a sound experimental study.

      There is a need for an adequately powered randomised trial to evaluate the beneficial effect
      of lipid modifying diet in pregnancy that is simple, accessible and acceptable. The
      investigators hypothesis is that pregnant women with metabolic risk factors will derive
      benefit from dietary intervention in preventing maternal and fetal complications.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Composite maternal outcomes: pre-eclampsia or gestational diabetes
time frame: At delivery
description: Diagnosis of pre-eclampsia defined as:
new onset hypertension after 20 weeks gestation defined as systolic BP ≥ 140 mm Hg or diastolic BP ≥ 90 mmHg, in at least two readings AND New onset proteinuria defined as spot urine Protein/creatinine ratio (PCR) test greater than 30mg/mmol or >24 hour urine 300mg/24 hours or 2+ or more on standard urinary dipstick tests after 20 weeks gestation
superimposed pre-eclampsia in women with chronic hypertension or chronic proteinuria
women with eclamptic seizures with no hypertension or proteinuria
Diagnosis of gestational diabetes defined as:
fasting venous glucose of 5·1 mmol/L or higher or
2 h venous glucose of 8·5 mmol/L or higher or
combination of these
measure: Composite fetal outcomes: stillbirth, small for gestational age or admission to neonatal intensive care unit
time frame: At delivery
measure: To assess the effect of targeted dietary intervention vs. usual antenatal dietary advice on other maternal and fetal outcomes
time frame: At delivery
measure: The number of participants with a change in lipid profiles from early pregnancy to delivery in women a) with and without dietary interventions b) with and without pre-eclampsia on the composite maternal and fetal outcomes.
time frame: At delivery
measure: The rates of composite maternal and fetal outcomes in the following subgroups of women in the intervention and control group: obese; raised triglycerides and with raised blood pressure.
time frame: Baseline and 36 weeks or delivery depending on which is sooner
measure: Development of a cohort for medium and long term follow up of mothers and babies after birth through applications to other grant giving bodies.
time frame: End of follow up, an average of 5 months
arm group label: Targeted ESTEEM diet
arm group type: Experimental
description: The ESTEEM dietary pattern is similar to that in a Mediterranean diet associated with reduced risk of pre-eclampsia.
The intervention will include structured meal plans and grocery lists, recipes for healthy diet and appropriate choices at restaurants
arm group label: Current clinical practice
arm group type: No Intervention
description: The control group will be provided the usual antenatal dietary advice. This includes advice on healthy and physical activity in women with normal weight and obesity and overweight. Folic acid and vit D supplementation are provided as per national recommendations. Participants will provide outcome data at point of delivery and food frequency questionnaire at baseline and 36 weeks or delivery depending on which is sooner.
arm group label: Non-randomised cohort
arm group type: Other
description: Non-randomised cohort of women with no metabolic risk factors will be followed up to delivery to collect outcome data
intervention type: Behavioral
intervention name: Targeted ESTEEM diet
description: The key components of the diet are:
High intake of vegetables, nuts, non-refined grains, legumes and fruits;Moderate to high consumption of fish;Small to moderate intake of poultry and dairy products such as yoghurt and cheese;Low consumption of red meat and processed meat and avoidance of sugary drinks, fast food and high fat food;High fibre;Intake of nuts including walnuts and almonds that are rich sources of monounsaturated and polyunsaturated fatty acids (30 g/day);Olive oil to cook and dress salads as the main source of fat (0.5 l/week)
The intervention will include structured meal plans and grocery lists, recipes for healthy diet and appropriate choices at restaurants
arm group label: Targeted ESTEEM diet
intervention type: Other
intervention name: Non-randomised cohort
description: Non-randomised cohort of women with no metabolic risk factors will be followed up to delivery to collect outcome data
arm group label: Non-randomised cohort
criteria: 
gender: Female
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Shakila Thangaratinam
role: Principal Investigator
affiliation: Queen Mary University of London
last name: Rehan Khan
role: Principal Investigator
affiliation: Barts & The London NHS Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Diabetes, Gestational
mesh term: Eclampsia
mesh term: Pre-Eclampsia
mesh term: Stillbirth
mesh term: Hypertension
mesh term: Insulin Resistance