Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000597493
Ethics application status
Approved
Date submitted
27/04/2016
Date registered
9/05/2016
Date last updated
4/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Maternal risk for cardiovascular and metabolic diseases subsequent to pregnancy complications - observational study
Scientific title
Cardiovascular assessment after Obstetric complications Follow
up For Education and Evaluation (COFFEE) Study
Secondary ID [1] 289002 0
Nil known
Universal Trial Number (UTN)
Trial acronym
COFFEE Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
risk factors for cardiovascular disease 298406 0
hypertension 298407 0
diabetes 298408 0
metabolic syndrome 298409 0
Condition category
Condition code
Cardiovascular 298509 298509 0 0
Coronary heart disease
Metabolic and Endocrine 298683 298683 0 0
Diabetes
Metabolic and Endocrine 298684 298684 0 0
Metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The participants will be women recruited to the SCOPE study (ANZCTRN12607000551493).
The prevalence of risk factors for coronary artery disease among women who experienced pregnancy complications (preeclampsia, gestational hypertension, small for gestational age pregnancy, spontaneous preterm birth and gestational diabetes) will be compared with that of women who had uncomplicated pregnancies 10 years after delivery of the first child.
Intervention code [1] 294487 0
Diagnosis / Prognosis
Comparator / control treatment
Women who had uncomplicated pregnancies
Control group
Active

Outcomes
Primary outcome [1] 298002 0
Prevalence of metabolic syndrome will be assessed.

The height, weight and waist circumference will be measured. Blood pressure (BP) will be measured 20 minutes after resting and in the absence of morning caffeine and cigarettes. If the resting BP greater than 140/90mmHg or if women had experienced a complication in the index pregnancy, the women will be provided a 24 hour ambulatory BP monitor. Hypertension will be diagnosed if more than 25% of the 24 hour BP records are greater than 140/90mmHg during the day and greater than 120/80mmHg during the night and the average BP over the 24 hour period is greater than 130/80mmHg. Urine will be collected in the 24 hours preceding the measurements. The 24 h urine sample will be assayed for albumin, protein, and creatinine output to calculate microalbuminuria corrected for creatinine output (g/mol creatinine) and total protein level (g/24 h). A fasting blood sample will be collected to measure glucose, insulin, glycosylated haemoglobin (HbA1c), LDL cholesterol, HDL cholesterol, triglycerides, blood urea, electrolytes, creatinine and uric acid. The homeostasis model assessment (insulin [mU/L] x glucose [mmol/L]/22.5) will be used to estimate the degree of insulin resistance (HOMA-ir). HbA1c will be expressed as HbA1c [mol]/Hb [mol] x 100%. MetS will be defined based on the guidelines of the World Health Organization as follows): the presence of hyperinsulinemia (fasting insulin equal to 9.2mU/L, fasting blood glucose equal to 6.1 mmol/L, or HOMA-ir equal to 2.2) along with any 2 or more of the following: (1) BMI equal or greater than 30 kg/m2, (2) dyslipidemia (triglycerides equal or greater than 1.69 mmol/L or high-density lipoprotein cholesterol equal or greater than 0.9 mmol/L), (3) hypertension: systolic BP equal or greater than 140 mmHg and/or diastolic BP equal or greater than 85 mmHg or the use of antihypertensive medication, and (4) microalbuminuria (equal or greater than 2.5 g/mol creatinine) or proteinuria (equal or greater than 0.30 g/24 h).
Timepoint [1] 298002 0
The outcome will be measured 10 years after delivery of first child
Secondary outcome [1] 322878 0
Prevalence of obesity

Obesity will be assessed using BMI calculations
Timepoint [1] 322878 0
10 years after delivery of first child
Secondary outcome [2] 323355 0
Prevalence of hypertension

Hypertension will be diagnosed if more than 25% of the 24 hour BP records are greater than 140/90mmHg during the day and greater than 120/80mmHg during the night and the average BP over the 24 hour period is greater than 130/80mmHg and assessed using continuous blood pressure monitor
Timepoint [2] 323355 0
10 years after delivery of first child
Secondary outcome [3] 323358 0
Prevalence of hyperinsulinaemia

Hyperinsulinaemia will be diagnosed if fasting insulin is equal to 9.2mU/L or fasting blood glucose is equal to 6.1 mmol/L, or HOMA-ir is equal to 2.2
Timepoint [3] 323358 0
10 years after delivery of first child
Secondary outcome [4] 323533 0
Quality of Life

Quality of Life will be assessed using the SF12 questionnaire
Timepoint [4] 323533 0
10 years after delivery of first child
Secondary outcome [5] 323534 0
Depression

Depression will be assessed using PHQ9 questionnaire
Timepoint [5] 323534 0
10 years after delivery of first child
Secondary outcome [6] 323535 0
Anxiety

Anxiety will be assessed using GAD 7 questionnaire
Timepoint [6] 323535 0
10 years after delivery of first child

Eligibility
Key inclusion criteria
All women who participated in the SCreening fOr Pregnancy Endpoints (SCOPE) study in Adelaide 10 years ago (n = 1164)
Minimum age
20 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
None - all women who participated in the Adelaide cohort of the SCOPE study are eligible

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data from women who experienced pregnancy complications will be compared with data from women who had uncomplicated pregnancies using multi variable logistic regression analyses.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/05/2016
Actual
12/05/2016
Date of last participant enrolment
Anticipated
30/08/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1164
Accrual to date
171
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 5628 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 13075 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 293373 0
Government body
Name [1] 293373 0
National Health and Medical Research Council of Australia
Country [1] 293373 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
Discipline of Obstetrics and Gynaecology, School of Medicine, Level 6, Medical School North, University of Adelaide, Frome Road, Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 292286 0
None
Name [1] 292286 0
Address [1] 292286 0
Country [1] 292286 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294828 0
Human Research Ethics Committee (TQEH/LMH/MH)
Ethics committee address [1] 294828 0
The Queen Elizabeth Hospital
Basil Hetzel Institute DX465101
28 Woodville Road
Woodville South SA 5011
Ethics committee country [1] 294828 0
Australia
Date submitted for ethics approval [1] 294828 0
10/12/2014
Approval date [1] 294828 0
30/01/2015
Ethics approval number [1] 294828 0
HREC/14/TQEH/277

Summary
Brief summary
There is evidence from around the world that women who suffered from pregnancy complications including preeclampsia (PE) and gestational diabetes mellitus (GDM) and those who delivered a small-for-gestational-age infant (SGA) or had a spontaneous preterm birth (sPTB) are more likely to develop various cardiovascular and metabolic diseases later in life and that these occur at a younger age than in women who had uncomplicated pregnancies. Despite increasing knowledge of the long term risks following pregnancy complications to women’s health, current clinical practice does not include follow up of women after these pregnancy complications.
The proposed study is a follow up of women recruited to the Adelaide cohort of the SCOPE study. The SCOPE study is an international, multi-centre, prospective cohort study which aimed to develop screening tests to predict PE, SGA infants and sPTB across different populations. SCOPE recruited 1164 mother-father-baby trios to the Adelaide SCOPE cohort between September 2005 and September 2008. Of the 1164 women who were recruited to the Adelaide SCOPE cohort, 861 had uncomplicated pregnancies, 93 developed PE, 118 had gestational hypertension, 95 normotensive women delivered SGA babies, 69 delivered preterm and 51 had GDM.
All women will be contacted 10-11 years after delivery of the first child. Those consenting will be recruited. The women will be screened for cardiovascular and metabolic risk factors,depression and quality of life. Information will be obtained on diet, exercise and general health. The SF12 questionnaire will be used to assess quality of life. The PHQ9 and GAD 7 questionnaires will be used to assess depression and general anxiety. The height, weight and waist circumference will be measured. Blood pressure (BP) will be measured 20 minutes after resting and in the absence of morning caffeine and cigarettes. If the resting BP is >140/90mmHg or if women had experienced a complication in the index pregnancy, the women will be provided a 24 hour ambulatory BP monitor. Hypertension will be diagnosed if >25% of the 24 hour BP records are >140/90mmHg during the day and >120/80mmHg during the night and the average BP over the 24 hour period is >130/80mmHg. A fasting blood sample will be collected to measure glucose, insulin, glycosylated haemoglobin (HbA1c), LDL cholesterol, HDL cholesterol, triglycerides, blood urea, electrolytes, creatinine and uric acid. Women with risk factors will be referred for specialist care if necessary.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65170 0
Prof Claire Roberts
Address 65170 0
Discipline of Obstetrics and Gynaecology, School of Medicine, Level 6, Medical School North, University of Adelaide, Frome Road, Adelaide, SA 5000
Country 65170 0
Australia
Phone 65170 0
(+61) 8 8313 3118
Fax 65170 0
(+61) 8 8313 4099
Email 65170 0
[email protected]
Contact person for public queries
Name 65171 0
Dr Prabha Andraweera
Address 65171 0
Discipline of Obstetrics and Gynaecology, School of Medicine, Level 6, Medical School North, University of Adelaide, Frome Road, Adelaide, SA 5000
Country 65171 0
Australia
Phone 65171 0
(+61) 8 8313 4086
Fax 65171 0
(+61) 8 8313 4099
Email 65171 0
[email protected]
Contact person for scientific queries
Name 65172 0
Dr Prabha Andraweera
Address 65172 0
Discipline of Obstetrics and Gynaecology, School of Medicine, Level 6, Medical School North, University of Adelaide, Frome Road, Adelaide, SA 5000
Country 65172 0
Australia
Phone 65172 0
(+61) 8 8313 4086
Fax 65172 0
(+61) 8 8313 4099
Email 65172 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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