ANZCTR - Registration

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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]

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

hypertension

diabetes

metabolic syndrome

Condition category

Condition code

Cardiovascular

Coronary heart disease

Metabolic and Endocrine

Diabetes

Metabolic and Endocrine

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]

Diagnosis / Prognosis

Comparator / control treatment

Women who had uncomplicated pregnancies

Control group

Active

Outcomes

Primary outcome [1]

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]

The outcome will be measured 10 years after delivery of first child

Secondary outcome [1]

Prevalence of obesity

Obesity will be assessed using BMI calculations

Timepoint [1]