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Maternal risk for cardiovascular and metabolic diseases subsequent to pregnancy complications - observational study

Cardiovascular assessment after Obstetric complications Follow up For Education and Evaluation (COFFEE) Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12616000597493
Acronym
COFFEE Study
Enrollment
171
Registered
2016-05-09
Start date
2016-05-12
Completion date
2018-08-30
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Sponsors

University of Adelaide
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
20 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

All women who participated in the SCreening fOr Pregnancy Endpoints (SCOPE) study in Adelaide 10 years ago (n = 1164)

Exclusion criteria

None - all women who participated in the Adelaide cohort of the SCOPE study are eligible

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026