Pregnancy in Diabetics
Conditions
Keywords
Blood pressure, Hypertension, White coat hypertension, Preeclampsia, Anti-hypertensiva
Brief summary
Aim: First, to investigate the prevalence of a) confirmed hypertension, b) white coat hypertension and c) normal blood pressure in pregnant women with pre-existing diabetes. Second, to explore the prevalence of preeclampsia and preterm delivery in women with pre-existing diabetes with a) confirmed hypertension, b) white coat hypertension and c) normal blood pressure before entering the third trimester of pregnancy. Third, to explore the influence of lifestyle, gestational weight gain and mental well-being on confirmed hypertension and preeclampsia in pregnant women with diabetes.The recruitment period was in 2018 extended to 2020 to perform the following studies: First whether home BP in early pregnancy is superior to office BP to predict preeclampsia. Second to evaluate the prevalence of preeclampsia after initiation of a new treatment strategy including prophylactic aspirin and, in case of insufficiency, vitamin D supplementation. Design: A prospective multicentre observational study where approximately 400 pregnant women with pre-existing diabetes are offered measurements of office blood pressure (BP) and home BP for three days three times during pregnancy as well as when the routinely measured office BP exceeds 135/85 mmHg. The prevalence of confirmed hypertension (office BP \>135/85 mmHg and home BP \>130/80 mmHg) and white coat hypertension (office BP \>135/85 mmHg but home BP ≤130/80 mmHg) will be determined. Women with confirmed hypertension are offered antihypertensive treatment mainly with methyldopa. In women with a) confirmed hypertension, b) white coat hypertension, and c) normal blood pressure before entering third trimester of pregnancy, the prevalence of preeclampsia and preterm delivery will be evaluated. Possible side effects of antihypertensive treatment including impaired fetal haemodynamics and lower infant birth weight will be recorded. The women will complete food diaries and questionnaires on lifestyle and mental health three times in pregnancy in order to evaluate the influence of these parameters on hypertension and preeclampsia.
Detailed description
Design: Home blood pressure and office blood pressure as predictors of preeclampsia will be evaluated in the total cohort. From February 2018, the routine care includes treatment with prophylactic aspirin in all women with pre-existing diabetes and screening for vitamin D insufficiency, treated with vitamin D depending on the severity of the insufficiency. The prevalence of preeclampsia after initiation of the new treatment strategy will be evaluated. The women included from 2016-2018, where aspirin was only initiated if other risk factors to preeclampsia apart from diabetes were present, will be used for comparison.
Interventions
DRUGAntihypertensiva, mainly Metyldopa
Sponsors
Odense University Hospital
Rigshospitalet, Denmark
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria for pregnant women with diabetes: * Women with pre-existing diabetes, older than 18 years and referred to The Center for Pregnant Women with Diabetes, Rigshospitalet, or the Centre for Diabetes and Pregnancy, Odense University Hospital, with a live singleton or twin pregnancy before 20 weeks during the inclusion period. * Women with diabetes diagnosed in pregnancy before 20 weeks (HbA1c ≥48 mmol/mol) may also be included as having type 2 diabetes. * Sufficient Danish language skills to read and understand the patient information sheet and to converse. Inclusion criteria for pregnant healthy women without diabetes: * Women above 18 years of age, with a live singleton pregnancy, referred to a nuchal translucency scan at 11-14 weeks at The Department of Obstetrics, Rigshospitalet. * Sufficient Danish language skills to read and understand the patient information sheet and to converse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early preterm delivery (Danish) | 4 years | Birth before 34 completed weeks |
| Preterm birth | 4 years | Birth before 37 completed weeks |
| Early preterm delivery (international) | 4 years | Birth before 32 completed weeks |
| Confirmed hypertension | 2 years | Office blood pressure \>135/85 mmHg measured twice at least 4 hours apart and home blood pressure \>130/80 mmHg in pregnancy, or diagnosed hypertension with antihypertensive treatment from before pregnancy |
| White coat hypertension | 2 years | Office blood pressure \>135/85 mmHg measured twice at least 4 hours apart, but home blood pressure ≤130/80 mmHg |
| Preeclampsia | 4 years | — |
| Early preeclampsia | 4 years | Preeclampsia occurring before 34 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chronic hypertension | 4 years | Hypertension diagnosed prior to pregnancy, or during pregnancy before 20 weeks |
| Gestational hypertension | 4 years | De novo hypertension appearing after 20 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| Duration of active labour | 2 years | — |
| Major congenital malformations | 4 years | Malformations that include ICD 10 codes: Q00-Q99. In addition, a congenital abnormality that requires medical or surgical treatment, has a serious adverse effect on health and development, or has significant cosmetic impact |
| Perinatal mortality | 4 years | Perinatal death includes infant deaths that occur at less than 28 days of age and fetal deaths with a stated or presumed period of gestation of 20 weeks or more |
| Perinatal morbidity | 4 years | The occurrence of at least one of the following complications: neonatal hypoglycaemia, neonatal jaundice, transient tachypnea of the newborn or admission to neonatal intensive care unit within the first 28 days of life |
| Neonatal hypoglycaemia (Danish definition) | 4 years | Plasma glucose \<5 mmol/L, measured within 4 hours of life. |
| Neonatal hypoglycaemia (common international) | 4 years | Neonatal hypoglycemia defined as a plasma glucose value \< 2.2 mmol/L, measured within 4 hours of life |
| Jaundice | 4 years | — |
| Transient tachypnea of the newborn | 4 years | A need for Continuous Positive Airway Pressure for more than 60 minutes |
| Infant birth weight SD-score | 4 years | — |
| Microalbuminuria | 4 years | 30-300 mg/day albumin or ACR, 30-300 mg/g of creatinine or 3.4-34 mg/mmol of creatinine |
| Diabetic nephropathy | 4 years | U-albumin \>300 mg/day or albumin to creatinine ratio\>300 mg/g of creatinine or \>34 mg/mmol of creatinine |
| Diabetic retinopathy | 4 years | Presence of any diabetic retinopathy at first examination in pregnancy |
| Kidney involvement | 4 years | Diabetic nephropathy or microalbuminuria |
| Pulsatility index (PI) of the middle cerebral artery (MCA) measured with Doppler flow measurements | 2 years | — |
| Pulsatility index (PI) of the umbilical artery (UA) measured with Doppler flow | 2 years | — |
| Ratio of the pulsatility index (PI) of the middle cerebral artery and the umbilical artery | 2 years | — |
| Body mass index (BMI) | 4 years | — |
| Apgar score | 4 years | A measure of the health of a newborn infant done at 1 and 5 min. The newborn is given points (0, 1, 2) for heart rate, respiratory effort, muscle tone, response to stimulation and skin coloration. A score of 10 points indicates excellent health. |
| Large for gestational age | 4 years | — |
| Small for gestational age | 4 years | — |
| Ponderal index | 2 years | — |
| Gestational weight gain | 4 years | — |
| Caesarean section | 4 years | — |
| Shoulder dystocia | 4 years | — |
| Degree of rupture | 2 years | — |
| Duration from induction of labour to delivery | 2 years | — |
Countries
Denmark
Outcome results
None listed