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| Name | Class |
|---|---|
| Odense University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant women with pre-existing diabetes | Inclusion of 400 women is anticipated. |
| |
| Healthy pregnant women | Inclusion of 100 women is anticipated |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antihypertensiva, mainly Metyldopa | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed hypertension | 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 | 2 years |
| White coat hypertension | Office blood pressure >135/85 mmHg measured twice at least 4 hours apart, but home blood pressure ≤130/80 mmHg | 2 years |
| Preeclampsia | 4 years | |
| Early preeclampsia | Preeclampsia occurring before 34 weeks | 4 years |
| Preterm birth | Birth before 37 completed weeks | 4 years |
| Early preterm delivery (international) | Birth before 32 completed weeks | 4 years |
| Early preterm delivery (Danish) | Birth before 34 completed weeks | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational hypertension | De novo hypertension appearing after 20 weeks | 4 years |
| Chronic hypertension | Hypertension diagnosed prior to pregnancy, or during pregnancy before 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Infant birth weight SD-score | 4 years | |
| Large for gestational age | 4 years | |
| Small for gestational age |
Inclusion Criteria:
Inclusion criteria for pregnant women with diabetes:
Inclusion criteria for pregnant healthy women without diabetes:
Exclusion Criteria:
Exclusion criteria for both study groups:
• Women diagnosed with severe diseases that could possibly bias BP measurements or pregnancy outcome. This is judged by the principal investigators.
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A cohorte of unselected consecutive pregnant women with pre-existing type 1 and type 2 diabetes will be included.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Pregnant Women with Diabetes | Copenhagen | Kbh Ø | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35766641 | Derived | Do NC, Vestgaard M, Asbjornsdottir B, Andersen LLT, Jensen DM, Ringholm L, Damm P, Mathiesen ER. Home Blood Pressure for the Prediction of Preeclampsia in Women With Preexisting Diabetes. J Clin Endocrinol Metab. 2022 Aug 18;107(9):e3670-e3678. doi: 10.1210/clinem/dgac392. | |
| 33368557 | Derived | Asbjornsdottir B, Vestgaard M, Do NC, Ringholm L, Andersen LLT, Jensen DM, Damm P, Mathiesen ER. Prevalence of anxiety and depression symptoms in pregnant women with type 2 diabetes and the impact on glycaemic control. Diabet Med. 2021 Mar;38(3):e14506. doi: 10.1111/dme.14506. Epub 2021 Jan 8. |
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| ID | Term |
|---|---|
| D011254 | Pregnancy in Diabetics |
| D006973 | Hypertension |
| D059466 | White Coat Hypertension |
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014652 | Vascular Diseases |
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| 4 years |
| 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 |
| Duration of active labour | 2 years |
| Major congenital malformations | 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 | 4 years |
| Perinatal mortality | 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 | 4 years |
| Perinatal morbidity | 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 | 4 years |
| Neonatal hypoglycaemia (Danish definition) | Plasma glucose <5 mmol/L, measured within 4 hours of life. | 4 years |
| Neonatal hypoglycaemia (common international) | Neonatal hypoglycemia defined as a plasma glucose value < 2.2 mmol/L, measured within 4 hours of life | 4 years |
| Jaundice | 4 years |
| Transient tachypnea of the newborn | A need for Continuous Positive Airway Pressure for more than 60 minutes | 4 years |
| Apgar score | 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. | 4 years |
| Microalbuminuria | 30-300 mg/day albumin or ACR, 30-300 mg/g of creatinine or 3.4-34 mg/mmol of creatinine | 4 years |
| Diabetic nephropathy | U-albumin >300 mg/day or albumin to creatinine ratio>300 mg/g of creatinine or >34 mg/mmol of creatinine | 4 years |
| Diabetic retinopathy | Presence of any diabetic retinopathy at first examination in pregnancy | 4 years |
| Kidney involvement | Diabetic nephropathy or microalbuminuria | 4 years |
| 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 |
| 31781957 | Derived | Do NC, Vestgaard M, Asbjornsdottir B, Nichum VL, Ringholm L, Andersen LLT, Jensen DM, Damm P, Mathiesen ER. Physical activity, sedentary behavior and development of preeclampsia in women with preexisting diabetes. Acta Diabetol. 2020 May;57(5):559-567. doi: 10.1007/s00592-019-01459-7. Epub 2019 Nov 28. |
| 31628489 | Derived | Vestgaard M, Asbjornsdottir B, Ringholm L, Andersen LLT, Jensen DM, Damm P, Mathiesen ER. White coat hypertension in early pregnancy in women with pre-existing diabetes: prevalence and pregnancy outcomes. Diabetologia. 2019 Dec;62(12):2188-2199. doi: 10.1007/s00125-019-05002-9. Epub 2019 Oct 18. |
| D002318 | Cardiovascular Diseases |
| D046110 | Hypertension, Pregnancy-Induced |