Skip to main content
OpenTrials
Completed

NCT Number: NCT02890836

Blood Pressure, Antihypertensive Treatment and Preeclampsia in Pregnant Wom-en With Pre-existing Diabetes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy in Diabetics Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases Vascular Diseases White Coat Hypertension

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Center for Pregnant Women with Diabetes

Copenhagen, Kbh Ø, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

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.

Treatment and study plan

Antihypertensiva, mainly Metyldopa

Drug

Primary outcomes

  1. Confirmed hypertension

    Time frame: 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

  2. White coat hypertension

    Time frame: 2 years

    Office blood pressure >135/85 mmHg measured twice at least 4 hours apart, but home blood pressure ≤130/80 mmHg

  3. Preeclampsia

    Time frame: 4 years

  4. Early preeclampsia

    Time frame: 4 years

    Preeclampsia occurring before 34 weeks

  5. Preterm birth

    Time frame: 4 years

    Birth before 37 completed weeks

  6. Early preterm delivery (international)

    Time frame: 4 years

    Birth before 32 completed weeks

  7. Early preterm delivery (Danish)

    Time frame: 4 years

    Birth before 34 completed weeks

Secondary outcomes

  1. Gestational hypertension

    Time frame: 4 years

    De novo hypertension appearing after 20 weeks

  2. Chronic hypertension

    Time frame: 4 years

    Hypertension diagnosed prior to pregnancy, or during pregnancy before 20 weeks

Other outcomes

  1. Infant birth weight SD-score

    Time frame: 4 years

  2. Large for gestational age

    Time frame: 4 years

  3. Small for gestational age

    Time frame: 4 years

  4. Ponderal index

    Time frame: 2 years

  5. Gestational weight gain

    Time frame: 4 years

  6. Caesarean section

    Time frame: 4 years

  7. Shoulder dystocia

    Time frame: 4 years

  8. Degree of rupture

    Time frame: 2 years

  9. Duration from induction of labour to delivery

    Time frame: 2 years

  10. Duration of active labour

    Time frame: 2 years

  11. Major congenital malformations

    Time frame: 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

  12. Perinatal mortality

    Time frame: 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

  13. Perinatal morbidity

    Time frame: 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

  14. Neonatal hypoglycaemia (Danish definition)

    Time frame: 4 years

    Plasma glucose <5 mmol/L, measured within 4 hours of life.

  15. Neonatal hypoglycaemia (common international)

    Time frame: 4 years

    Neonatal hypoglycemia defined as a plasma glucose value < 2.2 mmol/L, measured within 4 hours of life

  16. Jaundice

    Time frame: 4 years

  17. Transient tachypnea of the newborn

    Time frame: 4 years

    A need for Continuous Positive Airway Pressure for more than 60 minutes

  18. Apgar score

    Time frame: 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.

  19. Microalbuminuria

    Time frame: 4 years

    30-300 mg/day albumin or ACR, 30-300 mg/g of creatinine or 3.4-34 mg/mmol of creatinine

  20. Diabetic nephropathy

    Time frame: 4 years

    U-albumin >300 mg/day or albumin to creatinine ratio>300 mg/g of creatinine or >34 mg/mmol of creatinine

  21. Diabetic retinopathy

    Time frame: 4 years

    Presence of any diabetic retinopathy at first examination in pregnancy

  22. Kidney involvement

    Time frame: 4 years

    Diabetic nephropathy or microalbuminuria

  23. Pulsatility index (PI) of the middle cerebral artery (MCA) measured with Doppler flow measurements

    Time frame: 2 years

  24. Pulsatility index (PI) of the umbilical artery (UA) measured with Doppler flow

    Time frame: 2 years

  25. Ratio of the pulsatility index (PI) of the middle cerebral artery and the umbilical artery

    Time frame: 2 years

  26. Body mass index (BMI)

    Time frame: 4 years

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Odense University Hospital

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Sep 7, 2016
Registry last updated
May 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.