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Trial record 4 of 31 for:    "Preeclampsia/eclampsia 1" | "Antihypertensive Agents"

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

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ClinicalTrials.gov Identifier: NCT02890836
Recruitment Status : Recruiting
First Posted : September 7, 2016
Last Update Posted : July 8, 2019
Sponsor:
Collaborator:
Odense University Hospital
Information provided by (Responsible Party):
Marianne Vestgaard, Rigshospitalet, Denmark

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.

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.


Condition or disease Intervention/treatment
Pregnancy in Diabetics Drug: Antihypertensiva, mainly Metyldopa

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Blood Pressure, Antihypertensive Treatment and Preeclampsia in Pregnant Wom-en With Pre-existing Diabetes
Actual Study Start Date : February 2016
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : February 2021


Group/Cohort Intervention/treatment
Pregnant women with pre-existing diabetes
Inclusion of 400 women is anticipated.
Drug: Antihypertensiva, mainly Metyldopa
Healthy pregnant women
Inclusion of 100 women is anticipated



Primary Outcome Measures :
  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: 2 years ]
  4. Early preeclampsia [ Time Frame: 2 years ]
    Preeclampsia occurring before 34 weeks

  5. Preterm birth [ Time Frame: 2 years ]
    Birth before 37 completed weeks

  6. Early preterm delivery (international) [ Time Frame: 2 years ]
    Birth before 32 completed weeks

  7. Early preterm delivery (Danish) [ Time Frame: 2 years ]
    Birth before 34 completed weeks


Secondary Outcome Measures :
  1. Gestational hypertension [ Time Frame: 2 years ]
    De novo hypertension appearing after 20 weeks

  2. Chronic hypertension [ Time Frame: 2 years ]
    Hypertension diagnosed prior to pregnancy, or during pregnancy before 20 weeks


Other Outcome Measures:
  1. Infant birth weight SD-score [ Time Frame: 2 years ]
  2. Large for gestational age [ Time Frame: 2 years ]
  3. Small for gestational age [ Time Frame: 2 years ]
  4. Ponderal index [ Time Frame: 2 years ]
  5. Gestational weight gain [ Time Frame: 2 years ]
  6. Caesarean section [ Time Frame: 2 years ]
  7. Shoulder dystocia [ Time Frame: 2 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: 2 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: 2 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: 2 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: 2 years ]
    Plasma glucose <5 mmol/L, measured within 4 hours of life.

  15. Neonatal hypoglycaemia (common international) [ Time Frame: 2 years ]
    Neonatal hypoglycemia defined as a plasma glucose value < 2.2 mmol/L, measured within 4 hours of life

  16. Jaundice [ Time Frame: 2 years ]
  17. Transient tachypnea of the newborn [ Time Frame: 2 years ]
    A need for Continuous Positive Airway Pressure for more than 60 minutes

  18. Apgar score [ Time Frame: 2 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: 2 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: 2 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: 2 years ]
    Presence of any diabetic retinopathy at first examination in pregnancy

  22. Kidney involvement [ Time Frame: 2 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: 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
A cohorte of unselected consecutive pregnant women with pre-existing type 1 and type 2 diabetes will be included.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890836


Contacts
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Contact: Elisabeth Mathiesen, DMSc em@rh.dk
Contact: Marianne Vestgaard, MD marianne.jenlev.vestgaard@regionh.dk

Locations
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Denmark
Center for Pregnant Women with Diabetes Recruiting
Copenhagen, Kbh Ø, Denmark, 2100
Contact: Elisabeth Mathiesen, DMSc       em@rh.dk   
Contact: Marianne Vestgaard, MD       marianne.jenlev.vestgaard@regionh.dk   
Sponsors and Collaborators
Rigshospitalet, Denmark
Odense University Hospital

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Responsible Party: Marianne Vestgaard, MD, Ph.D student, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02890836     History of Changes
Other Study ID Numbers: H-15019186
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Marianne Vestgaard, Rigshospitalet, Denmark:
Blood pressure
Hypertension
White coat hypertension
Preeclampsia
Anti-hypertensiva
Additional relevant MeSH terms:
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Pre-Eclampsia
Pregnancy in Diabetics
Hypertension, Pregnancy-Induced
Pregnancy Complications
Antihypertensive Agents