Trial document




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  DRKS00010502

Trial Description

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Title

Effects of antihypertensive therapy on pregnancy outcome – An observational cohort study of the Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie Berlin

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Hypertension is the most prevalent cardiovascular disease in pregnancy. The aim of the study is to confirm that there is no increased risk for congenital malformations or spontaneous abortions after first trimester exposure to antihypertensives.

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Brief Summary in Scientific Language

The objective of this study is to evaluate prospectively ascertained pregnancies of hypertensive women with antihypertensive therapy during the first trimester with respect to major malformations and spontaneous abortions. The following antihypertensives will be analysed:
methyldopa, angiotensin-converting enzyme-inhibitors (ACE-inhibitors), ARBs (AT1-antagonists) and calcium-channel-blockers. Exposed pregnancies will be compared to a control group of pregnant women without antihypertensive therapy. In case of an increased risk a secondary analysis will be performed comparing the group treated with the study medication (Methyldopa, ACE-I, ARBs or calcium-channel blockers) with a disease control group of hypertensive pregnant women with monotherapy of metoprolol or bisoprolol in the first trimester. The study is expected to improve risk assessment of antihypertensive therapy in the first trimester and to contribute to safety of drug treatment during pregnancy

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Organizational Data

  •   DRKS00010502
  •   2016/05/20
  •   [---]*
  •   yes
  •   Approved
  •   EA1/107/16, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Q89.9 -  Congenital malformation, unspecified
  •   O03 -  Spontaneous abortion
  •   Congenital malformations and spontaneous abortions after antihypertensive therapy in the first trimester of pregnancy.
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Interventions/Observational Groups

  •   Study group: Antihypertensive treatment in first trimester
  •   Control group: No antihypertensive treatment in first trimester
  •   Disease control Group: Monotherapy with metoprolol or bisoprolol in first trimester
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Other
  •   Prognosis
  •   Parallel
  •   N/A
  •   Yes
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Primary Outcome

Risk for malformations and rate of spontaneous abortions

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Secondary Outcome

none

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2016/05/23
  •   5500
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

prospectively ascertained pregnancy

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Exclusion Criteria

Exclusion of concomitant therapy with known teratogens or fetotoxic drugs: carbamazepine, lenalidomide, methotrexate,mycophenolate, phenobarbital, phenytoin, retinoids, thalidomide, topiramate, valproate, ARBs (AT1-antagonists)* and ACE-inhibitors*. In addition malignant diseases are defined as exclusion criterion.

Therapy with ARBs (AT1-antagonists) and ACE-inhibitors* in the first trimester is only possible in the corresponding study groups of these substances, but pregnancies with continued therapy after week 20 are excluded.

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Addresses

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Sources of Monetary or Material Support

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    • Bundesministerium für Gesundheit
    • 53123  Bonn
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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    • Bundesinstitut für Arzneimittel und Medizinprodukte
    • Kurt-Georg-Kiesinger-Allee 3
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  •   Hoeltzenbein M, Beck E, Fietz AK, Wernicke J, Zinke S, Kayser A, Padberg S, Weber-Schoendorfer C, Meister R, Schaefer C. Pregnancy Outcome After First Trimester Use of Methyldopa: A Prospective Cohort Study. Hypertension. 2017;70:201-208.
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* This entry means the parameter is not applicable or has not been set.
*** This entry means that data is not displayed due to insufficient data privacy clearing.