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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00010502

Enrollment

5500

Registered

2016-05-20

Start date

2016-05-23

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital malformations and spontaneous abortions after antihypertensive therapy in the first trimester of pregnancy. Q89.9 O03

Interventions

Group 1: Study group: Antihypertensive treatment in first trimester Group 2: Control group: No antihypertensive treatment in first trimester Group 3: Disease control Group: Monotherapy with metoprolol

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: prospectively ascertained pregnancy

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Risk for malformations and rate of spontaneous abortions	—

Countries

Germany

Contacts

Public ContactMaria Hoeltzenbein

Pharmakovigilanz- und Beratungszentrum Embryonaltoxikologie

maria.hoeltzenbein@charite.de+4930450525702

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 26, 2026