Effects of late pregnancy antihypertensive beta-blocker therapy on fetal outcome - An observational cohort study of the Berlin Institute for Clinical Pharmacology and Toxicology

Effects of late pregnancy antihypertensive beta-blocker therapy on fetal outcome - An observational cohort study of the Berlin Institute for Clinical Pharmacology and Toxicology - Beta-blockers in late pregnancy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00012418

Enrollment

1092

Registered

2017-05-19

Start date

2017-07-01

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

MedDRA - 10056471 Bradycardia neonatal P05.0 P70.4 P22.8 P07.3 P95 Q02

Interventions

Group 1: Study group: Treatment with beta-blockers due to hypertension during the 2. and/ or 3. trimester. For all three groups the folowing applies: Data are recorded prospectively by a structured qu

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Prospectively ascertained pregnancies

Exclusion criteria

Exclusion criteria: Cases with maternal exposure to the following drugs considered as major teratogens: lenalidomide, carbamazepine, methotrexate, mycophenolate, phenobarbital, phenprocoumon, phenytoin, retinoids (acitretin, adapalen, isotretinoin, tazaroten, tretinoin), thalidomide, topiramate, valproic acid, warfarin. Cases with maternal exposure to the angiotensin-converting-enzyme-inhibitors (ACEIs) and angiotensin II-receptor blockers (ARBs). Women with acute malignancies.

Design outcomes

Primary

Measure	Time frame
Is there an increased rate of the following diagnoses after exposure to the study medication during the 2. and/ or 3. trimester? a.Neonates which are small-for geatational-age? b.Neonatal Bradycardia? c.Neonatal hypoglycaemia d.Neonatal apnoea? The Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy counsels patients or their physicians about the risk of medication during pregnancy. This counselling mainly takes place in early pregnancy when outcome or prenatal diagnostic is not known. If the pregnant patient agrees, data are recorded by a structured questionnaire. Eight weeks after the estimated date of birth a further questionnaire is send to collect data about the pregnancy outcome.	—

Measure

Time frame

Is there an increased rate of the following diagnoses after exposure to the study medication during the 2. and/ or 3. trimester? a.Neonates which are small-for geatational-age? b.Neonatal Bradycardia? c.Neonatal hypoglycaemia d.Neonatal apnoea? The Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy counsels patients or their physicians about the risk of medication during pregnancy. This counselling mainly takes place in early pregnancy when outcome or prenatal diagnostic is not known. If the pregnant patient agrees, data are recorded by a structured questionnaire. Eight weeks after the estimated date of birth a further questionnaire is send to collect data about the pregnancy outcome.

—

Secondary

Measure	Time frame
Is there an increased risk for preterm delivery, stillbirth or microcephaly after exposure to the study medication during the 2. and/ or 3. trimester? The Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy counsels patients or their physicians about the risk of medication during pregnancy. This counselling mainly takes place in early pregnancy when outcome or prenatal diagnostic is not known. If the pregnant patient agrees, data are recorded by a structured questionnaire. Eight weeks after the estimated date of birth a further questionnaire is send to collect data about the pregnancy outcome.	—

Measure

Time frame

Is there an increased risk for preterm delivery, stillbirth or microcephaly after exposure to the study medication during the 2. and/ or 3. trimester? The Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy counsels patients or their physicians about the risk of medication during pregnancy. This counselling mainly takes place in early pregnancy when outcome or prenatal diagnostic is not known. If the pregnant patient agrees, data are recorded by a structured questionnaire. Eight weeks after the estimated date of birth a further questionnaire is send to collect data about the pregnancy outcome.

—

Countries

Germany

Contacts

Public ContactAngela Kayser

Pharmakovigilanz- und Beratungszentrum Embryonaltoxikologie Charité Universitätsmedizin

angela.kayser@charite.de+49 30 450525702

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026