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

• Conditions: MedDRA - 10056471 Bradycardia neonatal; P05.0; P70.4; P22.8; P07.3; P95; Q02; Light for gestational age; Other neonatal hypoglycaemia; Other respiratory distress of newborn

• Registration Number: DRKS00012418
• Lead Sponsor: Pharmakovigilanz- und Beratungszentrum Embryonaltoxikologie Charité Universitätsmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-19
• Study Completion: 2019-03-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 1107

Inclusion Criteria

Prospectively ascertained pregnancies

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.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Is there an increased rate of the following diagnoses after exposure to the study medication during the 2. and/ or 3. trimester?<br>a.Neonates which are small-for geatational-age?<br>b.Neonatal Bradycardia?<br>c.Neonatal hypoglycaemia<br>d.Neonatal apnoea?<br><br>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.<br>

Secondary Outcome Measures

Name	Time	Method
Is there an increased risk for preterm delivery, stillbirth or microcephaly after exposure to the study medication during the 2. and/ or 3. trimester?<br><br>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.