Pregnancy Outcome After First Trimester Use of Methyldopa
| Autor: | Evelin Beck, Juliane Wernicke, Angela Kayser, Stephanie Padberg, Anne-Katrin Fietz, Maria Hoeltzenbein, Sandra Zinke, Corinna Weber-Schoendorfer, Christof Schaefer, Reinhard Meister |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
Adult
medicine.medical_specialty Early Pregnancy Loss Birth weight Pregnancy Complications Cardiovascular 030204 cardiovascular system & hematology Risk Assessment Congenital Abnormalities Pharmacovigilance 03 medical and health sciences 0302 clinical medicine Pregnancy Germany Internal Medicine medicine Humans Prospective Studies cardiovascular diseases Methyldopa Prospective cohort study Antihypertensive Agents 030219 obstetrics & reproductive medicine business.industry Obstetrics Pregnancy Outcome Infant Low Birth Weight medicine.disease Abortion Spontaneous Pregnancy Trimester First Low birth weight Hypertension Cohort Premature Birth Female medicine.symptom business medicine.drug Cohort study |
| Zdroj: | Hypertension. 70:201-208 |
| ISSN: | 1524-4563 0194-911X 0001-0502 |
| Popis: | Published experience on first trimester exposure to methyldopa is still limited, although it is recommended as first-line treatment for hypertensive disorders in pregnancy in most countries. The primary aim of this prospective observational cohort study was to analyze the rate of major birth defects and spontaneous abortions in women with methyldopa therapy for chronic hypertension. Outcomes of 261 pregnancies with first trimester exposure to methyldopa and 526 comparison pregnancies without chronic hypertension reported to the German Embryotox pharmacovigilance institute were evaluated. The rate of major birth defects in the exposed cohort was not significantly increased compared with the comparison cohort (3.7% versus 2.5%; adjusted odds ratio, 1.24; 95% confidence interval, 0.4–4.0). There was a tendency toward a higher rate of spontaneous abortions in exposed women. The risk of preterm birth was significantly higher, and adjusted birth weight scores were significantly lower in the methyldopa group. Head circumferences were significantly reduced in exposed boys only. There was neither evidence for an increased risk for birth defects or increase in early pregnancy loss nor evidence for growth restriction or a reduced head circumference in a sensitivity analysis comparing monotherapies with methyldopa to metoprolol. However, the significantly increased risk of preterm birth in methyldopa-treated pregnancies was confirmed. In conclusion, our study does not indicate a teratogenic risk of methyldopa. Further studies are needed to confirm its safety in the first trimester and clarify the influence of hypertension and methyldopa on preterm birth and intrauterine growth. Clinical Trial Registration— URL: https://drks-neu.uniklinik-freiburg.de/drks_web/ . Unique identifier: DRKS00010502. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|