TY - JOUR
T1 - Ciprofloxacin exposure and adverse pregnancy outcomes
T2 - a Danish nationwide cohort study
AU - Noergaard, Mia
AU - Gotfredsen, Ditte Resendal
AU - Sørensen, Anne Mette Skov
AU - Andersen, Jon Traerup
N1 - This article is protected by copyright. All rights reserved.
PY - 2022/8
Y1 - 2022/8
N2 - OBJECTIVE: To examine the association between maternal exposure to ciprofloxacin and the risk of miscarriage and major malformations.DESIGN: A nationwide register-based cohort study.SETTING: Data were obtained from the Medical Birth Registry, the National Hospital Registry, the Danish National Prescription Registry and Statistics Denmark.POPULATION: Data were collected in the period between 1997 and 2016 and included all registered pregnancies that ended in an elective termination, miscarriage, stillbirth or a live birth. Exposure was defined as redeeming one or more prescriptions of ciprofloxacin.METHODS: Miscarriage was defined as a diagnosis given before 22 weeks without any medical intervention. Major malformations were classified according to EUROCAT 1.4. We matched ciprofloxacin-exposed pregnancies to unexposed pregnancies on the propensity score in a ratio 1:4. To estimate the hazard ratio (HR) of miscarriage a Cox proportional hazard regression model was used. A log binomial model was used to estimate the relative risk ratio (RR) of major malformations.MAIN OUTCOME MEASURES: HR of miscarriage and the RR of major malformations.RESULTS: A total of 1 650 649 pregnancies were identified. Of these, 10 250 (2050 ciprofloxacin-exposed) and 6100 (1220 ciprofloxacin-exposed) were included in the miscarriage and major malformation analysis, respectively. The HR of miscarriage was 0.99 (95% confidence interval [CI] 0.84-1.17). For major malformation, the RR was 1.01 (95% CI 0.72-1.40). For the organ-specific major malformations and the sensitivity analyses, no significant increased risks were identified.CONCLUSION: We demonstrated no association between miscarriage and maternal ciprofloxacin exposure within the first 22 weeks of pregnancy, or between major malformations and maternal exposure during the first trimester.TWEETABLE ABSTRACT: No association between maternal ciprofloxacin exposure and adverse pregnancy outcomes.
AB - OBJECTIVE: To examine the association between maternal exposure to ciprofloxacin and the risk of miscarriage and major malformations.DESIGN: A nationwide register-based cohort study.SETTING: Data were obtained from the Medical Birth Registry, the National Hospital Registry, the Danish National Prescription Registry and Statistics Denmark.POPULATION: Data were collected in the period between 1997 and 2016 and included all registered pregnancies that ended in an elective termination, miscarriage, stillbirth or a live birth. Exposure was defined as redeeming one or more prescriptions of ciprofloxacin.METHODS: Miscarriage was defined as a diagnosis given before 22 weeks without any medical intervention. Major malformations were classified according to EUROCAT 1.4. We matched ciprofloxacin-exposed pregnancies to unexposed pregnancies on the propensity score in a ratio 1:4. To estimate the hazard ratio (HR) of miscarriage a Cox proportional hazard regression model was used. A log binomial model was used to estimate the relative risk ratio (RR) of major malformations.MAIN OUTCOME MEASURES: HR of miscarriage and the RR of major malformations.RESULTS: A total of 1 650 649 pregnancies were identified. Of these, 10 250 (2050 ciprofloxacin-exposed) and 6100 (1220 ciprofloxacin-exposed) were included in the miscarriage and major malformation analysis, respectively. The HR of miscarriage was 0.99 (95% confidence interval [CI] 0.84-1.17). For major malformation, the RR was 1.01 (95% CI 0.72-1.40). For the organ-specific major malformations and the sensitivity analyses, no significant increased risks were identified.CONCLUSION: We demonstrated no association between miscarriage and maternal ciprofloxacin exposure within the first 22 weeks of pregnancy, or between major malformations and maternal exposure during the first trimester.TWEETABLE ABSTRACT: No association between maternal ciprofloxacin exposure and adverse pregnancy outcomes.
KW - Abortion, Spontaneous/chemically induced
KW - Ciprofloxacin/adverse effects
KW - Cohort Studies
KW - Denmark/epidemiology
KW - Female
KW - Humans
KW - Pregnancy
KW - Pregnancy Trimester, First
UR - http://www.scopus.com/inward/record.url?scp=85122760461&partnerID=8YFLogxK
U2 - 10.1111/1471-0528.17083
DO - 10.1111/1471-0528.17083
M3 - Journal article
C2 - 34954900
SN - 1470-0328
VL - 129
SP - 1503
EP - 1511
JO - BJOG : an international journal of obstetrics and gynaecology
JF - BJOG : an international journal of obstetrics and gynaecology
IS - 9
ER -