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Observational cohort study of pregnancy outcome after first-trimester exposure to fluoroquinolones.

ABSTRACT: Fluoroquinolones are avoided during pregnancy due to developmental toxicity in animals. The aim of this study was to assess the fetal risk after intrauterine fluoroquinolone exposure. We performed an observational study of a prospectively ascertained cohort of pregnant women exposed to a fluoroquinolone during the first trimester. Pregnancy outcomes were compared to those of a cohort exposed to neither fluoroquinolones nor teratogenic or fetotoxic drugs. The outcomes evaluated were major birth defects (structural abnormalities of medical, surgical, or cosmetic relevance), spontaneous abortion, and elective termination of pregnancy. Pregnancy outcomes of 949 women with fluoroquinolone treatment were compared with those of 3,796 nonexposed controls. Neither the rate of major birth defects (2.4%; adjusted odds ratio [OR(adj)], 0.91; 95% confidence interval [CI], 0.6 to 1.5) nor the risk of spontaneous abortion (adjusted hazard ratio [HR(adj)], 1.01; 95% CI, 0.8 to 1.3) was increased. However, there was a nonsignificant increase in major birth defects after exposure to moxifloxacin (6/93, 6.5%; crude odds ratio [OR(crude)], 2.40; 95% CI, 0.8 to 5.6). Neither a critical exposure time window within the first trimester nor a specific pattern of birth defects was demonstrated for any of the fluoroquinolones. The rate of electively terminated pregnancies was increased among the fluoroquinolone-exposed women (HR(adj), 1.32; 95% CI, 1.03 to 1.7). The gestational ages at delivery and birth weights did not differ between groups. Our study did not detect an increased risk of spontaneous abortion or major birth defects. These reassuring findings support the recommendation to allow fluoroquinolone use in early pregnancy in selected cases. After the use of moxifloxacin, a detailed fetal ultrasound examination should be considered.

SUBMITTER: Padberg S

PROVIDER: S-EPMC4136025 | biostudies-literature | 2014 Aug

REPOSITORIES: biostudies-literature

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Observational cohort study of pregnancy outcome after first-trimester exposure to fluoroquinolones.

Padberg Stephanie S Wacker Evelin E Meister Reinhard R Panse Mary M Weber-Schoendorfer Corinna C Oppermann Marc M Schaefer Christof C

Antimicrobial agents and chemotherapy 20140519 8

Fluoroquinolones are avoided during pregnancy due to developmental toxicity in animals. The aim of this study was to assess the fetal risk after intrauterine fluoroquinolone exposure. We performed an observational study of a prospectively ascertained cohort of pregnant women exposed to a fluoroquinolone during the first trimester. Pregnancy outcomes were compared to those of a cohort exposed to neither fluoroquinolones nor teratogenic or fetotoxic drugs. The outcomes evaluated were major birth d ...[more]

PMID: 24841264

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Project description:ObjectiveTo investigate whether first-trimester maternal haemodynamic adaptation impacts placental, embryonic and fetal development as well as birth outcomes in pregnancies with and without placenta-related complications.DesignProspective observational cohort.SettingA Dutch tertiary hospital.PopulationTwo hundred and fourteen ongoing pregnancies.MethodsAt 7, 9 and 11 weeks of gestation, we assessed maternal haemodynamic adaptation (mean arterial blood pressure [MAP], uterine artery [UtA] blood flow) and placental development (placental volume [PV], uteroplacental vascular volume [uPVV]) using three-dimensional power Doppler ultrasound volumes, and embryonic development (crown-rump length, embryonic volume). At 22 and 32 weeks of gestation, fetal development was assessed by estimated fetal weight. Birth outcomes (birthweight, placental weight) were extracted from medical records. Linear mixed modelling and linear regression analyses were applied.Main outcome measuresBirthweight centile and placental weight.ResultsIn placenta-related complications (n= 55, 25.7%), reduced haemodynamic adaptation, i.e. higher UtA pulsatility index (PI) and resistance index (RI) trajectories, was associated with smaller increase in PV (β = -0.559, 95% CI -0.841 to -0.278, P< 0.001; β = -0.579, 95% CI -0.878 to -0.280, P< 0.001) and uPVV trajectories (UtA PI: β = -0.301, 95% CI -0.578 to -0.023, P= 0.034). At birth, reduced haemodynamic adaptation was associated with lower placental weight (UtA PI: β = -0.502, 95% CI -0.922 to -0.082, P= 0.022; UtA RI: β = -0.435, 95% CI -0.839 to -0.032, P= 0.036). In pregnancies without placenta-related complications, higher MAP trajectories were positively associated with birthweight centile (β = 0.398, 95% CI 0.049-0.748, P= 0.025).ConclusionsReduced first-trimester maternal haemodynamic adaptation impacts both placental size and vascularisation and birthweight centile, in particular in pregnancies with placenta-related complications.Tweetable abstractReduced first-trimester maternal haemodynamic adaptation to pregnancy impairs early placental development.

Dataset Information

Observational cohort study of pregnancy outcome after first-trimester exposure to fluoroquinolones.

Publications

Observational cohort study of pregnancy outcome after first-trimester exposure to fluoroquinolones.

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