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Developmental consequences of children born from mothers with telbivudine treatment during late pregnancy: A prospective study with 3-year follow-up.

ABSTRACT: We prospectively investigated the neurological development in infants born from mothers treated with telbivudine (LdT) in the third trimester for prevention of hepatitis B virus (HBV) mother-to-infant transmission. Mothers with high HBV load were assigned to either the LdT group (n = 81, 600 mg of LdT each day from gestational week 28 to delivery) or the Control group (n = 39, untreated). Their infants were followed for 36 months to assess physical and neurological developments with Gesell Developmental Schedule tools. At 12 months after birth, the mean scores in the LdT group for gross motor, fine motor, adaptive, linguistic, and personal social domains were similar to those in the Control group. At 36 months, infants in the LdT group had higher mean scores for gross motor than the Control group (98.42 ± 9.69 vs. 94.54 ± 7.48, P = 0.03). In the LdT group, the rates of normal development were higher for gross motor (96.30% vs. 82.05% P = 0.01) and lower for adaptive (74.07% vs. 92.31% P = 0.02). Multivariate regression analyses showed that exposure to LdT during pregnancy was independently associated with infant's development in gross motor (OR 6.49, 95% CI 1.37-30.20, P = 0.02) and adaptive (OR 0.18, 95% CI 0.05-0.71, P = 0.01) at 36 months. These results suggest that prenatal LdT exposure might affect neurological development in long-term observation.Abbreviations: LdT: telbivudine; HBV: hepatitis B virus; HBsAg: hepatitis B surface antigen; HBeAg: hepatitis Be antigen; HbsAb: hepatitis B surface antibody; ALT: alanine aminotransferase; NA: nucleoside/nucleotide analog; LAM: lamivudine; MTCT: mother-to-child transmission; GDS: Gesell Developmental Schedule; OR: odds ratio; CI: confidence interval; DQ: developmental quotient; RMB: renminbi; BMI: body mass Index; HBIG: hepatitis B immunoglobulin.

SUBMITTER: Yi W

PROVIDER: S-EPMC8205043 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundMetformin is widely used in pregnancy to treat gestational diabetes mellitus and polycystic ovary syndrome (PCOS). Association between PCOS and developmental delay in offspring, and larger head circumference of metformin-exposed newborns has been reported. The objective of this study was to explore whether metformin exposure in utero had any effect on offspring cognitive function.MethodThe current study is a follow-up of two randomized, placebo-controlled studies which were conducted at 11 public hospitals in Norway In the baseline studies (conducted in 2000-2003, and 2005-2009), participants were randomized to metformin 1700 and 2000 mg/d or placebo from first trimester to delivery. There was no intervention in the current study. We invited parents of 292 children to give permission for their children to participate; 93 children were included (mean age 7.7 years). The follow-up study was conducted in 2014-2016. The Wechsler Preschool and Primary Scale of Intelligence version III and the Wechsler Intelligence Scale for Children version IV were applied for cognitive assessment. Androstenedione and testosterone were measured in maternal blood samples at four time-points in pregnancy.ResultsWe found no difference in mean, full scale IQ in metformin (100.0 (SD 13.2)) vs. placebo-exposed (100.9 (SD 10.1)) children. There was an association between metformin exposure in utero and borderline intellectual function of children (full scale IQ between 70 and 85). Free testosterone index in gestational week 19, and androstenedione in gestational week 36 correlated positively to full scale IQ.ConclusionsWe found no evidence of long-term effect of metformin on average child cognitive function. The increase of borderline intellectual functioning in metformin-exposed children must be interpreted with caution due to small sample size.Trial registrationThe baseline study was registered on 12 September 2005 at the US National Institute of Health (ClinicalTrials.gov) # NCT00159536.

Project description:BackgroundThere are limited data on long-term outcomes of children whose mothers have followed exercise interventions during pregnancy. The aim of this paper was to investigate whether regular moderate intensity exercise during pregnancy affected the children's body mass index (BMI) and physical activity (PA) at 7 years of age, and determine the relationship between children's and mothers' BMI and PA.MethodsThis was a follow-up of a multicentre randomised controlled trial, carried out at St. Olavs Hospital, Trondheim University Hospital, and Stavanger University Hospital, Norway (2007-2009 and 2014-2016). Women were randomised to follow a 12-week structured exercise protocol or standard antenatal care during pregnancy. At the 7-year follow-up, parents reported their child's height, weight, and PA. The mothers also reported their own weight and PA. Main outcome variables were BMI, frequency and duration of moderate to vigorous PA (MVPA), and intensity of PA.ResultsA total of 855 women were randomised to exercise (n = 429) or standard antenatal care (n = 426) during pregnancy. At follow-up, 164 (38.2%) children and mothers in the intervention group and 117 (27.5%) in the control group participated. We found no group differences in the children's iso-BMI or PA. Findings were similar when we performed stratified analyses by sex, except boys in the control group spent more time on electrical devices than boys in the intervention group. Subgroup analyses of children of mothers who adhered to the exercise protocol and sensitivity analyses excluding children born preterm, children admitted to the neonatal intensive care unit, and children with diseases or health problems at the 7-year follow-up, did not change the results. Children's BMI, weekly leisure time MVPA and intensity of PA correlated with mothers' BMI, daily exercise, and intensity of exercise.ConclusionsRegular moderate intensity exercise during pregnancy did not affect BMI or PA of the children at 7 years. Good maternal health should be encouraged as it may influence the health of the next generation.Trial registrationThe initial RCT study was registered in ClinicalTrials.gov NCT00476567 .

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Developmental consequences of children born from mothers with telbivudine treatment during late pregnancy: A prospective study with 3-year follow-up.

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