Study protocol for a randomised trial for atosiban versus placebo in threatened preterm birth : The APOSTEL 8 study

Peer reviewedPublisher PD

Behavioral and neurodevelopmental outcome of children after maternal allopurinol administration during suspected fetal hypoxia:5-year follow up of the ALLO-trial

Objective To evaluate the long-term neurodevelopmental and behavioral outcome of antenatal allopurinol treatment during suspected fetal hypoxia. Study design We studied children born from women who participated in a randomized double-blind placebo controlled multicenter study (ALLO-trial). Labouring women in whom the fetus was suspected to have fetal hypoxia were randomly allocated to receive allopurinol or placebo. At 5 years of age, the children were assessed with 2 parent reported questionnaires, the Ages and Stages Questionnaire (ASQ) and the Child Behavior Checklist (CBCL). A child was marked abnormal for ASQ if it scored below 2 standard deviation under the normative mean of a reference population in at least one domain. For CBCL, a score above the cut-off value (95th percentile for narrowband scale, 85th percentile for broadband scale) in at least one scale was marked as abnormal. Results We obtained data from 138 out of the original 222 mildly asphyxiated children included in the ALLO-trial (response rate 62%, allopurinol n = 73, placebo n = 65). At 5 years of age, the number of children that scored abnormal on the ASQ were 11 (15.1%) in the allopurinol group versus 11 (9.2%) in the placebo group (relative risk (RR) 1.64, 95% confidence interval (CI): 0.64 to 4.17, p = 0.30). On CBCL 21 children (30.4%) scored abnormal in de allopurinol group versus 12 children (20.0%) in the placebo group (RR 1.52, 95% CI: 0.82 to 2.83, p = 0.18). Conclusion We found no proof that allopurinol administered to labouring women with suspected fetal hypoxia improved long-term developmental and behavioral outcome. These findings are limited due to the fact that the study was potentially underpowered

Deprived neighborhoods and spontaneous preterm birth: A national cohort study

Objective: Spontaneous preterm birth is the leading cause of infant morbidity and mortality in the developed world. Environmental socio-economic factors, such as neighborhood deprivation, are known to negatively affect birth outcomes, including overall preterm birth. However, the role of neighborhood deprivation in spontaneous preterm birth (SPTB) is unclear. The aim of the study is to 1) to determine the effect of neighborhood deprivation on SPTB birth and 2) to investigate the trend in rates of SPTB between 2010 and 2019 for each quintile of neighborhood deprivation. Study design: Based on the national perinatal registry, we included 1,584,225 singleton pregnancies resulting in a birth from 22 to 42 completed weeks of gestation between 2010 and 2019 in the Netherlands. Deprivation scores per neighborhood were derived from the Netherlands Institute of Social Research and were linked to the perinatal registry data, using the woman's home address. The scores were divided into quintiles (Q). Rates of SPTB were calculated, categorized into <37 weeks, <32 weeks and <28 weeks of gestation. We used logistic regression analysis to adjust for maternal age, parity and ethnicity. Results: Compared to the most affluent neighborhoods (Q1), women in all other quintiles had a statistically significant increased risk for SPTB. The largest effect was observed in the most deprived neighborhoods (Q5); adjusted odds ratio 1.16 (95% confidence interval 1.13 – 1.19). From 2010 to 2019, we observed an overall decrease of 0.21% in SPTB < 37 weeks (p < 0.0001). All quintiles showed a decrease in SPTBs < 37 weeks, but only in Q1, Q2 & Q5 this decline in SPTB was statistically significant. Conclusions: Pregnant women in deprived neighborhoods in the Netherlands are more at risk for spontaneous preterm birth. From 2010 to 2019, the rate of spontaneous preterm birth decreased. Efforts should be made by both governmental and medical professionals to develop intervention programs to reduce spontaneous preterm birth in more deprived neighborhoods

Behavioral and neurodevelopmental outcome of children after maternal allopurinol administration during suspected fetal hypoxia : 5-year follow up of the ALLO-trial

Objective To evaluate the long-term neurodevelopmental and behavioral outcome of antenatal allopurinol treatment during suspected fetal hypoxia. Study design We studied children born from women who participated in a randomized double-blind placebo controlled multicenter study (ALLO-trial). Labouring women in whom the fetus was suspected to have fetal hypoxia were randomly allocated to receive allopurinol or placebo. At 5 years of age, the children were assessed with 2 parent reported questionnaires, the Ages and Stages Questionnaire (ASQ) and the Child Behavior Checklist (CBCL). A child was marked abnormal for ASQ if it scored below 2 standard deviation under the normative mean of a reference population in at least one domain. For CBCL, a score above the cut-off value (95th percentile for narrowband scale, 85th percentile for broadband scale) in at least one scale was marked as abnormal. Results We obtained data from 138 out of the original 222 mildly asphyxiated children included in the ALLO-trial (response rate 62%, allopurinol n = 73, placebo n = 65). At 5 years of age, the number of children that scored abnormal on the ASQ were 11 (15.1%) in the allopurinol group versus 11 (9.2%) in the placebo group (relative risk (RR) 1.64, 95% confidence interval (CI): 0.64 to 4.17, p = 0.30). On CBCL 21 children (30.4%) scored abnormal in de allopurinol group versus 12 children (20.0%) in the placebo group (RR 1.52, 95% CI: 0.82 to 2.83, p = 0.18). Conclusion We found no proof that allopurinol administered to labouring women with suspected fetal hypoxia improved long-term developmental and behavioral outcome. These findings are limited due to the fact that the study was potentially underpowered