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Effect of nifedipine and atosiban on perinatal brain injury: secondary analysis of the APOSTEL-III trial.
Ultrasound Obstet Gynecol. 2018 Jun; 51(6):806-812.UO

Abstract

OBJECTIVE

Brain injury in neonates born prematurely is associated strongly with poor neurodevelopmental outcome. The aim of this study was to evaluate whether tocolysis with nifedipine or atosiban in women with threatened preterm birth can reduce the incidence of overall brain injury in neonates born prematurely.

METHODS

This was a secondary analysis of the APOSTEL-III trial (Dutch Clinical Trial Registry, no. NTR2947), a randomized clinical trial in which women with threatened preterm labor between 25 and 34 weeks of gestation were allocated to treatment with nifedipine or atosiban. In this secondary analysis, women delivered at ≤ 32 weeks of gestational age in the two main contributing centers were included. Primary outcome was the presence of neonatal brain injury, which was defined as presence of abnormalities on ultrasound investigation and classified into mild and severe. To evaluate type and severity of brain injury, all neonatal ultrasounds performed during neonatal intensive and medium care admission were analyzed. To test the robustness of our results, a sensitivity analysis was performed assessing differences in baseline or known risk factors for brain injury.

RESULTS

A total of 117 neonates (from 102 women) were studied, of which 51 had been exposed to nifedipine and 66 to atosiban. Brain injury was observed in 22 (43.1%) neonates in the nifedipine group compared with 37 (56.1%) in the atosiban group (OR, 0.60; 95% CI, 0.29-1.24). Presence of mild brain injury was comparable between the nifedipine (33.3%) and atosiban (48.5%) groups (OR, 0.53; 95% CI, 0.25-1.13). Severe brain injury was also comparable between the groups, observed in 9.8% of neonates in the nifedipine vs 7.6% of those in the atosiban group (OR, 1.33; 95% CI, 0.36-4.85). Intraventricular hemorrhage (≥ Grade I) was the most frequently seen ultrasound abnormality, observed in 18 (35.3%) neonates in the nifedipine group vs 25 (37.9%) in the atosiban group (OR, 0.90; 95% CI, 0.42-1.91). The sensitivity analysis, with adjustment for maternal age and gestational age at randomization, showed no statistical difference between the groups for presence of brain injury (OR, 0.58; 95% CI, 0.27-1.27).

CONCLUSION

In children born before 32 weeks of gestation after the use of tocolytics, the prevalence of brain injury was high. No significant differences were found with respect to overall brain injury between neonates exposed to nifedipine and those exposed to atosiban. However, as this study was a secondary analysis of the APOSTEL III trial, it was underpowered for brain injury. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd.

Authors+Show Affiliations

Department of Obstetrics and Gynecology, University Medical Center Utrecht, Utrecht, The Netherlands. Department of Obstetrics and Gynecology, Haaglanden Medical Center, The Hague, The Netherlands.Department of Obstetrics and Gynecology, University Medical Center Utrecht, Utrecht, The Netherlands.Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.Department of Neonatology, Academic Medical Center, Amsterdam, The Netherlands.Department of Neonatology, University Medical Center Utrecht, Utrecht, The Netherlands.The Robinson Research Institute, School of Pediatrics and Reproductive Health and The South Australian Health and Medical Research Institute, University of Adelaide, Adelaide, Australia.Department of Neonatology, University Medical Center Utrecht, Utrecht, The Netherlands.Department of Obstetrics and Gynecology, University Medical Center Utrecht, Utrecht, The Netherlands.Department of Obstetrics and Gynecology, University Medical Center Utrecht, Utrecht, The Netherlands. Department of Obstetrics and Gynecology, Academic Medical Center, Amsterdam, The Netherlands.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

28452086

Citation

Nijman, T A J., et al. "Effect of Nifedipine and Atosiban On Perinatal Brain Injury: Secondary Analysis of the APOSTEL-III Trial." Ultrasound in Obstetrics & Gynecology : the Official Journal of the International Society of Ultrasound in Obstetrics and Gynecology, vol. 51, no. 6, 2018, pp. 806-812.
Nijman TAJ, Goedhart MM, Naaktgeboren CN, et al. Effect of nifedipine and atosiban on perinatal brain injury: secondary analysis of the APOSTEL-III trial. Ultrasound Obstet Gynecol. 2018;51(6):806-812.
Nijman, T. A. J., Goedhart, M. M., Naaktgeboren, C. N., de Haan, T. R., Vijlbrief, D. C., Mol, B. W., Benders, M. J. N., Franx, A., & Oudijk, M. A. (2018). Effect of nifedipine and atosiban on perinatal brain injury: secondary analysis of the APOSTEL-III trial. Ultrasound in Obstetrics & Gynecology : the Official Journal of the International Society of Ultrasound in Obstetrics and Gynecology, 51(6), 806-812. https://doi.org/10.1002/uog.17512
Nijman TAJ, et al. Effect of Nifedipine and Atosiban On Perinatal Brain Injury: Secondary Analysis of the APOSTEL-III Trial. Ultrasound Obstet Gynecol. 2018;51(6):806-812. PubMed PMID: 28452086.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of nifedipine and atosiban on perinatal brain injury: secondary analysis of the APOSTEL-III trial. AU - Nijman,T A J, AU - Goedhart,M M, AU - Naaktgeboren,C N, AU - de Haan,T R, AU - Vijlbrief,D C, AU - Mol,B W, AU - Benders,M J N, AU - Franx,A, AU - Oudijk,M A, PY - 2016/10/29/received PY - 2017/04/03/revised PY - 2017/04/11/accepted PY - 2017/4/30/pubmed PY - 2018/10/30/medline PY - 2017/4/29/entrez KW - atosiban KW - neonatal outcome KW - neuroprotection KW - nifedipine KW - preterm birth KW - tocolysis SP - 806 EP - 812 JF - Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology JO - Ultrasound Obstet Gynecol VL - 51 IS - 6 N2 - OBJECTIVE: Brain injury in neonates born prematurely is associated strongly with poor neurodevelopmental outcome. The aim of this study was to evaluate whether tocolysis with nifedipine or atosiban in women with threatened preterm birth can reduce the incidence of overall brain injury in neonates born prematurely. METHODS: This was a secondary analysis of the APOSTEL-III trial (Dutch Clinical Trial Registry, no. NTR2947), a randomized clinical trial in which women with threatened preterm labor between 25 and 34 weeks of gestation were allocated to treatment with nifedipine or atosiban. In this secondary analysis, women delivered at ≤ 32 weeks of gestational age in the two main contributing centers were included. Primary outcome was the presence of neonatal brain injury, which was defined as presence of abnormalities on ultrasound investigation and classified into mild and severe. To evaluate type and severity of brain injury, all neonatal ultrasounds performed during neonatal intensive and medium care admission were analyzed. To test the robustness of our results, a sensitivity analysis was performed assessing differences in baseline or known risk factors for brain injury. RESULTS: A total of 117 neonates (from 102 women) were studied, of which 51 had been exposed to nifedipine and 66 to atosiban. Brain injury was observed in 22 (43.1%) neonates in the nifedipine group compared with 37 (56.1%) in the atosiban group (OR, 0.60; 95% CI, 0.29-1.24). Presence of mild brain injury was comparable between the nifedipine (33.3%) and atosiban (48.5%) groups (OR, 0.53; 95% CI, 0.25-1.13). Severe brain injury was also comparable between the groups, observed in 9.8% of neonates in the nifedipine vs 7.6% of those in the atosiban group (OR, 1.33; 95% CI, 0.36-4.85). Intraventricular hemorrhage (≥ Grade I) was the most frequently seen ultrasound abnormality, observed in 18 (35.3%) neonates in the nifedipine group vs 25 (37.9%) in the atosiban group (OR, 0.90; 95% CI, 0.42-1.91). The sensitivity analysis, with adjustment for maternal age and gestational age at randomization, showed no statistical difference between the groups for presence of brain injury (OR, 0.58; 95% CI, 0.27-1.27). CONCLUSION: In children born before 32 weeks of gestation after the use of tocolytics, the prevalence of brain injury was high. No significant differences were found with respect to overall brain injury between neonates exposed to nifedipine and those exposed to atosiban. However, as this study was a secondary analysis of the APOSTEL III trial, it was underpowered for brain injury. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd. SN - 1469-0705 UR - https://www.unboundmedicine.com/medline/citation/28452086/Effect_of_nifedipine_and_atosiban_on_perinatal_brain_injury:_secondary_analysis_of_the_APOSTEL_III_trial_ L2 - https://doi.org/10.1002/uog.17512 DB - PRIME DP - Unbound Medicine ER -