Eog van Vliet1, L Seinen2, C Roos2, E Schuit3,4, Hcj Scheepers5, Kwm Bloemenkamp6, J J Duvekot7, J van Eyck8, J H Kok9, F K Lotgering2, A van Baar10, A G van Wassenaer-Leemhuis9, M T Franssen11, M M Porath12, Jam van der Post13, A Franx1, Bwj Mol14, M A Oudijk1,13. 1. Department of Obstetrics and Gynaecology, University Medical Centre Utrecht, Utrecht, the Netherlands. 2. Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands. 3. Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, the Netherlands. 4. Stanford Prevention Research Centre, Department of Medicine, Stanford University, Stanford, CA, USA. 5. Department of Obstetrics and Gynaecology, Maastricht University Medical Centre, Maastricht, the Netherlands. 6. Department of Obstetrics and Gynaecology, Leiden University Medical Centre, Leiden, the Netherlands. 7. Department of Obstetrics and Gynaecology, Erasmus Medical Centre, Rotterdam, the Netherlands. 8. Department of Obstetrics and Gynaecology, Isala Clinics, Zwolle, the Netherlands. 9. Department of Neonatology, Academic Medical Centre, Amsterdam, the Netherlands. 10. Utrecht Centre for Child and Adolescent Studies, Utrecht University, Utrecht, the Netherlands. 11. Department of Obstetrics, University Medical Centre, University of Groningen, Groningen, the Netherlands. 12. Department of Obstetrics and Gynaecology, Máxima Medical Centre, Veldhoven, the Netherlands. 13. Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, the Netherlands. 14. The Robinson Institute, School of Paediatrics and Reproductive Health, University of Adelaide, Adelaide, SA, Australia.
Abstract
OBJECTIVE: To evaluate long-term effects of maintenance tocolysis with nifedipine on neurodevelopmental outcome of the infant. DESIGN, SETTING AND POPULATION: Follow up of infants of women who participated in a multicentre randomised controlled trial on maintenance tocolysis with nifedipine versus placebo. METHODS: Two years after the APOSTEL II trial on maintenance tocolysis with nifedipine versus placebo, we asked participants to complete the Ages and Stages Questionnaire. MAIN OUTCOME MEASURES: Infant development was measured in five domains. Developmental delay was defined as a score of ≤1 SD in one or more developmental domains. We performed exploratory subgroup analysis in women with preterm prolonged rupture of the membranes, and in women with a cervical length <10 mm at study entry. RESULTS: Of the 276 women eligible for follow up, 135 (52.5%) returned the questionnaire, encompassing data of 170 infants. At 2 years of age, infants of women with nifedipine maintenance tocolysis compared with placebo had a higher overall incidence of fine motor problems (22.2 versus 7.6%, OR 3.43, 95% CI 1.29-9.14, P = 0.01), and a lower incidence of poor problem-solving (21.1 versus 29.1%, OR 0.27, 95% CI 0.08-0.95, P = 0.04). CONCLUSIONS: This follow-up study revealed no clear benefit of nifedipine maintenance tocolysis at 2 years of age. As short-term adverse perinatal outcome was not reduced in the original APOSTEL II trial, we conclude that maintenance tocolysis does not appear to be beneficial at this time. TWEETABLE ABSTRACT: No clear benefit of nifedipine maintenance tocolysis in preterm labour on 2-year infant outcome.
OBJECTIVE: To evaluate long-term effects of maintenance tocolysis with nifedipine on neurodevelopmental outcome of the infant. DESIGN, SETTING AND POPULATION: Follow up of infants of women who participated in a multicentre randomised controlled trial on maintenance tocolysis with nifedipine versus placebo. METHODS: Two years after the APOSTEL II trial on maintenance tocolysis with nifedipine versus placebo, we asked participants to complete the Ages and Stages Questionnaire. MAIN OUTCOME MEASURES: Infant development was measured in five domains. Developmental delay was defined as a score of ≤1 SD in one or more developmental domains. We performed exploratory subgroup analysis in women with preterm prolonged rupture of the membranes, and in women with a cervical length <10 mm at study entry. RESULTS: Of the 276 women eligible for follow up, 135 (52.5%) returned the questionnaire, encompassing data of 170 infants. At 2 years of age, infants of women with nifedipine maintenance tocolysis compared with placebo had a higher overall incidence of fine motor problems (22.2 versus 7.6%, OR 3.43, 95% CI 1.29-9.14, P = 0.01), and a lower incidence of poor problem-solving (21.1 versus 29.1%, OR 0.27, 95% CI 0.08-0.95, P = 0.04). CONCLUSIONS: This follow-up study revealed no clear benefit of nifedipine maintenance tocolysis at 2 years of age. As short-term adverse perinatal outcome was not reduced in the original APOSTEL II trial, we conclude that maintenance tocolysis does not appear to be beneficial at this time. TWEETABLE ABSTRACT: No clear benefit of nifedipine maintenance tocolysis in preterm labour on 2-year infant outcome.
Authors: Tms van Winden; J Klumper; C E Kleinrouweler; M A Tichelaar; C A Naaktgeboren; T A Nijman; A L van Baar; A G van Wassenaer-Leemhuis; T J Roseboom; J Van't Hooft; C Roos; B W Mol; E Pajkrt; M A Oudijk Journal: BJOG Date: 2020-03-29 Impact factor: 6.531