J van 't Hooft1, J H van der Lee2, B C Opmeer3, A G van Wassenaer-Leemhuis4, A L van Baar5, D J Bekedam6, L J P Steenis5, S Liem1, E Schuit7, C Cuijpers1, E Bleeker1, M E Vinke1, N Simons1, I M de Graaf1, B W J Mol8, C van de Beek1. 1. Department of Obstetrics and Gynecology, Academic Medical Center, Amsterdam, The Netherlands. 2. Pediatric Clinical Research Office, Emma Children's Hospital, Academic Medical Center, Amsterdam, The Netherlands. 3. Clinical Research Unit, Academic Medical Center, Amsterdam, The Netherlands. 4. Department of Neonatology and Pediatrics, Emma Children's Hospital, Academic Medical Center, Amsterdam, The Netherlands. 5. Child and Adolescent Studies, Utrecht University, Utrecht, The Netherlands. 6. Department of Obstetrics and Gynecology, Onze Lieve Vrouwe Gasthuis-Oost, Amsterdam, The Netherlands. 7. Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands. 8. Department of Obstetrics and Gynaecology, Monash University, Clayton, Australia.
Abstract
OBJECTIVE: A recent randomized clinical trial (ProTWIN) showed that a cervical pessary prevented preterm birth and improved neonatal outcome in women with multiple pregnancy and cervical length (CL) < 38 mm. In this follow-up study, the long-term developmental outcome of these children was evaluated at 3 years' corrected age. METHODS: This was a follow-up study of ProTWIN, a multicenter trial conducted between 2009 and 2012 in which asymptomatic women with a multiple pregnancy were randomized to placement of a cervical pessary or no intervention. Current follow-up and analysis were limited to mothers with a mid-trimester CL < 38 mm (78 women (157 children) in the pessary group and 55 women (111 children) in the control group). At 3 years of corrected age, surviving children were invited for a Bayley Scales of Infant and Toddler Development-third edition (Bayley-III) assessment. Death after randomization or neurodevelopmental disability (Bayley-III score of ≤ 85, 1 SD below mean) rates were compared between the pessary and control groups, according to the intention-to-treat principle and using multiple imputation for missing data. Mean Bayley-III scores in surviving children were also assessed. A linear mixed-effects model was used to adjust for correlation between children of one mother. RESULTS: From the time of entry in the ProTWIN trial until follow-up at 3 years of age, a total of 27 children had died (six (5%) in the pessary vs 21 (26%) in the control group; odds ratio (OR), 0.13; 95% CI, 0.04-0.48). Bayley-III outcomes were collected for 173/241 (72%) surviving children (114 (75%) in the pessary vs 59 (66%) in the control group). The cumulative incidence of death or survival with a neurodevelopmental disability was 12 (10%) in the pessary vs 23 (29%) in the control group (OR, 0.26; 95% CI, 0.09-0.73). No statistical or clinically relevant differences were found with respect to cognitive, language and motor development among surviving children between the groups. Comparable results were found after multiple imputation. CONCLUSION: In women with twin pregnancy and a CL < 38 mm, the use of a cervical pessary strongly improved survival of the children without affecting neurodevelopment at 3 years' corrected age.
RCT Entities:
OBJECTIVE: A recent randomized clinical trial (ProTWIN) showed that a cervical pessary prevented preterm birth and improved neonatal outcome in women with multiple pregnancy and cervical length (CL) < 38 mm. In this follow-up study, the long-term developmental outcome of these children was evaluated at 3 years' corrected age. METHODS: This was a follow-up study of ProTWIN, a multicenter trial conducted between 2009 and 2012 in which asymptomatic women with a multiple pregnancy were randomized to placement of a cervical pessary or no intervention. Current follow-up and analysis were limited to mothers with a mid-trimester CL < 38 mm (78 women (157 children) in the pessary group and 55 women (111 children) in the control group). At 3 years of corrected age, surviving children were invited for a Bayley Scales of Infant and Toddler Development-third edition (Bayley-III) assessment. Death after randomization or neurodevelopmental disability (Bayley-III score of ≤ 85, 1 SD below mean) rates were compared between the pessary and control groups, according to the intention-to-treat principle and using multiple imputation for missing data. Mean Bayley-III scores in surviving children were also assessed. A linear mixed-effects model was used to adjust for correlation between children of one mother. RESULTS: From the time of entry in the ProTWIN trial until follow-up at 3 years of age, a total of 27 children had died (six (5%) in the pessary vs 21 (26%) in the control group; odds ratio (OR), 0.13; 95% CI, 0.04-0.48). Bayley-III outcomes were collected for 173/241 (72%) surviving children (114 (75%) in the pessary vs 59 (66%) in the control group). The cumulative incidence of death or survival with a neurodevelopmental disability was 12 (10%) in the pessary vs 23 (29%) in the control group (OR, 0.26; 95% CI, 0.09-0.73). No statistical or clinically relevant differences were found with respect to cognitive, language and motor development among surviving children between the groups. Comparable results were found after multiple imputation. CONCLUSION: In women with twin pregnancy and a CL < 38 mm, the use of a cervical pessary strongly improved survival of the children without affecting neurodevelopment at 3 years' corrected age.
Authors: Noor E Simons; Cornelieke van de Beek; Johanna H van der Lee; Brent C Opmeer; Aleid G van Wassenaer-Leemhuis; Anneloes L van Baar; Leonie Steenis; Sophie Liem; Ewoud Schuit; Dick Bekedam; Ben W J Mol; Janneke Van't Hooft Journal: Acta Obstet Gynecol Scand Date: 2019-06-18 Impact factor: 3.636
Authors: E V J van Limburg Stirum; S J Zegveld; N E Simons; M A de Boer; E Pajkrt; B W J Mol; M A Oudijk; J van 't Hooft Journal: Ultrasound Obstet Gynecol Date: 2022-06 Impact factor: 8.678
Authors: Emilie V J van Limburg Stirum; Larissa I van der Windt; Charlotte E van Dijk; Anneloes L van Baar; Aleid G Leemhuis; Madelon van Wely; Marjon A de Boer; Janneke van 't Hooft; Martijn A Oudijk; Eva Pajkrt Journal: BMJ Open Date: 2022-08-24 Impact factor: 3.006