P Tajik1,2, M Monfrance3, J van 't Hooft1, S M S Liem1, E Schuit1,4, K W M Bloemenkamp5, J J Duvekot6, B Nij Bijvank7, M T M Franssen8, M A Oudijk9, H C J Scheepers10, J M Sikkema11, M Woiski12, B W J Mol13, D J Bekedam14, P M Bossuyt2, M H Zafarmand1,15. 1. Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, The Netherlands. 2. Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Centre, Amsterdam, The Netherlands. 3. Department of Obstetrics and Gynaecology, Atrium Medical Centre, Heerlen, The Netherlands. 4. Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands. 5. Department of Obstetrics and Gynaecology, Leiden University Medical Centre, Leiden, The Netherlands. 6. Department of Obstetrics and Gynaecology, Erasmus Medical Centre, Rotterdam, The Netherlands. 7. Department of Obstetrics and Gynaecology, Isala Clinics, Zwolle, The Netherlands. 8. Department of Obstetrics and Gynaecology, University Medical Centre Groningen, Groningen, The Netherlands. 9. Department of Obstetrics and Gynaecology, University Medical Center Utrecht, Utrecht, The Netherlands. 10. Department of Obstetrics and Gynaecology, Maastricht University Medical Center, Maastricht, The Netherlands. 11. Department of Obstetrics and Gynaecology, ZGT, Almelo, The Netherlands. 12. Department of Obstetrics and Gynaecology, Radboud University Nijmegen, Nijmegen, The Netherlands. 13. The Robinson Institute, School of Paediatrics and Reproductive Health, University of Adelaide, Adelaide, Australia. 14. Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands. 15. Department of Public Health, Academic Medical Centre, Amsterdam, The Netherlands.
Abstract
OBJECTIVE: The ProTWIN Trial (NTR1858) showed that, in women with a multiple pregnancy and a cervical length < 25(th) percentile (38 mm), prophylactic use of a cervical pessary reduced the risk of adverse perinatal outcome. We investigated whether other maternal or pregnancy characteristics collected at baseline can improve identification of women most likely to benefit from pessary placement. METHODS: ProTWIN is a multicenter randomized trial in which 808 women with a multiple pregnancy were assigned to pessary or control. Using these data we developed a multivariable logistic model comprising treatment, cervical length, chorionicity, pregnancy history and number of fetuses, and the interaction of these variables with treatment as predictors of adverse perinatal outcome. RESULTS: Short cervix, monochorionicity and nulliparity were predictive factors for a benefit from pessary insertion. History of previous preterm birth and triplet pregnancy were predictive factors of possible harm from pessary. The model identified 35% of women as benefiting (95% CI, 32-39%), which is 10% more than using cervical length only (25%) for pessary decisions. The model had acceptable calibration. We estimated that using the model to guide the choice of pessary placement would reduce the risk of adverse perinatal outcome significantly from 13.5% when no pessary is inserted to 8.1% (absolute risk reduction, 5.4% (95% CI, 2.1-8.6%)). CONCLUSIONS: We developed and internally validated a multivariable treatment selection model, with cervical length, chorionicity, pregnancy history and number of fetuses. If externally validated, it could be used to identify women with a twin pregnancy who would benefit from a pessary, and lead to a reduction in adverse perinatal outcomes in these women.
RCT Entities:
OBJECTIVE: The ProTWIN Trial (NTR1858) showed that, in women with a multiple pregnancy and a cervical length < 25(th) percentile (38 mm), prophylactic use of a cervical pessary reduced the risk of adverse perinatal outcome. We investigated whether other maternal or pregnancy characteristics collected at baseline can improve identification of women most likely to benefit from pessary placement. METHODS: ProTWIN is a multicenter randomized trial in which 808 women with a multiple pregnancy were assigned to pessary or control. Using these data we developed a multivariable logistic model comprising treatment, cervical length, chorionicity, pregnancy history and number of fetuses, and the interaction of these variables with treatment as predictors of adverse perinatal outcome. RESULTS: Short cervix, monochorionicity and nulliparity were predictive factors for a benefit from pessary insertion. History of previous preterm birth and triplet pregnancy were predictive factors of possible harm from pessary. The model identified 35% of women as benefiting (95% CI, 32-39%), which is 10% more than using cervical length only (25%) for pessary decisions. The model had acceptable calibration. We estimated that using the model to guide the choice of pessary placement would reduce the risk of adverse perinatal outcome significantly from 13.5% when no pessary is inserted to 8.1% (absolute risk reduction, 5.4% (95% CI, 2.1-8.6%)). CONCLUSIONS: We developed and internally validated a multivariable treatment selection model, with cervical length, chorionicity, pregnancy history and number of fetuses. If externally validated, it could be used to identify women with a twin pregnancy who would benefit from a pessary, and lead to a reduction in adverse perinatal outcomes in these women.
Authors: Parvin Tajik; Mohammad Hadi Zafarmand; Aeilko H Zwinderman; Ben W Mol; Patrick M Bossuyt Journal: BMC Med Inform Decis Mak Date: 2018-06-28 Impact factor: 2.796
Authors: Rodolfo C Pacagnella; Ben W Mol; Anderson Borovac-Pinheiro; Renato Passini; Marcelo L Nomura; Kleber Cursino Andrade; Nathalia Ellovitch; Karayna Gil Fernandes; Thaísa Guedes Bortoletto; Cynara Maria Pereira; Maria Julia Miele; Marcelo Santucci França; Jose G Cecatti Journal: BMC Pregnancy Childbirth Date: 2019-11-27 Impact factor: 3.007