1. Mode of birth in women with low-lying placenta: protocol for a prospective multicentre 1:3 matched case–control study in Italy (the MODEL-PLACENTA study)
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Sara Ornaghi, Elisabetta Colciago, Isadora Vaglio Tessitore, Alessandra Abbamondi, Laura Antolini, Anna Locatelli, Annalisa Inversetti, Armando Pintucci, I Cetin, Benedetta Bracco, Elisa Fabbri, Valentina Sala, Mario Meroni, Grazia Volpe, Sara Benedetti, Camilla Bulfoni, Annamaria Marconi, Federica Lagrasta, Cinzia Lucia Paolini, Elisabetta Mazza, Massimo Candiani, Luca Valsecchi, Maddalena Smid, Federica Pasi, Mirko Pozzoni, Maria Castoldi, Michele Vignali, Giulia Dal Molin, Alice Guarano, Antonio Pellegrino, Clelia Callegari, Marta Betti, Sara Lazzarin, Federico Prefumo, Cristina Zanardini, Valentina Parolin, Anna Catalano, Edoardo Barbolini, Patrizio Antonazzo, Lucrezia Pignatti, Mauro Tintoni, Federico Spelzini, Anna Martinelli, Fabio Facchinetti, G Chiossi, Patrizia Vergani, Ornaghi, S, Colciago, E, Vaglio Tessitore, I, Abbamondi, A, Antolini, L, Locatelli, A, Inversetti, A, Pintucci, A, Cetin, I, Bracco, B, Fabbri, E, Sala, V, Meroni, M, Volpe, G, Benedetti, S, Bulfoni, C, Marconi, A, Lagrasta, F, Paolini, C, Mazza, E, Candiani, M, Valsecchi, L, Smid, M, Pasi, F, Pozzoni, M, Castoldi, M, Vignali, M, Dal Molin, G, Guarano, A, Pellegrino, A, Callegari, C, Betti, M, Lazzarin, S, Prefumo, F, Zanardini, C, Parolin, V, Catalano, A, Barbolini, E, Antonazzo, P, Pignatti, L, Tintoni, M, Spelzini, F, Martinelli, A, Facchinetti, F, Chiossi, G, and Vergani, P
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prenatal diagnosi ,maternal medicine ,prenatal diagnosis ,Cesarean Section ,Placenta ,education ,Placenta Previa ,ultrasonography ,General Medicine ,Ultrasonography, Prenatal ,Pregnancy ,Case-Control Studies ,Obstetrics and Gynaecology ,Humans ,Multicenter Studies as Topic ,Female ,Prospective Studies ,reproductive and urinary physiology - Abstract
IntroductionThe term placenta praevia defines a placenta that lies over the internal os, whereas the term low-lying placenta identifies a placenta that is partially implanted in the lower uterine segment with the inferior placental edge located at 1–20 mm from the internal cervical os (internal-os-distance). The most appropriate mode of birth in women with low-lying placenta is still controversial, with the majority of them undergoing caesarean section. The current project aims to evaluate the rate of vaginal birth and caesarean section in labour due to bleeding by offering a trial of labour to all women with an internal-os-distance >5 mm as assessed by transvaginal sonography in the late third trimester.Methods and analysisThe MODEL-PLACENTA is a prospective, multicentre, 1:3 matched case–control study involving 17 Maternity Units across Lombardy and Emilia-Romagna regions, Italy. The study includes women with a placenta located in the lower uterine segment at the second trimester scan. Women with a normally located placenta will be enrolled as controls. A sample size of 30 women with an internal-os-distance >5 mm at the late third trimester scan is needed at each participating Unit. Since the incidence of low-lying placenta decreases from 2% in the second trimester to 0.4% at the end of pregnancy, 150 women should be recruited at each centre at the second trimester scan. A vaginal birth rate ≥60% in women with an internal-os-distance >5 mm will be considered appropriate to start routinely admitting to labour these women.Ethics and disseminationEthical approval for the study was given by the Brianza Ethics Committee (No 3157, 2019). Written informed consent will be obtained from study participants. Results will be disseminated by publication in peer-reviewed journals and presentation in international conferences.Trial registration numberNCT04827433(pre-results stage)
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- 2021
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