BMJ Open (Dec 2021)
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)
- Fabio Facchinetti,
- Massimo Candiani,
- Federico Prefumo,
- Camilla Bulfoni,
- Patrizia Vergani,
- Sara Benedetti,
- Michele Vignali,
- Sara Lazzarin,
- 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,
- Annamaria Marconi,
- Federica Lagrasta,
- Cinzia Lucia Paolini,
- Elisabetta Mazza,
- Luca Valsecchi,
- Maddalena Smid,
- Federica Pasi,
- Mirko Pozzoni,
- Maria Castoldi,
- Giulia Dal Molin,
- Alice Guarano,
- Antonio Pellegrino,
- Clelia Callegari,
- Marta Betti,
- Cristina Zanardini,
- Valentina Parolin,
- Anna Catalano,
- Edoardo Barbolini,
- Patrizio Antonazzo,
- Lucrezia Pignatti,
- Mauro Tintoni,
- Federico Spelzini,
- Anna Martinelli,
- G Chiossi
Affiliations
- Fabio Facchinetti
- Obstetric Unit, Mother Infant Department, Azienda Ospedaliera Universitaria Policlinico di Modena, Modena, Italy
- Massimo Candiani
- School of Medicine and Surgery, Vita-Salute San Raffaele University, Milano, Italy
- Federico Prefumo
- 38 Department of Obstetrics and Gynaecology, Università degli Studi di Brescia, Brescia, Italy
- Camilla Bulfoni
- Department of Obstetrics and Gynaecology, ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy
- Patrizia Vergani
- 5 Clinic of Obstetrics and Gynecology, University of Milan-Bicocca, San Gerardo Hospital, Monza, Italy
- Sara Benedetti
- 32 Obstetrics and Gynecology, Maternal Infant Department, Grande Ospedale Metropolitano Niguarda, Milan, Italy
- Michele Vignali
- Department of Biomedical Sciences for Health, Università degli Studi di Milano Facoltà di Medicina e Chirurgia, Milano, Lombardia, Italy
- Sara Lazzarin
- 3 Department of Medicine and Surgery, University of Milan-Bicocca, Milan, Lombardia, Italy
- Sara Ornaghi
- School of Medicine and Surgery, University of Milan–Bicocca, Monza, Italy
- Elisabetta Colciago
- School of Medicine and Surgery, University of Milan–Bicocca, Monza, Italy
- Isadora Vaglio Tessitore
- School of Medicine and Surgery, University of Milan–Bicocca, Monza, Italy
- Alessandra Abbamondi
- School of Medicine and Surgery, University of Milan–Bicocca, Monza, Italy
- Laura Antolini
- School of Medicine and Surgery, University of Milan–Bicocca, Monza, Italy
- Anna Locatelli
- School of Medicine and Surgery, University of Milan–Bicocca, Monza, Italy
- Annalisa Inversetti
- Department of Obstetrics and Gynaecology, ASST di Vimercate, Carate Brianza, Italy
- Armando Pintucci
- Department of Obstetrics and Gynaecology, ASST di Monza, Desio, Italy
- I Cetin
- Department of BioMedical and Clinical Sciences, University of Milan, Milano, Italy
- Benedetta Bracco
- Department of BioMedical and Clinical Sciences, University of Milan, Milano, Italy
- Elisa Fabbri
- Department of BioMedical and Clinical Sciences, University of Milan, Milano, Italy
- Valentina Sala
- Department of BioMedical and Clinical Sciences, University of Milan, Milano, Italy
- Mario Meroni
- Department of Obstetrics and Gynaecology, ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy
- Grazia Volpe
- Department of Obstetrics and Gynaecology, Ca’ Grande Niguarda Hospital, ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy
- Annamaria Marconi
- School of Medicine and Surgery, University of Milan, Milano, Italy
- Federica Lagrasta
- School of Medicine and Surgery, University of Milan, Milano, Italy
- Cinzia Lucia Paolini
- School of Medicine and Surgery, University of Milan, Milano, Italy
- Elisabetta Mazza
- School of Medicine and Surgery, University of Milan, Milano, Italy
- Luca Valsecchi
- School of Medicine and Surgery, Vita-Salute San Raffaele University, Milano, Italy
- Maddalena Smid
- School of Medicine and Surgery, Vita-Salute San Raffaele University, Milano, Italy
- Federica Pasi
- School of Medicine and Surgery, Vita-Salute San Raffaele University, Milano, Italy
- Mirko Pozzoni
- School of Medicine and Surgery, Vita-Salute San Raffaele University, Milano, Italy
- Maria Castoldi
- School of Medicine and Surgery, Vita-Salute San Raffaele University, Milano, Italy
- Giulia Dal Molin
- School of Medicine and Surgery, University of Milan, Milano, Italy
- Alice Guarano
- School of Medicine and Surgery, University of Milan, Milano, Italy
- Antonio Pellegrino
- Department of Obstetrics and Gynaecology, Alessandro Manzoni Hospital, ASST di Lecco, Lecco, Italy
- Clelia Callegari
- Department of Obstetrics and Gynaecology, Alessandro Manzoni Hospital, ASST di Lecco, Lecco, Italy
- Marta Betti
- Department of Obstetrics and Gynaecology, Alessandro Manzoni Hospital, ASST di Lecco, Lecco, Italy
- Cristina Zanardini
- 15 Department of Obstetrics and Gynecology, ASST Spedali Civili, Brescia, Italy
- Valentina Parolin
- School of Medicine and Surgery, University of Milan–Bicocca, Monza, Italy
- Anna Catalano
- Department of Obstetrics and Gynaecology, Poliambulanza Foundation Hospitals, Brescia, Italy
- Edoardo Barbolini
- Department of Obstetrics and Gynaecology, Poliambulanza Foundation Hospitals, Brescia, Italy
- Patrizio Antonazzo
- Department of Obstetrics and Gynaecology, Maurizio Bufalini Hospital, Cesena, Italy
- Lucrezia Pignatti
- Department of Obstetrics and Gynaecology, Maurizio Bufalini Hospital, Cesena, Italy
- Mauro Tintoni
- Department of Obstetrics and Gynaecology, Maurizio Bufalini Hospital, Cesena, Italy
- Federico Spelzini
- Department of Obstetrics and Gynaecology, Infermi Hospital Rimini, Rimini, Italy
- Anna Martinelli
- Department of Obstetrics and Gynaecology, Infermi Hospital Rimini, Rimini, Italy
- G Chiossi
- Obstetric Unit, Mother Infant Department, Azienda Ospedaliera Universitaria Policlinico di Modena, Modena, Italy
- DOI
- https://doi.org/10.1136/bmjopen-2021-052510
- Journal volume & issue
-
Vol. 11,
no. 12
Abstract
Introduction The 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 analysis The 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 dissemination Ethical 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 number NCT04827433 (pre-results stage)
