Reference charts for the fetal cavum septi pellucidi’s width, length and length-to-width ratio: protocol for a prospective monocentric cross-sectional study in Italy (the ‘REC-FAST’ study)

Introduction The cavum septi pellucidi (CSP) is a fluid-filled cavity box situated on the midline between the medial walls of the two lateral ventricles and placed above the fornix and below the corpus callosum. The formation of the CSP begins at 14 weeks and is completed around 17 weeks.A regular C...

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Main Authors: Patrizia Vergani, Sara Ornaghi, Anna Locatelli, Elena Spada, Roberta Rovelli, Maria Verderio, Paola Camponovo, Laura Lanteri, Elettra Salmoiraghi, Sabrina Cozzolino
Format: Article
Language:English
Published: BMJ Publishing Group 2025-06-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/15/6/e098410.full
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author Patrizia Vergani
Sara Ornaghi
Anna Locatelli
Elena Spada
Roberta Rovelli
Maria Verderio
Paola Camponovo
Laura Lanteri
Elettra Salmoiraghi
Sabrina Cozzolino
author_facet Patrizia Vergani
Sara Ornaghi
Anna Locatelli
Elena Spada
Roberta Rovelli
Maria Verderio
Paola Camponovo
Laura Lanteri
Elettra Salmoiraghi
Sabrina Cozzolino
author_sort Patrizia Vergani
collection DOAJ
description Introduction The cavum septi pellucidi (CSP) is a fluid-filled cavity box situated on the midline between the medial walls of the two lateral ventricles and placed above the fornix and below the corpus callosum. The formation of the CSP begins at 14 weeks and is completed around 17 weeks.A regular CSP indirectly indicates the correct development of the corpus callosum and the midline of the fetal brain. Therefore, its evaluation is mandatory during routine obstetric scans. The available guidelines do not report specific recommendations on the morphology or biometry of the fetal CSP, thus leaving to the experience of the operator and, thus, to a subjective evaluation, the identification of potential anomalies.Our aim is to construct methodologically robust reference charts for the CSP’s width, length and length-to-width ratio in relation to gestational age and fetal biparietal diameter.Methods and analysis The REC-FAST study (Reference Charts for the Fetal cAvum SepTi pellucidi) is a prospective monocentric cross-sectional study on consecutively enrolled pregnant women accessing our Obstetric Unit at the Foundation IRCCS San Gerardo dei Tintori, Monza, Italy, for fetal ultrasound evaluation.Women will be eligible if carrying an uncomplicated singleton pregnancy between 190/7 and 366/7 weeks’ gestation with a certain pregnancy dating by first trimester ultrasound with crown-rump length measurement, and if aged between 18 and 45 years.After signing the informed consent, the ultrasound scan will be performed and the CSP’s width and length will be measured by means of the inner-to-inner technique and its morphology recorded.In order to achieve the statistical power required for properly constructing reference charts, we will divide our population into six groups according to the gestational age when the ultrasound scan will be performed (each group will cover a 3-week interval starting at 190/7 until 366/7 weeks). A minimum sample size of 80 will be reached for each gestational age group. Before charting, the data will be checked for consistency to identify any outliers. Where possible, outliers will be corrected by comparing with the original values (computation errors); otherwise, such data will be excluded. The fetal charts will be traced using the Cole and Green-Lambda, Median, and Sigmamethod (CG-LMS); in addition, the use of alternative modelling approaches, such as parametric models derived from the Extended Mechanistic Growth Function method, will be explored.Ethics and dissemination Ethical approval for this study was obtained by the Lombardy Ethics Committee n.3 (15 December 2023) prior to the commencement of the research. Written informed consent will be obtained from all participants. Women will be free to decline participation or to withdraw at any time.Findings will be presented at scientific meetings and published in peer-reviewed scientific journals in the field of obstetrics and fetal medicine. Also, they will be disseminated to study participants through dedicated online and in-person meetings and to the public through reach-out activities involving families and healthcare specialists.
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spelling doaj-art-7b82e173cb864b428cb90bd0ea4c51232025-08-20T03:31:49ZengBMJ Publishing GroupBMJ Open2044-60552025-06-0115610.1136/bmjopen-2024-098410Reference charts for the fetal cavum septi pellucidi’s width, length and length-to-width ratio: protocol for a prospective monocentric cross-sectional study in Italy (the ‘REC-FAST’ study)Patrizia Vergani0Sara Ornaghi1Anna Locatelli2Elena Spada3Roberta Rovelli4Maria Verderio5Paola Camponovo6Laura Lanteri7Elettra Salmoiraghi8Sabrina Cozzolino9School of Medicine and Surgery, University of Milan-Bicocca, Monza, ItalyUnit of Obstetrics, Foundation IRCCS San Gerardo dei Tintori, Monza, ItalyUnit of Obstetrics, Foundation IRCCS San Gerardo dei Tintori, Monza, ItalyLaboratorio Carlo Corchia - LCC, Florence, ItalyUnit of Obstetrics, Foundation IRCCS San Gerardo dei Tintori, Monza, ItalyUnit of Obstetrics, Foundation IRCCS San Gerardo dei Tintori, Monza, ItalyUnit of Obstetrics, Foundation IRCCS San Gerardo dei Tintori, Monza, ItalyUnit of Obstetrics, Foundation IRCCS San Gerardo dei Tintori, Monza, ItalyUnit of Obstetrics, Foundation IRCCS San Gerardo dei Tintori, Monza, ItalyUnit of Obstetrics, Foundation IRCCS San Gerardo dei Tintori, Monza, ItalyIntroduction The cavum septi pellucidi (CSP) is a fluid-filled cavity box situated on the midline between the medial walls of the two lateral ventricles and placed above the fornix and below the corpus callosum. The formation of the CSP begins at 14 weeks and is completed around 17 weeks.A regular CSP indirectly indicates the correct development of the corpus callosum and the midline of the fetal brain. Therefore, its evaluation is mandatory during routine obstetric scans. The available guidelines do not report specific recommendations on the morphology or biometry of the fetal CSP, thus leaving to the experience of the operator and, thus, to a subjective evaluation, the identification of potential anomalies.Our aim is to construct methodologically robust reference charts for the CSP’s width, length and length-to-width ratio in relation to gestational age and fetal biparietal diameter.Methods and analysis The REC-FAST study (Reference Charts for the Fetal cAvum SepTi pellucidi) is a prospective monocentric cross-sectional study on consecutively enrolled pregnant women accessing our Obstetric Unit at the Foundation IRCCS San Gerardo dei Tintori, Monza, Italy, for fetal ultrasound evaluation.Women will be eligible if carrying an uncomplicated singleton pregnancy between 190/7 and 366/7 weeks’ gestation with a certain pregnancy dating by first trimester ultrasound with crown-rump length measurement, and if aged between 18 and 45 years.After signing the informed consent, the ultrasound scan will be performed and the CSP’s width and length will be measured by means of the inner-to-inner technique and its morphology recorded.In order to achieve the statistical power required for properly constructing reference charts, we will divide our population into six groups according to the gestational age when the ultrasound scan will be performed (each group will cover a 3-week interval starting at 190/7 until 366/7 weeks). A minimum sample size of 80 will be reached for each gestational age group. Before charting, the data will be checked for consistency to identify any outliers. Where possible, outliers will be corrected by comparing with the original values (computation errors); otherwise, such data will be excluded. The fetal charts will be traced using the Cole and Green-Lambda, Median, and Sigmamethod (CG-LMS); in addition, the use of alternative modelling approaches, such as parametric models derived from the Extended Mechanistic Growth Function method, will be explored.Ethics and dissemination Ethical approval for this study was obtained by the Lombardy Ethics Committee n.3 (15 December 2023) prior to the commencement of the research. Written informed consent will be obtained from all participants. Women will be free to decline participation or to withdraw at any time.Findings will be presented at scientific meetings and published in peer-reviewed scientific journals in the field of obstetrics and fetal medicine. Also, they will be disseminated to study participants through dedicated online and in-person meetings and to the public through reach-out activities involving families and healthcare specialists.https://bmjopen.bmj.com/content/15/6/e098410.full
spellingShingle Patrizia Vergani
Sara Ornaghi
Anna Locatelli
Elena Spada
Roberta Rovelli
Maria Verderio
Paola Camponovo
Laura Lanteri
Elettra Salmoiraghi
Sabrina Cozzolino
Reference charts for the fetal cavum septi pellucidi’s width, length and length-to-width ratio: protocol for a prospective monocentric cross-sectional study in Italy (the ‘REC-FAST’ study)
BMJ Open
title Reference charts for the fetal cavum septi pellucidi’s width, length and length-to-width ratio: protocol for a prospective monocentric cross-sectional study in Italy (the ‘REC-FAST’ study)
title_full Reference charts for the fetal cavum septi pellucidi’s width, length and length-to-width ratio: protocol for a prospective monocentric cross-sectional study in Italy (the ‘REC-FAST’ study)
title_fullStr Reference charts for the fetal cavum septi pellucidi’s width, length and length-to-width ratio: protocol for a prospective monocentric cross-sectional study in Italy (the ‘REC-FAST’ study)
title_full_unstemmed Reference charts for the fetal cavum septi pellucidi’s width, length and length-to-width ratio: protocol for a prospective monocentric cross-sectional study in Italy (the ‘REC-FAST’ study)
title_short Reference charts for the fetal cavum septi pellucidi’s width, length and length-to-width ratio: protocol for a prospective monocentric cross-sectional study in Italy (the ‘REC-FAST’ study)
title_sort reference charts for the fetal cavum septi pellucidi s width length and length to width ratio protocol for a prospective monocentric cross sectional study in italy the rec fast study
url https://bmjopen.bmj.com/content/15/6/e098410.full
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