Study Results
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Basic Information
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UNKNOWN
2254 participants
OBSERVATIONAL
2015-02-28
2018-12-31
Brief Summary
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This study involves more than 25 hospitals in Italy.
Detailed Description
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Objectives: The aim of this study is to systematically assess the performance of ultrasound in the prenatal diagnosis of placenta accreta and its variants and to evaluate the role of the different specific ultrasound signs in predicting disorders of invasive placentation. The sonographic signs assessed in this study were: (1) vascular lacunae within the placenta, (2) loss of normal hypoechoic retroplacental zone, (3) interruption of the bladder line and/or focal exophytic masses extending into the bladder space, considered together and labeled as 'abnormalities of the uterus - bladder interface.
Design:prospective, multicenter, observational study of pregnant women with placenta previa.
Methods: The investigators hypothesized that ultrasound has a sensitivity of at least 80% and a specificity of at least 97%, with 10% confidence intervals, for antenatal diagnosis of invasive placentation.The investigators would require 2048 women with placenta previa, of whom approximately 61 (3%) will have morbidly adherent placenta, to test the null hypothesis with a 0.05 risk of type I error (alpha). Supposing a 10% of women with incomplete follow up the investigators aim to enroll 2254 women in this study.
Diagnostic criteria that suggested placenta accreta, increta, or percreta included one or more of the following situations: (1) obliteration of the clear space, defined as the obliteration of any part of the echolucent area located between the uterus and placenta; (2) visualization of placental lacunae, defined as multiple linear, irregular vascular spaces within the placenta; and (3) interruption of the posterior bladder wall-uterine interface such that the usual continuous echolucent line appears instead as a series of dashes.
The degree of placental invasion was defined as follows: (i) placenta accreta was assumed when placental 'cones' disrupted the decidual zone with mildly increased vascularization around these cones ; (ii) placenta increta was diagnosed when placental invasion into the myometrium was sonographically suspected as a result of the presence of irregular and diffuse demarcation of the placental - uterine wall interface and thinning of the myometrium that was overlying the placental - myometrial tissue. Placenta increta was also characterized by increased vascularization and irregularly shaped intraplacental vascular lacunae, resembling the characteristic 'moth damage' appearance ; and (iii) the sonographic finding of placenta percreta was defined by a complete absence of the myometrium, with the placenta extending to the serosa, or beyond, including vascular breakthrough.In addition, placenta percreta was also characterized by massive subplacental hypervascularization, with vessels extending irregularly into the placental - myometrial tissue and with numerous large intraplacental lacunae.
Clinical and histopathological assessment of placental invasion:
Sonographic findings were compared with the clinical outcome during and after delivery and the histomorphological examination of the placenta, performed by pathologists experienced in obstetric histopathology, who were blinded to the sonographic findings.
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Main Outcomes measure:
Primary Outcome: sensitivity (SN), specificity(SP), positive likelihood ratio (LR+), negative likelihood ratio (LR - ) and diagnostic odds ratio (DOR) of antenatal ultrasound and different sonographic signs for in prediction of morbidly adherent placenta.
Secondary Outcome: to evaluate whether the maximum degree of placental invasion (placenta accreta, increta or percreta) can be predicted with antenatal ultrasound.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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women with placenta praevia
women with placenta previa diagnosed at antenatal ultrasound in the third trimester of pregnancy (lower placental edge within 20 mm from the internal os above 26 week's gestation)
antenatal ultrasound
Transabdominal and Transvaginal ultrasound examinations were performed in the third trimester (with some fluid in the bladder so that the uterine bladder interface could be evaluated well).
Interventions
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antenatal ultrasound
Transabdominal and Transvaginal ultrasound examinations were performed in the third trimester (with some fluid in the bladder so that the uterine bladder interface could be evaluated well).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* prepartum bleeding or fetal distress requiring immediate emergency Cesarean section before the enrollment of the woman
18 Years
FEMALE
No
Sponsors
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Azienda Ospedaliera San Gerardo di Monza
OTHER
IRCCS Burlo Garofolo
OTHER
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
OTHER
Azienda Ospedaliero-Universitaria di Parma
OTHER
ARNAS Civico di Cristina Benefratelli, Palermo
UNKNOWN
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
University of Milan
OTHER
A.O.U. Città della Salute e della Scienza
OTHER
Ospedale Valduce, Como
UNKNOWN
Azienda Ospedaliera Bolognini di Seriate Bergamo
OTHER
NICOLA FRATELLI
OTHER
Responsible Party
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NICOLA FRATELLI
MD
Principal Investigators
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NICOLA FRATELLI, MD
Role: PRINCIPAL_INVESTIGATOR
BRESCIA UNIVERSITY, SPEDALI CIVILI DI BRESCIA
GIUSEPPE CALI, MD
Role: PRINCIPAL_INVESTIGATOR
ARNAS Civico di Cristina Benefratelli
Locations
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Brescia University, Spedali Civili Di Brescia
Brescia, Brescia, Italy
Azienda Ospedaliera San Gerardo di Monza
Monza, MB, Italy
ARNAS CIVICO di Cristina Benefratelli
Palermo, Palermo, Italy
Countries
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Central Contacts
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Facility Contacts
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NICOLA FRATELLI, MD
Role: primary
FEDERICO PREFUMO, Phd
Role: backup
PATRIZIA VERGANI, MD
Role: primary
GIUSEPPE CALI', MD
Role: primary
References
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Fitzpatrick KE, Sellers S, Spark P, Kurinczuk JJ, Brocklehurst P, Knight M. The management and outcomes of placenta accreta, increta, and percreta in the UK: a population-based descriptive study. BJOG. 2014 Jan;121(1):62-70; discussion 70-1. doi: 10.1111/1471-0528.12405. Epub 2013 Aug 7.
Fitzpatrick KE, Sellers S, Spark P, Kurinczuk JJ, Brocklehurst P, Knight M. Incidence and risk factors for placenta accreta/increta/percreta in the UK: a national case-control study. PLoS One. 2012;7(12):e52893. doi: 10.1371/journal.pone.0052893. Epub 2012 Dec 27.
Warshak CR, Ramos GA, Eskander R, Benirschke K, Saenz CC, Kelly TF, Moore TR, Resnik R. Effect of predelivery diagnosis in 99 consecutive cases of placenta accreta. Obstet Gynecol. 2010 Jan;115(1):65-69. doi: 10.1097/AOG.0b013e3181c4f12a.
Tan CH, Tay KH, Sheah K, Kwek K, Wong K, Tan HK, Tan BS. Perioperative endovascular internal iliac artery occlusion balloon placement in management of placenta accreta. AJR Am J Roentgenol. 2007 Nov;189(5):1158-63. doi: 10.2214/AJR.07.2417.
Eller AG, Porter TF, Soisson P, Silver RM. Optimal management strategies for placenta accreta. BJOG. 2009 Apr;116(5):648-54. doi: 10.1111/j.1471-0528.2008.02037.x. Epub 2009 Feb 4.
Dilauro MD, Dason S, Athreya S. Prophylactic balloon occlusion of internal iliac arteries in women with placenta accreta: literature review and analysis. Clin Radiol. 2012 Jun;67(6):515-20. doi: 10.1016/j.crad.2011.10.031. Epub 2012 Jan 2.
D'Antonio F, Iacovella C, Bhide A. Prenatal identification of invasive placentation using ultrasound: systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2013 Nov;42(5):509-17. doi: 10.1002/uog.13194. Epub 2013 Oct 2.
Chalubinski KM, Pils S, Klein K, Seemann R, Speiser P, Langer M, Ott J. Prenatal sonography can predict degree of placental invasion. Ultrasound Obstet Gynecol. 2013 Nov;42(5):518-24. doi: 10.1002/uog.12451. Epub 2013 Oct 9.
Oppenheimer L; MATERNAL FETAL MEDICINE COMMITTEE. RETIRED: Diagnosis and management of placenta previa. J Obstet Gynaecol Can. 2007 Mar;29(3):261-266. doi: 10.1016/S1701-2163(16)32401-X.
Comstock CH. Antenatal diagnosis of placenta accreta: a review. Ultrasound Obstet Gynecol. 2005 Jul;26(1):89-96. doi: 10.1002/uog.1926.
Cali G, Giambanco L, Puccio G, Forlani F. Morbidly adherent placenta: evaluation of ultrasound diagnostic criteria and differentiation of placenta accreta from percreta. Ultrasound Obstet Gynecol. 2013 Apr;41(4):406-12. doi: 10.1002/uog.12385.
Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, Lijmer JG, Moher D, Rennie D, de Vet HC; Standards for Reporting of Diagnostic Accuracy. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Standards for Reporting of Diagnostic Accuracy. Clin Chem. 2003 Jan;49(1):1-6. doi: 10.1373/49.1.1.
Wortman AC, Alexander JM. Placenta accreta, increta, and percreta. Obstet Gynecol Clin North Am. 2013 Mar;40(1):137-54. doi: 10.1016/j.ogc.2012.12.002.
Jones SR, Carley S, Harrison M. An introduction to power and sample size estimation. Emerg Med J. 2003 Sep;20(5):453-8. doi: 10.1136/emj.20.5.453.
Other Identifiers
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1837
Identifier Type: -
Identifier Source: org_study_id