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Antenatal Diagnosis of Placental Attachment Disorders (ADoPAD)

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ClinicalTrials.gov Identifier: NCT02442518
Recruitment Status : Unknown
Verified December 2015 by NICOLA FRATELLI, Università degli Studi di Brescia.
Recruitment status was:  Recruiting
First Posted : May 13, 2015
Last Update Posted : December 15, 2015
Sponsor:
Collaborators:
Azienda Ospedaliera San Gerardo di Monza
IRCCS Burlo Garofolo
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Azienda Ospedaliero-Universitaria di Parma
ARNAS Civico di Cristina Benefratelli, Palermo
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
University of Milan
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Ospedale Valduce, Como
Azienda Ospedaliera Bolognini di Seriate Bergamo
Information provided by (Responsible Party):
NICOLA FRATELLI, Università degli Studi di Brescia

Brief Summary:

The accuracy of sonographic prenatal detection of invasive placentation is unclear. The objective of this prospective, multicenter, observational study is to assess the performance of ultrasound for prenatal identification of invasive placentation in women with placenta previa.

This study involves more than 25 hospitals in Italy.


Condition or disease Intervention/treatment
Placenta Accreta Placenta Previa Procedure: antenatal ultrasound

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Detailed Description:

Background: Morbidly adherent placenta is a spectrum of conditions characterized by an abnormal adherence of the placenta to the implantation site. Three major variants of adherent placentation can be recognized according to the degree of trophoblastic invasion through the myometrium and the uterine serosa: placenta accreta, placenta increta and placenta percreta. All varieties of invasive placentation are associated with a significant increase in maternal morbidity.Placenta previa and previous uterine surgery represent the major risk factors for invasive placentation. Prenatal diagnosis of invasive placentation is associated with a reduced risk of maternal complications such as peripartum blood loss, need for transfusions and rate of hysterectomy, as it allows a preplanned treatment of the condition, however the performance of antenatal ultrasound and of different sonographic signs is not consistent across published studies because of limited sample size, retrospective design, variability of inclusion criteria and definition of invasive placentation.

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.


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Study Type : Observational
Estimated Enrollment : 2254 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Antenatal Diagnosis of Placental Attachment Disorders
Study Start Date : February 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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)
Procedure: 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).




Primary Outcome Measures :
  1. diagnostic accuracy of sonographic prenatal detection of invasive placentation [ Time Frame: clinical and histopathological assessment of placental invasion at delivery ]

Secondary Outcome Measures :
  1. maximum degree of placental invasion [ Time Frame: clinical and histopathological assessment of placental invasion at delivery ]

Biospecimen Retention:   Samples Without DNA
histopathological samples from women with placenta previa diagnosed with ultrasound in the 3rd trimester of pregnancy


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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)
Criteria

Inclusion Criteria:

  • Placenta previa diagnosed with ultrasound above 26 weeks' gestation (lower edge reached and/or overlapped the internal cervical os, or the lower edge was between 0.1 and 20.0 mm from the internal cervical os)

Exclusion Criteria:

  • Age < 18 years
  • prepartum bleeding or fetal distress requiring immediate emergency Cesarean section before the enrollment of the woman

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02442518


Contacts
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Contact: NICOLA FRATELLI, MD +390303995340 nicola.fratelli@spedalicivili.brescia.it
Contact: FEDERICO PREFUMO, Phd +390303995340 federico.prefumo@spedalicivili.brescia.it

Locations
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Italy
Azienda Ospedaliera San Gerardo di Monza Recruiting
Monza, MB, Italy
Contact: PATRIZIA VERGANI, MD       patrizia.vergani@unimib.it   
Brescia University, Spedali Civili Di Brescia Recruiting
Brescia, Italy, 25131
Contact: NICOLA FRATELLI, MD    +390303995340    nicola.fratelli@spedalicivili.brescia.it   
Contact: FEDERICO PREFUMO, Phd    +390303995340    federico.prefumo@spedalicivili.brescia.it   
ARNAS CIVICO di Cristina Benefratelli Recruiting
Palermo, Italy
Contact: GIUSEPPE CALI', MD       pinocali13@gmail.com   
Sponsors and Collaborators
NICOLA FRATELLI
Azienda Ospedaliera San Gerardo di Monza
IRCCS Burlo Garofolo
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Azienda Ospedaliero-Universitaria di Parma
ARNAS Civico di Cristina Benefratelli, Palermo
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
University of Milan
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Ospedale Valduce, Como
Azienda Ospedaliera Bolognini di Seriate Bergamo
Investigators
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Principal Investigator: NICOLA FRATELLI, MD BRESCIA UNIVERSITY, SPEDALI CIVILI DI BRESCIA
Principal Investigator: GIUSEPPE CALI, MD ARNAS Civico di Cristina Benefratelli

Publications:

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Responsible Party: NICOLA FRATELLI, MD, Università degli Studi di Brescia
ClinicalTrials.gov Identifier: NCT02442518     History of Changes
Other Study ID Numbers: 1837
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: December 15, 2015
Last Verified: December 2015
Keywords provided by NICOLA FRATELLI, Università degli Studi di Brescia:
placenta accreta
placenta previa
ultrasound
Additional relevant MeSH terms:
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Placenta Previa
Placenta Accreta
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases