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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

Tracking Information
First Submitted Date April 20, 2015
First Posted Date May 13, 2015
Last Update Posted Date December 15, 2015
Study Start Date February 2015
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 8, 2015)
diagnostic accuracy of sonographic prenatal detection of invasive placentation [ Time Frame: clinical and histopathological assessment of placental invasion at delivery ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02442518 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 8, 2015)
maximum degree of placental invasion [ Time Frame: clinical and histopathological assessment of placental invasion at delivery ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Antenatal Diagnosis of Placental Attachment Disorders
Official Title Antenatal Diagnosis of Placental Attachment Disorders
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.

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.

..........................................................................................................

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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
histopathological samples from women with placenta previa diagnosed with ultrasound in the 3rd trimester of pregnancy
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)
Condition
  • Placenta Accreta
  • Placenta Previa
Intervention 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).
Study Groups/Cohorts 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)
Intervention: Procedure: antenatal ultrasound
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 8, 2015)
2254
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2018
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT02442518
Other Study ID Numbers 1837
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party NICOLA FRATELLI, Università degli Studi di Brescia
Study Sponsor NICOLA FRATELLI
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
Investigators
Principal Investigator: NICOLA FRATELLI, MD BRESCIA UNIVERSITY, SPEDALI CIVILI DI BRESCIA
Principal Investigator: GIUSEPPE CALI, MD ARNAS Civico di Cristina Benefratelli
PRS Account Università degli Studi di Brescia
Verification Date December 2015