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Antenatal Diagnosis of Placental Attachment Disorders (ADoPAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

  Show Detailed Description

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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