Placenta Accreta Clinical Trial
— ADoPADOfficial title:
Antenatal Diagnosis of Placental Attachment Disorders
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.
Status | Recruiting |
Enrollment | 2254 |
Est. completion date | December 2018 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Italy | Brescia University, Spedali Civili Di Brescia | Brescia | |
Italy | Azienda Ospedaliera San Gerardo di Monza | Monza | MB |
Italy | ARNAS CIVICO di Cristina Benefratelli | Palermo |
Lead Sponsor | Collaborator |
---|---|
NICOLA FRATELLI | ARNAS Civico di Cristina Benefratelli, Palermo, Azienda Ospedaliera Bolognini di Seriate Bergamo, Azienda Ospedaliera Città della Salute e della Scienza di Torino, Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello, Azienda Ospedaliera San Gerardo di Monza, Azienda Ospedaliero-Universitaria di Parma, IRCCS Burlo Garofolo, Ospedale Valduce, Como, Policlinico Universitario Agostino Gemelli, University of Milan |
Italy,
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. Review. — View Citation
Calì 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. — View Citation
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. — View Citation
Comstock CH. Antenatal diagnosis of placenta accreta: a review. Ultrasound Obstet Gynecol. 2005 Jul;26(1):89-96. Review. — View Citation
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. Review. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Jones SR, Carley S, Harrison M. An introduction to power and sample size estimation. Emerg Med J. 2003 Sep;20(5):453-8. Review. Erratum in: Emerg Med J. 2004 Jan;21(1):126. — View Citation
Oppenheimer L; Society of Obstetricians and Gynaecologists of Canada. Diagnosis and management of placenta previa. J Obstet Gynaecol Can. 2007 Mar;29(3):261-73. — View Citation
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. — View Citation
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):65-9. doi: 10.1097/AOG.0b013e3181c4f12a. — View Citation
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. Review. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | diagnostic accuracy of sonographic prenatal detection of invasive placentation | clinical and histopathological assessment of placental invasion at delivery | No | |
Secondary | maximum degree of placental invasion | clinical and histopathological assessment of placental invasion at delivery | No |
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