Antenatal Diagnosis of Placental Attachment Disorders

NCT02442518 | Unknown DMC

• 1 other identifier: 1837
• Study Type: observational
• Target: 2,254
• Locations: 1 country
• Sites: 3

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.

Conditions

Placenta Accreta; Placenta Previa

Keywords

placenta accreta; placenta previa; ultrasound

Outcome Measures

Primary Outcomes (1)

• diagnostic accuracy of sonographic prenatal detection of invasive placentation

  clinical and histopathological assessment of placental invasion at delivery

Secondary Outcomes (1)

• maximum degree of placental invasion

  clinical and histopathological assessment of placental invasion at delivery

Study Arms (1)

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

Interventions

antenatal ultrasound PROCEDURE

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).

women with placenta praevia

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• NICOLA FRATELLI: lead
• Azienda Ospedaliera San Gerardo di Monza: collaborator
• IRCCS Burlo Garofolo: collaborator
• Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello: collaborator
• Azienda Ospedaliero-Universitaria di Parma: collaborator
• ARNAS Civico di Cristina Benefratelli, Palermo: collaborator
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: collaborator
• University of Milan: collaborator
• A.O.U. Città della Salute e della Scienza: collaborator
• Ospedale Valduce, Como: collaborator
• Azienda Ospedaliera Bolognini di Seriate Bergamo: collaborator

Study Sites (3)

Brescia University, Spedali Civili Di Brescia

Brescia, Brescia, 25131, Italy

RECRUITING

Azienda Ospedaliera San Gerardo di Monza

Monza, MB, Italy

RECRUITING

ARNAS CIVICO di Cristina Benefratelli

Palermo, Palermo, Italy

RECRUITING

Related Publications (14)

• 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.

  PMID: 23924326 BACKGROUND

• 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.

  PMID: 23300807 BACKGROUND

• 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.

  PMID: 20027036 BACKGROUND

• 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.

  PMID: 17954654 BACKGROUND

• 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.

  PMID: 19191778 BACKGROUND

• 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.

  PMID: 22218410 BACKGROUND

• 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.

  PMID: 23943408 BACKGROUND

• 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.

  PMID: 23471888 BACKGROUND

• 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.

  PMID: 17346497 BACKGROUND

• Comstock CH. Antenatal diagnosis of placenta accreta: a review. Ultrasound Obstet Gynecol. 2005 Jul;26(1):89-96. doi: 10.1002/uog.1926.

  PMID: 15971281 BACKGROUND

• 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.

  PMID: 23288834 BACKGROUND

• 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.

  PMID: 12507953 BACKGROUND

• 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.

  PMID: 23466142 BACKGROUND

• 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.

  PMID: 12954688 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

histopathological samples from women with placenta previa diagnosed with ultrasound in the 3rd trimester of pregnancy

MeSH Terms

Conditions

Placenta Accreta; Placenta Previa

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Study Officials

• NICOLA FRATELLI, MD

  BRESCIA UNIVERSITY, SPEDALI CIVILI DI BRESCIA

  PRINCIPAL INVESTIGATOR

• GIUSEPPE CALI, MD

  ARNAS Civico di Cristina Benefratelli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

NICOLA FRATELLI, MD

CONTACT

+390303995340; nicola.fratelli@spedalicivili.brescia.it

FEDERICO PREFUMO, Phd

CONTACT

+390303995340; federico.prefumo@spedalicivili.brescia.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: May 13, 2015
• Study Start: February 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 15, 2015

Record last verified: 2015-12

Locations

IT (3)