NCT05307016|Unknown
Morbidly Adherent Placenta, Diagnosis and Proper Management
Dilemma of the Appropriate Surgical Intervention of Morbidly Adherent Placenta: Could it be Solved Prenatally?
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Dilemma of the Appropriate Surgical Intervention of Morbidly Adherent Placenta: Could it be Solved Prenatally?
Sponsor study identifier
observational
100
1 country
1
Study Start
February 1, 2022
Actual (reported)Primary Completion
February 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The main idea of this study is to establish the diagnostic criteria for cases of morbidly adherent placenta (MAP) using different ultrasonographic modalities and compare this with intra-operative findings and postoperative histopathological assessment
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 1, 2022
Actual (reported)March 23, 2022
Actual (reported)April 1, 2022
Actual (reported)February 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Acurray of ultrasonographic features for diagnosis of different degrees of MAP
The sensitivity and specificity of the ultrasonographic findings of MAP according to the final intraoperative diagnosis and available histopathological data
All pregnancies complicated by any degree of placenta previa undergoing pre-labor CS at gestational age (36+0 to 40+0) weeks
The validity of ultrasonographic findings of MAP for selecting the appropriate surgical intervention
All pregnancies complicated by any degree of placenta previa undergoing pre-labor CS at gestational age (36+0 to 40+0) weeks
Evaluating the accuracy of this criteria in all types of placenta previa
All pregnancies complicated by any degree of placenta previa undergoing pre-labor CS at gestational age (36+0 to 40+0) weeks
Studying all factors that may affect the accuracy of this criteria such as number of previous CS, qualifications of the previous CS, presence or absence of antepartum hemorrhage.
All pregnancies complicated by any degree of placenta previa undergoing pre-labor CS at gestational age (36+0 to 40+0) weeks
All pregnancies complicated with any degree of Placenta previa anterior, posterior or centralis undergoing pre-labor CS at gestational age (36+0 to 40+0)
transabdominal and transvaginal two-dimensional power Doppler ultrasound volumes of the placental bed were obtained according to a predefined protocol with the participant in a semi-recumbent position and a full bladder using a RAB4-8-D 3D/4D curved array abdominal transducer (4-8.5 MHz) on a Voluson E8. Predetermined machine settings were used. To allow for differences in attenuation of the power Doppler signal resulting from variation in placental site and maternal adiposity. Intraoperative staging of degree of placental invasion will be done according to clinical grading system by Collins et al., 2015. Specimens obtained from patients who underwent hysterectomy or resection of segment of anterior uterine wall in cases with anterior placenta previa will be immersed in formalin 10% concentration and will be sent for histopathological evaluation that will be done by the same pathologist.
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All patients presented to the department of Obstetrics and Gynecology in Sohag University hospital between February 2022 and February 2023 complicated with any degree of Placenta previa undergoing pre-labor CS at gestational age (36+0 to 40+0),. The attending physician will explain the nature of the study and all patients will be asked to sign an informed consent. A senior physician will evaluate the patient to confirm the diagnosis of placenta previa and degree of invasion in query accreta patients by using transabdominal and transvaginal US (Voluson,p8). All data will be saved in closed excel sheet and patients will be operated by a different surgical team, intraoperative staging of degree of placental invasion will be done according to clinical grading system by Collins et al., 2015 in addition to histopathological evaluation when available.
Sohag University, Medical school
Sohag, 82524, Egypt
Gielchinsky Y, Rojansky N, Fasouliotis SJ, Ezra Y. Placenta accreta--summary of 10 years: a survey of 310 cases. Placenta. 2002 Feb-Mar;23(2-3):210-4. doi: 10.1053/plac.2001.0764.
Publications Committee, Society for Maternal-Fetal Medicine; Belfort MA. Placenta accreta. Am J Obstet Gynecol. 2010 Nov;203(5):430-9. doi: 10.1016/j.ajog.2010.09.013.
Jauniaux E, Collins SL, Jurkovic D, Burton GJ. Accreta placentation: a systematic review of prenatal ultrasound imaging and grading of villous invasiveness. Am J Obstet Gynecol. 2016 Dec;215(6):712-721. doi: 10.1016/j.ajog.2016.07.044. Epub 2016 Jul 26.
First Submitted
March 23, 2022
First Posted
April 1, 2022
Study Start
February 1, 2022
Actual (reported)Primary Completion
February 1, 2023
Estimated (date passed)Comparison Between Bladder Dissection Before and After Uterine Incision in Cesarean Section for Morbidly Adherent Placenta
Contact the study team to confirm eligibility.
Palacios Jaraquemada JM, Bruno CH. Magnetic resonance imaging in 300 cases of placenta accreta: surgical correlation of new findings. Acta Obstet Gynecol Scand. 2005 Aug;84(8):716-24. doi: 10.1111/j.0001-6349.2005.00832.x.
Collins SL, Stevenson GN, Al-Khan A, Illsley NP, Impey L, Pappas L, Zamudio S. Three-Dimensional Power Doppler Ultrasonography for Diagnosing Abnormally Invasive Placenta and Quantifying the Risk. Obstet Gynecol. 2015 Sep;126(3):645-653. doi: 10.1097/AOG.0000000000000962.
Collins SL, Stevenson GN, Noble JA, Impey L, Welsh AW. Influence of power Doppler gain setting on Virtual Organ Computer-aided AnaLysis indices in vivo: can use of the individual sub-noise gain level optimize information? Ultrasound Obstet Gynecol. 2012 Jul;40(1):75-80. doi: 10.1002/uog.10122.
Hecht JL, Baergen R, Ernst LM, Katzman PJ, Jacques SM, Jauniaux E, Khong TY, Metlay LA, Poder L, Qureshi F, Rabban JT 3rd, Roberts DJ, Shainker S, Heller DS. Classification and reporting guidelines for the pathology diagnosis of placenta accreta spectrum (PAS) disorders: recommendations from an expert panel. Mod Pathol. 2020 Dec;33(12):2382-2396. doi: 10.1038/s41379-020-0569-1. Epub 2020 May 15.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 1, 2022
Record last verified: 2022-03
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