Morbidly Adherent Placenta, Diagnosis and Proper Management

NCT05307016 | Unknown

• 1 other identifier: Soh-Med-22-01-35
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Morbidly Adherent Placenta

Keywords

ultrasonography; Intraoperative staging; Histopathological assessment

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Study Arms (1)

MAP patients

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)

Diagnostic Test: Two dimensional ultrasonography power and color doppler

Interventions

Two dimensional ultrasonography power and color doppler DIAGNOSTIC_TEST

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.

Also known as: Intra-operative clinical staging during routine cesarean section of cases, postoperative histopathological assessment of available specimens

MAP patients

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• o 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), patients will be divided into subgroups according to number of previous CS, presence or absence of antepartum hemorrhage and qualifications of operative theatre in previous deliveries (public or private sector).

You may not qualify if:

• Women with history of medical co-morbidities such as chronic hypertension, Diabetes mellitus, renal diseases, autoimmune diseases, history of organ transplantation and immunosuppressive therapy, hematological diseases, history of thrombotic events, cardiopulmonary diseases, liver diseases Acute and chronic inflammatory diseases.
• Pregnancy induced medical disorders like: Gestational hypertension, preeclampsia, Gestational diabetes, Gestational thrombocytopenia and proteinuria.
• Fetal anomalies.
• Emergency CS if the patient is in labor.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University, Medical school

Sohag, 82524, Egypt

RECRUITING

Related Publications (7)

• 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.

  PMID: 11945088 BACKGROUND

• 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.

  PMID: 21055510 BACKGROUND

• 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.

  PMID: 27473003 BACKGROUND

• 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.

  PMID: 16026395 BACKGROUND

• 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.

  PMID: 26214694 BACKGROUND

• 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.

  PMID: 22009687 BACKGROUND

• 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.

  PMID: 32415266 BACKGROUND

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

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

Central Study Contacts

hatem awaga, Lecturer

CONTACT

01550777310; hatemaboelftooh@yahoo.com

Amr Abdelkareem, Lecturer

CONTACT

01001259562; amoor0_ssss@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics and Gynecology

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 1, 2022
• Study Start: February 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: May 1, 2023
• Last Updated: April 1, 2022

Record last verified: 2022-03

Locations

EG (1)