Morbidly Adherent Placenta, Diagnosis and Proper Management

NCT ID: NCT05307016

Last Updated: 2022-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2023-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study is a clinical trial that will include all patients fulfilling the eligibility criteria and presented to the emergency unit of the department of Obstetrics and Gynecology in Sohag University hospital (Egyptian tertiary referral hospital) between February 2022 and February 2023. 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). 2D gray scale ultrasound, color and power doppler ultrasound will be performed firstly followed by 3D ultrasound.

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 \[5\] in addition to histopathological evaluation when available, such as in cases of hysterectomy and cases with anterior placenta who were treated by excision of part of anterior uterine wall suitable for histopathological evaluation.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Morbidly Adherent Placenta

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

Two dimensional ultrasonography power and color doppler

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Two dimensional ultrasonography power and color doppler

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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Intra-operative clinical staging during routine cesarean section of cases postoperative histopathological assessment of available specimens

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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).

Exclusion Criteria

* 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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sohag University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hatem Awaga

Lecturer of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sohag University, Medical school

Sohag, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

hatem awaga, Lecturer

Role: CONTACT

01550777310

Amr Abdelkareem, Lecturer

Role: CONTACT

01001259562

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

hatem awaga, Lecturer

Role: primary

01550777310

Amr Abdelkareem, Lecturer

Role: backup

01001259562

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 11945088 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21055510 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27473003 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16026395 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26214694 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22009687 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32415266 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Soh-Med-22-01-35

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Management of Placenta Accreta Spectrum
NCT04609527 UNKNOWN PHASE2/PHASE3