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Clinical Trial Summary

Placenta accreta spectrum (PAS) is a set of placentation disorders that are associated with trophoblastic invasion through the physiologic decidual-myometrial junction zone. PAS may be associated with massive obstetric hemorrhage, surgical injuries, maternal intensive care unit (ICU) admission, reoperation, and prolonged hospitalization.

This study aims at estimating the validity of "MOGGE placenta accreta risk-antepartum score" or "MOGGE PAR-A score" in predicting potential outcomes once PAS is diagnosed antenatally. In addition, it evaluates the validity of "MOGGE placenta accreta risk-peripartum score" or "MOGGE PAR-P score" in calculating the probability of the same outcomes using baseline features in conjugation with both disease-and surgery-related peripartum variables,thereby,assist designation of the most suitable management. Finally , MOGGE CON-PAS score was created for the subgroup of women who were subject to conservative management to predict probability of uterine preservation success.


Clinical Trial Description

Incidence of PAS has significantly increased in concordance with rising trend of cesarean section delivery (CS) among contemporary population.

Although cesarean hysterectomy, without trying to separate placenta (placenta in-situ), is the standard management of PAS, uterine preservation may be routinely offered to women who are concerned about preserving their uteri and may be considered the primary approach in many institutes all over the world.

The "Placenta Accreta Spectrum International Database (PAS-ID)" is an international database that was launched by Middle-East Obstetrics and Gynaecology Graduate Education (MOGGE) Foundation to conduct the current study.

Eligible patients ,with criteria mentioned in following sections, will be counseled on participation by one of the research team. They will be added to study database by an independent investigator(observing investigator) who will collect baseline data and calculate MOGGE PAR-A score using MOGGE PAR score 1.0 software (available at: https://www.mogge-obgyn.com/clinical-studies). The observing investigator will continue to collect clinical data in subsequent visits, through delivery and postpartum visit to calculate MOGGE PAR-P score at the end of follow-up. If patient management involves a uterus preserving procedure, MOGGE CON-PAS score will be calculated as well(it will be available at: https://www.mogge-obgyn.com/clinical-studies). The observing investigator should not be a part of patients'clinical care team, which should be blinded to the calculated scores. data will be collected using an excel spreadsheet designed for this study. Concerned data include patient age, parity, body mass index,smoking, ethnicity, previous gynecologic surgeries, obstetric complications, gestational age at diagnosis and delivery(in weeks), method of diagnosis, administration of antenatal steroids, indication of delivery, pre-delivery and post-delivery hemoglobin (g/dl), operative management, placental site, degree of placental invasion, type of cesarean incision and its relation to the placenta, intra-operative and postoperative complications, intra-operative blood loss in ml, and transfusion of blood products ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04525001
Study type Observational [Patient Registry]
Source Assiut University
Contact Sherif A Shazly, M.Sc
Phone +15075131392
Email sherif.shazly.mogge@gmail.com
Status Not yet recruiting
Phase
Start date October 2020
Completion date September 2021

See also
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Completed NCT04427592 - New Conservative Technique for Placenta Accreta Spectrum N/A
Completed NCT04314791 - Accuracy of Placenta Accreta Index in Diagnosing Placenta Accreta Spectrum
Recruiting NCT05752513 - Early vs Late Bladder Dissection During CS Hysterectomy in Patients With PAS With Bladder Invasion N/A
Not yet recruiting NCT04229953 - Accuracy of Three /Four-dimensional Ultrasound in Diagnosing Placenta Accreta Spectrum
Completed NCT05500404 - Diagnostic Accuracy of Placental Thickness in Lower Uterine Segment Measured By Ultrasound in Prediction of Placenta Accreta Spectrum in Patients With Placenta Previa. A Diagnostic Test Accuracy Study
Recruiting NCT05510076 - Evaluation of Different Surgical Approaches Used for Conservative Management of Placenta Accreta Spectrum in Sohag University Hospital
Not yet recruiting NCT05481606 - Cesarean Scar Pregnancy and Clinical Outcomes
Recruiting NCT04866888 - Placenta Accreta Spectrum Outcome After Uterine Conservation N/A