MOGGE PAR Scores for Prediction of Outcomes of PAS

Sponsor

Assiut University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04525001

Collaborator

Middle-East OBGYN Graduate Education Foundation (Other)

200

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Placenta Accreta Spectrum

Detailed 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

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

200 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

MOGGE PAR-A and PAR-P Scores for Prediction of Adverse Outcomes of Placenta Accreta Spectrum: A Multi-center International Validation Study Protocol

Anticipated Study Start Date :

Oct 1, 2020

Anticipated Primary Completion Date :

Jul 1, 2021

Anticipated Study Completion Date :

Sep 1, 2021

Outcome Measures

Primary Outcome Measures

Number of women who experience placenta accreta spectrum related massive blood loss [From skin incision to 24 hours postoperative (Total of 24 hours)]
Blood loss > 2500 ml or intra-operative disseminated intravscular coagulopathy (DIC) or transfusion of 10 or more packed red blood cell units
Number of mothers admitted to intensive care unit [From skin incision to 24 hours postoperative (Total of 24 hours)]
Admission to intensive care unit after delivery
Days of maternal hospitalization after delivery [From Cesarean delivery till hospital discharge (Assessment up to 6 weeks)]
Maternal admission to hospital for more than 7 days after delivery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Pregnant women with suspected Placenta Accreta Spectrum (PAS),confirmed by clinical and/ or histo-pathological findings.
They must be planned to deliver in one of centers recruited in this study.