NCT04525001

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 24, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

August 24, 2020

Status Verified

August 1, 2020

Enrollment Period

9 months

First QC Date

August 19, 2020

Last Update Submit

August 21, 2020

Conditions

Placenta Accreta Spectrum

Keywords

cesarean sectionUterine preservationMOGGE PAR scoreHysterectomyMassive hemorrhage

Outcome Measures

Primary Outcomes (3)

  • Number of women who experience placenta accreta spectrum related massive blood loss

    Blood loss \> 2500 ml or intra-operative disseminated intravscular coagulopathy (DIC) or transfusion of 10 or more packed red blood cell units

    From skin incision to 24 hours postoperative (Total of 24 hours)

  • Number of mothers admitted to intensive care unit

    Admission to intensive care unit after delivery

    From skin incision to 24 hours postoperative (Total of 24 hours)

  • Days of maternal hospitalization after delivery

    Maternal admission to hospital for more than 7 days after delivery

    From Cesarean delivery till hospital discharge (Assessment up to 6 weeks)

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study comprises eligible women in 20 centers (anticipated), representing North-America, South-America, Europe, Africa and Asia (all over the world)

You may qualify if:

  • 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.

You may not qualify if:

  • Women who reject participation or whose diagnosis with PAS is eventually excluded based on clinical and/or histo-pathological findings.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Jauniaux E, Collins S, Burton GJ. Placenta accreta spectrum: pathophysiology and evidence-based anatomy for prenatal ultrasound imaging. Am J Obstet Gynecol. 2018 Jan;218(1):75-87. doi: 10.1016/j.ajog.2017.05.067. Epub 2017 Jun 24.

    PMID: 28599899BACKGROUND

  • Silver RM, Branch DW. Placenta Accreta Spectrum. N Engl J Med. 2018 Apr 19;378(16):1529-1536. doi: 10.1056/NEJMcp1709324. No abstract available.

    PMID: 29669225BACKGROUND

  • Society of Gynecologic Oncology; American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine; Cahill AG, Beigi R, Heine RP, Silver RM, Wax JR. Placenta Accreta Spectrum. Am J Obstet Gynecol. 2018 Dec;219(6):B2-B16. doi: 10.1016/j.ajog.2018.09.042.

    PMID: 30471891BACKGROUND

  • Cal M, Ayres-de-Campos D, Jauniaux E. International survey of practices used in the diagnosis and management of placenta accreta spectrum disorders. Int J Gynaecol Obstet. 2018 Mar;140(3):307-311. doi: 10.1002/ijgo.12391. Epub 2017 Dec 22.

    PMID: 29149470BACKGROUND

  • Shazly SA, Hortu I, Shih JC, Melekoglu R, Fan S, Ahmed FUA, Karaman E, Fatkullin I, Pinto PV, Irianti S, Tochie JN, Abdelbadie AS, Ergenoglu AM, Yeniel AO, Sagol S, Itil IM, Kang J, Huang KY, Yilmaz E, Liang Y, Aziz H, Akhter T, Ambreen A, Ates C, Karaman Y, Khasanov A, Larisa F, Akhmadeev N, Vatanina A, Machado AP, Montenegro N, Effendi JS, Suardi D, Pramatirta AY, Aziz MA, Siddiq A, Ofakem I, Dohbit JS, Fahmy MS, Anan MA; and Middle East Obstetrics and Gynecology Graduate Education (MOGGE) foundation - Artificial intelligence (AI) unit. Prediction of clinical outcomes in women with placenta accreta spectrum using machine learning models: an international multicenter study. J Matern Fetal Neonatal Med. 2022 Dec;35(25):6644-6653. doi: 10.1080/14767058.2021.1918670. Epub 2021 Jul 7.

    PMID: 34233555BACKGROUND

  • Mohri M, Rostamizadeh A, Talwalkar A: Foundations of machine learning: MIT press; 2018.

    BACKGROUND

  • Shazly SA, Anan MA, Makukhina TB, Melekoglu R, Ahmed FUA, Pinto PV, Takahashi H, Ahmed NB, Sayed EG, Elassall GM, Said AE, Fahmy MS, Dawyee DM, Penzhoyan GA, Amirkhanyan AM, Yilmaz E, Celik NZ, Aziz H, Akhter T, Ambreen A, Abdelbadie AS. Placenta accreta risk-antepartum score in predicting clinical outcomes of placenta accreta spectrum: A multicenter validation study. Int J Gynaecol Obstet. 2022 Aug;158(2):424-431. doi: 10.1002/ijgo.13993. Epub 2021 Nov 14.

    PMID: 34674270DERIVED

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Study Officials

  • Sherif A Shazly, M.Sc

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherif A Shazly, M.Sc

CONTACT

+15075131392sherif.shazly.mogge@gmail.com

Alaa HA Hegazy, M.Sc

CONTACT

+201221421220alaa.hegazy.mogge@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.B.B.Ch, M.S.c in Gynecology and Obstetrics

Study Record Dates

First Submitted

August 19, 2020

First Posted

August 24, 2020

Study Start

October 1, 2020

Primary Completion

July 1, 2021

Study Completion

September 1, 2021

Last Updated

August 24, 2020

Record last verified: 2020-08