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Placenta Accreta SpectrumPARNCT04525001

MOGGE PAR Scores for Prediction of Outcomes of PAS

An observational study of Placenta Accreta Spectrum, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Placenta Accreta Spectrum
How many people
200 participants
Where
No sites listed yet
Study dates
Oct 2020to Sep 2021
How long will I take part?
6 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

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

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

Sherif A Shazly, M.Sc contact

+15075131392

sherif.shazly.mogge@gmail.com

Alaa HA Hegazy, M.Sc contact

+201221421220

alaa.hegazy.mogge@gmail.com

About this study

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

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.

Read the 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

Keywords
cesarean section, Uterine preservation, MOGGE PAR score, Hysterectomy, Massive hemorrhage
Medical subject headings
Placenta Accreta

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. Number of mothers admitted to intensive care unit

    Admission to intensive care unit after delivery

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

  3. Days of maternal hospitalization after delivery

    Maternal admission to hospital for more than 7 days after delivery

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2020
  2. Study startOct 2020 (estimated)
  3. Primary completionJul 2021 (estimated)
  4. Study completionSep 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
200 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04525001
Sponsor's protocol ID
PAR scores
Acronym
PAR
Status last verified
Aug 2020
First submitted
19 Aug 2020
Last updated
24 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 28599899

  • 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.

    PubMed 29669225

  • 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.

    PubMed 30471891

  • 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.

    PubMed 29149470

  • 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.

    PubMed 34233555

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

  • 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.

    PubMed 34674270

Questions about this trial

What is this clinical trial studying?

An observational study of Placenta Accreta Spectrum, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sherif A Shazly, M.Sc (+15075131392, sherif.shazly.mogge@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of women who experience placenta accreta spectrum related massive blood loss (time frame: From skin incision to 24 hours postoperative (Total of 24 hours)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04525001, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2020.

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