NCT03813212

Brief Summary

This study aim to assess the accuracy of magnetic resonance imaging (MRI) compared to gray-scale and colour Doppler ultrasound (US) for the prenatal diagnosis of placenta accreta.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

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

November 17, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 23, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

July 17, 2020

Status Verified

July 1, 2020

Enrollment Period

2 years

First QC Date

November 17, 2018

Last Update Submit

July 16, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Determination of degree of placental invasion

    Determination of degree of placental invasion by comparing the results obtained by ultrasound , MRI with the final pathological examination after operation ( the excised part of myometrium with the attached placenta or hysterectomy specimen ).

    Baseline

Secondary Outcomes (1)

  • Change Maternal morbidity and mortality

    Baseline

Interventions

MRIDEVICE

Magnetic resonance imaging. Trans-abdominal sonography (TAS) and transvaginal sonography (TVS) will be performed using a 3.5 or 5 MHz transabdominal convex transducer and a 7 MHz trans-vaginal transducer.

Also known as: Ultrasound

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Haemodynamically stable pregnant women, who attend the antenatal care clinic at Ain Shams University Hospital or are referred from other hospitals for further evaluation. The recruited patients have to fulfill the inclusion criteria,

You may qualify if:

  • Haemodynamically stable pregnant women who have the following risk factors for placenta accreta : persistent anterior placenta previa, prior uterine surgery (such as a previous cesarean section, uterine curettage, or myomectomy).
  • Maternal age : 20-40 years old.
  • BMI : 18-29.9 kg/m2.

You may not qualify if:

  • Haemodynamically unstable patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine ainshams university

Cairo, 11865, Egypt

RECRUITING

Related Publications (2)

  • Lopes ES, Feitosa FEL, Brazil AV, de Castro JDV, da Costa JIF, Araujo Junior E, Peixoto AB, Carvalho FHC. Assessment of Sensitivity and Specificity of Ultrasound and Magnetic Resonance Imaging in the Diagnosis of Placenta Accreta. Rev Bras Ginecol Obstet. 2019 Jan;41(1):17-23. doi: 10.1055/s-0038-1675803. Epub 2018 Nov 14.

    PMID: 30428490BACKGROUND
  • Haunschild C, Yeaton-Massey A, Lyell DJ. Antenatal Management of Placenta Accreta. Clin Obstet Gynecol. 2018 Dec;61(4):766-773. doi: 10.1097/GRF.0000000000000394.

    PMID: 30204620BACKGROUND

MeSH Terms

Conditions

Placenta Accreta

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Safaa Thabet, M.B.B.,Ch

CONTACT

Malames Faisal, Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 17, 2018

First Posted

January 23, 2019

Study Start

January 1, 2019

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

July 17, 2020

Record last verified: 2020-07

Locations