NCT06755047

Brief Summary

Placenta Accreta spectrum is a major obstetric disease nowadays. Different methods are used for antenatal diagnosis. In our study, investigators are aiming to compare 2 common ways for diagnosis, i.e; 3D Ultrasound and 2D with color Doppler.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

December 12, 2024

Completed
19 days until next milestone

Study Start

First participant enrolled

December 31, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

January 1, 2025

Status Verified

December 1, 2024

Enrollment Period

3 months

First QC Date

December 12, 2024

Last Update Submit

December 31, 2024

Conditions

Placenta Accreta

Outcome Measures

Primary Outcomes (1)

  • Vascular index

    3D Vascularization index

    1 months

Secondary Outcomes (1)

  • 2D ultrasound

    1 months

Study Arms (2)

3D Ultrasound

3D ultrasound placental volume, vascularization index, flow index and VF index

Radiation: 3D Ultrasound

2D ultrasound

lacunar vascular flow, abnormal utero-placental interference, myometrial thinning (\>1mm), absence of the retroplacental myometrium, interruptions or irregularities at the level of the utero-vesical interference, lower uterine segment hypervascularity

Radiation: 2D ultrasound

Interventions

3D UltrasoundRADIATION

3D placental volume and vascular indices

3D Ultrasound
2D ultrasoundRADIATION

2D placental criteria of invasion and color Doppler

2D ultrasound

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with placenta previa from 24 -39 weeks will be counselled to participate in the study. Patients will be enrolled in one of the 2 groups. Group 1, 3D Ultrasound with placental volume and vascular indices will be calculated. Group 2 , 2D ultrasound parameters and color Doppler study will be performed.

You may qualify if:

  • pregnant women with placenta previa

You may not qualify if:

  • congenital anomalies of placenta Placental separation Uterine anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's Health Hospital

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Central Study Contacts

Mohamed Fekry, PhD

CONTACT

0882312mohamedbeethoven2040@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer obstetric and gynecology, Specialist Urogynecology

Study Record Dates

First Submitted

December 12, 2024

First Posted

January 1, 2025

Study Start

December 31, 2024

Primary Completion

April 1, 2025

Study Completion

May 1, 2025

Last Updated

January 1, 2025

Record last verified: 2024-12

Locations

EG(1)