NCT04938050

Brief Summary

This study objective is to assess the accuracy of a specialized pro forma in suggesting the probability of Morbidly Adherent Placenta, its extent and its correlation with intraoperative findings.

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
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2021

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

June 18, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

June 18, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 24, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

December 8, 2022

Status Verified

December 1, 2022

Enrollment Period

1.6 years

First QC Date

June 18, 2021

Last Update Submit

December 7, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Clinical significance of ultrasound signs in morbidly adherent placenta(most sensitive US sign)

    June 2021- July 2022

  • Accuracy of our specialized pro forma in assessing extent of morbidly adherent placenta(focal , diffuse)

    June 2021- July 2022

  • Accuracy of our specialized pro forma in assessing depth of invasion of placenta accreta spectrum (accrete, increta and percreta)

    June 2021- July 2022

Secondary Outcomes (1)

  • 1- Correlation between US signs and intraoperative findings including morbidity and mortality

    June 2021- July 2022

Interventions

UltrasoundDIAGNOSTIC_TEST

Ultrasound evaluation, with grayscale and color Doppler imaging.

Eligibility Criteria

Age28 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

21 pregnant females during their late 3rd trimester between (34 0/7: 37 0/7 weeks gestation)

You may qualify if:

  • Age group 28:42 years.
  • Pregnant women in their late third trimester (34 0/7 weeks: 37 0/7 weeks).
  • With a single living fetus in the current pregnancy.
  • A previous delivery by at least 1 cesarean section or history of uterine surgery including (surgical evacuation, myomectomy or endometrium ablation)
  • Having an anterior placenta previa or anterior low-lying placenta by ultrasound assessment.

You may not qualify if:

  • Cases with a non-previa placenta, posterior low lying placenta or posterior previa placenta.
  • Maternal chronic medical disorders( diabetes mellitus, hypertension)
  • Patients presented with severe attack of bleeding.
  • Patients presented with rupture of membrane.
  • Emergency delivery regardless the cause.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university Kasr Alainy OBGYN hospital

Cairo, Egypt

RECRUITING

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

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

June 18, 2021

First Posted

June 24, 2021

Study Start

June 18, 2021

Primary Completion

January 30, 2023

Study Completion

February 28, 2023

Last Updated

December 8, 2022

Record last verified: 2022-12

Locations