NCT04253197

Brief Summary

The investigators evaluated the efficacy of a staging system introduced by the American Institute of ultrasound in medicine 2015 including sonographic parameters associated with morbidly adherent placenta for antenatal prediction of placental invasion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 14, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 30, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

2.4 years

First QC Date

January 30, 2020

Last Update Submit

January 31, 2020

Conditions

Obstetric Labor ComplicationsStaging of Placental Invasion

Outcome Measures

Primary Outcomes (1)

  • Confirmation of the stage of myometrial placental invasion

    By ultrasound, placental invasion in myometrium was given a stage

    1 hour

Secondary Outcomes (1)

  • Blood loss

    1 hour

Study Arms (1)

Morbidly adherent placenta

OTHER

This arm was given stage according to ultrasound features.

Device: Ultrasound

Interventions

UltrasoundDEVICE

Pregnant women in 3rd trimester with anterior placenta previa and lower cesarean section scar. Ultrasound was done and according to parameters of the morbidly adherent placenta, a staging system was conducted.

Morbidly adherent placenta

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Prior lower segment cesarean section
  • Low lying anterior placenta
  • Singleton pregnancy

You may not qualify if:

  • Medical disorders
  • vasa previa

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni-Suef University

Cairo, 11211, Egypt

Location

Related Publications (2)

  • Albayrak M, Ozdemir I, Koc O, Demiraran Y. Post-partum haemorrhage from the lower uterine segment secondary to placenta praevia/accreta: successful conservative management with Foley balloon tamponade. Aust N Z J Obstet Gynaecol. 2011 Aug;51(4):377-80. doi: 10.1111/j.1479-828X.2011.01309.x. Epub 2011 Apr 18.

    PMID: 21806571BACKGROUND

  • American institute of ultrasound in medicine 2015.

    BACKGROUND

MeSH Terms

Conditions

Obstetric Labor Complications

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Pregnant women in 3rd trimester
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor in Obstetrics and Gynecology Department

Study Record Dates

First Submitted

January 30, 2020

First Posted

February 5, 2020

Study Start

March 14, 2017

Primary Completion

July 20, 2019

Study Completion

December 25, 2019

Last Updated

February 5, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)