NCT03267446

Brief Summary

The aim of this study is to assess the value of adding 3D power Doppler (as a diagnostic technique) to gray scale technique in the antenatal diagnosis of morbidly adherent placenta as well as predict the surgical outcome regarding the type of surgery and the intra operative morbidities.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

August 29, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

August 30, 2017

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

August 29, 2017

Last Update Submit

August 29, 2017

Conditions

Antepartum Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Sensitivity of 3D power Doppler in detecting morbidly adherent placenta.

    12 months

Study Arms (1)

Interventional group

EXPERIMENTAL

Patients confirmed having one or more of the signs of morbidly adherent placenta will be examined by 3D Ultrasound and 3D power Doppler. Patients will then be prepared for the operation.Cesarean hysterectomy will be done with removal of the uterus and the placenta as one mass.Cases with focal invasion of the uterus will be given a trial for conservative management. The whole specimen will be sent for histopathological examination, and the determination of length and depth of invasion.

Device: 3D Doppler Ultrasound

Interventions

3D Doppler UltrasoundDEVICE

3D volumes will be obtained in automatic sweeps using a motorized curved-array transducer while the women held their breath. In order to interpret the data consistently, the settings of power, On Voluson E10; GE Medical Systems)

Interventional group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 18 - 45.
  • Pregnant 32 weeks or more.
  • Placenta previa (Major and Minor).
  • History of previous cesarean section.

You may not qualify if:

  • Medical disorders such as bleeding disorders.
  • Lethal fetal anomalies.
  • Delivery before 34 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr el aini hospital

Cairo, 12211, Egypt

RECRUITING

Study Officials

  • Ahmed M Hussein, MD

    Cairo Univeristy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed M Hussein, MD

CONTACT

01223 515652ahmed_mhussein@live.com

Dina M Dakhly, MD

CONTACT

01003498919dinadakhly@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 29, 2017

First Posted

August 30, 2017

Study Start

August 29, 2017

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

August 30, 2017

Record last verified: 2017-08

Locations

EG(1)