CClinicalTrials.gg
Status unknownNCT03267446Updated Aug 30, 2017

Doppler Imaging and Morbidly Adherent Placenta

An interventional study of 3D Doppler Ultrasound in Antepartum Hemorrhage, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-30.

Sponsored by Cairo University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Antepartum Hemorrhage
03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Medical disorders such as bleeding disorders.
  • Lethal fetal anomalies.
  • Delivery before 34 weeks.
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Interventional group

    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

  • Device3D Doppler Ultrasound

    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)

05

What researchers measure

Primary outcomes

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

    Time frame: 12 months

06

Study locations

1 of 1 sites recruiting
  • Kasr el aini hospital
    Cairo, 12211, Egypt
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03267446
Lead sponsor
Cairo University
Responsible party
Ahmed Mahmoud Hussein (Assistant Professor, Cairo University) — Principal investigator
First posted
Aug 30, 2017
Start date
Aug 29, 2017
Primary completion
Sep 1, 2018 (estimated)
Completion
Sep 1, 2018 (estimated)
Last update
Aug 30, 2017

Study contacts

Ahmed M Hussein, MD
Contact
ahmed_mhussein@live.com
01223 515652 ext. 002
Dina M Dakhly, MD
Contact
dinadakhly@gmail.com
01003498919 ext. 002
Ahmed M Hussein, MD
principal investigator · Cairo Univeristy

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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