Doppler Imaging and Morbidly Adherent Placenta

NCT ID: NCT03267446

Last Updated: 2017-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-29

Study Completion Date

2018-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Antepartum Hemorrhage

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

3D Doppler Ultrasound

Intervention Type DEVICE

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)

Interventions

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3D 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)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Medical disorders such as bleeding disorders.
* Lethal fetal anomalies.
* Delivery before 34 weeks.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mahmoud Hussein

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed M Hussein, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo Univeristy

Locations

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Kasr el aini hospital

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed M Hussein, MD

Role: CONTACT

01223 515652 ext. 002

Dina M Dakhly, MD

Role: CONTACT

01003498919 ext. 002

Facility Contacts

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Ahmed M Hussein, MD

Role: primary

01223515652 ext. 002

Other Identifiers

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CU28817

Identifier Type: -

Identifier Source: org_study_id

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