Comparison Between Uterine Artery Doppler and Placental V... | NCT03838887

Studies
Comparison Between Uterine Artery Doppler and Placental Vascular Indices in Prediction of Preeclampsia

NCT03838887

Sponsor

National Research Centre, Egypt

Status

Unknown status

Last Update Posted

Aug 18, 2021Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Pre-Eclampsia

Interventions

ultrasound machine

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2021Actual

Primary Completion Date

Dec 1, 2021Estimated

Completion Date

Jan 1, 2022Estimated

First Submitted Date

Feb 3, 2019

First Submission Date that Met QC Criteria

Feb 10, 2019

First Posted Date

Feb 12, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 11, 2021

Last Update Posted Date

Aug 18, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sherif Elsirgany, Researcher ,Family Planning and Reproductive Health Department, National Research Centre, EgyptPrincipal Investigator

Lead Sponsor

National Research Centre, EgyptOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

• Preeclampsia is a multisystem disorder that can cause considerable maternal and fetal morbidity and mortality. Late preeclampsia (with delivery >34 weeks) is more frequent and less serious than early preeclampsia (with delivery <34 weeks). Poor early placentation has been especially associated with early disease. Early identification of women at risk of preeclampsia is currently a crucial aim of antenatal care since they may benefit from prophylactic treatment and increased surveillance.

Detailed Description

The introduction of three-dimensional (3D) ultrasound techniques, with the option of calculating placental volume and measuring vascular indices, has created an excellent opportunity to study early changes in the uteroplacental circulation space, which includes the maternal spiral arteries and the intervillous space. This technology may allow a more direct evaluation of the abnormal placentation process thought to herald the development of preeclampsia.
The aim of this study was to assess the usefulness of placental volume and 3D vascular indices as reliable predictors of early preeclampsia in comparison to uterine artery Doppler

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control group		Pregnant women: Age between 18-35 years Parity: primigravidas and multiparas. Have no history of preeclampsia or eclampsia. Have no history of chronic hypertension. Not diabetic. Not have antiphospholipid syndrome. Not have autoimmune disease such as SLE	Device: ultrasound machine
High risk group		Pregnant women with: History of preeclampsia -Eclapmsia Chronic hypertension Diabetic Antiphospholipid syndrome. Autoimmune syndrome such as SLE.	Device: ultrasound machine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ultrasound machine	Device	Ultrasound machine with a vocal software	High risk group control group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
placental vascular indices in prediction of preeclampsia	placental vascular indices in prediction of preeclampsia compared to uterine artery doppler in prediction of preeclampsia	one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A. Control group: Pregnant women:
1. Age between 18-35 years
2. Parity: primigravidas and multiparas.
3. Have no history of preeclampsia or eclampsia.
4. Have no history of chronic hypertension.
5. Not diabetic.
6. Not have antiphospholipid syndrome.
7. Not have autoimmune disease such as SLE.

B. High risk group: Pregnant women with:

History of preeclampsia -Eclapmsia
Chronic hypertension
Diabetic
Antiphospholipid syndrome.
Autoimmune syndrome such as SLE.

Exclusion Criteria:

• Smoking
- Dichorionic placentae
- Fetal anomaly
- Uterine fibroid at the site of placental implantation
- Subchorionic hematoma

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

examination of pregnant women

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

All pregnant women will be examined for antenatal care in the outpatient clinic and fetal medicine unit of obstetrics and gynecology department then they will be divided into two groups control and high risk

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
SHERIF MOHAMMED ELSIRGANY, DOCTOR	Contact	+201223607191		SHERIFELSIRGANY@YAHOO.COM

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Research Centre	Recruiting	Cairo		1234	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011225	Pre-Eclampsia

Ancestor Terms

ID	Term
D046110	Hypertension, Pregnancy-Induced
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided