Certain Maternal Antibodies in Relation to Doppler in Hyp... | NCT03214393

Studies
Certain Maternal Antibodies in Relation to Doppler in Hypertension With Pregnancy

NCT03214393

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Jul 11, 2017Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Pre-Eclampsia

Interventions

Doppler
serum antibodies

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

Jul 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2017Estimated

Primary Completion Date

Jul 30, 2018Estimated

Completion Date

Aug 30, 2018Estimated

First Submitted Date

Jul 10, 2017

First Submission Date that Met QC Criteria

Jul 10, 2017

First Posted Date

Jul 11, 2017Actual

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

Jul 10, 2017

Last Update Posted Date

Jul 11, 2017Actual

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

Relation of certain maternal serum antibodies to Doppler changes will be studied in cases suffering from hypertension with pregnancy.

Detailed Description

Assessment will be done for maternal serum anti-beta 2 glycoprotein 1 antibodies and anticardiolipin antibodies in cases of preeclampsia after 32 weeks of pregnancy. In addition, fetal Doppler changes will be assessed.

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
Pre-Eclampsia		pregnant women with Pre-Eclampsia will be assessed by serum antibodies and Doppler	Diagnostic Test: Doppler Diagnostic Test: serum antibodies

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Doppler	Diagnostic Test	Doppler will be done to pregnant women with Pre-Eclampsia	Pre-Eclampsia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
percentage of cases that develop severe pre-eclampsia	percentage of cases that develop severe pre-eclampsia will be assessed by an investigator	It will be calculated after 1 year from the start of the study

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant women 32 weeks or more gestational age
Pre-eclampsia
Singleton pregnancy

Exclusion Criteria:

Intrauterine fetal death
Fetus with apparent congenital anomalies
Pregnant females with other medical disorders
History of essential hypertension.
History of antepartum hemorrhage.
History of rupture of membranes.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Pregnant females 32 weeks gestation or more with pre-eclampsia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Doaa Sh Belal, MD	Contact	0020223682030		doaash@live.com

Overall Officials

Name	Affiliation	Role
Doaa Sh Belal, MD	Cairo U	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Obstetrics and Gynecology		Cairo	Greater Cairo	11956	Egypt

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

Intervention Browse Module

MeSH Terms

ID	Term
D015150	Echocardiography, Doppler

Ancestor Terms

ID	Term
D004452	Echocardiography
D057791	Cardiac Imaging Techniques
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided