Placental Protein 13 Serum Endoglin and Uterine Doppler I... | NCT02350036

Studies
Placental Protein 13 Serum Endoglin and Uterine Doppler Indeces as Predictors of Pre-eclampsia

NCT02350036

Sponsor

Cairo University

Status

Completed

Last Update Posted

Mar 21, 2017Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Preeclampsia

Interventions

ultrasound monitoring

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

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015Actual

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Jan 26, 2015

First Submission Date that Met QC Criteria

Jan 28, 2015

First Posted Date

Jan 29, 2015Estimated

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

Mar 18, 2017

Last Update Posted Date

Mar 21, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

50 pregnant females were divided in two groups, twenty five as a control group and twenty five as high risk group; they were subjected to uterine artery Doppler, measurement of maternal serum and detection of (MTHFR) gene polymorphisms in first trimester at 11 to 14 weeks of gestation, all pregnancies were followed until 40 weeks for development of pre-eclampsia

Detailed Description

50 pregnant females were divided in two groups, twenty five as a control group and twenty five as high risk group; they were subjected to uterine artery Doppler, measurement of maternal serum (pp-13) and detection of (MTHFR) gene polymorphisms in first trimester at 11 to 14 weeks of gestation, all pregnancies were followed until 40 weeks for development of pre-eclampsia

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

9 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
preeclmapsia		women developed preeclampsia. ultrasound monitoring and uterine artery Doppler	Other: ultrasound monitoring
control		women with normal blood pressure all through pregnancy. ultrasound monitoring and uterine artery Doppler	Other: ultrasound monitoring

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ultrasound monitoring	Other	Uterine artery Doppler assessment	control preeclmapsia

Measure	Description	Time Frame
development of preeclampsia		40 weeks pregnancy

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pregnant women at 11 to 14 weeks of gestation

Exclusion Criteria:

fetal anomalies other medical diseases as diabetes mellitus, renal or liver diseases

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

pregnant women at 11 to 14 weeks of gestation

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahmed Maged	Kasr Alainy medical school	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kasr Alainy medical school		Cairo	Cairo Governorate	12151	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