microRNAs Role in Pre-eclampsia Diagnosis | NCT03562715

Studies
microRNAs Role in Pre-eclampsia Diagnosis

NCT03562715

Sponsor

Cairo University

Status

Completed

Last Update Posted

Jun 19, 2018Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Preeclampsia

Interventions

Not provided

Countries

Not provided

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

Jun 2018

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

Nov 28, 2016Actual

Primary Completion Date

Jun 15, 2017Actual

Completion Date

Dec 25, 2017Actual

First Submitted Date

Jun 8, 2018

First Submission Date that Met QC Criteria

Jun 8, 2018

First Posted Date

Jun 19, 2018Actual

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

Jun 8, 2018

Last Update Posted Date

Jun 19, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nadine wagdi maurice, Teaching assistant at biochemistry department Faculty of pharmacy, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Pre-eclampsia is one of the most threatening pregnancy complications. So far neither a secure, competent therapy for PE nor effective biomarkers for a premature discovery has been achieved.The aim of our study was to identify miRNAs 136, 494 and 495 genes expression in exosomes of peripheral blood compared to umbilical cord mesenchymal stem cells conditioned media released exososomes in patients with PE, as valuable markers for PE early prediction.

Detailed Description

Not provided

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

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control group		Blood samples were collected from 100 control with normal pregnancies. Thirty fresh umbilical cord samples of women with healthy pregnancies (n=15) were retrieved during caesarean deliveries and umibilical cord mesenchymal stem cells (UCMSCs) were isolated from Wharton jelly.
Preeclampsia group		Blood samples were collected from 100 patients with PE. Thirty fresh umbilical cord samples of PE patients (n=15) were retrieved during caesarean deliveries and UCMSCs were isolated from Wharton jelly.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The expression of miRNAs 136, 494 and 495 in exosomes of peripheral blood and UCMSCs conditioned media		2-3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

To have an uncomplicated pregnancy:

gestational age at venipuncture between 20 - 42 weeks
no medical, obstetrical, or surgical complications
absence of labor at the time of venipuncture
delivery of a normal term (≥ 37 weeks) neonate whose birth weight was between the 10th and 90th percentile for gestational age

Exclusion Criteria:

Patients with chronic hypertension, renal disease, and fetuses affected with congenital anomalies were excluded

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

23 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

PE group included 100 females with a mean age of 28.77 ± 5.72 years, while control group comprised of 100 females with a mean age of 28.06 ± 5.65 years. All enrolled patients were clinically diagnosed by physical examination and laboratory investigations.

Sampling Method

Probability Sample

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