Effect of Dexamethasone on Fetal Heart Rate Variables In... | NCT05374135

Studies
Effect of Dexamethasone on Fetal Heart Rate Variables In Case Of Imminent Preterm Labor

NCT05374135

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

May 16, 2022Actual

Enrollment

97Estimated

Phase

Not provided

Conditions

Fetal Heart Rate or Rhythm Abnormality Affecting Fetus

Interventions

Not provided

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

May 2022

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

May 1, 2021Actual

Primary Completion Date

Dec 30, 2021Actual

Completion Date

Dec 2022Estimated

First Submitted Date

May 10, 2022

First Submission Date that Met QC Criteria

May 10, 2022

First Posted Date

May 16, 2022Actual

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

May 10, 2022

Last Update Posted Date

May 16, 2022Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Effect of dexamethasone on fetal heart rate variability in case of preterm labour: prospective cohort study

Detailed Description

prospective cohort study on Effect of dexamethasone on fetal heart rate variability in case of preterm labour

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

97Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in fetal heart rate variability in relation to dexamethasone administration		Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Preterm labor

Exclusion Criteria:

Twins

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Pregnant women

Minimum Age

15 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Pregnant women

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ereny W Youssif, Master	Contact	01004252510		Erenywagih@gmail.com
Tarek A Abdelradi, Professor	Contact

Overall Officials

Name	Affiliation	Role
Tarek Kh Al-Hussini	Assiut University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut university	Recruiting	Asyut			Egypt