NCT05374135

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 16, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

May 16, 2022

Status Verified

May 1, 2022

Enrollment Period

8 months

First QC Date

May 10, 2022

Last Update Submit

May 10, 2022

Conditions

Fetal Heart Rate or Rhythm Abnormality Affecting Fetus

Outcome Measures

Primary Outcomes (1)

  • Changes in fetal heart rate variability in relation to dexamethasone administration

    Baseline

Eligibility Criteria

Age15 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women

You may qualify if:

  • Preterm labor

You may not qualify if:

  • Twins

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, Egypt

RECRUITING

Study Officials

  • Tarek Kh Al-Hussini

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ereny W Youssif, Master

CONTACT

01004252510Erenywagih@gmail.com

Tarek A Abdelradi, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ereny wagih youssif

Study Record Dates

First Submitted

May 10, 2022

First Posted

May 16, 2022

Study Start

May 1, 2021

Primary Completion

December 30, 2021

Study Completion

December 1, 2022

Last Updated

May 16, 2022

Record last verified: 2022-05

Locations

EG(1)