Fetal Heart Rate or Rhythm Abnormality Affecting FetusNCT05374135
Effect of Dexamethasone on Fetal Heart Rate Variables In Case Of Imminent Preterm Labor
An observational study of Fetal Heart Rate or Rhythm Abnormality Affecting Fetus, run by Assiut University at 1 site in Egypt.
Trial summary
Effect of dexamethasone on fetal heart rate variability in case of preterm labour: prospective cohort study Read more about this study
- Who is it for?
- Ages 15 to 50 years, women only
- Conditions the study is for
- Fetal Heart Rate or Rhythm Abnormality Affecting Fetus
- How many people
- 97 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2021to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- Women only
- Child, Adult
Study population: Pregnant women
Who may be able to join
- Preterm labor
Who cannot join
- Twins
Trial locations and contacts
1 site in 1 country.
Tarek A Abdelradi, Professor contact
About this study
Effect of dexamethasone on fetal heart rate variability in case of preterm labour: prospective cohort study
Read the detailed description
prospective cohort study on Effect of dexamethasone on fetal heart rate variability in case of preterm labour
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in fetal heart rate variability in relation to dexamethasone administration
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start1 May 2021
- Primary completion30 Dec 2021
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Heart Rate or Rhythm Abnormality Affecting FetusStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 97 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ereny Wagih Youssif, Assiut University
- Investigators
- Tarek Kh Al-Hussini, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374135
- Sponsor's protocol ID
- Dexamethasone effect on FHR
- Status last verified
- May 2022
- First submitted
- 10 May 2022
- Last updated
- 16 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexamethasone on Fetal Heart Rate Variables In Case Of Imminent Preterm Labor
- ClinicalTrials.gov ID
- NCT05374135
- Acronym / sponsor ID
- Dexamethasone effect on FHR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- Dec 2022 (estimated)
- First posted
- 16 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- Pregnant women
Key inclusion criteria (1 listed)
- Preterm labor
Key exclusion criteria (1 listed)
- Twins
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in fetal heart rate variability in relation to dexamethasone administration
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
Related trials for Fetal Heart Rate or Rhythm Abnormality Affecting Fetus
RecruitingPhase 4
Oxytocin and Fetal Heart Rate Changes
Fetal Bradycardia Complicating Labor and Delivery, Fetal Bradycardia During Labor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarek A Abdelradi, Professor contact
Tarek Kh Al-Hussini principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Heart Rate or Rhythm Abnormality Affecting Fetus, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ereny W Youssif, Master (01004252510, Erenywagih@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in fetal heart rate variability in relation to dexamethasone administration (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2022.