EchocardiographyNCT03638245
Evaluation of the Fetal MPI in Abnormal Cardiotocography Cases in 3rd Trimester of Pregnancy and Fetal Outcome.
An observational study of Echocardiography, run by Ali Mohamed AbdEl-Halim Ali Mehanna.
Trial summary
The study will focus in evaluation of fetal cardiac function by using myocardial performance index in fetuses with abnormal cardiotocography in 3rd trimester. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Echocardiography
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2018to 10 Mar 2020
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pregnant women in 3rd trimester attending for CTG
Who may be able to join
- Women between 30-40 weeks gestational age.
- Women pregnant in singleton fetus.
Who cannot join
- Multiple pregnancies.
- Fetal congenital malformation.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Fetal Myocardial Performance Index in Abnormal Cardiotocography Cases in 3rd Trimester of Pregnancy and Fetal Outcome
The study will focus in evaluation of fetal cardiac function by using myocardial performance index in fetuses with abnormal cardiotocography in 3rd trimester.
Read the detailed description
The study will focus in evaluation of fetal cardiac function by using myocardial performance index in fetuses with abnormal cardiotocography in 3rd trimester.
Study Hypothesis:
In women with non reassuring fetal cardiotocography, myocardial performance index may predict fetal distress accurately.
Study Question:
In pregnant women in the third trimester with abnormal cardiotocography, Does myocardial performance index predict fetal distress accurately?
Study Objectives:
This study aims to assess the accuracy of myocardial performance index in predicting fetal distress in pregnant women with non reassuring cardiotocography in third trimester.
- Conditions
- Echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Abnormal CTG | This group includes pregnancies that showed abnormalities in CTG. | |
| Normal CTG | This group includes pregnancies that showed no abnormalities in CTG. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the Fetal Myocardial Performance Index.
Evaluation of the Fetal Myocardial Performance Index in Abnormal Cardiotocography Cases in 3rd Trimester of Pregnancy and Fetal Outcome.
Measured: 3rd Trimester CTG, immediately followed by Fetal Echocardiography at the same set
Secondary outcomes (1)
Neonatal outcome observation
APGAR score at the first and fifth minute
Measured: Immediately postnatal (first five minutes after delivery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start10 Oct 2018 (estimated)
- Primary completion10 Mar 2019 (estimated)
- Study completion10 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EchocardiographyStudies of the same condition, open and under way.
- 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
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ali Mohamed AbdEl-Halim Ali Mehanna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ali Mohamed AbdEl-Halim Ali Mehanna, Ain Shams Maternity Hospital
- Investigators
- Mohamed H Nasr El din, MD, Study chair, ProfessorAmr MA El Helaly, MD, Study director, Assistant ProfessorNoha AA Sakna, MD, Study director, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638245
- Sponsor's protocol ID
- USCU 230
- Status last verified
- Aug 2018
- First submitted
- 13 Aug 2018
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Fetal Myocardial Performance Index in Abnormal Cardiotocography Cases in 3rd Trimester of Pregnancy and Fetal Outcome
- ClinicalTrials.gov ID
- NCT03638245
- Acronym / sponsor ID
- USCU 230
- Conditions
- Echocardiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Ali Mohamed AbdEl-Halim Ali MehannaUniversity, hospital or other
- Study start
- 10 Oct 2018 (estimated)
- Primary completion
- 10 Mar 2019 (estimated)
- Study completion
- 10 Mar 2020 (estimated)
- First posted
- 20 Aug 2018 (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.
The study will focus in evaluation of fetal cardiac function by using myocardial performance index in fetuses with abnormal cardiotocography in 3rd trimester.
Detailed description
The study will focus in evaluation of fetal cardiac function by using myocardial performance index in fetuses with abnormal cardiotocography in 3rd trimester.
Study Hypothesis:
In women with non reassuring fetal cardiotocography, myocardial performance index may predict fetal distress accurately.
Study Question:
In pregnant women in the third trimester with abnormal cardiotocography, Does myocardial performance index predict fetal distress accurately?
Study Objectives:
This study aims to assess the accuracy of myocardial performance index in predicting fetal distress in pregnant women with non reassuring cardiotocography in third trimester.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abnormal CTG | – | –This group includes pregnancies that showed abnormalities in CTG. |
| Normal CTG | – | –This group includes pregnancies that showed no abnormalities in CTG. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women in 3rd trimester attending for CTG
Key inclusion criteria (2 listed)
- Women between 30-40 weeks gestational age.
- Women pregnant in singleton fetus.
Key exclusion criteria (2 listed)
- Multiple pregnancies.
- Fetal congenital malformation.
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
Evaluation of the Fetal Myocardial Performance Index.
Time frame: 3rd Trimester CTG, immediately followed by Fetal Echocardiography at the same set
Evaluation of the Fetal Myocardial Performance Index in Abnormal Cardiotocography Cases in 3rd Trimester of Pregnancy and Fetal Outcome.
1 secondary outcome
Neonatal outcome observation
Time frame: Immediately postnatal (first five minutes after delivery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
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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.
Mohamed H Nasr El din, MD study chair
Professor
Amr MA El Helaly, MD study director
Assistant Professor
Noha AA Sakna, MD study director
Lecturer
Questions about this trial
What is this clinical trial studying?
An observational study of Echocardiography, run by Ali Mohamed AbdEl-Halim Ali Mehanna.
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 2 inclusion and 2 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 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Ali MA Mehanna, MSc. (+201116778899, alymehanna90@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the Fetal Myocardial Performance Index. (time frame: 3rd Trimester CTG, immediately followed by Fetal Echocardiography at the same set). 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 20 Aug 2018.