Fetal HypoxiaNCT03108040
Evaluation of Fetal Cardiac Function and Vascular Hemodynamics in Intrauterine Growth Restriction
An observational study of Fetal Hypoxia, run by Assiut University at 1 site in Egypt.
Trial summary
Intrauterine growth restriction (IUGR) is one of the major contributors to perinatal mortality and morbidity and is characterized by complex hemodynamic changes involving placental and fetal arterial, cardiac and venous circulations .However, the temporal sequence of these modifications in relation to other… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Fetal Hypoxia
- How many people
- 534 participants
- Where
- 1 siteEgypt
- Study dates
- 10 May 2017to 10 Jan 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 18 to 40 years
- Women only
- Adult
Study population: observational study conducted at academic perinatalcenter that investigates relationships between antenatal testing parameters and outcome in IUGR fetuses Patients who give written consent to participate in the study undergo a uniform antenatal assessment protocol that includes umbilical artery (UA), middle cerebral artery (MCA) and ductus venosus (DV) Doppler ultrasound studies as well as detailed fetal echocardiography and five-component biophysical profile score. - Criteria for study eligibility are: * Singleton fetus with normal fetal anatomy documentedon a detailed sonogram. * Fetal abdominal circumference <5th percentile forgestational age.• * Evidence of placental insufficiency documented by an elevated umbilical artery pulsatility index (UA-PI) by reference ranges.
Who may be able to join
- Singleton fetus with normal fetal anatomy documented a detailed sonogram.
- Fetal abdominal circumference <5th percentile for gestational age.
- Evidence of placental insufficiency documented by an elevated umbilical artery pulsatility index (UA-PI) by reference ranges.
Who cannot join
- evidence of fetal infection
- chorioamnionitis
- fetal anomalies
- abnormal fetal karyotype
- patient withdrawal from the study and/or unavailability for follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Non Invasive Fetal Cardiac Functions and Fetal Arterial&Venous Doppler Study in Intrauterine Growth Restriction as Predictive Parameters of Perinatal Outcome
Intrauterine growth restriction (IUGR) is one of the major contributors to perinatal mortality and morbidity and is characterized by complex hemodynamic changes involving placental and fetal arterial, cardiac and venous circulations .However, the temporal sequence of these modifications in relation to other hemodynamic changes of the fetal arterial and venous circulations is unknown.
The aim of this study was to evaluate cardiac function and other hemodynamic changes in a group of fetuses with IUGR and clinical impact on perinatal outcome .
- Conditions
- Fetal Hypoxia
- Medical subject headings
- Fetal Hypoxia
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial performance index
Ratio between isovolumetric time to ejection time
Measured: 5 minutes
Aortic isthmus flow index
Aortic isthmus flow index = Ratio of (systolic velocity time integral+diastolic velocity time integral) / systolic velocity time integral
Measured: 5 minutes
Cerebroplacental ratio
cerebroplacental ratio = Rtio middle cerebral artery pulsatility index / umbilical artery pulsatility index
Measured: 5 minutes
Preload Index in inferior vena cava
Preload Index in inferior vena cava = ratio of peak systolic velocity in atrial contraction /peak systolic velocity ventricular systole
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start10 May 2017
- Primary completion10 Jul 2019
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal HypoxiaStudies 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
- Cross-sectional
- Enrolment
- 534 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sief el eslam Ahmed Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108040
- Sponsor's protocol ID
- AUN80
- Status last verified
- Feb 2020
- First submitted
- 5 Apr 2017
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Non Invasive Fetal Cardiac Functions and Fetal Arterial&Venous Doppler Study in Intrauterine Growth Restriction as Predictive Parameters of Perinatal Outcome
- ClinicalTrials.gov ID
- NCT03108040
- Acronym / sponsor ID
- AUN80
- Conditions
- Fetal Hypoxia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 534 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 May 2017 (actual)
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 11 Apr 2017 (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.
Intrauterine growth restriction (IUGR) is one of the major contributors to perinatal mortality and morbidity and is characterized by complex hemodynamic changes involving placental and fetal arterial, cardiac and venous circulations .However, the temporal sequence of these modifications in relation to other hemodynamic changes of the fetal arterial and venous circulations is unknown.
The aim of this study was to evaluate cardiac function and other hemodynamic changes in a group of fetuses with IUGR and clinical impact on perinatal outcome .
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- observational study conducted at academic perinatalcenter that investigates relationships between antenatal testing parameters and outcome in IUGR fetuses Patients who give written consent to participate in the study undergo a uniform antenatal assessment protocol that includes umbilical artery (UA), middle cerebral artery (MCA) and ductus venosus (DV) Doppler ultrasound studies as well as detailed fetal echocardiography and five-component biophysical profile score. - Criteria for study eligibility are: * Singleton fetus with normal fetal anatomy documentedon a detailed sonogram. * Fetal abdominal circumference <5th percentile forgestational age.• * Evidence of placental insufficiency documented by an elevated umbilical artery pulsatility index (UA-PI) by reference ranges.
Key inclusion criteria (3 listed)
- Singleton fetus with normal fetal anatomy documented a detailed sonogram.
- Fetal abdominal circumference <5th percentile for gestational age.
- Evidence of placental insufficiency documented by an elevated umbilical artery pulsatility index (UA-PI) by reference ranges.
Key exclusion criteria (5 listed)
- evidence of fetal infection
- chorioamnionitis
- fetal anomalies
- abnormal fetal karyotype
- patient withdrawal from the study and/or unavailability for follow-up.
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
Myocardial performance index
Time frame: 5 minutes
Ratio between isovolumetric time to ejection time
Aortic isthmus flow index
Time frame: 5 minutes
Aortic isthmus flow index = Ratio of (systolic velocity time integral+diastolic velocity time integral) / systolic velocity time integral
Cerebroplacental ratio
Time frame: 5 minutes
cerebroplacental ratio = Rtio middle cerebral artery pulsatility index / umbilical artery pulsatility index
Preload Index in inferior vena cava
Time frame: 5 minutes
Preload Index in inferior vena cava = ratio of peak systolic velocity in atrial contraction /peak systolic velocity ventricular systole
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Fetal Hypoxia
Recruiting
Sustained Cord Circulation at Emergency Cesarean Section
Asphyxia Neonatorum, Fetal Hypoxia
Recruiting
Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers
Chorioamnionitis Affecting Fetus or Newborn, Amnioinfusion
Not yet recruitingObservational study
Post Market Clinical Follow-up to Assess the Portable Nitric Oxide Generation and Delivery System (INOwill N200) for the Treatment of Neonatal Hypoxic Respiratory Failure Complicated by Pulmonary Hypertension
Persistent Pulmonary Hypertension of the Newborn, Hypoxic Respiratory Failure
Not yet recruitingObservational study
Gemini Flash 3.6 Versus Human Observers for FIGO-Based Interpretation of Intrapartum Cardiotocography
Fetal Hypoxia, Fetal Distress
Not yet recruitingObservational study
Evaluation of Neonatal Acute Hypoxia at Delivery Using Fetal Physiology and Eucapnic pH Assessment
Neonatal Acidemia and Hypoxia
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hypoxia, 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 18 Feb 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial performance index (time frame: 5 minutes). The study lists 4 primary outcomes in all. 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 18 Feb 2020.