Respiratory Distress SyndromeNCT02586922
Fetal Lung Volume and Pulmonary Artery Resistance Index Measurement in Term Diabetic Pregnancy
An observational study of Respiratory Distress Syndrome, run by Ain Shams University.
Trial summary
The aim of this study is to determine cut-off values for fetal lung volume by VOCAL and pulmonary artery resistance index by pulsed Doppler in fetuses of diabetic mothers, and correlate the results with postnatal respiratory distress of the term neonates. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- Three-dimensional (3D) ultrasonography
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Jul 2017
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: This is a prospective observational study which will be carried out at Ain Shams University Maternity Hospital, Obstetrics and Gynecology department, Faculty of Medicine, Ain Shams University, from December 2015 to December 2016. Diabetic pregnant women 38 weeks gestation admitted for elective termination by Caesarian section due to various obstetric indications
Who may be able to join
- -Diabetic pregnant women 38 weeks gestation admitted for elective termination due to various obstetric indications
Who cannot join
- Twins.
- Pregnancy complicated by medical disorders other than Diabetes Mellitus (hypertension, pre-eclampsia, cardiac disorders, thyroid disorders, anemia with pregnancy...etc).
- Autoimmune disorders.
- Congenital fetal anomalies.
- Macrosomia and intrauterine growth restriction (IUGR).
- Intrauterine fetal death (IUFD).
- Amniotic fluid index <5cm or >20cm.
- Patients taking steroids within one week of measurement of lung volume.
About this study
Official title: Fetal Lung Volume and Pulmonary Artery Resistance Index Measurement in Term Diabetic Pregnancy and Their Correlation With Neonatal Outcome: a Pilot Study
The aim of this study is to determine cut-off values for fetal lung volume by VOCAL and pulmonary artery resistance index by pulsed Doppler in fetuses of diabetic mothers, and correlate the results with postnatal respiratory distress of the term neonates.
Read the detailed description
Research question:
Can the assessment of fetal lung volume by Virtual Organ Computed-aided Analysis (VOCAL) and pulmonary artery resistance index by pulsed Doppler predict neonatal respiratory distress syndrome in term fetuses of diabetic mothers?
Research hypothesis:
The assessment of fetal lung volume by VOCAL and pulmonary artery resistance index by pulsed Doppler can predict neonatal respiratory distress syndrome in term fetuses of diabetic mothers.
- Conditions
- Respiratory Distress Syndrome
- Being tested
- Three-dimensional (3D) ultrasonography
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-dimensional (3D) ultrasonographyDevice
A longitudinal section of fetal chest will be obtained that clearly depicts the lung. A 3D window will be activated . After complete electronic sweep and assurance of absence of fetal or maternal movements to avoid motion artifacts, 3D multi-planar view will be then obtained
What is being measured
The primary outcome is the main question the study is designed to answer.
neonatal respiratory distress
Occurrence of neonatal respiratory distress immediately after delivery utilizing APGAR score at birth in numbers
Measured: immediately after delivery
Secondary outcomes (1)
• Neonatal mortality rate
- Follow up for early neonatal mortality rate after Neonatal Intensive Care Unit admission
Measured: One week after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionJun 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr mohamed laban, Ain Shams University
- Investigators
- Mohamed Laban, Professor, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586922
- Sponsor's protocol ID
- LVPT
- Status last verified
- Jul 2017
- First submitted
- 22 Oct 2015
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Lung Volume and Pulmonary Artery Resistance Index Measurement in Term Diabetic Pregnancy and Their Correlation With Neonatal Outcome: a Pilot Study
- ClinicalTrials.gov ID
- NCT02586922
- Acronym / sponsor ID
- LVPT
- Conditions
- Respiratory Distress Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 27 Oct 2015 (estimated)
- 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 aim of this study is to determine cut-off values for fetal lung volume by VOCAL and pulmonary artery resistance index by pulsed Doppler in fetuses of diabetic mothers, and correlate the results with postnatal respiratory distress of the term neonates.
Detailed description
Research question:
Can the assessment of fetal lung volume by Virtual Organ Computed-aided Analysis (VOCAL) and pulmonary artery resistance index by pulsed Doppler predict neonatal respiratory distress syndrome in term fetuses of diabetic mothers?
Research hypothesis:
The assessment of fetal lung volume by VOCAL and pulmonary artery resistance index by pulsed Doppler can predict neonatal respiratory distress syndrome in term fetuses of diabetic mothers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This is a prospective observational study which will be carried out at Ain Shams University Maternity Hospital, Obstetrics and Gynecology department, Faculty of Medicine, Ain Shams University, from December 2015 to December 2016. Diabetic pregnant women 38 weeks gestation admitted for elective termination by Caesarian section due to various obstetric indications
Key inclusion criteria (1 listed)
- -Diabetic pregnant women 38 weeks gestation admitted for elective termination due to various obstetric indications
Key exclusion criteria (8 listed)
- Twins.
- Pregnancy complicated by medical disorders other than Diabetes Mellitus (hypertension, pre-eclampsia, cardiac disorders, thyroid disorders, anemia with pregnancy...etc).
- Autoimmune disorders.
- Congenital fetal anomalies.
- Macrosomia and intrauterine growth restriction (IUGR).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Three-dimensional (3D) ultrasonographyA longitudinal section of fetal chest will be obtained that clearly depicts the lung. A 3D window will be activated . After complete electronic sweep and assurance of absence of fetal or maternal movements to avoid motion artifacts, 3D multi-planar view will be then obtained | Device | – |
Primary outcome
neonatal respiratory distress
Time frame: immediately after delivery
Occurrence of neonatal respiratory distress immediately after delivery utilizing APGAR score at birth in numbers
1 secondary outcome
• Neonatal mortality rate
Time frame: One week after delivery
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 19 Jul 2017.
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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 Laban, Professor principal investigator
Ain Shams University
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome, run by Ain Shams University.
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 8 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 19 Jul 2017. 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?
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?
neonatal respiratory distress (time frame: immediately after delivery). 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 19 Jul 2017.