Preterm BirthNCT04296591
This Study Was to Investigate the Efficacy of Fetal Right Heart Doppler Findings in Determination of Pulmonary Maturity
An observational study of Preterm Birth and Prenatal Care Late, run by Karadeniz Technical University.
Trial summary
Objective: The aim of this study was to investigate the efficacy of fetal right heart doppler findings in determination of pulmonary maturity. Materials and Methods: Pregnant women refered to the Department of Obstetrics and Gynecology at Karadeniz Technical University were included in the study. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Prenatal Care Late, Preterm Labor
- What is being tested?
- fetal heart doppler findings
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 Aug 2019
- How long will I take part?
- 6 Months
- 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: total of 70 pregnant women (n: 70), 25 in the study group and 45 in the control group
Who may be able to join
- preterm and term pregnancy
- caesarean cases
Who cannot join
- pregestational diabetes mellitus
- gestational diabetes mellitus
- morbid obesity
- thyroid dysfunction
- fetal anomaly diagnosed an euploidy or anomaly.
About this study
Official title: Relationship Between Fetal Right Heart Doppler Findings With Lamellar Body and Fetal Lung Maturity
Objective: The aim of this study was to investigate the efficacy of fetal right heart doppler findings in determination of pulmonary maturity.
Materials and Methods: Pregnant women refered to the Department of Obstetrics and Gynecology at Karadeniz Technical University were included in the study. Pregnant women with pregestational or gestational diabetes mellitus, morbid obesity, thyroid dysfunction and fetal abnormality aneuploidy were not included in the study. The study was planned on women with late preterm and term pregnancy. Late preterm cases between 34-37 weeks were included in study group and term cases over 37 weeks were in control group. The doppler findings of main pulmonary artery and right pulmonary artery, mitral valve e/a wave ratio and lamellar body count were determined as the main outcomes. During caesarean section, 5cc amniotic fluid was taken to measure lamellar bodies count. Perinatal results of patients were recorded. p<0.05 was considered as statistical significance.
Read the detailed description
MATERIAL AND METHODS This study is a prospective clinical study and it was initiated after the approval of Karadeniz Technical University Faculty of Medicine Clinical Research Ethics Committee numbered 2017/88.
Between 2017-2019 years, pregnant women included in the study who admitted to the Department of Obstetrics and Gynecology at Karadeniz Technical University. The study was planned on cases who will undergo cesarean section over 34. week of gestation. They were not included in the study if pregnant women with pregestational or gestational diabetes mellitus, morbid obesity, thyroid dysfunction and fetal anomaly diagnosed aneuploidy or anomaly. Demographic data, ultrasonographic data and doppler parameters of all patients were recorded and evaluated prospectively. Informed consent was obtained from all participants prior to participation to work. Newborn results after birth were recorded.
Patients were divided into two groups. The study group consisted of late preterm cases (34-37 weeks of gestation) and the control group consisted of term cases (<37 weeks of gestation).
Doppler data of main pulmonary artery and right pulmonary artery, mitral valve e/a wave ratio and lamellar body count were determined as the main research parameters. In both groups, fetal thorax and heart circumference ratio, mitral e/a wave ratio, right pulmonary artery and main pulmonary doppler indexes (PI, RI, S / D, AT / ET) were evaluated before cesarean section. All ultrasonographic examinations and measurements were performed by a single operator with color doppler ultrasonography device. Doppler measurements were performed in supine and slightly left-facing position. Doppler index measurements of two groups were recorded separately for each pregnant.
Lamellar Body Count Lamellar body counting; at least 2cc of amniotic fluid not infected with blood during the cesarean section was taken into the EDTA tube and not centrifuged in thestudy. The sample was studied by using automatic blood counting device which is used for counting the shaped elements of blood called Coulter Counter which makes automatic blood count in hematology laboratories. The value specified in the platelet count part was accepted as the number of lamellar bodies in the report.
Statistical analysis All data were analyzed using with IBM SPSS Statistics 11 (IBM SPSS, Turkey). In addition to descriptive statistical methods, Student's t test was used to compare the quantitative data.
- Conditions
- Preterm Birth, Prenatal Care Late, Preterm Labor
- Being tested
- fetal heart doppler findings
- Keywords
- LAMELLAR BODY, pulmonary maturation, doppler ultrasonography, fetal pulmonary artery
- Medical subject headings
- Premature Birth, Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fetal heart doppler findingsDiagnostic test
Also called lamellar body count
Doppler data of main pulmonary artery and right pulmonary artery, mitral valve e/a wave ratio and lamellar body count were determined as the main research parameters. In both groups, fetal thorax and heart circumference ratio, mitral e/a wave ratio, right pulmonary artery and main pulmonary doppler indexes (PI, RI, S / D, AT / ET) were evaluated before cesarean section.
| Study group | Role | What they receive |
|---|---|---|
| study group | The study group consisted of late preterm cases(34-37 weeks of gestation) and Receives: Diagnostic Test: fetal heart doppler findings | |
| control group | the control group consisted of term cases (<37 weeks of gestation). Receives: Diagnostic Test: fetal heart doppler findings |
What is being measured
The primary outcome is the main question the study is designed to answer.
lamellar body count
lamellar body count was higher in the control group
Measured: immediately after the procedure(1year)
Doppler data of main pulmonary artery and right pulmonary artery, mitral valve e/a wave ratio
this data was measured before cesarian section.significant/ nonsignificant differences were detected between groups
Measured: immediately after the procedure (1year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start1 Jan 2017
- Primary completion1 Jun 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, erhan hüseyin cömert, Karadeniz Technical University
- Investigators
- ERHAN HUSEYIN COMERT, Principal investigator, Karadeniz Technical UniversityTURHAN ARAN, PROF, Study director, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296591
- Sponsor's protocol ID
- EComert
- Status last verified
- Mar 2020
- First submitted
- 25 Feb 2020
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Fetal Right Heart Doppler Findings With Lamellar Body and Fetal Lung Maturity
- ClinicalTrials.gov ID
- NCT04296591
- Acronym / sponsor ID
- EComert
- Conditions
- Preterm Birth, Prenatal Care Late, Preterm Labor
- Keywords
- LAMELLAR BODY, pulmonary maturation, doppler ultrasonography, fetal pulmonary artery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 5 Mar 2020 (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.
Objective: The aim of this study was to investigate the efficacy of fetal right heart doppler findings in determination of pulmonary maturity.
Materials and Methods: Pregnant women refered to the Department of Obstetrics and Gynecology at Karadeniz Technical University were included in the study. Pregnant women with pregestational or gestational diabetes mellitus, morbid obesity, thyroid dysfunction and fetal abnormality aneuploidy were not included in the study. The study was planned on women with late preterm and term pregnancy. Late preterm cases between 34-37 weeks were included in study group and term cases over 37 weeks were in control group. The doppler findings of main pulmonary artery and right pulmonary artery, mitral valve e/a wave ratio and lamellar body count were determined as the main outcomes. During caesarean section, 5cc amniotic fluid was taken to measure lamellar bodies count. Perinatal results of patients were recorded. p<0.05 was considered as statistical significance.
Detailed description
MATERIAL AND METHODS This study is a prospective clinical study and it was initiated after the approval of Karadeniz Technical University Faculty of Medicine Clinical Research Ethics Committee numbered 2017/88.
Between 2017-2019 years, pregnant women included in the study who admitted to the Department of Obstetrics and Gynecology at Karadeniz Technical University. The study was planned on cases who will undergo cesarean section over 34. week of gestation. They were not included in the study if pregnant women with pregestational or gestational diabetes mellitus, morbid obesity, thyroid dysfunction and fetal anomaly diagnosed aneuploidy or anomaly. Demographic data, ultrasonographic data and doppler parameters of all patients were recorded and evaluated prospectively. Informed consent was obtained from all participants prior to participation to work. Newborn results after birth were recorded.
Patients were divided into two groups. The study group consisted of late preterm cases (34-37 weeks of gestation) and the control group consisted of term cases (<37 weeks of gestation).
Doppler data of main pulmonary artery and right pulmonary artery, mitral valve e/a wave ratio and lamellar body count were determined as the main research parameters. In both groups, fetal thorax and heart circumference ratio, mitral e/a wave ratio, right pulmonary artery and main pulmonary doppler indexes (PI, RI, S / D, AT / ET) were evaluated before cesarean section. All ultrasonographic examinations and measurements were performed by a single operator with color doppler ultrasonography device. Doppler measurements were performed in supine and slightly left-facing position. Doppler index measurements of two groups were recorded separately for each pregnant.
Lamellar Body Count Lamellar body counting; at least 2cc of amniotic fluid not infected with blood during the cesarean section was taken into the EDTA tube and not centrifuged in thestudy. The sample was studied by using automatic blood counting device which is used for counting the shaped elements of blood called Coulter Counter which makes automatic blood count in hematology laboratories. The value specified in the platelet count part was accepted as the number of lamellar bodies in the report.
Statistical analysis All data were analyzed using with IBM SPSS Statistics 11 (IBM SPSS, Turkey). In addition to descriptive statistical methods, Student's t test was used to compare the quantitative data.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | Diagnostic Test: fetal heart doppler findingsThe study group consisted of late preterm cases(34-37 weeks of gestation) and |
| control group | – | Diagnostic Test: fetal heart doppler findingsthe control group consisted of term cases (<37 weeks of gestation). |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- total of 70 pregnant women (n: 70), 25 in the study group and 45 in the control group
Key inclusion criteria (2 listed)
- preterm and term pregnancy
- caesarean cases
Key exclusion criteria (5 listed)
- pregestational diabetes mellitus
- gestational diabetes mellitus
- morbid obesity
- thyroid dysfunction
- fetal anomaly diagnosed an euploidy or anomaly.
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 |
|---|---|---|
| fetal heart doppler findingsAlso: lamellar body countDoppler data of main pulmonary artery and right pulmonary artery, mitral valve e/a wave ratio and lamellar body count were determined as the main research parameters. In both groups, fetal thorax and heart circumference ratio, mitral e/a wave ratio, right pulmonary artery and main pulmonary doppler indexes (PI, RI, S / D, AT / ET) were evaluated before cesarean section. | Diagnostic test | control group, study group |
Primary outcome
lamellar body count
Time frame: immediately after the procedure(1year)
lamellar body count was higher in the control group
Doppler data of main pulmonary artery and right pulmonary artery, mitral valve e/a wave ratio
Time frame: immediately after the procedure (1year)
this data was measured before cesarian section.significant/ nonsignificant differences were detected between groups
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 5 Mar 2020.
- Individual participant dataSharing planned: Undecided
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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.
ERHAN HUSEYIN COMERT principal investigator
Karadeniz Technical University
TURHAN ARAN, PROF study director
Karadeniz Technical University
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth and Prenatal Care Late, run by Karadeniz Technical 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 2 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 5 Mar 2020. 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?
lamellar body count (time frame: immediately after the procedure(1year)). The study lists 2 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 5 Mar 2020.