This Study Was to Investigate the Efficacy of Fetal Right Heart Doppler Findings in Determination of Pulmonary Maturity

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.

Study Overview

• Status: Completed
• Conditions: Preterm Birth; Preterm Labor; Prenatal Care Late
• Intervention / Treatment: Diagnostic test: fetal heart doppler findings

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 Type: Observational
• Enrollment (Actual): 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

total of 70 pregnant women (n: 70), 25 in the study group and 45 in the control group

Description

Inclusion Criteria:

• preterm and term pregnancy
• caesarean cases

Exclusion Criteria:

• pregestational diabetes mellitus
• gestational diabetes mellitus
• morbid obesity
• thyroid dysfunction
• fetal anomaly diagnosed an euploidy or anomaly.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
study group; The study group consisted of late preterm cases(34-37 weeks of gestation) and	Diagnostic test: fetal heart doppler findings; 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.; Other Names: lamellar body count
control group; the control group consisted of term cases (<37 weeks of gestation).	Diagnostic test: fetal heart doppler findings; 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.; Other Names: lamellar body count

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lamellar body count	lamellar body count was higher in the control group	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	immediately after the procedure (1year)

Collaborators and Investigators

• Sponsor: Karadeniz Technical University
• Investigators: Principal Investigator: ERHAN HUSEYIN COMERT, Karadeniz Technical University; Study Director: TURHAN ARAN, PROF, Karadeniz Technical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: February 25, 2020
• First Submitted That Met QC Criteria: March 4, 2020
• First Posted (Actual): March 5, 2020

Study Record Updates

• Last Update Posted (Actual): March 5, 2020
• Last Update Submitted That Met QC Criteria: March 4, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: LAMELLAR BODY; pulmonary maturation; doppler ultrasonography; fetal pulmonary artery
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Premature Birth; Obstetric Labor, Premature
• Other Study ID Numbers: EComert

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No