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

Sponsor
Karadeniz Technical University (Other)
Overall Status
Completed
CT.gov ID
NCT04296591
Collaborator
(none)
1
30.9

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
1 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Relationship Between Fetal Right Heart Doppler Findings With Lamellar Body and Fetal Lung Maturity
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Jun 1, 2019
Actual Study Completion Date :
Aug 1, 2019

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. lamellar body count [immediately after the procedure(1year)]

      lamellar body count was higher in the control group

    2. Doppler data of main pulmonary artery and right pulmonary artery, mitral valve e/a wave ratio [immediately after the procedure (1year)]

      this data was measured before cesarian section.significant/ nonsignificant differences were detected between groups

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Karadeniz Technical University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    erhan hüseyin cömert, research asistant, Karadeniz Technical University
    ClinicalTrials.gov Identifier:
    NCT04296591
    Other Study ID Numbers:
    • EComert
    First Posted:
    Mar 5, 2020
    Last Update Posted:
    Mar 5, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by erhan hüseyin cömert, research asistant, Karadeniz Technical University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 5, 2020