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

NCT04296591 | Completed

• 1 other identifier: EComert
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Preterm Birth; Prenatal Care Late; Preterm Labor

Keywords

LAMELLAR BODY; pulmonary maturation; doppler ultrasonography; fetal pulmonary artery

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

study group

The study group consisted of late preterm cases(34-37 weeks of gestation) and

Diagnostic Test: fetal heart doppler findings

control group

the control group consisted of term cases (\<37 weeks of gestation).

Diagnostic Test: fetal heart doppler findings

Interventions

fetal heart doppler findings DIAGNOSTIC_TEST

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.

Also known as: lamellar body count

control group; study group

Eligibility Criteria

• Gender Eligibility Details: pregnancy woman
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• preterm and term pregnancy
• caesarean cases

You may not qualify if:

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

Sponsors & Collaborators

• Karadeniz Technical University: lead

MeSH Terms

Conditions

Premature Birth; Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• ERHAN HUSEYIN COMERT

  Karadeniz Technical University

  PRINCIPAL INVESTIGATOR

• TURHAN ARAN, PROF

  Karadeniz Technical University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research asistant

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: March 5, 2020
• Study Start: January 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: August 1, 2019
• Last Updated: March 5, 2020

Record last verified: 2020-03