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NCT02813954 Clinical Trial

The Predictive Value of Amniotic Fluid pH and Electrolytes on Neonatal Respiratory Disorders

Respiratory Distress Syndrome Clinical Trial

Official title:
The Predictive Value of Amniotic Fluid pH and Electrolytes on Neonatal Respiratory Disorders

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02813954
Other study ID # 12
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2015
Est. completion date April 2016

Study information
Verified date August 2022
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Amniotic fluid (AF) is a complex structure with a changing content by gestational time. AF pH can be affected by both maternal and fetal conditions such as preterm ruptures of membranes, prematurity and fetal distress. While fetal urine is the major content of AF since 20th gestational week, fetal lung liquid (FLL) also acts as a minor content. Secretion of FLL depends on chloride transport and postnatal clearance of FLL is provided by active reabsorption of sodium (Na) ions. Down-regulation of epithelial Na channels (ENaCs) and an increase of pulmonary compliance accompany to pulmonary adaptation developing at the first hours of life. Lower genomic expression of Na channels in airways is shown to be associated to respiratory distress syndrome (RDS) in preterm. Although pH and electrolyte value of AF is thought to be relevant to fetal and maternal conditions such as gestational age, antenatal steroids and preterm birth, there is no study about this topic in the literature.

Recruitment information / eligibility
Status Completed
Enrollment 184
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 25 Hours
Eligibility Inclusion Criteria: Accepted to participate with informed consent Normal healthy pregnancies Exclusion Criteria: Congenital abnormalities Chromosomal abnormalities Blood contaminated AF Declined to participate

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Blood Gas Sampling
analyzing amniotic fluid by blood gas device

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary The Predictive Value of Amniotic Fluid pH and Electrolytes on Neonatal Respiratory Disorders 8 months
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