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NCT02691559 Clinical Trial

The Possible Effect Of Amniotic Fluid pH On Neonatal Morbidities In Maternal Inflammation/Infection Associated Pregnancies

Respiratory Distress Syndrome Clinical Trial

Official title:
The Possible Effect Of Amniotic Fluid pH On Neonatal Morbidities In Maternal Inflammation/Infection Associated Pregnancies

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02691559
Other study ID # 1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2015
Est. completion date April 2016

Study information
Verified date November 2019
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Amniotic fluid (AF) pH can be affected by the maternal and/or fetal conditions such as PPROM, prematurity or fetal distress. It is known that fetal urine is the major content of AF since 20th gestational week. Besides fetal alveolar fluid (FAF), gastrointestinal tract, umbilical cord and fetal side of placenta are important sources for AF. Bombesin-like peptides, 8-hydroxydeoxyguanosine in fetal urine and leukotriene E(4), lecithin, sphingomyelin, lamellar body in FAF are molecules acting on fetal lung maturation. Varying levels of these molecules relevant to the stage of lung maturation may constitute an association to AF pHTo detect the possible effect of AF pH on neonatal respiratory morbidities 1 milliliters of AF is aspirated during C-section before incision of membranes. pH value of AFs were analyzed by the blood gas machine (Siemens RAPIDLab®1200 Systems) of NICU. Maternal and neonatal demographic features and clinical outcomes, incidences of morbidities such as respiratory distress syndrome (RDS), transient tachypnea of the newborn (TTN) are all recorded.

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 5 Minutes
Eligibility Inclusion Criteria:

Inflammation/infection associated pregnancies Normal healthy pregnancies

Exclusion Criteria:

Congenital abnormalities Chromosomal abnormalities Blood contaminated amniotic fluid

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Amniotic fluid analysis by blood gas device
Amniotic fluid analysis by blood gas device in maternal inflammation group vs normal pregnancy group

Locations
Country Name City State
Turkey Kanuni Sultan Suleyman Training and Research Hospital Istanbul

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

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary A total of 200 amniotic fluid (1ml per one) would be collected and analyzed for the study. Amniotic fluid will be analysed for the value of its pH through study completion, an average of 8 months
Primary A total of 200 amniotic fluid (1ml per one) would be collected and analyzed for the study. Amniotic fluid will be analysed for the value of its contents of electrolytes such as sodium, potassium, chlorid. through study completion, an average of 8 months
Secondary A total of 200 amniotic fluid (1ml per one) would be collected and analyzed for the study. Amniotic fluid will be analyzed for primary outcome measures by conventional methods and devices. through study completion, an average of 8 months
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