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

Not Applicable

Completed

• Conditions: Transient Tachypnea of Newborn; Intrauterine Growth Retardation; Respiratory Distress Syndrome
• Interventions: Device: Amniotic fluid analysis by blood gas device

• Registration Number: NCT02691559
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2016-02-01
• Study First Submitted QC: 2016-02-24
• Study First Posted: 2016-02-25
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

Inflammation/infection associated pregnancies Normal healthy pregnancies

Read More

Exclusion Criteria

Congenital abnormalities Chromosomal abnormalities Blood contaminated amniotic fluid

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
normal pregnancy group	Amniotic fluid analysis by blood gas device	Amniotic fluid analysis by blood gas device: The control group will consist of infants born to mothers without infection/inflammation. In all deliveries amniotic fluid will be taken and will be analyzed by blood gas device.
maternal inflammation group	Amniotic fluid analysis by blood gas device	Amniotic fluid analysis by blood gas device: evaluate the possible association between maternal inflammation and amniotic fluid pH two groups will be designed. One group will consist of infants born to mothers with infection/inflammation whereas the control group will consist of infants born to mothers without infection/inflammation. In all deliveries amniotic fluid will be taken and will be analyzed by blood gas device.

Primary Outcome Measures

Name	Time	Method
A total of 200 amniotic fluid (1ml per one) would be collected and analyzed for the study.	through study completion, an average of 8 months	Amniotic fluid will be analysed for the value of its contents of electrolytes such as sodium, potassium, chlorid.

Secondary Outcome Measures

Name	Time	Method
A total of 200 amniotic fluid (1ml per one) would be collected and analyzed for the study.	through study completion, an average of 8 months	Amniotic fluid will be analyzed for primary outcome measures by conventional methods and devices.

Trial Locations

Locations (1)

Kanuni Sultan Suleyman Training and Research Hospital; 🇹🇷 Istanbul, Turkey