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

Study Overview
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Brief Summary
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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.

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

Conditions
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Respiratory Distress Syndrome, Transient Tachypnea of Newborn, Intrauterine Growth Retardation

Intervention / Treatment
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* Device: Amniotic fluid analysis by blood gas device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inflammation/infection associated pregnancies Normal healthy pregnancies Exclusion Criteria: Congenital abnormalities Chromosomal abnormalities Blood contaminated amniotic fluid

Ages Eligible for Study
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Maximum Age: 5 Minutes

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: maternal inflammation group<br>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. | Device: Amniotic fluid analysis by blood gas device<br>* Amniotic fluid analysis by blood gas device in maternal inflammation group vs normal pregnancy group<br>|
| Active Comparator: normal pregnancy group<br>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. | Device: Amniotic fluid analysis by blood gas device<br>* Amniotic fluid analysis by blood gas device in maternal inflammation group vs normal pregnancy group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |