Back to resultsThe Possible Effect Of Amniotic Fluid pH On Neonatal Morbidities In Maternal Inflammation/Infection Associated Pregnancies
Primary Purpose
Respiratory Distress Syndrome, Transient Tachypnea of Newborn, Intrauterine Growth Retardation
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Amniotic fluid analysis by blood gas device
Sponsored by
About this trial
This is an interventional diagnostic trial for Respiratory Distress Syndrome
Eligibility Criteria
Inclusion Criteria:
Inflammation/infection associated pregnancies Normal healthy pregnancies
Exclusion Criteria:
Congenital abnormalities Chromosomal abnormalities Blood contaminated amniotic fluid
Sites / Locations
- Kanuni Sultan Suleyman Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
maternal inflammation group
normal pregnancy group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02691559
First Posted
February 1, 2016
Last Updated
November 26, 2019
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02691559
Brief Title
The Possible Effect Of Amniotic Fluid pH On Neonatal Morbidities In Maternal Inflammation/Infection Associated Pregnancies
Official Title
The Possible Effect Of Amniotic Fluid pH On Neonatal Morbidities In Maternal Inflammation/Infection Associated Pregnancies
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Transient Tachypnea of Newborn, Intrauterine Growth Retardation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
184 (Actual)
8. Arms, Groups, and Interventions
Arm Title
maternal inflammation group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
normal pregnancy group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Amniotic fluid analysis by blood gas device
Intervention Description
Amniotic fluid analysis by blood gas device in maternal inflammation group vs normal pregnancy group
Primary Outcome Measure Information:
Title
A total of 200 amniotic fluid (1ml per one) would be collected and analyzed for the study.
Description
Amniotic fluid will be analysed for the value of its pH
Time Frame
through study completion, an average of 8 months
Title
A total of 200 amniotic fluid (1ml per one) would be collected and analyzed for the study.
Description
Amniotic fluid will be analysed for the value of its contents of electrolytes such as sodium, potassium, chlorid.
Time Frame
through study completion, an average of 8 months
Secondary Outcome Measure Information:
Title
A total of 200 amniotic fluid (1ml per one) would be collected and analyzed for the study.
Description
Amniotic fluid will be analyzed for primary outcome measures by conventional methods and devices.
Time Frame
through study completion, an average of 8 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
5 Minutes
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Inflammation/infection associated pregnancies Normal healthy pregnancies
Exclusion Criteria:
Congenital abnormalities Chromosomal abnormalities Blood contaminated amniotic fluid
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seda Yilmaz Semerci, MD
Organizational Affiliation
Postdoctoral Fellow of Neonatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kanuni Sultan Suleyman Training and Research Hospital
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Possible Effect Of Amniotic Fluid pH On Neonatal Morbidities In Maternal Inflammation/Infection Associated Pregnancies
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