Respiratory Distress Syndrome Clinical Trial
Official title:
The Possible Effect Of Amniotic Fluid pH On Neonatal Morbidities In Maternal Inflammation/Infection Associated Pregnancies
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 |
Verified date | November 2019 |
Source | Kanuni Sultan Suleyman Training and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Kanuni Sultan Suleyman Training and Research Hospital | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Kanuni Sultan Suleyman Training and Research Hospital |
Turkey,
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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