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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02691559

Enrollment

184

Registered

2016-02-25

Start date

2015-08-31

Completion date

2016-04-30

Last updated

2019-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICEAmniotic fluid analysis by blood gas device

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 5 Minutes

Healthy volunteers

Yes

Inclusion criteria

Inflammation/infection associated pregnancies Normal healthy pregnancies

Exclusion criteria

Congenital abnormalities Chromosomal abnormalities Blood contaminated amniotic fluid

Design outcomes

Primary

Measure	Time frame	Description
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 pH

Secondary

Measure	Time frame	Description
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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026