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

NCT ID: NCT02691559

Last Updated: 2019-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-04-30

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.

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Detailed Description

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Conditions

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Respiratory Distress Syndrome Transient Tachypnea of Newborn Intrauterine Growth Retardation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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maternal inflammation group

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.

Group Type ACTIVE_COMPARATOR

Amniotic fluid analysis by blood gas device

Intervention Type DEVICE

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

normal pregnancy group

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.

Group Type ACTIVE_COMPARATOR

Amniotic fluid analysis by blood gas device

Intervention Type DEVICE

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

Interventions

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Amniotic fluid analysis by blood gas device

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

Intervention Type DEVICE

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
Maximum Eligible Age

5 Minutes

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seda Yilmaz Semerci

Fellowship of Neonatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seda Yilmaz Semerci, MD

Role: PRINCIPAL_INVESTIGATOR

Postdoctoral Fellow of Neonatology

Locations

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Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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1

Identifier Type: -

Identifier Source: org_study_id

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