NCT02691559

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2016

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 25, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

November 27, 2019

Status Verified

November 1, 2019

Enrollment Period

8 months

First QC Date

February 1, 2016

Last Update Submit

November 26, 2019

Conditions

Respiratory Distress SyndromeTransient Tachypnea of NewbornIntrauterine Growth Retardation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

maternal inflammation group

ACTIVE COMPARATOR

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

normal pregnancy group

ACTIVE COMPARATOR

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

Interventions

Amniotic fluid analysis by blood gas deviceDEVICE

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

maternal inflammation groupnormal pregnancy group

Eligibility Criteria

AgeUp to 5 Minutes
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Inflammation/infection associated pregnancies Normal healthy pregnancies

You may not qualify if:

  • Congenital abnormalities Chromosomal abnormalities Blood contaminated amniotic fluid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory Distress SyndromeTransient Tachypnea of the NewbornFetal Growth Retardation

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersRespiratory Distress Syndrome, NewbornTachypneaInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsFetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGrowth DisordersPathologic Processes

Study Officials

  • Seda Yilmaz Semerci, MD

    Postdoctoral Fellow of Neonatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellowship of Neonatology

Study Record Dates

First Submitted

February 1, 2016

First Posted

February 25, 2016

Study Start

August 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

November 27, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)