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

November 26, 2019 updated by: Seda Yilmaz Semerci, Kanuni Sultan Suleyman Training and Research Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

184

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Kanuni Sultan Suleyman Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 5 minutes (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Inflammation/infection associated pregnancies Normal healthy pregnancies

Exclusion Criteria:

Congenital abnormalities Chromosomal abnormalities Blood contaminated amniotic fluid

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Device: Amniotic fluid analysis by blood gas device
Amniotic fluid analysis by blood gas device in maternal inflammation group vs normal pregnancy group
Active Comparator: 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.
Device: Amniotic fluid analysis by blood gas device
Amniotic fluid analysis by blood gas device in maternal inflammation group vs normal pregnancy group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A total of 200 amniotic fluid (1ml per one) would be collected and analyzed for the study.
Time Frame: through study completion, an average of 8 months
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.
Time Frame: through study completion, an average of 8 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
A total of 200 amniotic fluid (1ml per one) would be collected and analyzed for the study.
Time Frame: through study completion, an average of 8 months
Amniotic fluid will be analyzed for primary outcome measures by conventional methods and devices.
through study completion, an average of 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Investigators

  • Principal Investigator: Seda Yilmaz Semerci, MD, Postdoctoral Fellow of Neonatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

February 1, 2016

First Submitted That Met QC Criteria

February 24, 2016

First Posted (Estimate)

February 25, 2016

Study Record Updates

Last Update Posted (Actual)

November 27, 2019

Last Update Submitted That Met QC Criteria

November 26, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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