Respiratory Distress SyndromeNCT02691559
The Possible Effect Of Amniotic Fluid pH On Neonatal Morbidities In Maternal Inflammation/Infection Associated Pregnancies
A study testing Amniotic fluid analysis by blood gas device in people with Respiratory Distress Syndrome and Transient Tachypnea of Newborn, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 5 minutesHealthy volunteers can take part
- Conditions the study is for
- Respiratory Distress Syndrome, Transient Tachypnea of Newborn, Intrauterine Growth Retardation
- What is being tested?
- Amniotic fluid analysis by blood gas device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 minutes
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Inflammation/infection associated pregnancies Normal healthy pregnancies
Who cannot join
- Congenital abnormalities Chromosomal abnormalities Blood contaminated amniotic fluid
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul
About this study
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.
- Conditions
- Respiratory Distress Syndrome, Transient Tachypnea of Newborn, Intrauterine Growth Retardation
- Being tested
- Amniotic fluid analysis by blood gas device
- Medical subject headings
- Respiratory Distress Syndrome, Transient Tachypnea of the Newborn, Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amniotic fluid analysis by blood gas deviceDevice
Amniotic fluid analysis by blood gas device in maternal inflammation group vs normal pregnancy group
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Amniotic fluid analysis by blood gas device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Amniotic fluid will be analyzed for primary outcome measures by conventional methods and devices.
Measured: through study completion, an average of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startAug 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Yilmaz Semerci, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Seda Yilmaz Semerci, MD, Principal investigator, Postdoctoral Fellow of Neonatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02691559
- Sponsor's protocol ID
- 1
- Status last verified
- Nov 2019
- First submitted
- 1 Feb 2016
- Last updated
- 27 Nov 2019
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Possible Effect Of Amniotic Fluid pH On Neonatal Morbidities In Maternal Inflammation/Infection Associated Pregnancies
- ClinicalTrials.gov ID
- NCT02691559
- Acronym / sponsor ID
- 1
- Conditions
- Respiratory Distress Syndrome, Transient Tachypnea of Newborn, Intrauterine Growth Retardation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 25 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| maternal inflammation group | Active comparator | Device: Amniotic fluid analysis by blood gas deviceAmniotic 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. |
| normal pregnancy group | Active comparator | Device: Amniotic fluid analysis by blood gas deviceAmniotic 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. |
Who may qualify
- Ages
- Up to 5 minutes
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Inflammation/infection associated pregnancies Normal healthy pregnancies
Key exclusion criteria (1 listed)
- Congenital abnormalities Chromosomal abnormalities Blood contaminated amniotic fluid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amniotic fluid analysis by blood gas deviceAmniotic fluid analysis by blood gas device in maternal inflammation group vs normal pregnancy group | Device | maternal inflammation group, normal pregnancy group |
Primary outcome
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
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seda Yilmaz Semerci, MD principal investigator
Postdoctoral Fellow of Neonatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amniotic fluid analysis by blood gas device in people with Respiratory Distress Syndrome and Transient Tachypnea of Newborn, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2019.