- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04047966
Study of the Fetal and Maternal Microbiota in Preganant Women With Fetal Defect Growth (BIOCIR)
Study of the Fetal and Maternal Microbiota in Preganant Women With Fetal Defect Growth Nad Its Relationship With Inflammatory Biomarkers
Study Overview
Status
Conditions
Detailed Description
It is an observational and prospective study to determine the influence of the gastrointestinal microbiome on the intrauterine growth restriction (IUGR). For this purpose, investigators are planning to recruit 63 women with a diagnoses of IUGR and 63 pregnant women with a normal intrauterine growth.
Samples will be taken during third trimester (fecal and blood maternal sample), intrapartum (maternal blood, umbilical cord blood and placenta tissue sample) and post partum samples (meconic and newborn fecal samples at 6 weeks of life).
Also, obstetric and nutritional information will be registered by means of specific questionnaires.
Fecal samples will be use to study the gastrointestinal microbiome by Next Generation Sequencing techniques, whereas inflammatory biomarkers will be determine in plasma samples.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Barcelona, Spain, 08950
- Obstetrics and Gynecology, Hospital Sant Joan de Déu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Intrauterine Growth restriction (32-36 weeks)
- Vaginal delivery
- Delivery at 37 weeks
Exclusion Criteria:
- Alcohol, tabacco or other drugs consumption during pregnancy
- Antibiotic use before recruitment (3 months) or during pregnancy until delivery
- Gestational diabetes
- Fetuses anormalities
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Fetal growth restriction
63 fetuses with defects in fetal growth qith an estimated fetal weight below 10th percentile
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Control group
63 control fetuses with an estimated fetal weight about the 10th percentile
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gastrointestinal microbiome composition (16S RNA amplicon sequencing)
Time Frame: From May to July 2020
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To determine the main gastrointestinal microbiota composition, by 16S RNA amplicon sequencing, in fecal samples of pregnant women and their newborn (meconic)
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From May to July 2020
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma levels of inflammatoy biomarkers
Time Frame: From May to July 2020
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To determine plasma inflammatory biomarkers levels (LPS, LBP, IL6, 8, 10, 13,15 IFN-gamma, VEGF) in pregnant woman by inmunoassay determination
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From May to July 2020
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Carolina Gomez Llorente, PhD, Universidad de Granada
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UGranada
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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