Study of the Fetal and Maternal Microbiota in Preganant Women With Fetal Defect Growth

Study Overview
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Brief Summary
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It is an observational and prospective study that will include consecutively 63 controls (fetuses with estimated fetal weight above the 10th centile) and 63 fetuses with defects in fetal growth (estimated fetal weight below the 10th percentile) during the third trimester (32-26 weeks) with gestational age at birth equal or over 37 weeks. Investigators will collect: (1) Obstetric and nutritional questionnaires, (2) maternal samples between 32-36 weeks (feces), (3) intrapartum samples (maternal blood, cord blood and placenta) and (4) postpartum samples (meconic and newborn feces at 6 weeks of life)

Detailed Description
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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.

Official Title
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Study of the Fetal and Maternal Microbiota in Preganant Women With Fetal Defect Growth Nad Its Relationship With Inflammatory Biomarkers

Conditions
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Intrauterine Growth Restriction

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fetal growth restriction<br>63 fetuses with defects in fetal growth qith an estimated fetal weight below 10th percentile | |
| Control group<br>63 control fetuses with an estimated fetal weight about the 10th percentile | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal microbiome composition (16S RNA amplicon sequencing) | To determine the main gastrointestinal microbiota composition, by 16S RNA amplicon sequencing, in fecal samples of pregnant women and their newborn (meconic) | From May to July 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma levels of inflammatoy biomarkers | To determine plasma inflammatory biomarkers levels (LPS, LBP, IL6, 8, 10, 13,15 IFN-gamma, VEGF) in pregnant woman by inmunoassay determination | From May to July 2020 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intrauterine Growth restriction, Gastrointestinal microbiome, Inflammatory biomarkers