Clinical trial NCT04047966: Study of the Fetal and Maternal Microbiota in Preganant Women With Fetal Defect Growth
Official title: Study of the Fetal and Maternal Microbiota in Preganant Women With Fetal Defect Growth Nad Its Relationship With Inflammatory Biomarkers
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Intrauterine Growth Restriction
Keywords: Intrauterine Growth restriction
Gastrointestinal microbiome
Inflammatory biomarkers
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: Hospital Sant Joan de Deu
First posted: 2019-08-07
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Gastrointestinal microbiome composition (16S RNA amplicon sequencing)
timeFrame: From May to July 2020
Secondary outcomes:
measure: Plasma levels of inflammatoy biomarkers
timeFrame: From May to July 2020
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Obstetrics and Gynecology, Hospital Sant Joan de Déu
Study officials:
affiliation: Universidad de Granada
name: Carolina Gomez Llorente, PhD
role: PRINCIPAL_INVESTIGATOR
References: