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

Intrauterine Growth Restriction Clinical Trial

— BIOCIR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04047966
• Other study ID #: UGranada
• Status: Terminated
• Start date: March 2, 2018
• Est. completion date: October 31, 2020

Study information

• Verified date: November 2020
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Intrauterine Growth Restriction

Locations

Country	Name	City	State
Spain	Obstetrics and Gynecology, Hospital Sant Joan de Déu	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Granada	Hospital Sant Joan de Deu

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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