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

Terminated

• Conditions: Intrauterine Growth Restriction

• Registration Number: NCT04047966
• Lead Sponsor: Universidad de Granada

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.

Study Timeline

• Study Start: 2018-03-02
• Study First Submitted: 2019-07-11
• Study First Submitted QC: 2019-08-06
• Study First Posted: 2019-08-07
• Primary Completion: 2020-10-31
• Study Completion: 2020-10-31
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 42

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Obstetrics and Gynecology, Hospital Sant Joan de Déu; 🇪🇸 Barcelona, Spain