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

NCT04047966 | Terminated

• 1 other identifier: UGranada
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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)

Conditions

Intrauterine Growth Restriction

Keywords

Intrauterine Growth restriction; Gastrointestinal microbiome; Inflammatory biomarkers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Plasma levels of inflammatoy biomarkers

  From May to July 2020

Study Arms (2)

Fetal growth restriction

63 fetuses with defects in fetal growth qith an estimated fetal weight below 10th percentile

Control group

63 control fetuses with an estimated fetal weight about the 10th percentile

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Intrauterine Growth restriction (32-36 weeks)
• Vaginal delivery
• Delivery at 37 weeks

You may not qualify if:

• Alcohol, tabacco or other drugs consumption during pregnancy
• Antibiotic use before recruitment (3 months) or during pregnancy until delivery
• Gestational diabetes
• Fetuses anormalities

Sponsors & Collaborators

• Universidad de Granada: lead
• Hospital Sant Joan de Deu: collaborator

Study Sites (1)

Obstetrics and Gynecology, Hospital Sant Joan de Déu

Barcelona, 08950, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

We will recruit fecal samples to obtain bacterial DNA for metagenomics analysis

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carolina Gomez Llorente, PhD

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: August 7, 2019
• Study Start: March 2, 2018
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: November 5, 2020

Record last verified: 2020-11

Locations

ES (1)