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

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ClinicalTrials.gov Identifier: NCT04047966
Recruitment Status : Terminated (Due to the current pandemic situation, recruitment has been disrupted by the inability to recruit more patients)
First Posted : August 7, 2019
Last Update Posted : November 5, 2020
Sponsor:
Collaborator:
Hospital Sant Joan de Deu
Information provided by (Responsible Party):
Carolina Gómez Llorente, 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)

Condition or disease
Intrauterine Growth Restriction

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.

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Study Type : Observational
Actual Enrollment : 42 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Study of the Fetal and Maternal Microbiota in Preganant Women With Fetal Defect Growth Nad Its Relationship With Inflammatory Biomarkers
Actual Study Start Date : March 2, 2018
Actual Primary Completion Date : October 31, 2020
Actual Study Completion Date : October 31, 2020

Group/Cohort
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



Primary Outcome Measures :
  1. Gastrointestinal microbiome composition (16S RNA amplicon sequencing) [ Time Frame: 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 :
  1. Plasma levels of inflammatoy biomarkers [ Time Frame: 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


Biospecimen Retention:   Samples With DNA
We will recruit fecal samples to obtain bacterial DNA for metagenomics analysis


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04047966


Locations
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Spain
Obstetrics and Gynecology, Hospital Sant Joan de Déu
Barcelona, Spain, 08950
Sponsors and Collaborators
Universidad de Granada
Hospital Sant Joan de Deu
Investigators
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Principal Investigator: Carolina Gomez Llorente, PhD Universidad de Granada
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Responsible Party: Carolina Gómez Llorente, Principal Investigator, Universidad de Granada
ClinicalTrials.gov Identifier: NCT04047966    
Other Study ID Numbers: UGranada
First Posted: August 7, 2019    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carolina Gómez Llorente, Universidad de Granada:
Intrauterine Growth restriction
Gastrointestinal microbiome
Inflammatory biomarkers
Additional relevant MeSH terms:
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Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes