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

U

University of Granada (UGR)

Status

Terminated

Conditions

Intrauterine Growth Restriction

Study type

Observational

Funder types

Other

Identifiers

NCT04047966
UGranada

Details and patient eligibility

About

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)

Full 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.

Enrollment

42 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

42 participants in 2 patient groups

Fetal growth restriction
Description:
63 fetuses with defects in fetal growth qith an estimated fetal weight below 10th percentile
Control group
Description:
63 control fetuses with an estimated fetal weight about the 10th percentile

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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