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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-02

Study Completion Date

2020-10-31

Brief Summary

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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

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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.

Conditions

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Intrauterine Growth Restriction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Fetal growth restriction

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

No interventions assigned to this group

Control group

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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Carolina Gómez Llorente

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carolina Gomez Llorente, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Granada

Locations

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Obstetrics and Gynecology, Hospital Sant Joan de Déu

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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UGranada

Identifier Type: -

Identifier Source: org_study_id