Study of the Fetal and Maternal Microbiota in Preganant Women With Fetal Defect Growth (BIOCIR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease|
|Intrauterine Growth Restriction|
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 Type :||Observational|
|Actual Enrollment :||42 participants|
|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|
Fetal growth restriction
63 fetuses with defects in fetal growth qith an estimated fetal weight below 10th percentile
63 control fetuses with an estimated fetal weight about the 10th percentile
- 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)
- 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
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
|Obstetrics and Gynecology, Hospital Sant Joan de Déu|
|Barcelona, Spain, 08950|
|Principal Investigator:||Carolina Gomez Llorente, PhD||Universidad de Granada|