Intrauterine Growth RestrictionBIOCIRNCT04047966
Study of the Fetal and Maternal Microbiota in Preganant Women With Fetal Defect Growth
An observational study of Intrauterine Growth Restriction, run by Universidad de Granada at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrauterine Growth Restriction
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- 2 Mar 2018to 31 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Intrauterine Growth restriction (32-36 weeks)
- Vaginal delivery
- Delivery at 37 weeks
Who cannot join
- Alcohol, tabacco or other drugs consumption during pregnancy
- Antibiotic use before recruitment (3 months) or during pregnancy until delivery
- Gestational diabetes
- Fetuses anormalities
Trial locations and contacts
1 site in 1 country.
Spain1 site
Obstetrics and Gynecology, Hospital Sant Joan de Déu
Barcelona, 08950
About this study
Official title: Study of the Fetal and Maternal Microbiota in Preganant Women With Fetal Defect Growth Nad Its Relationship With Inflammatory Biomarkers
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)
Read the 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.
- Conditions
- Intrauterine Growth Restriction
- Keywords
- Intrauterine Growth restriction, Gastrointestinal microbiome, Inflammatory biomarkers
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From May to July 2020
Secondary outcomes (1)
Plasma levels of inflammatoy biomarkers
To determine plasma inflammatory biomarkers levels (LPS, LBP, IL6, 8, 10, 13,15 IFN-gamma, VEGF) in pregnant woman by inmunoassay determination
Measured: From May to July 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start2 Mar 2018
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Why it stopped: Due to the current pandemic situation, recruitment has been disrupted by the inability to recruit more patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine Growth RestrictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Sant Joan de Deu
- Responsible party
- Principal investigator, Carolina Gómez Llorente, Universidad de Granada
- Investigators
- Carolina Gomez Llorente, PhD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047966
- Sponsor's protocol ID
- UGranada
- Acronym
- BIOCIR
- Status last verified
- Nov 2020
- First submitted
- 11 Jul 2019
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Fetal and Maternal Microbiota in Preganant Women With Fetal Defect Growth Nad Its Relationship With Inflammatory Biomarkers
- ClinicalTrials.gov ID
- NCT04047966
- Acronym / sponsor ID
- BIOCIR / UGranada
- Conditions
- Intrauterine Growth Restriction
- Keywords
- Intrauterine Growth restriction, Gastrointestinal microbiome, Inflammatory biomarkers
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to the current pandemic situation, recruitment has been disrupted by the inability to recruit more patients
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- Hospital Sant Joan de Deu
- Study start
- 2 Mar 2018 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 7 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Intrauterine Growth restriction (32-36 weeks)
- Vaginal delivery
- Delivery at 37 weeks
Key exclusion criteria (4 listed)
- Alcohol, tabacco or other drugs consumption during pregnancy
- Antibiotic use before recruitment (3 months) or during pregnancy until delivery
- Gestational diabetes
- Fetuses anormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
1 secondary outcome
Plasma levels of inflammatoy biomarkers
Time frame: From May to July 2020
Results and safety
The study was stopped early (reason given: Due to the current pandemic situation, recruitment has been disrupted by the inability to recruit more patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolina Gomez Llorente, PhD principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrauterine Growth Restriction, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to the current pandemic situation, recruitment has been disrupted by the inability to recruit more patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal microbiome composition (16S RNA amplicon sequencing) (time frame: From May to July 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.