Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04047966
Other study ID # UGranada
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date March 2, 2018
Est. completion date October 31, 2020

Study information

Verified date November 2020
Source Universidad de Granada
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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)


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.


Recruitment information / eligibility

Status Terminated
Enrollment 42
Est. completion date October 31, 2020
Est. primary completion date October 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Study Design


Locations

Country Name City State
Spain Obstetrics and Gynecology, Hospital Sant Joan de Déu Barcelona

Sponsors (2)

Lead Sponsor Collaborator
Universidad de Granada Hospital Sant Joan de Deu

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) From May to July 2020
Secondary 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 From May to July 2020
See also
  Status Clinical Trial Phase
Completed NCT04506970 - Predicting Placental Pathologies by Ultrasound Imaging
Recruiting NCT03866863 - Intra Uterine Growth Restriction
Recruiting NCT03662178 - Investigating the Structured Use of Ultrasound Scanning for Fetal Growth
Not yet recruiting NCT05720169 - Fetal, Obstetrics and Reproduction Genomics
Completed NCT04633551 - Vascular Inflammation and Anti-inflammatory Supplements After Adverse Pregnancy Outcomes N/A
Recruiting NCT05500989 - PlacEntal Acute Atherosis RefLecting Subclinical Atherosclerosis
Recruiting NCT04141189 - Comparison of Follow-up Protocols in Terms of Fetal, Neonatal and Maternal Results in Intrauterine Growth Retardation N/A
Completed NCT03726697 - Effect of Tahneek on Hypoglycemia in Newborn Infants N/A
Recruiting NCT03398629 - Diagnosis and Management of Intrauterine Growth Restriction and Congenital Anomalies
Recruiting NCT02473991 - Correlation Between Placental Thickness in the Second and Third Trimester and Fetal Weight N/A
Completed NCT02696577 - The Effect of Omega 3 on Pregnancy Complicated by Asymmetrical Intrauterine Growth Restriction Phase 2
Recruiting NCT04766866 - sFlt1/PlGF and Planned Delivery to Prevent Preeclampsia at Term. N/A
Not yet recruiting NCT03865628 - Ultrasound Evaluation of Fetal Hemodynamics and Perinatal Complications
Completed NCT05328453 - Sonographic 3D Measurement of Fetal Thymus May be Used to Predict the Small Baby in Pregnancy.
Completed NCT05800938 - The Effect of Oral Isosorbide Mononitrate Therapy on Umbilical Artery Doppler Resistance Index in Pregnancies With Intrauterine Growth Restriction: Prospective Randomized Control Trial Phase 4
Not yet recruiting NCT06226051 - Growing Little PEAPODS Study
Recruiting NCT02807324 - Women Specific Cardiac Recovery After Preeclampsia
Recruiting NCT02515292 - Evaluation of Infants With Intrauterine Growth Restriction N/A
Active, not recruiting NCT01942525 - Influence of Intrauterine Growth Restriction on Amplitude-integrated EEG in Preterm Infants N/A
Withdrawn NCT04557475 - Transplacental Aspirin Therapy for Early Onset Fetal Growth Restriction Phase 3