Biobank on Prematurity, Preeclampsia and Other Pregnancy Complications

Preterm Birth Clinical Trial

Official title:

Biobank of Data and of Human Biological Samples on Prematurity, Preeclampsia and Other Pregnancy Complications

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02744365
• Other study ID #: 2015-2272
• Status: Recruiting
• Start date: April 2015
• Est. completion date: April 2028

Study information

• Verified date: March 2022
• Source: CHU de Quebec-Universite Laval
• Contact: Emmanuel Bujold, MD, MSc
• Phone: 418-525-4444
• Email: emmanuel.bujold[@]crchudequebec.ulaval.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Biobank includes data and biological specimens of women from three original studies: 1) First-trimester Prediction of Preeclampsia (PREDICTION Study, NCT02189148), 2) Pre-Eclampsia And growth Retardation, an evaluative Longitudinal study (PEARL Study, NCT02379832), 3) Effect of Low Dose Aspirin on Birthweight in Twins: The GAP Trial (NCT02280031) and 4)PREDICTION2: Prediction of Preeclampsia and other Pregnancy Complications Following Combined Iterative Screening.

Description:

This Biobank is comprised of: 1) medical, social, obstetrical and ultrasonographic data, 2) human biological samples (maternal plasma, serum and buffy coat, maternal urine, cord blood) and 3) the results derived from these (biochemical or ultrasonographic markers, genetics, risk calculations ...)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7845
• Est. completion date: April 2028
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• (specific to each study)

Exclusion Criteria:

• pregnant women <18 years old at recruitment
• negative fetal heart at recruitment
• women not able to provide an informed consent to the study

Related Conditions & MeSH terms

• Congenital Abnormalities
• Fetal Anomalies
• Pre-Eclampsia
• Preeclampsia
• Pregnancy Complications
• Premature Birth
• Preterm Birth

Intervention

Other:
• Observational
All women of the biobank have provided: blood samples (plasma, serum and Buffy-coat) urine samples demographic and clinical data (maternal age, BMI, smoking status, obstetrical and medical history) mean arterial blood pressure ultrasound examination (datation of pregnancy at recruitment, uterine arteries doppler, placental volume, nuchal translucency in the majority of the cases) access to medical record (for pregnancy/delivery outcomes, newborn birthweight, gestational age at delivery)

Locations

Country	Name	City	State
Canada	CHU de Quebec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	early onset preeclampsia	Preeclampsia will be defined according to the Canadian Guidelines for Diagnosis, Evaluation, and Management of the Hypertensive Disorders of Pregnancy guidelines, as de novo hypertension with diastolic blood pressure >90 mmHg on two occasions at least four hours apart, after 20 weeks of pregnancy, associated with proteinuria =300 mg/24 h or at least '2 +' protein on urine dipstick or an adverse conditions	diagnosed between 20 and 34 weeks of gestation
Secondary	Severe preeclampsia	Severe Preeclampsia will be defined by the presence of at least one of the following adverse condition: 1) systolic blood pressure = 160 mmHg and diastolic blood pressure = 110 mmHg after 4 h of bed rest, 2) proteinuria = 5 g/24 h or at least '3 +' protein on urine dipstick, or 3) oliguria < 400 ml/24 h; 4) cerebral or visual disturbances; epigastric pain; pulmonary edema or cyanosis; thrombocytopenia <100,000mm	between 20 and 42 weeks of gestation
Secondary	Fetal growth restriction	Fetal growth restriction will be defined as a birth weight below the 10th centile (or below the 3rd centile for severe FGR) of Canadian reference growth charts.	between 20 and 42 weeks of gestation
Secondary	spontaneous preterm birth	sPTB is a birth occuring spontaneously between 20 and 36 6/7 weeks of gestation	between 20 and 36 6/7 weeks of gestation
Secondary	Fetal aneuploidies	Any fetal chromosome that has an abnormal number of copies. Example: trisomy 13, 18 or 21.	diagnosed during or after pregnancy