Recruiting

Observational Study

Sponsor:

CHU de Quebec-Universite Laval

Code:

NCT02744365

Conditions

Preeclampsia

Preterm Birth

Pregnancy Complications

Fetal Anomalies

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Observational

Study Details

Brief 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.

Conditions

Preeclampsia

Preterm Birth

Pregnancy Complications

Fetal Anomalies

Study ID

NCT02744365

Start date

Apr, 2015

Status verified date

Mar, 2022

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

7845 participants

Anticipated

Interventions and Outcome Measures

Arms

Prediction Group

The women recruited in the biobank through the Prediction Study (NCT02189148) are low-risk pregnant women between 11 and 13 6/7 weeks of gestation (N=7600 maximum).

PEARL Group

The women recruited in the biobank through the PEARL Study (NCT02379832) are :

1. low-risk pregnant women between 11 and 13 6/7 weeks of gestation (controls, N=45)
2. pregnant women with diagnosis of preeclampsia between 20 and 41 6/7 weeks of gestation (cases, N=45)

GAP Group

The women recruited in the biobank through the GAP Trial (NCT02280031) are women pregnant with twins between 11 3/7 and 13 6/7 weeks of gestation(N=50 maximum) randomized for placebo or aspirin.

PREDICTION 2 Group

The women recruited in the biobank through the Prediction-2 Study (NCT03067298) are nulliparous pregnant women between 14 and 15 6/7 weeks of gestation (N=1000 maximum).

HAUPE Study

Women that are at risk of pre-eclampsia and great obstetrical syndroms (elevated maternal age, invitro fertilization, chronic disease) (N=60) and a control group not at risk (N=60)

Interventions

Observational

All women of the biobank have provided:

1. blood samples (plasma, serum and Buffy-coat)
2. urine samples
3. demographic and clinical data (maternal age, BMI, smoking status, obstetrical and medical history)
4. mean arterial blood pressure
5. ultrasound examination (datation of pregnancy at recruitment, uterine arteries doppler, placental volume, nuchal translucency in the majority of the cases)
6. access to medical record (for pregnancy/delivery outcomes, newborn birthweight, gestational age at delivery)

Primary outcome measure

  • early onset preeclampsia [ Time Frame: diagnosed between 20 and 34 weeks of gestation ]

Central Contacts and Locations

Central contacts

Emmanuel Bujold, MD, MSc

418-525-4444emmanuel.bujold@crchudequebec.ulaval.ca

Sylvie Tapp, MSc

418-525-4444sylvie.tapp@crchudequebec.ulaval.ca

Locations

CHU de Quebec

Recruiting

Quebec, Canada, G1V 4G2

Contacts

Emmanuel Bujold, MD, MSc

418-525-4444emmanuel.bujold@crchudequebec.ulaval.ca

Sylvie Tapp, MSc

418-525-4444sylvie.tapp@crchudequebec.ulaval.ca

More Information

Sponsor

CHU de Quebec-Universite Laval

Last update posted

Mar 16, 2022

Last verified

Mar, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CHU de Quebec-Universite Laval on 2022-03-16.