Preterm Birth Clinical Trial
— PREDICTIONOfficial title:
First-trimester Prediction of Preeclampsia and Other Placenta-mediated Pregnancy Complications
Verified date | July 2018 |
Source | CHU de Quebec-Universite Laval |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Preeclampsia is a complication of pregnancy related to adverse maternal and neonatal outcomes, including fetal growth restriction and perinatal death. Several measures are used or under investigation (low-dose aspirin, low-molecular weight heparin, calcium, folic acid, among others) for the prevention of preeclampsia. Unfortunately, most high-risk women who could benefit from those preventive measures are not identified until late in pregnancy. Recent evidences suggest that the investigators could identify women at risk of developing preeclampsia using a combination of serum and ultrasound biomarkers in the first-trimester of pregnancy. This screening test needs external validation. A first-trimester screening strategy will strengthen clinical research on preeclampsia and will contribute to the development of strategy combining the prediction and prevention of the disease and its related complications.
Status | Completed |
Enrollment | 7554 |
Est. completion date | March 2018 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - gestational age between 11 3/7 and 13 6/7 weeks; - nulliparous women (no previous delivery = 20 weeks). Exclusion Criteria: - pregnant women <18 years old at recruitment; - multiple pregnancies; - fetal congenital malformation; - positive for HIV or hepatitis C or hepatitis B; - negative fetal heart at recruitment; - women planning a delivery outside the participating hospitals; - women not able to provide an informed consent to the study. |
Country | Name | City | State |
---|---|---|---|
Canada | South Alberta Maternal Fetal Medicine Centre, University of Calgary | Calgary | Alberta |
Canada | CHU Ste-Justine | Montreal | Quebec |
Canada | CHU de Québec | Quebec city | Quebec |
Canada | Sinai Health System, Mount Sinai Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
CHU de Quebec-Universite Laval | Canadian Institutes of Health Research (CIHR), Laval University |
Canada,
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 |
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