Preterm Birth Clinical Trial
— PREDICTION2Official title:
Prediction of Preeclampsia and Other Pregnancy Complications Following Combined Iterative Screening
NCT number | NCT03067298 |
Other study ID # | 2017-3219 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2016 |
Est. completion date | June 2021 |
Verified date | March 2022 |
Source | CHU de Quebec-Universite Laval |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Preterm birth (PTB), preeclampsia (PE), fetal growth restriction (FGR) and intra-uterine fetal death (IUFD) constitutes the main causes of perinatal morbidity and mortality and are called "Great Obstetrical Syndromes". Algorithms to predict those outcomes have been developed by combining maternal characteristics (history, age, BMI, blood pressure), biochemical (sFlt-1, β-hCG, PlGF, AFP) and sonographic (uterine artery Doppler, 3D of placenta, cervical length, nasal bone measurement, nuchal translucency) markers. Another prospective observational study ("PREDICTION study" NCT 02189148) is also ongoing, which aims to validate those algorithms at the first trimester of pregnancy. Recent data suggest that repeating the same measurements later in pregnancy could improve the detection rates, allowing closer monitoring of high-risk patients and potential therapeutics under investigation. The current study (PREDICTION2) is an ancillary study of PREDICTION and aims at validating the use of these markers in a combined iterative manner in the prediction of preeclampsia and other obstetrical outcomes.
Status | Completed |
Enrollment | 805 |
Est. completion date | June 2021 |
Est. primary completion date | June 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - nulliparous pregnant women participating in Prediction study (NCT02189148) Exclusion Criteria: - <18 years old at recruitment; - multiple pregnancies; - fetal congenital malformation; - positive for HIV or hepatitis C; - fetal demise 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 | CHU de Quebec | Quebec |
Lead Sponsor | Collaborator |
---|---|
Emmanuel Bujold | Laval University, Thermo Fisher Scientific |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | preeclampsia | 1) de novo hypertension with systolic blood pressure = 140 mmHg or diastolic blood pressure >90 mmHg on two occasions at least four hours apart, after 20 weeks of pregnancy, and 2) associated with proteinuria =300 mg/24 h or at least '2 +' protein on urine dipstick or an adverse conditions | >20 weeks of preeclampsia | |
Secondary | Fetal growth restriction | defined as a birth weight below the 10th centile (or below the 3rd centile for severe FGR) of Canadian reference growth charts. | neonatal weight at birth (on the day of birth) | |
Secondary | Preterm birth | defined as delivery <37 weeks of gestation. | between 20-37 weeks of gestation | |
Secondary | Intra uterine fetal death | fetal death during pregnancy | from the 20th week of gestation to the moment of birth |
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