Preterm Birth Clinical Trial
— PEARLOfficial title:
Pré-Eclampsie et Retard de Croissance: Une étude Longitudinale Évaluative (PERLE)
Verified date | July 2017 |
Source | CHU de Quebec-Universite Laval |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Preeclampsia may have several causes leading to different characteristics of the pathology. Differentiation between the "type of preeclampsia" would help to treat patients more accurately. This project aims to identify early markers that are specific to each type of preeclampsia (early or late, with or without growth restriction). Through a case-control study, many data will be collected prospectively (serum markers, ultrasonographic markers, maternal factors) among nulliparous women with no sign of preeclampsia (as soon as the first trimester) and nulliparous women with preeclampsia (at diagnosis).
Status | Completed |
Enrollment | 76 |
Est. completion date | December 31, 2017 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Nulliparous women (no previous delivery = 20 weeks) - Expect to deliver in recruiting center - Control group: recruited between 11 - 13 6/7 weeks of gestation - Case group: recruited at time of diagnosis of preeclampsia > 20 weeks of gestation Exclusion Criteria: - multiple pregnancy - pregnant women <18 years old at recruitment |
Country | Name | City | State |
---|---|---|---|
Canada | CHU de Québec | Québec |
Lead Sponsor | Collaborator |
---|---|
CHU de Quebec-Universite Laval | Chaire Jeanne-et-Jean-Louis Lévesque en périnatalogie, 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 | 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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