Pre-Eclampsia And Growth Restriction: a Longitudinal Study

NCT02379832 | Completed

• 1 other identifier: B14-07-2037
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Preeclampsia; Severe Preeclampsia; Fetal Growth Restriction; Preterm Birth

Keywords

preeclampsia; preterm birth; pregnancy; placenta; intra-uterine growth restriction; fetal growth restriction; ultrasound; doppler; biomarkers; serum; PAPP-A; PlGF; sFlt-1; endoglin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Fetal growth restriction

  between 20 and 42 weeks of gestation

Study Arms (2)

Cases

Nulliparous women recruited at diagnosis of preeclampsia No intervention, only observation of biochemical and ultrasonographic markers at recruitment and at delivery N= 45

Control

Nulliparous women recruited at the beginning of pregnancy. No intervention, only observation of biochemical and ultrasonographic markers at recruitment (1st trimester), 3 other times during pregnancy (2nd and 3rd trimester) and at delivery N= 45

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Nulliparous pregnant women

You may qualify if:

• 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

You may not qualify if:

• multiple pregnancy
• pregnant women \<18 years old at recruitment

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead
• Chaire Jeanne-et-Jean-Louis Lévesque en périnatalogie: collaborator
• Laval University: collaborator

Study Sites (1)

CHU de Québec

Québec, G1V 4G2, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Maternal serum Cord blood

MeSH Terms

Conditions

Pre-Eclampsia; Fetal Growth Retardation; Premature Birth

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications

Study Officials

• Emmanuel Bujold, MD, MSc

  CHU de Québec

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 2, 2015
• First Posted: March 5, 2015
• Study Start: March 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: December 31, 2017
• Last Updated: July 23, 2019

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)