Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Biomarkers and Preeclampsia Outcomes (REPORTS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03801447
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : January 15, 2019
Sponsor:
Collaborator:
Maternity Center of Tunis
Information provided by (Responsible Party):
Dacima Consulting

Brief Summary:
Prospective, observational, monocentric, non-interventional study.

Condition or disease
Preeclampsia

Detailed Description:

In practice, patients with preeclampsia are referred to the hospital for medical management only clinical signs & symptoms and standard biological tests are available for patient individualized care. Hence, a new diagnostic tool to distinguish and stratify the different patients referred is in need of proper triage.

REPORTS study aims to determine the diagnostic utility of 2 preeclampsia biomarkers (sFlt-1/PlGF ratio) in clinical decision making in preeclamptic women.

Data are collected by DACIMA Clinical Suite, according to FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation)


Layout table for study information
Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ratio of Angiogenesis-related Biomarkers (sFlt-1/PlGF) in the Prediction Of mateRnal & feTal outcomeS
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Biomarkers ratio [ Time Frame: Every day from date of inclusion until date of delivery or up to 21 days whichever came first, in women with severe preeclampsia ]
    sFlt-1/PlGF ratio


Secondary Outcome Measures :
  1. Biomarkers ratio [ Time Frame: Every two day from date of inclusion until date of delivery or up to 21 days whichever came first, in women with moderate preeclampsia ]
    sFlt-1/PlGF ratio

  2. Biomarkers ratio [ Time Frame: Weekly from date of inclusion until date of delivery or up to 3 weeks whichever came first, in women with mild preeclampsia ]
    sFlt-1/PlGF ratio

  3. Maternal outcome [ Time Frame: From date of inclusion until the date of first documented event, assessed up to 24 weeks ]
    Incidence of retroplacental hematoma, or HELLP syndrome (Hemolysis, Elevated liver enzyme levels, and Low Platelet levels), or Renal failure.

  4. Fetal outcome [ Time Frame: From date of inclusion until the date of first documented event, assessed up to 24 weeks ]
    Incidence of a composite fetal outcome (in utero fetal death or, Intrauterine growth restriction, or APGAR < 7, or Prematurity)

  5. Fetal outcome [ Time Frame: Date of delivery ]
    Rate of in utero fetal death or, Intrauterine growth restriction, or APGAR < 7, or Prematurity



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Preeclampsia was defined according to the ACOG (The American College of Obstetricians and Gynecologists). The diagnosis of Preeclampsia was based on clinical judgment and routine laboratory findings at inclusion.

Patients were suspected of Preeclampsia if they:

  • presented with new onset hypertension and or proteinuria at or after 20 weeks of gestation
  • developed an aggravation of their preexisting hypertension and or preexisting proteinuria
  • or if they presented with symptoms such as right upper quadrant abdominal pain or headache with visual disturbances or PE-related findings (low platelets, elevated liver transaminases, Vascular Fetal Growth Restriction)
Criteria

Inclusion Criteria:

  • Suspected or confirmed preeclampsia
  • Singleton pregnancy
  • Between 26 weeks of gestation and 37 weeks of gestation & 6 days

Exclusion Criteria:

  • Multiple pregnancies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03801447


Contacts
Layout table for location contacts
Contact: Dalenda Chelli, MD +21622889018 dalenda.chelli@sted-tn.com
Contact: Rabie Razgallah, MD +21620509729 r.razgallah@dacimasoftware.com

Locations
Layout table for location information
Tunisia
Maternity Center of Tunis Recruiting
Tunis, Tunisia, 1006
Contact: Dalenda Chelli, MD    +21622889018    dalenda.chelli@sted-tn.com   
Contact: Rabie Razgallah, MD    +21620509729    r.razgallah@dacimasoftware.com   
Sponsors and Collaborators
Dacima Consulting
Maternity Center of Tunis
Investigators
Layout table for investigator information
Study Chair: Dalenda Chelli, MD Maternité de la Rabta - Tunis

Layout table for additonal information
Responsible Party: Dacima Consulting
ClinicalTrials.gov Identifier: NCT03801447     History of Changes
Other Study ID Numbers: DAC-003-REPORTS
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications