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OpenTrials
Completed

NCT Number: NCT03801447

Biomarkers and Preeclampsia Outcomes

Prospective, observational, monocentric, non-interventional study.

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Key information

Conditions

Preeclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

20 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Maternity Center of Tunis

Tunis, 1006, Tunisia

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Multiple pregnancies

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Dacima Consulting

Other

Collaborators

  • Maternity Center of Tunis

Registry information

Official study title

Ratio of Angiogenesis-related Biomarkers (sFlt-1/PlGF) in the Prediction Of mateRnal & feTal outcomeS

Acronym: REPORTS

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jan 11, 2019
Registry last updated
Aug 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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