PreeclampsiaREPORTSNCT03801447
Biomarkers and Preeclampsia Outcomes
An observational study of Preeclampsia, run by Dacima Consulting at 1 site in Tunisia.
Trial summary
Prospective, observational, monocentric, non-interventional study. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Preeclampsia
- How many people
- 600 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Apr 2018to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- No healthy volunteers
- Adult
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)
Who may be able to join
- Suspected or confirmed preeclampsia
- Singleton pregnancy
- Between 26 weeks of gestation and 37 weeks of gestation \& 6 days
Who cannot join
- Multiple pregnancies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ratio of Angiogenesis-related Biomarkers (sFlt-1/PlGF) in the Prediction Of mateRnal & feTal outcomeS
Prospective, observational, monocentric, non-interventional study.
Read the 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)
- Conditions
- Preeclampsia
- Medical subject headings
- Pre-Eclampsia
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers ratio
sFlt-1/PlGF ratio
Measured: Every day from date of inclusion until date of delivery or up to 21 days whichever came first, in women with severe preeclampsia
Secondary outcomes (5)
Biomarkers ratio
sFlt-1/PlGF ratio
Measured: Every two day from date of inclusion until date of delivery or up to 21 days whichever came first, in women with moderate preeclampsia
Biomarkers ratio
sFlt-1/PlGF ratio
Measured: Weekly from date of inclusion until date of delivery or up to 3 weeks whichever came first, in women with mild preeclampsia
Maternal outcome
Incidence of retroplacental hematoma, or HELLP syndrome (Hemolysis, Elevated liver enzyme levels, and Low Platelet levels), or Renal failure.
Measured: From date of inclusion until the date of first documented event, assessed up to 24 weeks
Fetal outcome
Incidence of a composite fetal outcome (in utero fetal death or, Intrauterine growth restriction, or APGAR < 7, or Prematurity)
Measured: From date of inclusion until the date of first documented event, assessed up to 24 weeks
Fetal outcome
Rate of in utero fetal death or, Intrauterine growth restriction, or APGAR < 7, or Prematurity
Measured: Date of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start1 Apr 2018
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dacima Consulting
- Sponsor type
- University, hospital or other
- Collaborators
- Maternity Center of Tunis
- Responsible party
- Sponsor
- Investigators
- Dalenda Chelli, MD, Study chair, Maternité de la Rabta - TunisYoucef Djedid, MD, Principal investigator, Maternité de la Rabta - Tunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801447
- Sponsor's protocol ID
- DAC-003-REPORTS
- Acronym
- REPORTS
- Status last verified
- Aug 2022
- First submitted
- 27 May 2018
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ratio of Angiogenesis-related Biomarkers (sFlt-1/PlGF) in the Prediction Of mateRnal & feTal outcomeS
- ClinicalTrials.gov ID
- NCT03801447
- Acronym / sponsor ID
- REPORTS / DAC-003-REPORTS
- Conditions
- Preeclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Dacima ConsultingUniversity, hospital or other
- Collaborators
- Maternity Center of Tunis
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 11 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, observational, monocentric, non-interventional study.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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)
Key inclusion criteria (3 listed)
- Suspected or confirmed preeclampsia
- Singleton pregnancy
- Between 26 weeks of gestation and 37 weeks of gestation \& 6 days
Key exclusion criteria (1 listed)
- Multiple pregnancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
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
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
Maternal outcome
Time frame: From date of inclusion until the date of first documented event, assessed up to 24 weeks
Fetal outcome
Time frame: From date of inclusion until the date of first documented event, assessed up to 24 weeks
Fetal outcome
Time frame: Date of delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Preeclampsia
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
RecruitingPhase 4
Optimizing Preeclampsia Postpartum With Point-of-care Ultrasound
Preeclampsia, Preeclampsia Postpartum
RecruitingPhase 3
The Efficacy of Aspirin Combined With Hydroxychloroquine Treatment in High Risk Pregnancies for Preeclampsia
Preeclampsia
Not yet recruitingPhase 4
Biomarkers in Management of Post Partum Preeclampsia
Preeclampsia Severe, Preeclampsia Postpartum
Active, not recruitingEarly Phase 1
Sensitivity of Angiotensin II Type II Receptors in Women Following Preeclampsia
Preeclampsia Postpartum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dalenda Chelli, MD study chair
Maternité de la Rabta - Tunis
Youcef Djedid, MD principal investigator
Maternité de la Rabta - Tunis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia, run by Dacima Consulting at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2022.