- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06758960
Analysis of Biological Progression and Regression of HELLP Syndrome in Time
March 29, 2026 updated by: Meryem Essafti, CHU Mohammed VI Marrakech
Biological Evolution of HELLP Syndrome
Prospective observational study about progression and regression of biological parameters of HELLP syndrome
Study Overview
Status
Completed
Conditions
Detailed Description
Data collection included a comprehensive review of pathological histories, identification of complications based on clinical presentation, daily monitoring of biological parameters, documentation of transfusion events, recording of corticosteroid administration according to gestational age, and detailed reporting of extraction and analgesia techniques.
Study Type
Observational
Enrollment (Actual)
72
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Marrakech - Safi
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Marrakesh, Marrakech - Safi, Morocco, 40000
- CHU Mohammed VI of Marrakech
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Pregnant patients admitted to the maternal ICU from the Obstetrics Emergency department of marrakesh
Description
Inclusion Criteria:
- Pregnant women who are admitted to the maternal ICU for a biological HELLP syndrome
Exclusion Criteria:
- Patients whose biological presentation was attributable to other conditions, such as microangiopathies or leukemia.
- Patients who benefited from plasma exchange therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Platelets count
Time Frame: Up to 10 days
|
Platelets count will be monitored daily before and after delivery
|
Up to 10 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Concentration of Lactate dehydrogenase
Time Frame: Up to 10 days
|
Monitored daily before and after delivery
|
Up to 10 days
|
|
Concentration of Liver enzymes
Time Frame: Up to 10 days
|
daily monitoring of alkaline phosphatase, alanine transaminase before and after delivery
|
Up to 10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Meryem Essafti, Assistant Professor, CHU Mohammed VI Marrakech
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Martin JN Jr, Blake PG, Lowry SL, Perry KG Jr, Files JC, Morrison JC. Pregnancy complicated by preeclampsia-eclampsia with the syndrome of hemolysis, elevated liver enzymes, and low platelet count: how rapid is postpartum recovery? Obstet Gynecol. 1990 Nov;76(5 Pt 1):737-41. doi: 10.1097/00006250-199011000-00001.
- Martin JN Jr, Blake PG, Perry KG Jr, McCaul JF, Hess LW, Martin RW. The natural history of HELLP syndrome: patterns of disease progression and regression. Am J Obstet Gynecol. 1991 Jun;164(6 Pt 1):1500-9; discussion 1509-13. doi: 10.1016/0002-9378(91)91429-z.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2023
Primary Completion (Actual)
July 31, 2025
Study Completion (Actual)
August 31, 2025
Study Registration Dates
First Submitted
December 15, 2024
First Submitted That Met QC Criteria
December 28, 2024
First Posted (Actual)
January 6, 2025
Study Record Updates
Last Update Posted (Actual)
March 31, 2026
Last Update Submitted That Met QC Criteria
March 29, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Cytopenia
- Pathologic Processes
- Female Urogenital Diseases and Pregnancy Complications
- Pregnancy Complications
- Death
- Hematologic Diseases
- Hypertension, Pregnancy-Induced
- Blood Platelet Disorders
- Parental Death
- Pathological Conditions, Signs and Symptoms
- Hemic and Lymphatic Diseases
- Pre-Eclampsia
- Thrombocytopenia
- Maternal Death
- HELLP Syndrome
Other Study ID Numbers
- 67/2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All data collected throughout the trial will be shared
IPD Sharing Time Frame
Beginning 3 months and ending 1 year after the publication of results
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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