HELLP SyndromeNCT06758960
Analysis of Biological Progression and Regression of HELLP Syndrome in Time
An observational study of HELLP Syndrome and Preeclampsia, run by CHU Mohammed VI Marrakech at 1 site in Morocco.
Trial summary
Prospective observational study about progression and regression of biological parameters of HELLP syndrome Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- HELLP Syndrome, Preeclampsia
- How many people
- 72 participants
- Where
- 1 siteMorocco
- Study dates
- 1 Jul 2023to 31 Aug 2025
- How long will I take part?
- 14 Days
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnant patients admitted to the maternal ICU from the Obstetrics Emergency department of marrakesh
Who may be able to join
- Pregnant women who are admitted to the maternal ICU for a biological HELLP syndrome
Who cannot join
- Patients whose biological presentation was attributable to other conditions, such as microangiopathies or leukemia.
- Patients who benefited from plasma exchange therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biological Evolution of HELLP Syndrome
Prospective observational study about progression and regression of biological parameters of HELLP syndrome
Read the 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.
- Conditions
- HELLP Syndrome, Preeclampsia
- Keywords
- Preeclampsia, HELLP syndrome, Thrombocytopenia, Maternal mortality
- Medical subject headings
- HELLP Syndrome, Pre-Eclampsia, Thrombocytopenia, Maternal Death
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelets count
Platelets count will be monitored daily before and after delivery
Measured: Up to 10 days
Secondary outcomes (2)
Concentration of Lactate dehydrogenase
Monitored daily before and after delivery
Measured: Up to 10 days
Concentration of Liver enzymes
daily monitoring of alkaline phosphatase, alanine transaminase before and after delivery
Measured: Up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start1 Jul 2023
- Primary completion31 Jul 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HELLP SyndromeStudies 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
- 72 participants (actual)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- CHU Mohammed VI Marrakech
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meryem Essafti, CHU Mohammed VI Marrakech
- Investigators
- Meryem Essafti, Assistant Professor, Study director, CHU Mohammed VI Marrakech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758960
- Sponsor's protocol ID
- 67/2024
- Status last verified
- Mar 2026
- First submitted
- 15 Dec 2024
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data collected throughout the trial will be shared
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.
PubMed 2216215Martin 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.
PubMed 2048596
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Evolution of HELLP Syndrome
- ClinicalTrials.gov ID
- NCT06758960
- Acronym / sponsor ID
- 67/2024
- Conditions
- HELLP Syndrome, Preeclampsia
- Keywords
- Preeclampsia, HELLP syndrome, Thrombocytopenia, Maternal mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- CHU Mohammed VI MarrakechUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 6 Jan 2025 (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 study about progression and regression of biological parameters of HELLP syndrome
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 14 Days
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant patients admitted to the maternal ICU from the Obstetrics Emergency department of marrakesh
Key inclusion criteria (1 listed)
- Pregnant women who are admitted to the maternal ICU for a biological HELLP syndrome
Key exclusion criteria (2 listed)
- Patients whose biological presentation was attributable to other conditions, such as microangiopathies or leukemia.
- Patients who benefited from plasma exchange therapy
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
Platelets count
Time frame: Up to 10 days
Platelets count will be monitored daily before and after delivery
2 secondary outcomes
Concentration of Lactate dehydrogenase
Time frame: Up to 10 days
Concentration of Liver enzymes
Time frame: Up to 10 days
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 31 Mar 2026.
- Background: PubMed 2216215Martin 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.
- Background: PubMed 2048596Martin 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.
- Individual participant dataSharing planned: Yes. All data collected throughout the trial will be shared
Related trials for HELLP Syndrome
RecruitingObservational study
PROTECT-Africa: Biomarker Validation for Preeclampsia Triage
Hypertension, Pregnancy-Induced, HELLP Syndrome
Not yet recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension
Not yet recruitingPhase 4
Vitamin D Supplementation Among Pregnant Women in Uganda for the Prevention of Hypertensive Disorders in Pregnancy, and Other Adverse Maternal and Foetal Outcomes
Preeclampsia, Eclampsia
Not yet recruitingObservational study
Study of Prognostic Values of Platelet Indices and Inflammatory Markers in Patients With HELLP Syndrome.
HELLP Syndrome
Not yet recruitingObservational study
sCD163 in HELLP Syndrome
HELLP Syndrome Complicating Pregnancy
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.
Meryem Essafti, Assistant Professor study director
CHU Mohammed VI Marrakech
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 HELLP Syndrome and Preeclampsia, run by CHU Mohammed VI Marrakech at 1 site in Morocco.
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 1 inclusion and 2 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 31 Mar 2026. 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 Morocco. 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?
Platelets count (time frame: Up to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06758960, which also lists 2 linked publications.
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 31 Mar 2026.