NCT06758960

Brief Summary

Prospective observational study about progression and regression of biological parameters of HELLP syndrome

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 6, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

2.1 years

First QC Date

December 15, 2024

Last Update Submit

March 29, 2026

Conditions

Keywords

PreeclampsiaHELLP syndromeThrombocytopeniaMaternal mortality

Outcome Measures

Primary Outcomes (1)

  • Platelets count

    Platelets count will be monitored daily before and after delivery

    Up to 10 days

Secondary Outcomes (2)

  • Concentration of Lactate dehydrogenase

    Up to 10 days

  • Concentration of Liver enzymes

    Up to 10 days

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFEMALE
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant patients admitted to the maternal ICU from the Obstetrics Emergency department of marrakesh

You may qualify if:

  • Pregnant women who are admitted to the maternal ICU for a biological HELLP syndrome

You may not qualify if:

  • Patients whose biological presentation was attributable to other conditions, such as microangiopathies or leukemia.
  • Patients who benefited from plasma exchange therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Mohammed VI of Marrakech

Marrakesh, Marrakech - Safi, 40000, Morocco

Location

Related Publications (2)

  • 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.

    PMID: 2216215BACKGROUND
  • 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.

    PMID: 2048596BACKGROUND

MeSH Terms

Conditions

HELLP SyndromePre-EclampsiaThrombocytopeniaMaternal Death

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBlood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopeniaParental DeathDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Meryem Essafti, Assistant Professor

    CHU Mohammed VI Marrakech

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
14 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 15, 2024

First Posted

January 6, 2025

Study Start

July 1, 2023

Primary Completion

July 31, 2025

Study Completion

August 31, 2025

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

All data collected throughout the trial will be shared

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Beginning 3 months and ending 1 year after the publication of results

Locations