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Clinical Trials/NCT06620887
NCT06620887
Completed
Not Applicable

SICKLE CELL DISEASE AND PREGNANCY : HEMAGO Monitoring and Impact on the Occurrence of Maternal, Obstetrics and Perinatal Complications in Sickle Cell Patients

Hospices Civils de Lyon3 sites in 1 country100 target enrollmentFebruary 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sickle Cell Disease and Pregnancy
Sponsor
Hospices Civils de Lyon
Enrollment
100
Locations
3
Primary Endpoint
Composite criterion including in the mother : Maternal complications → Obstetrics complications → Sickle cell complications → intensive care hospitalization → death ?
Status
Completed
Last Updated
last year

Overview

Brief Summary

Sickle cell disease is the most common monosemic genetic disease in the world and affects approximately 32,000 people in France. In recent years, improvements in the management of this pathology have led to a steady increase in the life expectancy of sickle cell patients.

Women with sickle cell disease are increasingly likely to have one or more pregnancies.

Several studies have shown that these pregnancies are marked by maternal morbidity due to acute sickling crises, thromboembolism, infection, chronic end-organ dysfunction, or pre-eclampsia (PE), while neonatal outcomes may be intrauterine growth retardation (IUGR), preterm delivery, small infants for gestational age, stillbirth, and neonatal death.

Consequently, monitoring pregnancies in sickle cell patients represents a complex medical challenge due to the risk of potentially serious maternal and fetal complications. Multidisciplinary follow-up is then crucial to monitor and manage these possible complications.

The double hematologist-obstetrician consultation program (HEMAGO) offers complete and adapted close follow-up, in order to minimize the risks for the mother and the unborn child.

This study aims to evaluate the impact of this HEMAGO monitoring on the various maternal and obstetric complications by comparing the outcome of pregnancies of patients who were followed before the implementation of this device to patients who were followed in the frame their pregnancy through this program.

Registry
clinicaltrials.gov
Start Date
February 1, 2024
End Date
April 30, 2024
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • sickle cell disease female
  • followed up for at least one pregnancy in the maternity of Croix-Rousse Hospital, Femme Mère Enfant Hospital and Lyon Sud Hospital

Exclusion Criteria

  • Minor woman

Outcomes

Primary Outcomes

Composite criterion including in the mother : Maternal complications → Obstetrics complications → Sickle cell complications → intensive care hospitalization → death ?

Time Frame: These are follow-up consultations once a month until 24 weeks then every 15 days until delivery. comparing results before (January 2005 to March 2016) and after HEMAGO (April 2016 - February 29, 2024)

Maternal complications : * Obstetrics complications : pre-eclampsia or Hellp syndrome / intra-uterine growth restriction (IUGR) / preterm labor / chorioamniotis / intrauterine death * Sickle cell complications (vaso-occlusive crisis (VOC) / acute chest syndrome / cerebral stroke) * lung or urinary infections * thromboembolism * intensive care hospitalization collection of data done by rereading obstetric records by a single person.

Study Sites (3)

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