Clinical trial NCT06620887: HEMAGO Monitoring and Impact on the Occurrence of Complications During Pregnancy in Sickle Cell Patients
Official title: SICKLE CELL DISEASE AND PREGNANCY : HEMAGO Monitoring and Impact on the Occurrence of Maternal, Obstetrics and Perinatal Complications in Sickle Cell Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sickle Cell Disease and Pregnancy
Keywords: Sickle cell disease ; genetic disease ; anemia ; pregnancy ; obstetrics complications
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cohort of sickle cell patients followed in the red blood cell pathology department at the Edouard Herriot Hospital and having had a pregnancy follow-up consultation in one of the three maternity wards in Lyon.

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.


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

Primary outcomes:
measure: Composite criterion including in the mother : Maternal complications → Obstetrics complications → Sickle cell complications → intensive care hospitalization → death ?
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de gynécologie-obstétrique de l'Hôpital Femme Mère Enfant
city: Lyon
country: France
facility: Croix-Rousse Hospital - Service de Gynécologie-Obstétrique
city: Lyon
country: France
facility: Service de gynécologie-obstétrique de l'Hôpital de Lyon Sud
Study officials:
affiliation: Service de Gynécologie-Obstétrique Hôpital de la Croix-Rousse/Groupement Hospitalier Nord
name: Dr FICHEZ Axel, Dr
role: PRINCIPAL_INVESTIGATOR
References: