Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06620887
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
HEMAGO Monitoring and Impact on the Occurrence of Complications During Pregnancy in Sickle Cell Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
SICKLE CELL DISEASE AND PREGNANCY HEMAGO Monitoring and Impact on the Occurrence of Maternal Obstetrics and Perinatal Complications in Sickle Cell Patients
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEMAGO
Brief Summary:
Sickle cell disease is the most common monosemic genetic disease in the world and affects approximately 32000 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None