NCT06620887

HEMAGO Monitoring and Impact on the Occurrence of Complications During Pregnancy in Sickle Cell Patients

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sickle Cell Disease and Pregnancy

Interventions

Type	Name	Description
OTHER	Evaluate the impact of HEMAGO program on maternal morbidity and mortality in sickle cell disease patients during their pregnancies.	HEMAGO pregnancy monitoring is a joint consultation program between the sickle cell disease hematologist and an obstetrician. This program was implemented in April 2016 at the Croix-Rousse maternity Hospital. This program offers close, complete and personalized pregnancy monitoring for each patient with major sickle cell syndrome. These are follow-up consultations once a month until 24 weeks then every 15 days until delivery. At each consultation, doctors evaluate a general and obstetric clinical examination. The team establishes a precise schedule adapted to each patient for pregnancy monitoring : monthly blood tests, monthly ultrasounds with maternal and fetal Doppler, adaptation of basic treatment, transfusion exchange program according to eligibility criteria, and organization of childbirth.

Timeline

• Start date: 2024-02-01
• Primary completion: 2024-02-01
• Completion: 2024-04-30
• First posted: 2024-10-01
• Last updated: 2024-10-01

Locations

3 sites across 1 country: France