NCT06620887Completed
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
Source: ClinicalTrials.gov · Last updated 1 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 100 (actual)
- First submitted
- 27 Sept 2024
- Start date
- 1 Feb 2024
- Primary completion date
- 1 Feb 2024
- Lead sponsor
- Hospices Civils de Lyon
- Diseases
- Sickle cell disease
- NCT number
- NCT06620887
What you commit to
- Study type: Observational
- Participants enrolled: 100
- From 1 Feb 2024 to the primary completion date, 1 Feb 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Minor woman
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Service de gynécologie-obstétrique de l'Hôpital Femme Mère Enfant Coordinator of this site? Confirm its status | Bron | France | Unknown status |
| Croix-Rousse Hospital - Service de Gynécologie-Obstétrique Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Service de gynécologie-obstétrique de l'Hôpital de Lyon Sud Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.