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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
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

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Service de gynécologie-obstétrique de l'Hôpital Femme Mère Enfant
Coordinator of this site? Confirm its status
BronFranceUnknown status
Croix-Rousse Hospital - Service de Gynécologie-Obstétrique
Coordinator of this site? Confirm its status
LyonFranceUnknown status
Service de gynécologie-obstétrique de l'Hôpital de Lyon Sud
Coordinator of this site? Confirm its status
LyonFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.