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

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.

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Key information

Conditions

Sickle Cell Disease and Pregnancy Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Service de gynécologie-obstétrique de l'Hôpital Femme Mère Enfant, Bron, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evaluate the impact of HEMAGO program on maternal morbidity and mortality in sickle cell disease patients during their pregnancies.

Other

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.

Primary outcomes

Composite criterion including in the mother : Maternal complications → Obstetrics complications → Sickle cell complications → intensive care hospitalization → death ?

Time frame: 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)
Maternal complications :
- Obstetrics complications : pre-eclampsia or Hellp syndrome / intra-uterine growth restriction (IUGR) / preterm labor / chorioamniotis / intrauterine death
- Sickle cell complications (vaso-occlusive crisis (VOC) / acute chest syndrome / cerebral stroke)
- lung or urinary infections
- thromboembolism
- intensive care hospitalization
collection of data done by rereading obstetric records by a single person.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: HEMAGO

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Oct 1, 2024
Registry last updated: Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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