Sickle Cell Disease and PregnancyHEMAGONCT06620887
HEMAGO Monitoring and Impact on the Occurrence of Complications During Pregnancy in Sickle Cell Patients
An observational study of Sickle Cell Disease and Pregnancy, run by Hospices Civils de Lyon at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sickle Cell Disease and Pregnancy
- What is being tested?
- Evaluate the impact of HEMAGO program on maternal morbidity and mortality in sickle cell disease patients during their pregnancies.
- How many people
- 100 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Feb 2024to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: cohort of sickle cell patients followed in the red blood cell pathology department at the Edouard Herriot Hospital and having had a pregnancy follow-up consultation in one of the three maternity wards in Lyon.
Who may be able to join
- 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
Who cannot join
- Minor woman
Trial locations and contacts
3 sites in 1 country.
France3 sites
Service de gynécologie-obstétrique de l'Hôpital Femme Mère Enfant
Bron, 69500
Croix-Rousse Hospital - Service de Gynécologie-Obstétrique
Lyon, 69003
Service de gynécologie-obstétrique de l'Hôpital de Lyon Sud
Lyon
About this study
Official title: SICKLE CELL DISEASE AND PREGNANCY : HEMAGO Monitoring and Impact on the Occurrence of Maternal, Obstetrics and Perinatal Complications 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.
Read more
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
- Being tested
- Evaluate the impact of HEMAGO program on maternal morbidity and mortality in sickle cell disease patients during their pregnancies.
- Keywords
- Sickle cell disease ; genetic disease ; anemia ; pregnancy ; obstetrics complications
- Medical subject headings
- Anemia, Sickle Cell, Genetic Diseases, Inborn, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Pregnancies before HEMAGO | Pregnancies follow-up before HEMAGO : complications and outcomes of pregnancies in sickle cell patients which had a classical follow-up. Receives: Other: Evaluate the impact of HEMAGO program on maternal morbidity and mortality in sickle cell disease patients during their pregnancies. | |
| Pregnancies HEMAGO following-up | Pregnancies in sickle cell patients follow-up by HEMAGO : complications and outcomes of pregnancies in sickle cell disease patients which were monitored by HEMAGO program. Receives: Other: Evaluate the impact of HEMAGO program on maternal morbidity and mortality in sickle cell disease patients during their pregnancies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite criterion including in the mother : Maternal complications → Obstetrics complications → Sickle cell complications → intensive care hospitalization → death ?
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Feb 2024
- Primary completion1 Feb 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell Disease and PregnancyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr FICHEZ Axel, Dr, Principal investigator, Service de Gynécologie-Obstétrique Hôpital de la Croix-Rousse/Groupement Hospitalier Nord
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620887
- Sponsor's protocol ID
- 24-5120
- Acronym
- HEMAGO
- Status last verified
- Sep 2024
- First submitted
- 27 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SICKLE CELL DISEASE AND PREGNANCY : HEMAGO Monitoring and Impact on the Occurrence of Maternal, Obstetrics and Perinatal Complications in Sickle Cell Patients
- ClinicalTrials.gov ID
- NCT06620887
- Acronym / sponsor ID
- HEMAGO / 24-5120
- Conditions
- Sickle Cell Disease and Pregnancy
- Keywords
- Sickle cell disease ; genetic disease ; anemia ; pregnancy ; obstetrics complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnancies before HEMAGO | – | Other: Evaluate the impact of HEMAGO program on maternal morbidity and mortality in sickle cell disease patients during their pregnancies.Pregnancies follow-up before HEMAGO : complications and outcomes of pregnancies in sickle cell patients which had a classical follow-up. |
| Pregnancies HEMAGO following-up | – | Other: Evaluate the impact of HEMAGO program on maternal morbidity and mortality in sickle cell disease patients during their pregnancies.Pregnancies in sickle cell patients follow-up by HEMAGO : complications and outcomes of pregnancies in sickle cell disease patients which were monitored by HEMAGO program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cohort of sickle cell patients followed in the red blood cell pathology department at the Edouard Herriot Hospital and having had a pregnancy follow-up consultation in one of the three maternity wards in Lyon.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Minor woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Pregnancies HEMAGO following-up, Pregnancies before HEMAGO |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
Related trials for Sickle Cell Disease and Pregnancy
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
RecruitingObservational study
Development of Non-Invasive Prenatal Diagnosis for Single Gene Disorders
Invasive PreNatal Diagnosis in a Context of Family History of Single-gene Disorders, Including, Sickle Cell Disease
RecruitingPhase 2
Safety, Efficacy, and Pharmacokinetics of CSL889 in Adults and Adolescents With Sickle Cell Disease During Vaso-Occlusive Crisis
Sickle Cell Disease Vaso-occlusive Crisis
Active, not recruitingObservational study
Cooperative Assessment of Late Effects for SCD Curative Therapies
Sickle Cell Disease, Pulmonary Disease
RecruitingObservational study
Domestication and Implementation of the PEN-Plus Clinical Model in the Zambian Health System
Cardiac Diseases, Sickle Cell Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr FICHEZ Axel, Dr principal investigator
Service de Gynécologie-Obstétrique Hôpital de la Croix-Rousse/Groupement Hospitalier Nord
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease and Pregnancy, run by Hospices Civils de Lyon at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.