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

September 30, 2024 updated by: Hospices Civils de Lyon

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69500
        • Service de gynécologie-obstétrique de l'Hôpital Femme Mère Enfant
      • Lyon, France, 69003
        • Croix-Rousse Hospital - Service de Gynécologie-Obstétrique
      • Lyon, France
        • Service de gynécologie-obstétrique de l'Hôpital de Lyon Sud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnancies before HEMAGO
Pregnancies follow-up before HEMAGO : complications and outcomes of pregnancies in sickle cell patients which had a classical follow-up.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Dr FICHEZ Axel, Dr, Service de Gynécologie-Obstétrique Hôpital de la Croix-Rousse/Groupement Hospitalier Nord

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Actual)

February 1, 2024

Study Completion (Actual)

April 30, 2024

Study Registration Dates

First Submitted

September 27, 2024

First Submitted That Met QC Criteria

September 30, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 30, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-5120

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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