This study will analyze obstetric, endocrine and metabolic follow-up data in women treated with DEX. It will reveal the prevalence and importance of weight gain, insomnia, edema, stretch marks, arterial hypertension and gestational diabetes, describe pregnancy outcome, and analyze the corticotropic axis during and up to 3 months after pregnancy, with the aim of improving the management of these women and preventing comorbidities. A few studies suggest problems in women treated with DEX during pregnancy. However, all these studies are retrospective, based on self-questionnaires, and have not evaluated all pregnancy outcomes. Moreover, it would appear that a third of women treated with DEX no longer wish to resume the treatment (8). Compliance with treatment is strongly linked to its efficacy. It is therefore important to start investigating the pregnancy outcomes of women treated with DEX. This project is relevant because it has the potential to improve current clinical practice and recommendations related to this treatment, and thus have a direct impact on future patient care. The results of this study will guide us in the management of women presenting an indication for prenatal DEX treatment, and will help to inform the Order of November 15, 2022.
Main objective: The main aim of this study was to assess the incidence of metabolic complications (hypertension and diabetes) in mothers treated with DEX during pregnancy. Secondary objectives: 1. To assess the prevalence and importance of adverse effects of DEX: weight gain, stretch marks, insomnia in mothers treated with DEX. 2. Describe pregnancy outcomes and compare them with a reference population (data from the 2010 French perinatal survey (15)). 3. Analyze the corticotropic axis of DEX-treated mothers during and after pregnancy.
Study Type
OBSERVATIONAL
Enrollment
35
Hopital Haut Leveque - Endocrinologie
Bordeaux, France
RECRUITINGEndocrinologie - Hospices civils de Lyon
Bron, France
RECRUITINGHospices civils de Lyon Biochimie et Biologie moléculaire UM Pathologies endocriniennes
Bron, France
RECRUITINGHospices civils de Lyon Laboratoire de Biologie Médicale Multi Sites
Bron, France
RECRUITINGHospices civils de Lyon Service de médecine de la reproduction
Bron, France
RECRUITINGEndocrinologie - CHU Grenoble - Hôpital Michallon
Grenoble, France
RECRUITINGEndocrinologie et médecine de la reproduction - Hôpital Bicêtre APHP
Le Kremlin-Bicêtre, France
RECRUITINGEndocrinologie pédiatrique - Hôpital Bicêtre APHP
Le Kremlin-Bicêtre, France
RECRUITINGHopital Bicêtre
Le Kremlin-Bicêtre, France
RECRUITINGCHRU Lille - Hôpital Claude Huriez Endocrinologie, diabétologie et métabolisme
Lille, France
RECRUITING...and 7 more locations
proportion of patients who developed hypertension and/or diabetes in mothers treated with DEX
proportion of patients who developed hypertension and/or diabetes in mothers treated with
Time frame: on completion of studies, on average 4 year
Assess weight gain, stretch marks and insomnia in mothers treated with DEX Describe complications and illnesses of pregnancy Cortisol and S-DHEA levels during DEX treatment
1. Assess weight gain in kilograms, stretch marks and insomnia in mothers treated with DEX 2. Describe complications and illnesses of pregnancy, delivery and neonatal outcome: spontaneous or fetal miscarriage, death, hemorrhage in the second or third trimester, or any other medical problem during pregnancy, cesarean section, induced labor, gestational age in days, birth weight in kilograms, etc. Compare these data with the outcome of the pregnancy, and with a reference population (data from the 2010 French perinatal survey (15)). 3. Cortisol and S-DHEA levels during DEX treatment, baseline and regular Synacthen® cortisol levels after DEX discontinuation, duration of hydrocortisone substitution in weeks.
Time frame: on completion of studies, on average 4 year
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