- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07652554
The Role of Hormonal and Metabolic Disorders in the Debelopment of Gestational Diabetes Mellitus (GDM)
The work was carried out at the V. P. Demikhov City Clinical Hospital, a clinical base of the Department, and consisted of two consecutive stages, during which clinical material was collected between 2019 and 2021≥5.1mmol/L, but < 7.0 mmol/L, or when performing OGTT with 75 g of glucose during pregnancy at 24-28 weeks (after 1 hour ≥10.0 mmol/l and/or after 2 hours ≥8.5, but < 11.1 mmol/l). Individual outpatient records, data from instrumental and laboratory studies, and birth histories of pregnant women withThe 1st group consisted of 359 pregnant women who were diagnosed with GSD as part of the 1st stage of the disease screening (gestational age less than 24 weeks). The 2nd group included 151 pregnant women who were diagnosed with GSD as part of the 2nd stage of the disease screening (24 weeks of gestation or moreTo assess the dynamics of anthropometric indicators, the following were studied: body weight, height, BMI at the time of registration at the women's consultation, and gestational weight gain over the entire period of pregnancy. To assess the characteristics of the glycemic profile and calculate the parameters of glycemic variability, pregnant women underwent glycemic monitoring using the FreeStyle Libre Flash system (Abbott Diabetes Care, Witney,United Kingdom)current pregnancy Diagnosis of GDM (O24.4) was carried out in accordance with the criteria regulated by domestic clinical guidelines [21]. The diagnostic threshold for GDM was an increase in fasting blood glucose levels ≥5.1mmol/L, but < 7.0 mmol/L, or when performing OGTT with 75 g of glucose during pregnancy at 24-28 weeks (after 1 hour ≥10.0 mmol/l and/or after 2 hours ≥8.5, but < 11.1 mmol/l). Individual outpatient records, data from instrumental and laboratory studies, and birth histories of pregnant women with GDM, as well as the development history of newborns born to mothers with GDM. The main risk factors for the development of GDM (age, parity of childbirth, heredity, GDM and its indirect signs in the medical history, obesity, gestational weight gain (GWG); 40 gestational age and venous plasma glucose level at the time of diagnosis GDM; methods of GDM treatment (diet therapy/insulin therapy); complications of the current pregnancy (fetoplacental insufficiency (FPI), preeclampsia, eclampsia, threat of pregnancy termination, threat of premature birth, polyhydramnios, oligohydramnios). 213 women with GDM from the total analyzed group were delivered at the maternity hospital No. 8 in 2019-2020. Based on the birth histories and development histories of newborns from this group, the main outcomes of pregnancy, the frequency of complications during childbirth on the part of the mother and the fetus (macrosomia, birth trauma, fetal respiratory distress syndrome, weakness of labor activity, premature birth, premature rupture of membranes (PROM), congenital malformations, etc.), were evaluated. The postpartum glycemic levels of women with GDM and newborns were assessed.
The clinical and anamnestic features and risk factors for the development of adverse outcomes in GDM were established. To assess the risk factors for the development of perinatal complications in GDM, as well as the impact of its course and treatment on the development of perinatal pathology, all pregnant women were divided into two groups based on the gestational age at which GDM was detected.
The 1st group consisted of 359 pregnant women who were diagnosed with GDM as part of the 1st stage of the disease screening (gestational age less than 24 weeks). The 2nd group included 151 pregnant women who were diagnosed with GDM as part of the 2nd stage of the disease screening (24 weeks of gestation or more).
At the 2nd stage of the study, a prospective non-interventional observational study was conducted to identify the etiopathogenetic mechanisms of the development of GDM and to determine the clinical and laboratory markers of the formation of adverse perinatal outcomes. For this purpose, a new study group was formed using a random sample method, which included 91 pregnant women with a confirmed diagnosis of GSD at different stages of gestation, and they were monitored dynamically.
Inclusion criteria:
- Pregnant women aged 18-45 years
- Established diagnosis of gestational diabetes mellitus in accordance with current clinical guidelines
- Single-pregnancy
- Signed informed consent form
Exclusion criteria:
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- Diabetes mellitus diagnosed before pregnancy
- Manifest diabetes mellitus detected during the current pregnancy
- Multiple pregnancies
- Severe concomitant pathology
Exclusion criteria:
• Refusal to participate in the study A set of research interventions was carried out in this group of subjects. To assess the clinical, anamnestic, metabolic, and hormonal profile, the primary medical documentation of pregnant women was analyzed (outpatient card of a pregnant woman, history of childbirth, and history of newborn development). To assess the dynamics of anthropometric indicat
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Moscow, Russia
- State clinical hospital named after V.P. Demikhov
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
Established diagnosis of gestational diabetes mellitus in accordance with current clinical guidelines
Exclusion Criteria:
Diabetes mellitus diagnosed before pregnancy Manifest diabetes mellitus detected during the current pregnancy
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Group 1
GDM diagnosed at 1st screening
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Group 2
GDM diagnosed at 2nd screening
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Change in basal and stimulated insulin secretion
Lasso di tempo: 3 months postpartum
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3 months postpartum
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Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- GDM10191315
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