- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus 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). 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). To 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. 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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Opintotyyppi
Ilmoittautuminen (Todellinen)
Yhteystiedot ja paikat
Opiskelupaikat
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Moscow, Venäjä
- State clinical hospital named after V.P. Demikhov
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Lapsi
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
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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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
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Concentration of basal and stimulated insulin secretion
Aikaikkuna: 3 months postpartum
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3 months postpartum
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Yhteistyökumppanit ja tutkijat
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
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