- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01565564
Randomized Translational Study to Examine the Effects of Shared Care in Management of Gestational Diabetes
A Randomized Translational Study to Examine the Effects of Shared Care Versus Usual Care in Management of Gestational Diabetes in a Three-tier Prenatal Care Network in Tianjin, China
Research question (s)/hypothesis:
- . The effectiveness of the shared care management of gestational diabetes mellitus;
- . The cost-effectiveness of the shared care management;
- . Its sustainability
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Method (s) Tianjin three-tier antenatal care network established a universal screening program for gestational diabetes mellitus (GDM) in 1998 and up to 2008, the screening program had screened 115348 pregnant women. GDM will be defined as either fasting plasma glucose (PG) ≥5.1 mmol/L or 1-hour PG≥ 10.0 mmol/L or 2-hour PG≥ 8.5 mmol/L after 75 g glucose tolerance test. A total of 920 pregnant women who have GDM and agree to participate will be randomly assign to have the shared care (diet, physical activity and insulin if indicated) or the local usual antenatal care. The sample size has ≥80% power at a 5% type I error to detect the difference in the primary endpoint, birth weight ≥4000 gram and the secondary endpoint, pregnancy-induced hypertension. Hyperglycemia and other clinical data in the two groups of women will be collected during the shared care or the usual care. Logistic regression and cost-effectiveness analysis will be used in the data analysis.
Public health significance: The introduction of the proven management of GDM in Tianjin antenatal care network will justify the universal screening for GDM and reduce the rate of macrosomic infants and reduce pregnancy-induced hypertension, and thus improve pregnancy outcomes of women with GDM.
Sustainability plan: Just as the universal GDM screening in 1998, the shared care model will be introduced into the Tianjin antenatal care network as part of the usual care routine after the proposed study. The success of the care model will also be publicized and expanded to suburban districts and rural counties of Tianjin, possibly other parts of world where universal screening for GDM is a routine practice.
ACKNOWLEDGEMENT This project is supported by a BRIDGES grant from the International Diabetes Federation. BRIDGES, an International Diabetes Federation project, is supported by an educational grant from Lilly Diabetes."
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Tianjin
-
Tianjin, Tianjin, Kina
- Tianjin Women and Children's Health Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- All pregnant women who are diagnosed to have GDM.
Exclusion Criteria:
- Diagnosis of overt diabetes during OGTT;
- Younger than 18 years of age;
- Non-singleton pregnancy;
- Maternal-foetal ABO blood type incompatibility;
- Maternal diseases such as chronic hypertension,thyrotoxicosis, prepregnancy diabetes and use of long-term medications that may affect glucose metabolism.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: The usual care arm
|
Andre navn:
|
Aktiv komparator: The shared care arm
|
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
The Rate of Macrosomia.
Tidsramme: At the time of birth.
|
Macrosomia is defined as birthweight ≥ 4000 gram.
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At the time of birth.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
The Rate of Pregnancy-induced Hypertension.
Tidsramme: From enrolment at 24-28 gestational weeks till after delivery, an average of 12 weeks.
|
Pregnancy-induced hypertension includes gestational hypertension and preeclampsia/eclampsia.
|
From enrolment at 24-28 gestational weeks till after delivery, an average of 12 weeks.
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Gongshu Liu, MD, Women and Children's Health Center
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Li J, Liu J, Zhang C, Liu G, Leng J, Wang L, Li W, Yu Z, Hu G, Chan JCN, Yang X. Effects of Lifestyle Intervention of Maternal Gestational Diabetes Mellitus on Offspring Growth Pattern Before Two Years of Age. Diabetes Care. 2021 Mar;44(3):e42-e44. doi: 10.2337/dc20-2750. Epub 2021 Jan 25. No abstract available.
- Yang X, Tian H, Zhang F, Zhang C, Li Y, Leng J, Wang L, Liu G, Dong L, Yu Z, Hu G, Chan JC. A randomised translational trial of lifestyle intervention using a 3-tier shared care approach on pregnancy outcomes in Chinese women with gestational diabetes mellitus but without diabetes. J Transl Med. 2014 Oct 28;12:290. doi: 10.1186/s12967-014-0290-2. Erratum In: J Transl Med. 2015;13:70. Liu, Gongsu [corrected to Liu, Gongshu].
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2009-02
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