- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01171456
Early Intervention for Gestational Diabetes
Early Medical Intervention in Women at Risk for Gestational Diabetes
Gestational diabetes (GDM) represents a significant and growing source nationwide of morbidity and mortality for both mothers and infants. Between 5 and 10% of pregnancies are complicated by GDM. Infants exposed in utero to hyperglycemia from GDM have an increased risk of neonatal complications as well as an increased prevalence of a number of chronic diseases, including type 2 diabetes and schizophrenia. Recent research shows that treatment with metformin begun as soon as hyperglycemia is detected in pregnancy is safe and effective. Additional studies demonstrated that metformin is able to decrease the incidence of type 2 diabetes among individuals at risk for this disease. Based upon these findings, the investigators propose to test the hypothesis that metformin therapy for women at risk for gestational diabetes, started prior to conception and before the onset of hyperglycemia, both decreases the incidence of and improves the maternal and neonatal outcomes from GDM.
The investigators intend to conduct a prospective, randomized, double-blind placebo controlled range-finding study to measure the effects of early metabolic intervention with metformin in women at risk for GDM before the commencement of pregnancy or prior to completion of the first trimester. The target sample size for this pilot study is 100 women. The effect size observed will provide preliminary data for a subsequent study which will be sufficiently powered to detect small or moderate effects from early metabolic intervention in women at risk for GDM.
The specific aims of the proposed research consist of the following:
- Determine whether treating women at risk for GDM with metformin prior to conception and/or completion of the 1st trimester decreases the incidence of GDM at 26 weeks' gestation.
- Evaluate the effects on maternal and fetal pregnancy outcomes of pre-conception metabolic intervention with metformin in women at risk for GDM.
Use these pilot study results to:
- identify specific demographic characteristics associated with an intervention effect
- calculate effect size for specific outcomes
- provide range-finding data for a subsequent study design
Metformin therapy for women at risk for gestational diabetes, started prior to conception and before the onset of hyperglycemia, both decreases the incidence of and improves the maternal and neonatal outcomes from GDM.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Utah
-
Murray, Utah, États-Unis, 84107
- Intermountain Medical Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
Women delivered >37 weeks gestation in the Intermountain Healthcare Urban Central Region within the last 18 months to ascertain those at risk for GDM in their next pregnancy because of:
- A history of gestational diabetes in their immediately prior pregnancy
- A family history (i.e. type 2 diabetes in a first or second degree relative) of type 2 diabetes
- Delivery of an infant > 4000 gms.
- B.M.I. > 30 six months postpartum
- Hemoglobin A1C > 6.1% six months postpartum
Exclusion Criteria:
Pre-conception exclusion criteria will include any of the following:
- History of >1 miscarriage or fetal demise
- No contraindication to metformin (prior metformin intolerance, metabolic acidosis, GI disease)
- Hypertension (BP >135/85)
- No other endocrine, metabolic, renal, or autommune medical disorders
- Prior preterm birth
- Prior delivery complicated by shoulder dystocia
- Prior delivery complicated by neonatal palsy
- Multifetal pregnancy, including first-trimester embryonic demise of one or more
- Uterine malformations
- Illicit drug or alcohol abuse during current pregnancy
- Intent to deliver elsewhere
- Non-availability for prospective specimen/data collection
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: Metformine
|
Administration of Metformin or placebo prior to conception to prevent the onset of GDM.
|
Comparateur placebo: Metformin Placebo
|
Administration of Metformin or placebo prior to conception to prevent the onset of GDM.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Effect of metformin versus placebo on the development of GDM
Délai: Pre-conception to delivery (at 8 week intervals)
|
Pre-conception to delivery (at 8 week intervals)
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Effects on maternal and fetal pregnancy outcomes of pre-conception metabolic intervention with metformin.
Délai: Pre-conception until discharge from hospital after delivery (at 4 week intervals)
|
Pre-conception until discharge from hospital after delivery (at 4 week intervals)
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Ware Branch, M.D., Intermountain Health Care, Inc.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1017118
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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