Gestational Metabolic Abnormalities and Maternal and Infant Nutrition and Health
|ClinicalTrials.gov Identifier: NCT01405547|
Recruitment Status : Completed
First Posted : July 29, 2011
Last Update Posted : December 20, 2012
|Condition or disease|
|Gestational Diabetes Hyperglycemia Insulin Resistance Obesity|
The current investigation is a prospective study conducted within ongoing cohort studies of women and their offspring. Pregnant women attending outpatient obstetrics clinics in Toronto, Canada are recruited. The overall study protocol includes four study visits between the second half of pregnancy and the first year of infant's life and interim phone call interviews:
- Pregnant women undergo an oral glucose tolerance test at an expected average of 30 weeks of gestation and complete medical and lifestyle questionnaires including food frequency questionnaires.
- Infant birth anthropometry measurements and human milk samples are collected at an expected average of 3 days postpartum. The timing of onset of lactogenesis II is asked at 3d, 5d, 7d postpartum or until the event occurrence up to day 7.
- At 3 months postpartum, follow-up assessments including infant anthropometry, medical and lifestyle questionnaires and human milk sample collection are completed.
- Interim telephone interviews are conducted at 6 weeks and 5, 7, 9 months postpartum to characterize infant feeding and supplementation behaviors.
- At 12 months postpartum, infant anthropometric assessments are conducted.
|Study Type :||Observational|
|Actual Enrollment :||271 participants|
|Official Title:||Impact of Maternal Metabolic Abnormalities in Pregnancy on Human Milk and Subsequent Infant Metabolic Development|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
- Infant growth [ Time Frame: Growth from birth to anthrometry at 12mo ]
- Human milk composition [ Time Frame: At 3d and at 3mo postpartum ]
- Onset of lactogenesis II [ Time Frame: At 3d, 5d, 7d postpartum until the event occurrence of milk-coming-in up to day 7. ]If the participant reports no milk-coming-in at the day 7 postpartum interview, the response is recorded as no milk-coming-in by day 7 postpartum.
- Gestational diabetes [ Time Frame: An expected average of 30 weeks of gestation ]
- Gestational metabolic abnormalities [ Time Frame: An expected average of 30 weeks of gestation ]
- Getational hyperglycemia and insulinemia (insulin resistance/sensitivity) [ Time Frame: An expected average of 30 weeks of gestation ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01405547
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5T 3L9|
|Study Chair:||Anthony Hanley, PhD||University of Toronto|
|Study Director:||Sylvia Ley, PhD||University of Toronto|