Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05773677
Status:
RECRUITING
Last Update Posted:
2023-03-20
First Post:
2023-02-24
Brief Title:
Diet in Twin Pregnancy the Wellness of Mother and Babies
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
FIT Food in Twins Diet in Twin Pregnancy the Wellness of Mother and Babies
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIT
Brief Summary:
The aim of this study is to evaluate how variations in maternal nutrition may affect twin pregnancy and in particular
incidence of maternal obstetric complications
gestational diabetes
gestational hypertension or preeclampsia
intrahepatic cholestasis ICP
fetal growth development and birth weight of the babies
incidence of maternal obstetric complications
gestational diabetes
gestational hypertension or preeclampsia
intrahepatic cholestasis ICP
fetal growth development and birth weight of the babies
Detailed Description:
Study design
At the time of recruitment each patient will perform an initial clinical nutrition examination during which will be evaluated on the basis of BMI and specific anthropometric parameters the necessary nutritional intake
Patients included in the study will then be classified on the basis of pre-pregnancy BMI into 2 classes
normal weight BMI 18-25
overweight BMI 25-30 A specific diet will be developed for each patient which will also take into account any food allergies or intolerances
Each diet will be then eventually modified and revised throughout the pregnancy according to the evolution of the same
Patients will then continue their regular obstetrical examinations at the Obstetrical Day Hospital every 4 weeks in case of uncomplicated dichorionic twin pregnancy and every 2 weeks in case of uncomplicated monochorionic twin pregnancy
Once a month in coincidence with the appointment at the Obstetric Day Hospital the enrolled patients will be evaluated by the dedicated team of nutritionists
At the time of recruitment each patient will perform an initial clinical nutrition examination during which will be evaluated on the basis of BMI and specific anthropometric parameters the necessary nutritional intake
Patients included in the study will then be classified on the basis of pre-pregnancy BMI into 2 classes
normal weight BMI 18-25
overweight BMI 25-30 A specific diet will be developed for each patient which will also take into account any food allergies or intolerances
Each diet will be then eventually modified and revised throughout the pregnancy according to the evolution of the same
Patients will then continue their regular obstetrical examinations at the Obstetrical Day Hospital every 4 weeks in case of uncomplicated dichorionic twin pregnancy and every 2 weeks in case of uncomplicated monochorionic twin pregnancy
Once a month in coincidence with the appointment at the Obstetric Day Hospital the enrolled patients will be evaluated by the dedicated team of nutritionists
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None