NCT05773677

Diet in Twin Pregnancy: the Wellness of Mother and Babies.

FIT: Food in Twins. Diet in Twin Pregnancy: the Wellness of Mother and Babies.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

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.

Conditions

• Twin Pregnancy, Antepartum Condition or Complication
• Gestational Diabetes
• Gestational Hypertension
• Intrahepatic Cholestasis of Pregnancy
• Food Habits
• Diet, Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Specific Diet	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.

Timeline

• Start date: 2022-10-10
• Primary completion: 2023-10-01
• Completion: 2024-04-01
• First posted: 2023-03-17
• Last updated: 2023-03-20

Locations

1 site across 1 country: Italy