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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Dietary Supplement: Specific Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: dichorionic-diamniotic twin pregnancies monochorionic-diamniotic twin pregrancies monochorionic- monoamniotic twin pregnancies spontaneous onset or by homologous PMA techniques Age between 18 and 40 years Gestational age between 8 weeks+0 days and 25 weeks+6 days Exclusion Criteria: Pregestational diabetes mellitus (type I and II) Chronic hypertension Previous bariatric surgery Chronic gastrointestinal disease (Celiac disease, Crohn's disease, Ulcerative Rectocolitis) Age less than 18 years or more than 40 years Gestational age less than 8 weeks or more than 26 weeks Fetal structural and/or genetic abnormalities Heterologous PMA Maternal eating disorders Drug and/or alcohol use Multiple pregnancies with more than two babies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Case group: prospective Control group: retrospective
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Case Group: with diet<br>Prescription of specific diet in pregnancy | Dietary Supplement: Specific Diet<br>* 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.<br>|
| No Intervention: Control Group: no diet<br>Retrospective group with no diet | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of maternal obstetric complications: | gestational diabetes gestational hypertension or preeclampsia -intrahepatic cholestasis (ICP) | From enrollment in the study to delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fetal growth and birth weight of the babies | estimated fetal weight and actual fetal weight at delivery (expressed in grams) | From enrollment in the study to delivery | 
| maternal weight gain | expressed in kilograms | From enrollment in the study to delivery | 
| differences in early or late enrollment of patients | advantage of early enrollment in reducing the incidence of the above complications (expressed as percentage) | From enrollment in the study to delivery |