Diet, Healthy, Food Habits, Gestational Diabetes, Gestational Hypertension, Intrahepatic Cholestasis of Pregnancy, Twin Pregnancy, Antepartum Condition or Complication
Conditions
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
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.
Interventions
DIETARY_SUPPLEMENTSpecific 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.
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Case group: prospective Control group: retrospective
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of maternal obstetric complications: | From enrollment in the study to delivery | * gestational diabetes * gestational hypertension or preeclampsia -intrahepatic cholestasis (ICP) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| fetal growth and birth weight of the babies | From enrollment in the study to delivery | estimated fetal weight and actual fetal weight at delivery (expressed in grams) |
| maternal weight gain | From enrollment in the study to delivery | expressed in kilograms |
| differences in early or late enrollment of patients | From enrollment in the study to delivery | advantage of early enrollment in reducing the incidence of the above complications (expressed as percentage) |
Countries
Italy
Outcome results
None listed