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

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

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

Study Overview

• Status: Recruiting
• Conditions: Diet, Healthy; Gestational Diabetes; Intrahepatic Cholestasis of Pregnancy; Food Habits; Twin Pregnancy, Antepartum Condition or Complication; Gestational Hypertension
• Intervention / Treatment: Dietary supplement: Specific Diet

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00168
    • Recruiting
    • FPGemelliIRCCS
    • Contact: Daniela Visconti, MD; Phone Number: +393397316686; Email: daniela.visconti@policlinicogemelli.it
    • Sub-Investigator: Ludovica Puri, MD
    • Sub-Investigator: Valentina Esposito, MD
    • Sub-Investigator: Antonio Lanzone, MD
    • Sub-Investigator: Esmeralda Capristo, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Case Group: with diet; Prescription of specific diet in pregnancy	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.
No Intervention: Control Group: no diet; Retrospective group with no diet

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2022
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: February 24, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 17, 2023

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Liver Diseases; Pregnancy Complications; Biliary Tract Diseases; Hypertension; Bile Duct Diseases; Diabetes, Gestational; Cholestasis; Hypertension, Pregnancy-Induced; Cholestasis, Intrahepatic
• Other Study ID Numbers: 5078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No