search
Back to results

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

Primary Purpose

Twin Pregnancy, Antepartum Condition or Complication, Gestational Diabetes, Gestational Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Specific Diet
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Twin Pregnancy, Antepartum Condition or Complication

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • FPGemelliIRCCSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Case Group: with diet

Control Group: no diet

Arm Description

Prescription of specific diet in pregnancy

Retrospective group with no diet

Outcomes

Primary Outcome Measures

incidence of maternal obstetric complications:
gestational diabetes gestational hypertension or preeclampsia -intrahepatic cholestasis (ICP)

Secondary Outcome Measures

fetal growth and birth weight of the babies
estimated fetal weight and actual fetal weight at delivery (expressed in grams)
maternal weight gain
expressed in kilograms
differences in early or late enrollment of patients
advantage of early enrollment in reducing the incidence of the above complications (expressed as percentage)

Full Information

First Posted
February 24, 2023
Last Updated
March 16, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
search

1. Study Identification

Unique Protocol Identification Number
NCT05773677
Brief Title
Diet in Twin Pregnancy: the Wellness of Mother and Babies.
Acronym
FIT
Official Title
FIT: Food in Twins. Diet in Twin Pregnancy: the Wellness of Mother and Babies.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Twin Pregnancy, Antepartum Condition or Complication, Gestational Diabetes, Gestational Hypertension, Intrahepatic Cholestasis of Pregnancy, Food Habits, Diet, Healthy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Case group: prospective Control group: retrospective
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Case Group: with diet
Arm Type
Experimental
Arm Description
Prescription of specific diet in pregnancy
Arm Title
Control Group: no diet
Arm Type
No Intervention
Arm Description
Retrospective group with no diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Specific Diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
incidence of maternal obstetric complications:
Description
gestational diabetes gestational hypertension or preeclampsia -intrahepatic cholestasis (ICP)
Time Frame
From enrollment in the study to delivery
Secondary Outcome Measure Information:
Title
fetal growth and birth weight of the babies
Description
estimated fetal weight and actual fetal weight at delivery (expressed in grams)
Time Frame
From enrollment in the study to delivery
Title
maternal weight gain
Description
expressed in kilograms
Time Frame
From enrollment in the study to delivery
Title
differences in early or late enrollment of patients
Description
advantage of early enrollment in reducing the incidence of the above complications (expressed as percentage)
Time Frame
From enrollment in the study to delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
FPGemelliIRCCS
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Visconti, MD
Phone
+393397316686
Email
daniela.visconti@policlinicogemelli.it
First Name & Middle Initial & Last Name & Degree
Ludovica Puri, MD
First Name & Middle Initial & Last Name & Degree
Valentina Esposito, MD
First Name & Middle Initial & Last Name & Degree
Antonio Lanzone, MD
First Name & Middle Initial & Last Name & Degree
Esmeralda Capristo, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs