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

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)

Overall Status

Recruiting

CT.gov ID

NCT05773677

Collaborator

(none)

200

Enrollment

Location

Arms

17.7

Anticipated Duration (Months)

11.3

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Twin Pregnancy, Antepartum Condition or Complication Gestational Diabetes Gestational Hypertension Intrahepatic Cholestasis of Pregnancy Food Habits Diet, Healthy	Dietary Supplement: Specific Diet	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Case group: prospective Control group: retrospectiveCase group: prospective Control group: retrospective

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 10, 2022

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

incidence of maternal obstetric complications: [From enrollment in the study to delivery]
gestational diabetes gestational hypertension or preeclampsia -intrahepatic cholestasis (ICP)

Secondary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	FPGemelliIRCCS	Roma		Italy	00168

Sponsors and Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Visconti Daniela, Principal Investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

ClinicalTrials.gov Identifier:

NCT05773677

Other Study ID Numbers:

5078

First Posted:

Mar 17, 2023

Last Update Posted:

Mar 20, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cholestasis

Cholestasis, Intrahepatic

Diabetes, Gestational

Hypertension, Pregnancy-Induced

Study Results

No Results Posted as of Mar 20, 2023