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

Gestational Diabetes Clinical Trial

— FIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05773677
• Other study ID #: 5078
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2022
• Est. completion date: April 2024

Study information

• Verified date: March 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Italy	FPGemelliIRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of maternal obstetric complications:	gestational diabetes; gestational hypertension or preeclampsia -intrahepatic cholestasis (ICP)	From enrollment in the study to delivery
Secondary	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
Secondary	maternal weight gain	expressed in kilograms	From enrollment in the study to delivery
Secondary	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