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

Not Applicable

Recruiting

• Conditions: Gestational Hypertension; Food Habits; Gestational Diabetes; Intrahepatic Cholestasis of Pregnancy; Twin Pregnancy, Antepartum Condition or Complication; Diet, Healthy
• Interventions: Dietary Supplement: Specific Diet

• Registration Number: NCT05773677
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-10-10
• Study First Submitted: 2023-02-24
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-06
• Last Update Submitted: 2023-03-16
• Study First Posted: 2023-03-17
• Last Update Posted: 2023-03-20
• Primary Completion: 2023-10
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Case Group: with diet	Specific Diet	Prescription of specific diet in pregnancy

Primary Outcome Measures

Name	Time	Method
incidence of maternal obstetric complications:	From enrollment in the study to delivery	* gestational diabetes; * gestational hypertension or preeclampsia -intrahepatic cholestasis (ICP)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

FPGemelliIRCCS; 🇮🇹 Roma, Italy