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

NCT05773677 | Unknown DMC

• 1 other identifier: 5078
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• incidence of maternal obstetric complications:

  * gestational diabetes * gestational hypertension or preeclampsia -intrahepatic cholestasis (ICP)

  From enrollment in the study to delivery

Secondary Outcomes (3)

• fetal growth and birth weight of the babies

  From enrollment in the study to delivery

• maternal weight gain

  From enrollment in the study to delivery

• differences in early or late enrollment of patients

  From enrollment in the study to delivery

Study Arms (2)

Case Group: with diet

EXPERIMENTAL

Prescription of specific diet in pregnancy

Dietary Supplement: Specific Diet

Control Group: no diet

NO INTERVENTION

Retrospective group with no diet

Interventions

Specific Diet DIETARY_SUPPLEMENT

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.

Case Group: with diet

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

FPGemelliIRCCS

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational; Hypertension, Pregnancy-Induced; Intrahepatic Cholestasis of Pregnancy; Feeding Behavior

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Behavior, Animal; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Case group: prospective Control group: retrospective

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 17, 2023
• Study Start: October 10, 2022
• Primary Completion: October 1, 2023
• Study Completion: April 1, 2024
• Last Updated: March 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)