Gestational Diabetes Clinical Trial
— FITOfficial title:
FIT: Food in Twins. Diet in Twin Pregnancy: the Wellness of Mother and Babies.
NCT number | NCT05773677 |
Other study ID # | 5078 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 10, 2022 |
Est. completion date | April 2024 |
Verified date | March 2023 |
Source | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
Country | Name | City | State |
---|---|---|---|
Italy | FPGemelliIRCCS | Roma |
Lead Sponsor | Collaborator |
---|---|
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Italy,
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 |
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