An interventional study of Specific Diet in Twin Pregnancy, Antepartum Condition or Complication, Gestational Diabetes and Gestational Hypertension, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Status unknown at 1 site in Italy. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-20.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Prevention
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:
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:
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.
220 studies on the registry are indexed under Cholestasis; 37 are open to participants now.
This study's planned enrollment of 200 is above the median of 55 across 135 interventional studies indexed under Cholestasis.
Browse Cholestasis studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Prescription of specific diet in pregnancy
Dietary Supplement: Specific Diet
Retrospective group with no 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.
incidence of maternal obstetric complications:
* gestational diabetes * gestational hypertension or preeclampsia -intrahepatic cholestasis (ICP)
Time frame: From enrollment in the study to delivery
fetal growth and birth weight of the babies
estimated fetal weight and actual fetal weight at delivery (expressed in grams)
Time frame: From enrollment in the study to delivery
maternal weight gain
expressed in kilograms
Time frame: From enrollment in the study to delivery
differences in early or late enrollment of patients
advantage of early enrollment in reducing the incidence of the above complications (expressed as percentage)
Time frame: From enrollment in the study to delivery
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS