Twin Pregnancy, Antepartum Condition or ComplicationFITNCT05773677
Diet in Twin Pregnancy: the Wellness of Mother and Babies.
A study testing Specific Diet in people with Twin Pregnancy, Antepartum Condition or Complication and Gestational Diabetes, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Twin Pregnancy, Antepartum Condition or Complication, Gestational Diabetes, Gestational Hypertension
- What is being tested?
- Specific Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 10 Oct 2022to Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- Fetal structural and/or genetic abnormalities
- Heterologous PMA
- Maternal eating disorders
- Drug and/or alcohol use
- Multiple pregnancies with more than two babies
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
FPGemelliIRCCS
Roma, 00168
Daniela Visconti, MD, +393397316686, daniela.visconti@policlinicogemelli.it
Ludovica Puri, MD
About this study
Official title: FIT: Food in Twins. Diet in Twin Pregnancy: the Wellness of Mother and Babies.
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
Read the 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.
- Conditions
- Twin Pregnancy, Antepartum Condition or Complication, Gestational Diabetes, Gestational Hypertension, Intrahepatic Cholestasis of Pregnancy, Food Habits, Diet, Healthy
- Being tested
- Specific Diet
- Medical subject headings
- Diabetes, Gestational, Hypertension, Pregnancy-Induced, Intrahepatic Cholestasis of Pregnancy, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific DietDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Case Group: with diet | Experimental | Prescription of specific diet in pregnancy Receives: Dietary Supplement: Specific Diet |
| Control Group: no diet | No intervention | Retrospective group with no diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of maternal obstetric complications:
- gestational diabetes
- gestational hypertension or preeclampsia -intrahepatic cholestasis (ICP)
Measured: From enrollment in the study to delivery
Secondary outcomes (3)
fetal growth and birth weight of the babies
estimated fetal weight and actual fetal weight at delivery (expressed in grams)
Measured: From enrollment in the study to delivery
maternal weight gain
expressed in kilograms
Measured: 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)
Measured: From enrollment in the study to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start10 Oct 2022
- Primary completionOct 2023 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Twin Pregnancy, Antepartum Condition or ComplicationStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Case group: prospective Control group: retrospective
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Visconti Daniela, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773677
- Sponsor's protocol ID
- 5078
- Acronym
- FIT
- Status last verified
- Mar 2023
- First submitted
- 24 Feb 2023
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FIT: Food in Twins. Diet in Twin Pregnancy: the Wellness of Mother and Babies.
- ClinicalTrials.gov ID
- NCT05773677
- Acronym / sponsor ID
- FIT / 5078
- Conditions
- Twin Pregnancy, Antepartum Condition or Complication, Gestational Diabetes, Gestational Hypertension, Intrahepatic Cholestasis of Pregnancy, Food Habits, Diet, Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Case group: prospective Control group: retrospective
| Arm | Type | Receives |
|---|---|---|
| Case Group: with diet | Experimental | Dietary Supplement: Specific DietPrescription of specific diet in pregnancy |
| Control Group: no diet | No intervention | –Retrospective group with no diet |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specific DietA 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. | Dietary supplement | Case Group: with diet |
Primary outcome
incidence of maternal obstetric complications:
Time frame: From enrollment in the study to delivery
* gestational diabetes * gestational hypertension or preeclampsia -intrahepatic cholestasis (ICP)
3 secondary outcomes
fetal growth and birth weight of the babies
Time frame: From enrollment in the study to delivery
maternal weight gain
Time frame: From enrollment in the study to delivery
differences in early or late enrollment of patients
Time frame: From enrollment in the study to delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific Diet in people with Twin Pregnancy, Antepartum Condition or Complication and Gestational Diabetes, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of maternal obstetric complications: (time frame: From enrollment in the study to delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.