Modifying Nutrition to Modify Delivery in Nulliparous Women
NCT ID: NCT06419192
Last Updated: 2024-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
150 participants
INTERVENTIONAL
2024-07-31
2025-09-30
Brief Summary
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According to several studies, regular consumption of dates during the last month of pregnancy may increase the rate of spontaneous labour and natural childbirth.
Single-centre, randomised, open-label, 3-arm study :
Experimental group n°1: 'dietary advice + food provided'. Advice to eat 7 dates a day from 37 weeks' gestation until delivery. The quantity of dates required will be provided to the women.
Experimental group 2: 'dietary advice alone'. Advice to eat 7 dates a day from 37 weeks' gestation until delivery. The food will not be provided.
Control group: no specific dietary advice. Routine care group.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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dietary advice + food supplied
Eat 7 dates a day from 37 weeks' gestation (SA) until delivery. Women will be provided with the quantity of dates they need.
dietary advice
Eat 7 dates a day from 37 weeks' gestation until delivery. Women will be provided with the quantity of dates they need.
food supplied
Eat 7 dates a day from 37 weeks' gestation until delivery. Women will be provided with the quantity of dates they need.
dietary advice alone
Advise to eat 7 dates a day from 37 weeks' gestation (SA) until delivery. The food will not be provided.
dietary advice alone
Advise to eat 7 dates a day from 37SA until delivery. The food will not be provided.
usual care
No specific dietary advice
No interventions assigned to this group
Interventions
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dietary advice
Eat 7 dates a day from 37 weeks' gestation until delivery. Women will be provided with the quantity of dates they need.
dietary advice alone
Advise to eat 7 dates a day from 37SA until delivery. The food will not be provided.
food supplied
Eat 7 dates a day from 37 weeks' gestation until delivery. Women will be provided with the quantity of dates they need.
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* Nulliparous
* Single pregnancy with fetus in cephalic presentation
* Pregnancy with physiological course
* Gestational age ≥ 34 and ⩽ 37 SA
* Membership of a social security scheme (CMU accepted)
* Signed informed consent
Exclusion Criteria
* Presence of a foetal malformation
* Diabetes of any type (1, 2 or gestational)
* Food allergy contraindicating participation in the study
* Illiterate or non-French-speaking women
* Women under guardianship or trusteeship
18 Years
FEMALE
No
Sponsors
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University Hospital, Tours
OTHER
Responsible Party
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Principal Investigators
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Adeline DE WITT, MD
Role: STUDY_DIRECTOR
University Hospital, Orléans
Locations
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Gynaecology-obstetrics, University Hospital, Tours
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DR230083
Identifier Type: -
Identifier Source: org_study_id
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