Modifying Nutrition to Modify Delivery in Nulliparous Women

NCT ID: NCT06419192

Last Updated: 2024-05-17

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-31

Study Completion Date

2025-09-30

Brief Summary

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In France, around 20% of women exceed the term of 41 weeks' amenorrhoea (SA). Maternal and foetal morbidity and mortality are increased when the term is exceeded, which justifies inducing labour. However, induction also increases maternal and foetal morbidity.

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.

Detailed Description

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Conditions

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Pregnant Woman

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

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.

Group Type EXPERIMENTAL

dietary advice

Intervention Type OTHER

Eat 7 dates a day from 37 weeks' gestation until delivery. Women will be provided with the quantity of dates they need.

food supplied

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

dietary advice alone

Intervention Type OTHER

Advise to eat 7 dates a day from 37SA until delivery. The food will not be provided.

usual care

No specific dietary advice

Group Type NO_INTERVENTION

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.

Intervention Type OTHER

dietary advice alone

Advise to eat 7 dates a day from 37SA until delivery. The food will not be provided.

Intervention Type OTHER

food supplied

Eat 7 dates a day from 37 weeks' gestation until delivery. Women will be provided with the quantity of dates they need.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pregnant women
* 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

* Any contraindication to vaginal delivery
* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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France

Central Contacts

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Adeline DE WITT, MD

Role: CONTACT

02 47 47 47 36

Facility Contacts

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Caroline DIGUISTO, MD

Role: primary

Other Identifiers

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DR230083

Identifier Type: -

Identifier Source: org_study_id

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