NCT06419192

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 17, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

May 17, 2024

Status Verified

May 1, 2024

Enrollment Period

1 year

First QC Date

May 10, 2024

Last Update Submit

May 16, 2024

Conditions

Pregnant Woman

Outcome Measures

Primary Outcomes (1)

  • Rate of compliance with dietary advice to eat 7 dates a day at the end of pregnancy in nulliparous women.

    From 37 weeks'amenorrhoea to delivery (up to 41 weeks)

Secondary Outcomes (1)

  • Evaluation of women's experience of the intervention using a post-partum questionnaire

    Following childbirth, during the stay in the maternity ward ; assessed up to 5 days

Study Arms (3)

dietary advice + food supplied

EXPERIMENTAL

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

Other: dietary adviceOther: food supplied

dietary advice alone

EXPERIMENTAL

Advise to eat 7 dates a day from 37 weeks' gestation (SA) until delivery. The food will not be provided.

Other: dietary advice alone

usual care

NO INTERVENTION

No specific dietary advice

Interventions

dietary adviceOTHER

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

dietary advice + food supplied
dietary advice aloneOTHER

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

dietary advice alone
food suppliedOTHER

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

dietary advice + food supplied

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynaecology-obstetrics, University Hospital, Tours

Tours, 37044, France

Location

MeSH Terms

Interventions

Nutrition Assessment

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Adeline DE WITT, MD

    University Hospital, Orléans

    STUDY DIRECTOR

Central Study Contacts

Adeline DE WITT, MD

CONTACT

02 47 47 47 36adelinelauriedw@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2024

First Posted

May 17, 2024

Study Start

July 1, 2024

Primary Completion

July 1, 2025

Study Completion

September 1, 2025

Last Updated

May 17, 2024

Record last verified: 2024-05

Locations

FR(1)