Modifying Nutrition to Modify Delivery in Nulliparous Women

Not Applicable

Not yet recruiting

• Conditions: Pregnant Woman
• Interventions: Other: dietary advice; Other: dietary advice alone; Other: food supplied

• Registration Number: NCT06419192
• Lead Sponsor: University Hospital, Tours

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-10
• Study First Submitted QC: 2024-05-16
• Last Update Submitted: 2024-05-16
• Study First Posted: 2024-05-17
• Last Update Posted: 2024-05-17
• Study Start: 2024-07
• Primary Completion: 2025-07
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dietary advice + food supplied	dietary advice	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 + food supplied	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 alone	dietary advice alone	Advise to eat 7 dates a day from 37 weeks' gestation (SA) until delivery. The food will not be provided.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Gynaecology-obstetrics, University Hospital, Tours; 🇫🇷 Tours, France