Modifying Nutrition to Modify Delivery in Nulliparous Women

Pregnant Woman Clinical Trial

— MAMAN  

Official title:

Evaluation of the Feasibility and Acceptability of Dietary Advice to Encourage Spontaneous Work: Randomised Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06419192
• Other study ID #: DR230083
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: September 2025

Study information

• Verified date: May 2024
• Source: University Hospital, Tours
• Contact: Adeline DE WITT, MD
• Phone: 02 47 47 47 36
• Email: adelinelauriedw[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: September 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnant Woman

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Gynaecology-obstetrics, University Hospital, Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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