Modifying Nutrition to Modify Delivery in Nulliparous Women (MAMAN)

Regional University Hospital Center (CHRU)

Status: Not yet enrolling

Conditions: Pregnant Woman

Treatments: Other: food supplied; Other: dietary advice alone; Other: dietary advice

Study type: Interventional

Funder types: Other

Identifiers

NCT06419192

DR230083

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

dietary advice + food supplied

Experimental group

Description:

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

Treatment:

Other: dietary advice

Other: food supplied

dietary advice alone

Experimental group

Description:

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

Treatment:

Other: dietary advice alone

usual care

No Intervention group

Description:

No specific dietary advice