Pregnant Woman
Conditions
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.
Interventions
OTHERdietary advice
Eat 7 dates a day from 37 weeks' gestation until delivery. Women will be provided with the quantity of dates they need.
OTHERdietary advice alone
Advise to eat 7 dates a day from 37SA until delivery. The food will not be provided.
OTHERfood supplied
Eat 7 dates a day from 37 weeks' gestation until delivery. Women will be provided with the quantity of dates they need.
Sponsors
University Hospital, Tours
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
France
Contacts
Primary ContactAdeline DE WITT, MD
Outcome results
None listed