## Protocol Section
### Identification Module
**NCT ID:** NCT06419192

**Acronym:** MAMAN

**Brief Title:** Modifying Nutrition to Modify Delivery in Nulliparous Women

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

#### Organization Study ID Info
**ID:** DR230083
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Tours
### Status Module
#### Completion Date
**Date:** 2025-09

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-07

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital, Tours

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Pregnant Woman

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 150

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: dietary advice

- Other: food supplied

**Label:** dietary advice + food supplied

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Other: dietary advice alone

**Label:** dietary advice alone

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** No specific dietary advice

**Label:** usual care

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- dietary advice + food supplied

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

**Name:** dietary advice

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- dietary advice alone

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

**Name:** dietary advice alone

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- dietary advice + food supplied

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

**Name:** food supplied

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

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

**Time Frame:** From 37 weeks'amenorrhoea to delivery (up to 41 weeks)

#### Secondary Outcomes

**Measure:** Evaluation of women's experience of the intervention using a post-partum questionnaire

**Time Frame:** Following childbirth, during the stay in the maternity ward ; assessed up to 5 days

### Eligibility Module

**Eligibility Criteria:** 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

**Gender Based:** True

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** adelinelauriedw@gmail.com

**Name:** Adeline DE WITT, MD

**Phone:** 02 47 47 47 36

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Tours

**Contacts:**

***Contact 1:***

- **Email:** C.DIGUISTO@chu-tours.fr

- **Name:** Caroline DIGUISTO, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Caroline DIGUISTO, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** France

**Facility:** Gynaecology-obstetrics, University Hospital, Tours

**Zip:** 37044

#### Overall Officials

**Official 1:**

**Affiliation:** University Hospital, Orléans

**Name:** Adeline DE WITT, MD

**Role:** STUDY_DIRECTOR

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
