Pregnant WomanMAMANNCT06419192
Modifying Nutrition to Modify Delivery in Nulliparous Women
A study testing dietary advice, dietary advice alone and food supplied in people with Pregnant Woman, run by University Hospital, Tours at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnant Woman
- What is being tested?
- dietary advice, dietary advice alone and food supplied
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2024to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site
Gynaecology-obstetrics, University Hospital, Tours
Tours, 37044
Caroline DIGUISTO, MD, C.DIGUISTO@chu-tours.fr
Caroline DIGUISTO, MD
About this study
Official title: Evaluation of the Feasibility and Acceptability of Dietary Advice to Encourage Spontaneous Work: Randomised Pilot Study
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.
Read more
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
- Pregnant Woman
- Being tested
- dietary advice, dietary advice alone, food supplied
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary adviceOther
Eat 7 dates a day from 37 weeks' gestation until delivery. Women will be provided with the quantity of dates they need.
dietary advice aloneOther
Advise to eat 7 dates a day from 37SA until delivery. The food will not be provided.
food suppliedOther
Eat 7 dates a day from 37 weeks' gestation until delivery. Women will be provided with the quantity of dates they need.
| Study group | Role | What they receive |
|---|---|---|
| dietary advice + food supplied | Experimental | Eat 7 dates a day from 37 weeks' gestation (SA) until delivery. Women will be provided with the quantity of dates they need. Receives: Other: dietary advice; Other: food supplied |
| dietary advice alone | Experimental | Advise to eat 7 dates a day from 37 weeks' gestation (SA) until delivery. The food will not be provided. Receives: Other: dietary advice alone |
| usual care | No intervention | No specific dietary advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of compliance with dietary advice to eat 7 dates a day at the end of pregnancy in nulliparous women.
Measured: From 37 weeks'amenorrhoea to delivery (up to 41 weeks)
Secondary outcomes (1)
Evaluation of women's experience of the intervention using a post-partum questionnaire
Measured: Following childbirth, during the stay in the maternity ward ; assessed up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study startJul 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomanStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adeline DE WITT, MD, Study director, University Hospital, Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419192
- Sponsor's protocol ID
- DR230083
- Acronym
- MAMAN
- Status last verified
- May 2024
- First submitted
- 10 May 2024
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Feasibility and Acceptability of Dietary Advice to Encourage Spontaneous Work: Randomised Pilot Study
- ClinicalTrials.gov ID
- NCT06419192
- Acronym / sponsor ID
- MAMAN / DR230083
- Conditions
- Pregnant Woman
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dietary advice + food supplied | Experimental | Other: dietary advice, Other: food suppliedEat 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 | Experimental | Other: dietary advice aloneAdvise to eat 7 dates a day from 37 weeks' gestation (SA) until delivery. The food will not be provided. |
| usual care | No intervention | –No specific dietary advice |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pregnant women
- Age ≥ 18 years
- Nulliparous
- Single pregnancy with fetus in cephalic presentation
- Pregnancy with physiological course
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietary adviceEat 7 dates a day from 37 weeks' gestation until delivery. Women will be provided with the quantity of dates they need. | Other | dietary advice + food supplied |
| dietary advice aloneAdvise to eat 7 dates a day from 37SA until delivery. The food will not be provided. | Other | dietary advice alone |
| food suppliedEat 7 dates a day from 37 weeks' gestation until delivery. Women will be provided with the quantity of dates they need. | Other | dietary advice + food supplied |
Primary outcome
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)
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adeline DE WITT, MD study director
University Hospital, Orléans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary advice, dietary advice alone and food supplied in people with Pregnant Woman, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adeline DE WITT, MD (02 47 47 47 36, adelinelauriedw@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.