Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2026-02-28 @ 10:52 PM
Study NCT ID:
NCT06419192
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modifying Nutrition to Modify Delivery in Nulliparous Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015596', 'term': 'Nutrition Assessment'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-16', 'studyFirstSubmitDate': '2024-05-10', 'studyFirstSubmitQcDate': '2024-05-16', 'lastUpdatePostDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of compliance with dietary advice to eat 7 dates a day at the end of pregnancy in nulliparous women.', 'timeFrame': "From 37 weeks'amenorrhoea to delivery (up to 41 weeks)"}], 'secondaryOutcomes': [{'measure': "Evaluation of women's experience of the intervention using a post-partum questionnaire", 'timeFrame': 'Following childbirth, during the stay in the maternity ward ; assessed up to 5 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnant Woman']}, 'descriptionModule': {'briefSummary': "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.\n\nAccording to several studies, regular consumption of dates during the last month of pregnancy may increase the rate of spontaneous labour and natural childbirth.\n\nSingle-centre, randomised, open-label, 3-arm study :\n\nExperimental 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.\n\nExperimental group 2: 'dietary advice alone'. Advice to eat 7 dates a day from 37 weeks' gestation until delivery. The food will not be provided.\n\nControl group: no specific dietary advice. Routine care group."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women\n* Age ≥ 18 years\n* Nulliparous\n* Single pregnancy with fetus in cephalic presentation\n* Pregnancy with physiological course\n* Gestational age ≥ 34 and ⩽ 37 SA\n* Membership of a social security scheme (CMU accepted)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Any contraindication to vaginal delivery\n* Presence of a foetal malformation\n* Diabetes of any type (1, 2 or gestational)\n* Food allergy contraindicating participation in the study\n* Illiterate or non-French-speaking women\n* Women under guardianship or trusteeship'}, 'identificationModule': {'nctId': 'NCT06419192', 'acronym': 'MAMAN', 'briefTitle': 'Modifying Nutrition to Modify Delivery in Nulliparous Women', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': 'Evaluation of the Feasibility and Acceptability of Dietary Advice to Encourage Spontaneous Work: Randomised Pilot Study', 'orgStudyIdInfo': {'id': 'DR230083'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dietary advice + food supplied', 'description': "Eat 7 dates a day from 37 weeks' gestation (SA) until delivery. Women will be provided with the quantity of dates they need.", 'interventionNames': ['Other: dietary advice', 'Other: food supplied']}, {'type': 'EXPERIMENTAL', 'label': 'dietary advice alone', 'description': "Advise to eat 7 dates a day from 37 weeks' gestation (SA) until delivery. The food will not be provided.", 'interventionNames': ['Other: dietary advice alone']}, {'type': 'NO_INTERVENTION', 'label': 'usual care', 'description': 'No specific dietary advice'}], 'interventions': [{'name': 'dietary advice', 'type': 'OTHER', 'description': "Eat 7 dates a day from 37 weeks' gestation until delivery. Women will be provided with the quantity of dates they need.", 'armGroupLabels': ['dietary advice + food supplied']}, {'name': 'dietary advice alone', 'type': 'OTHER', 'description': 'Advise to eat 7 dates a day from 37SA until delivery. The food will not be provided.', 'armGroupLabels': ['dietary advice alone']}, {'name': 'food supplied', 'type': 'OTHER', 'description': "Eat 7 dates a day from 37 weeks' gestation until delivery. Women will be provided with the quantity of dates they need.", 'armGroupLabels': ['dietary advice + food supplied']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37044', 'city': 'Tours', 'country': 'France', 'contacts': [{'name': 'Caroline DIGUISTO, MD', 'role': 'CONTACT', 'email': 'C.DIGUISTO@chu-tours.fr'}, {'name': 'Caroline DIGUISTO, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gynaecology-obstetrics, University Hospital, Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'centralContacts': [{'name': 'Adeline DE WITT, MD', 'role': 'CONTACT', 'email': 'adelinelauriedw@gmail.com', 'phone': '02 47 47 47 36'}], 'overallOfficials': [{'name': 'Adeline DE WITT, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Orléans'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}