Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT00270920
Status:
COMPLETED
Last Update Posted:
2008-07-15
First Post:
2005-12-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Randomised Controlled Trial to Compare Antenatal Preparation and Postnatal Counseling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 450}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2006-03'}, 'lastUpdateSubmitDate': '2008-07-10', 'studyFirstSubmitDate': '2005-12-28', 'studyFirstSubmitQcDate': '2005-12-28', 'lastUpdatePostDateStruct': {'date': '2008-07-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Study the effect of a standard two-encounter postnatal lactation counseling protocol on the initiation and maintenance of exclusive breastfeeding in mothers'}], 'secondaryOutcomes': [{'measure': 'Compare the effect of a standard two-encounter postnatal lactation counseling protocol with a single-encounter antenatal breastfeeding education protocol on the initiation and maintenance of exclusive breastfeeding in mothers.'}]}, 'conditionsModule': {'keywords': ['Initiation, Maintenance, Breastfeeding'], 'conditions': ['Breastfeeding']}, 'referencesModule': {'references': [{'pmid': '10217083', 'type': 'BACKGROUND', 'citation': 'Morrow AL, Guerrero ML, Shults J, Calva JJ, Lutter C, Bravo J, Ruiz-Palacios G, Morrow RC, Butterfoss FD. Efficacy of home-based peer counselling to promote exclusive breastfeeding: a randomised controlled trial. Lancet. 1999 Apr 10;353(9160):1226-31. doi: 10.1016/S0140-6736(98)08037-4.'}, {'pmid': '11089824', 'type': 'RESULT', 'citation': 'Haider R, Ashworth A, Kabir I, Huttly SR. Effect of community-based peer counsellors on exclusive breastfeeding practices in Dhaka, Bangladesh: a randomised controlled trial [see commments]. Lancet. 2000 Nov 11;356(9242):1643-7. doi: 10.1016/s0140-6736(00)03159-7.'}, {'pmid': '17670909', 'type': 'DERIVED', 'citation': 'Su LL, Chong YS, Chan YH, Chan YS, Fok D, Tun KT, Ng FS, Rauff M. Antenatal education and postnatal support strategies for improving rates of exclusive breast feeding: randomised controlled trial. BMJ. 2007 Sep 22;335(7620):596. doi: 10.1136/bmj.39279.656343.55. Epub 2007 Aug 1.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomised controlled trial to compare antenatal preparation and postnatal counseling strategies for improving breastfeeding rates.\n\nThe objectives are:\n\n1. to study the effect of a standard two-encounter postnatal lactation counseling protocol on the initiation and maintenance of exclusive breastfeediing in mothers\n2. to compare the effect of a standard two-encounter postnatal lactation counseling protocol with a single-encounter antenatal breastfeeding education protocol on the initiation and maintenance of exclusive breastfeeding in mothers.', 'detailedDescription': 'All pregnant mothers who wish to breastfeed after 34 weeks of gestation, and who do not have a high risk pregnancy as determined by investigator or have a multiple pregnancy in current pregnancy and have given their written informed consent will be randomised into three groups. Group 1 will receive standard hospital care. Group 2 will receive 1 session of antenatal counseling and Group 3 will receive 2 sessions of postanatal lactation counseling. All will receive postnatal follow up phone calls using questions from Case Report Forms at 2 weeks, 8 weeks, 3 months, 6 months and 12 months. The mothers who are not contactable for 3 consecutive months will be withdrawn from the study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPregnant woman who wants to breastfeed her child after 34 weeks of gestation and written informed consent given\n\nExclusion Criteria:\n\nPregnant women with high risk pregnancy as determined by the investigator.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00270920', 'briefTitle': 'A Randomised Controlled Trial to Compare Antenatal Preparation and Postnatal Counseling', 'organization': {'class': 'OTHER', 'fullName': 'National University Hospital, Singapore'}, 'officialTitle': 'A Randomised Controlled Trial to Compare Antenatal Preparation and Postnatal Counseling Strategies for Improving Breastfeeding Rates', 'orgStudyIdInfo': {'id': 'NUS IRB 03003'}, 'secondaryIdInfos': [{'id': 'NHG RPR 03002'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Lactation counseling', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '119074', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'National University Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Mary Rauff, MBBS, FRCOG', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University of Singapore /National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University Hospital, Singapore', 'class': 'OTHER'}}}}