Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT00857051
Status:
COMPLETED
Last Update Posted:
2009-09-25
First Post:
2009-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Postpartum Support: Can we Facilitate the Transition to Motherhood?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009040', 'term': 'Motion Pictures'}], 'ancestors': [{'id': 'D001296', 'term': 'Audiovisual Aids'}, {'id': 'D018961', 'term': 'Educational Technology'}, {'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 552}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-24', 'studyFirstSubmitDate': '2009-03-05', 'studyFirstSubmitQcDate': '2009-03-05', 'lastUpdatePostDateStruct': {'date': '2009-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stress as measure by the Cohen Perceived Stress Scale (PSS-10)', 'timeFrame': '2 - 3 months'}], 'secondaryOutcomes': [{'measure': 'Depression', 'timeFrame': '2 - 3 months'}, {'measure': 'Anxiety', 'timeFrame': '2 - 3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stress'], 'conditions': ['Stress']}, 'referencesModule': {'references': [{'pmid': '25315167', 'type': 'DERIVED', 'citation': 'Osman H, Saliba M, Chaaya M, Naasan G. Interventions to reduce postpartum stress in first-time mothers: a randomized-controlled trial. BMC Womens Health. 2014 Oct 15;14:125. doi: 10.1186/1472-6874-14-125.'}, {'pmid': '23902627', 'type': 'DERIVED', 'citation': 'Hamade H, Chaaya M, Saliba M, Chaaban R, Osman H. Determinants of exclusive breastfeeding in an urban population of primiparas in Lebanon: a cross-sectional study. BMC Public Health. 2013 Jul 31;13:702. doi: 10.1186/1471-2458-13-702.'}]}, 'descriptionModule': {'briefSummary': 'We are conducting a study to look interventions that may reduce stress in the postpartum period for first- time mothers. One of these interventions is an educational film that describes the common stressors that first-time parents go through in the early postpartum period. The other is a hotline service that women can call at anytime during the first 3 months postpartum to ask about problems she or the baby may be experiencing.', 'detailedDescription': "The postpartum period is a very stressful experience for most mothers. It is generally accepted that women are physically and psychologically stressed during the postpartum. After delivery a woman may have worries about the health of her baby and her own health, as well as the changes in her body, their impact on her sexual life and her relationship with her husband. In addition, she may have financial concerns, concerns about breastfeeding, and be worried about bonding with her baby.\n\nFirst-time mothers also have to adapt to their new role as mothers and may be worried about their abilities to take care of the baby. This may cause first-time mothers to develop postpartum depression and other emotional problems. First-time mothers can feel overwhelmed, exhausted, and isolated in their new roles.\n\nWe are conducting a study to look interventions that may reduce stress in the postpartum period for first- time mothers. One of these interventions is an educational film that describes the common stressors that first-time parents go through in the early postpartum period. The other is a hotline service that women can call at anytime during the first 3 months postpartum to ask about problems she or the baby may be experiencing. The hotline will be answered by a trained midwife.\n\nWomen will be recruited from all hospitals in Beirut after delivery and before they leave the hospital. If they agree to participate in the study, they will be randomly assigned to receive the film, the hotline service, both the film and the hotline service, or a CD containing children's songs. Women will be visited at home at 2 - 3 months after delivery by a researcher to complete questionnaires designed to measure stress, depression and anxiety in the postpartum.\n\nParticipants will not receive any financial compensation for participating in the study. Although women may benefit from the interventions, we will not know that until we complete the study. However, participation in this study may benefit mothers in the future if we find that the hotline or educational video are useful. There are no risks associated with participation in this study.\n\nConfidentiality of the collected information will be ensured. All information collected will be used for research purposes and will be kept anonymous."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy first-time mothers with singleton baby delivered at term with no complications.\n\nExclusion Criteria:\n\n* Mothers with chronic health problems,\n* Pregnancy complications, OR\n* Infants with congenital problems or conditions requiring admission to the intensive care nursery.'}, 'identificationModule': {'nctId': 'NCT00857051', 'briefTitle': 'Postpartum Support: Can we Facilitate the Transition to Motherhood?', 'organization': {'class': 'OTHER', 'fullName': 'American University of Beirut Medical Center'}, 'officialTitle': 'Postpartum Support: Can we Facilitate the Transition to Motherhood?', 'orgStudyIdInfo': {'id': 'FM.HO.04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'A 22 minute DVD that discusses common stressor in the early postpartum.', 'interventionNames': ['Other: Film']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'A 24 hour hotline available for the first 3 months postpartum.', 'interventionNames': ['Other: Hotline Service']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Both the film and the hotline will be given to this arm.', 'interventionNames': ['Other: Hotline Service', 'Other: Film']}, {'type': 'NO_INTERVENTION', 'label': '4', 'description': "A CD of children's music will be given to mothers in this arm."}], 'interventions': [{'name': 'Hotline Service', 'type': 'OTHER', 'description': 'A 24 hour hotline to answer questions about baby care or mother self-care. Hotline will be answered by a midwife and answers will be based on algorithms.', 'armGroupLabels': ['2', '3']}, {'name': 'Film', 'type': 'OTHER', 'description': 'A DVD addressing common stressors in the early postpartum.', 'armGroupLabels': ['1', '3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beirut', 'country': 'Lebanon', 'facility': 'American University of Beirut', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}], 'overallOfficials': [{'name': 'Hibah Osman, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'American University of Beirut Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American University of Beirut Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wellcome Trust', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Hibah Osman, MD, MPH', 'oldOrganization': 'American University of Beirut'}}}}