Postpartum Support: Can we Facilitate the Transition to Motherhood?
1 other identifier
interventional
552
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2009
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 5, 2009
CompletedFirst Posted
Study publicly available on registry
March 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedSeptember 25, 2009
March 1, 2009
4 months
March 5, 2009
September 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Stress as measure by the Cohen Perceived Stress Scale (PSS-10)
2 - 3 months
Secondary Outcomes (2)
Depression
2 - 3 months
Anxiety
2 - 3 months
Study Arms (4)
1
EXPERIMENTALA 22 minute DVD that discusses common stressor in the early postpartum.
2
EXPERIMENTALA 24 hour hotline available for the first 3 months postpartum.
3
EXPERIMENTALBoth the film and the hotline will be given to this arm.
4
NO INTERVENTIONA CD of children's music will be given to mothers in this arm.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Healthy first-time mothers with singleton baby delivered at term with no complications.
You may not qualify if:
- Mothers with chronic health problems,
- Pregnancy complications, OR
- Infants with congenital problems or conditions requiring admission to the intensive care nursery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- American University of Beirut Medical Centerlead
- Wellcome Trustcollaborator
Study Sites (1)
American University of Beirut
Beirut, Lebanon
Related Publications (2)
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: 25315167DERIVEDHamade 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.
PMID: 23902627DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hibah Osman, MD, MPH
American University of Beirut Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 5, 2009
First Posted
March 6, 2009
Study Start
March 1, 2009
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
September 25, 2009
Record last verified: 2009-03