A Self-Guided Breastfeeding Program
Preparing Mothers for Feeding Their Newborns: A Self-Guided Program for Pregnant Women
1 other identifier
interventional
335
0 countries
N/A
Brief Summary
This intervention would be a series of self-help-style educational and motivational activity sheets for patients to complete independently. This will be a randomized clinical control trial. Subjects will complete a pre delivery questionnaire and a postpartum questionnaire. Subjects in the intervention arm will complete 3 activity sheets prenatally during their wait time at the clinic. The first worksheet can be completed the day of recruitment after consent is signed. Subjects will be contacted by phone at 3 and 6 months postpartum to assess long term duration of breast feeding.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2015
Typical duration for not_applicable
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
August 20, 2015
CompletedFirst Submitted
Initial submission to the registry
October 18, 2016
CompletedFirst Posted
Study publicly available on registry
December 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 27, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2017
CompletedNovember 21, 2017
November 1, 2017
1.9 years
October 18, 2016
November 17, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
improving duration of BF.
It was propose using a 3-part prenatal self-help guide to educate and prepare mothers for breastfeeding.
16 Months
Study Arms (2)
A - Intervention
ACTIVE COMPARATOREducation on Breast Feeding 3 activity sheets prenatally-study related. Complete a pre-questionnaire, a pre-delivery and a postpartum questionnaire
B - Standard of Care
NO INTERVENTIONComplete a pre-questionnaire, a pre-delivery and a postpartum questionnaire
Interventions
Subjects in the intervention arm will complete 3 activity sheets prenatally-study related.
Eligibility Criteria
You may qualify if:
- Patients \< 32 weeks gestation.
You may not qualify if:
- Patient who have not had an ultrasound confirming viable intrauterine pregnancy.
- Patients beyond 32 weeks gestation will be excluded as some are unlikely to return for a sufficient number of prenatal visits to complete the intervention.
- Patients with medical contraindications to breastfeeding such as HIV or active substance abuse.
- Patients planning to take medications in the postpartum period that are incompatible with breastfeeding such as anti-metabolites.
- Patients giving birth to a nonviable infant.
- Patients without adequate reading and writing skills to complete the questionnaires and activity sheets.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jaye Shyken, MD
St. Louis University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
October 18, 2016
First Posted
December 12, 2016
Study Start
August 20, 2015
Primary Completion
July 27, 2017
Study Completion
July 27, 2017
Last Updated
November 21, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share