Doula Support for Young Mothers: A Randomized Trial
1 other identifier
interventional
248
1 country
1
Brief Summary
The goal of this study was to evaluate the impact of a doula home visiting intervention on young, low-income mothers' birth outcomes, breastfeeding, postpartum depressive symptoms, and parenting, and on their children's development.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2001
Longer than P75 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
January 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 14, 2013
CompletedFirst Posted
Study publicly available on registry
August 20, 2013
CompletedSeptember 5, 2013
September 1, 2013
5.6 years
August 14, 2013
September 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Breastfeeding Initiation
Three days postpartum
Positive parenting behavior (Parent Child Observation Guide)
Videotaped interactions between mothers and infants coded by masked observers
4 months postpartum
Secondary Outcomes (11)
Breastfeeding duration
4- and 12 months postpartum
Positive parenting behaviors (Parent Child Observation Guide)
12- and 24 months postpartum
Use of labor anesthesia
Start of labor through childbirth
Labour Agentry Scale
1 day postpartum
Adult Adolescent Parenting Inventory (AAPI)
4 months postpartum
- +6 more secondary outcomes
Study Arms (2)
Doula
EXPERIMENTALMothers received doula home visiting services in addition to normal prenatal and obstetric clinical care and had access to social work case management.
Usual Care
NO INTERVENTIONMothers received normal prenatal and obstetric clinical care and had access to social work case management.
Interventions
This intervention included doulas providing weekly home visits during the last trimester of pregnancy and up to three months postpartum. Home visits focused on prenatal health, preparation for childbirth, breastfeeding education, and developing a relationship with the baby. Doulas also were present in the hospital during labor, delivery, and postpartum providing emotional support, non-medical comfort measures, and breastfeeding counseling.
Eligibility Criteria
You may qualify if:
- pregnant and less than 34 weeks gestation
- planning to deliver at study hospital
- between ages 14 and 21
You may not qualify if:
- planning to move out of community after giving birth
- planning to give up custody of infant
- prior c-section delivery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Chicagolead
- HRSA/Maternal and Child Health Bureaucollaborator
Study Sites (1)
University of Chicago
Chicago, Illinois, 60637, United States
Related Publications (1)
Edwards RC, Thullen MJ, Korfmacher J, Lantos JD, Henson LG, Hans SL. Breastfeeding and complementary food: randomized trial of community doula home visiting. Pediatrics. 2013 Nov;132 Suppl 2:S160-6. doi: 10.1542/peds.2013-1021P.
PMID: 24187119DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sydney L Hans, PhD
University of Chicago
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2013
First Posted
August 20, 2013
Study Start
January 1, 2001
Primary Completion
August 1, 2006
Study Completion
August 1, 2006
Last Updated
September 5, 2013
Record last verified: 2013-09