NCT01925664

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
248

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 20, 2013

Completed
Last Updated

September 5, 2013

Status Verified

September 1, 2013

Enrollment Period

5.6 years

First QC Date

August 14, 2013

Last Update Submit

September 4, 2013

Conditions

Keywords

DoulasParentingBreastfeedingPregnancy in Adolescence

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

EXPERIMENTAL

Mothers received doula home visiting services in addition to normal prenatal and obstetric clinical care and had access to social work case management.

Behavioral: Doula

Usual Care

NO INTERVENTION

Mothers received normal prenatal and obstetric clinical care and had access to social work case management.

Interventions

DoulaBEHAVIORAL

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.

Doula

Eligibility Criteria

Age14 Years - 21 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

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

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

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.

MeSH Terms

Conditions

Breast FeedingDepression, Postpartum

Interventions

Doulas

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorPuerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Sydney L Hans, PhD

    University of Chicago

    PRINCIPAL INVESTIGATOR

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

Locations