Best Beginnings for Babies Birth Sister Program Evaluation

NCT02550730 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 411

Last updated 2018-07-06

No results posted yet for this study

Summary

Peer support during labor, birth and the perinatal period (also known as "doula" support) has been shown in some studies to reduce cesarean rates, postpartum depression and increase breastfeeding rates. The purpose of this program evaluation is to prospectively assess the clinical and cost outcomes of Boston Medical Center's Birth Sister doula program, one of the few established, hospital-based programs in the United States. To enhance the capability of the Birth Sisters Program to impact social determinants of perinatal health in a low-income population, the program evaluation will include the addition of Medical Legal Partnership for Children's (MLP) training and referral services. This program will be described as the Birth Sisters Best Beginnings services (BBB). The evaluation will compare the effects of BBB compared with no Birth Sister support for women receiving maternity care at Boston Medical Center. Eligible women will be randomly assigned either BBB services or usual care. All women will be consented and interviewed in the mid-second trimester of pregnancy and interviewed again at 6-8 weeks postpartum. Women randomized to the BBB will be offered 8 prenatal Birth Sister visits in the home or at Boston Medical Center starting at 6 months of pregnancy, continuous support through labor and birth, and up to 4 postpartum Birth Sister visits in the home or at Boston Medical Center. The usual care group will receive no birth sister support but does have access to standard interdisciplinary maternity care services. The primary outcomes will be reduction in cesarean rate. Secondary outcomes will include cost, labor interventions, infant outcomes, satisfaction with care and psychosocial outcomes, including depression, social functioning and self-efficacy.

Conditions

  • Labor Pain

Interventions

BEHAVIORAL

Birth Sisters Best Beginnings for Babies

Birth Sisters Best Beginnings for Babies support during Pregnancy, Labor and Delivery and six weeks postpartum. Participants assigned to the Birth Sister group receive community doula services with consultation from the Medical Legal Partnership when indicated beginning at 24 weeks. Participants receive up to 8 two-hour prenatal home visits; continuous support through labor and birth, and up to 4 two-hour postpartum home visits through 6-8 weeks postpartum.

OTHER

Usual maternity care

Usual prenatal, intrapartum and postpartum maternity care

Sponsors & Collaborators

  • Boston Medical Center

    lead OTHER

Principal Investigators

  • Julie Mottl-Santiago, MPH, CNM · Boston University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2018-05-31
Completion
2018-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02550730 on ClinicalTrials.gov