Best Beginnings for Babies Birth Sister Program Evaluation

NCT02550730 | Completed

• 1 other identifier: H-33788
• Study Type: interventional
• Target: 411
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Rates of cesarean sections

  total cesareans/total births as assessed by medical record abstraction

  at delivery

Secondary Outcomes (1)

• Rates of preterm birth

  at delivery

Other Outcomes (6)

• Low birth weight,

  at delivery

• Rates of breastfeeding initiation

  8 weeks postpartum

• Reductions in depressive symptoms

  8 weeks postpartum

Study Arms (2)

Birth Sisters

EXPERIMENTAL

Half of the women who agree to participate in the evaluation will be randomized to the Birth Sisters Best beginnings for Babies Program, which includes community doula support and consultation with Medical Legal Partnership when indicated.

Behavioral: Birth Sisters Best Beginnings for Babies

Routine care

ACTIVE COMPARATOR

Half of the women who agree to participate in the evaluation will be randomized to the usual maternity care group

Other: Usual maternity care

Interventions

Birth Sisters Best Beginnings for Babies BEHAVIORAL

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.

Birth Sisters

Usual maternity care OTHER

Usual prenatal, intrapartum and postpartum maternity care

Routine care

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Being a pregnant Woman 16 to 24 gestational age
• First Time Mother
• Singleton
• Public insurance
• No known fetal anomaly

You may not qualify if:

• \< 18 years of age
• high risk pregnancy defined by care in the high-risk prenatal clinic

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 021182335, United States

Location

Related Publications (1)

• Mottl-Santiago J, Dukhovny D, Cabral H, Rodrigues D, Spencer L, Valle EA, Feinberg E. Effectiveness of an Enhanced Community Doula Intervention in a Safety Net Setting: A Randomized Controlled Trial. Health Equity. 2023 Sep 7;7(1):466-476. doi: 10.1089/heq.2022.0200. eCollection 2023.

  PMID: 37731785 DERIVED

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Julie Mottl-Santiago, MPH, CNM

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Midwife and Assistant Professor

Study Record Dates

• First Submitted: June 23, 2015
• First Posted: September 15, 2015
• Study Start: August 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: June 1, 2018
• Last Updated: July 6, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)