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NCT02550730 · ClinicalTrials.gov registry record · NA

Best Beginnings for Babies Birth Sister Program Evaluation

A NA study of Labor Pain, sponsored by Boston Medical Center.

Completed
Registry status
NA
Development phase
411
Enrollment target
1
Study location

NCT02550730 is a NA study of Labor Pain that has completed, run by Boston Medical Center. The registered enrollment target is 411 participants, above the 174-participant average among 14 other Labor Pain trials with a reported enrollment target (136% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT02550730, a NA study of Labor Pain, has completed, sponsored by Boston Medical Center.

COMPLETED
Registry status
NA
Development phase
411 participants
Enrollment target
1
Study location

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 Studied

Interventions

  • BEHAVIORAL Birth Sisters Best Beginnings for Babies
  • OTHER Usual maternity care

Study Locations (1)

Massachusetts

  • Boston Medical Center - Boston

Trial Details

FieldValue
Enrollment Target 411 participants
Start Date 2015-08
Est. Completion 2018-06
Phase NA

Sponsor

Boston Medical Center

253 total trials

What the Registry Record Tells You About NCT02550730

The ClinicalTrials.gov registry entry for NCT02550730 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 411 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 174-participant average among 14 other Labor Pain trials with a reported enrollment target (136% higher). The listed sponsor is Boston Medical Center, which has 253 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Labor Pain appearing as the primary indexed condition, and to 2 interventions - of which Birth Sisters Best Beginnings for Babies is the first listed.

NCT02550730 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT02550730 about?

NCT02550730 is a clinical study titled "Best Beginnings for Babies Birth Sister Program Evaluation". 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 ...

What is the current status of trial NCT02550730?

This trial is currently completed. It is a NA study. The enrollment target is 411 participants. The study started on 2015-08. Estimated completion is 2018-06.

What conditions does trial NCT02550730 study?

This clinical trial studies the following conditions: Labor Pain.

What interventions are being tested in trial NCT02550730?

The interventions under investigation include: Birth Sisters Best Beginnings for Babies (BEHAVIORAL), Usual maternity care (OTHER).

Who is sponsoring clinical trial NCT02550730?

This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02550730 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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