The 4th Trimester Initiative: The Impact of Parental Support on Pregnant Trainee Wellbeing

Summary

The goal of this clinical trial is to determine the impact of a parental support package for new trainee mothers which focuses on mentorship, lactation, and sleep, and access to perinatal care. The main questions it aims to answer are whether this set of interventions will improve trainee wellbeing and decrease medical error.

Participants will be randomized to intervention and control groups. The intervention group will receive:

1. A Snoo smart sleep bassinet
2. A Willow wearable breast pump
3. Access to Maven Clinic for 24/7 on-demand perinatal care
4. A faculty mentor in their own department

The control group will receive the standard support currently offered by training programs.

All participants will wear a Fitbit to track sleep and will take a series of surveys querying pregnancy, birth, and postpartum experiences; wellbeing; and professional satisfaction.

Researchers will compare intervention and control groups to see if the intervention group has:

1. decreased rates of burnout
2. increased professional fulfillment
3. decreased thoughts of leaving the profession
4. increased perception of organizational and personal value alignment
5. increased sleep
6. decreased risk of medical errors
7. increased personal fulfillment of breastfeeding goals
8. decreased risk of postpartum depression

Conditions

• Pregnancy Related
• Burnout, Professional
• Wellness, Psychological

Interventions

DEVICE

Snoo smart bassinet

Participants in the intervention arm will be shipped a Snoo bassinet during their third trimester. The bassinet must be returned to the company at 6 months

DEVICE

Willow wearable breast pump

Participants in the intervention arm will be shipped a Willow wearable breast pump and milk storage bags during the third trimester, which participants may keep

BEHAVIORAL

Maven Clinic on-demand perinatal consultation

Participants in the intervention arm will receive immediate access to Maven Clinic for 24/7 on-demand consultation with perinatal specialists.

BEHAVIORAL

Faculty mentor

After enrollment, participants in the intervention arm will be paired with a faculty mentor who is also a mother to discuss issues related to work-family integration during pregnancy and early infancy.

Sponsors & Collaborators

• Brigham and Women's Hospital

  collaborator OTHER

• Boston Children's Hospital

  collaborator OTHER

• Beth Israel Deaconess Medical Center

  collaborator OTHER

• Massachusetts General Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-05-25

Primary Completion

2026-01-25

Completion

2026-01-25

FDA Device

Yes

Countries

• United States

Study Locations