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

NCT06014892 | Completed FDA Device

• 1 other identifier: 2022P001157
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 4

Brief 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. 1.A Snoo smart sleep bassinet
2. 2.A Willow wearable breast pump
3. 3.Access to Maven Clinic for 24/7 on-demand perinatal care
4. 4.A faculty mentor in their own department
5. 5.decreased rates of burnout
6. 6.increased professional fulfillment
7. 7.decreased thoughts of leaving the profession
8. 8.increased perception of organizational and personal value alignment
9. 9.increased sleep
10. 10.decreased risk of medical errors
11. 11.increased personal fulfillment of breastfeeding goals
12. 12.decreased risk of postpartum depression

Conditions

Pregnancy Related; Burnout, Professional; Wellness, Psychological

Keywords

burnout; postpartum depression; lactation; resident attrition

Outcome Measures

Primary Outcomes (1)

• Burnout measured by emotional exhaustion and Interpersonal Disengagement components of the Stanford Professional Fulfillment Index

  Emotional exhaustion and Interpersonal Disengagement are EACH scored on a scale of 0-10; The Emotional Exhaustion and Interpersonal Disengagement Scores are then averaged for score 0-10. Higher scores indicate higher likelihood of emotional exhaustion, interpersonal disengagement, and burnout (higher score is worse outcome)

  At Enrollment; 16 weeks postpartum; 24 weeks postpartum

Secondary Outcomes (14)

• Professional Fulfillment measured by the Stanford Professional Fulfillment Index

  At Enrollment; 16 weeks postpartum; 24 weeks postpartum; 1 year postpartum

• Self reported medical error resulting in patient harm

  4 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks postpartum

• Self reported medical error resulting in near miss for patient harm

  4 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks postpartum

• Organizational and Personal Values Alignment

  At Enrollment; 16 weeks postpartum; 24 weeks postpartum

• Negative Impact of Work on Personal Relationships

  At Enrollment; 16 weeks postpartum; 24 weeks postpartum

Other Outcomes (9)

• Burnout measured by emotional exhaustion and Interpersonal Disengagement components of the Stanford Professional Fulfillment Index

  12 months postpartum

• Professional Fulfillment measured by the Stanford Professional Fulfillment Index

  12 months postpartum

• Organization and personal values alignment

  12 months postpartum

Study Arms (2)

Intervention

EXPERIMENTAL

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

Device: Snoo smart bassinet; Device: Willow wearable breast pump; Behavioral: Maven Clinic on-demand perinatal consultation; Behavioral: Faculty mentor

Control

NO INTERVENTION

The control arm will receive: Current standard in the residency training program.

Interventions

Snoo smart bassinet DEVICE

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

Intervention

Willow wearable breast pump DEVICE

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

Intervention

Maven Clinic on-demand perinatal consultation BEHAVIORAL

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

Intervention

Faculty mentor BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently pregnant
• Part of a residency or fellowship training program at MGH, BWH, BCH, or BIDMC during pregnancy and for 6 months postpartum
• Clinically active and will remain clinically active until 6 months postpartum

You may not qualify if:

• significant cardiopulmonary, gastrointestinal, or neurologic comorbidities in participant or her fetus
• on research elective or dedicated research time from time of enrollment until 6 months postpartum.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Brigham and Women's Hospital: collaborator
• Boston Children's Hospital: collaborator
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (4)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (18)

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• Castillo-Angeles M, Smink DS, Rangel EL. Perspectives of US General Surgery Program Directors on Cultural and Fiscal Barriers to Maternity Leave and Postpartum Support During Surgical Training. JAMA Surg. 2021 Jul 1;156(7):647-653. doi: 10.1001/jamasurg.2021.1807.

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  PMID: 30422299 BACKGROUND

• Sandler BJ, Tackett JJ, Longo WE, Yoo PS. Pregnancy and Parenthood among Surgery Residents: Results of the First Nationwide Survey of General Surgery Residency Program Directors. J Am Coll Surg. 2016 Jun;222(6):1090-6. doi: 10.1016/j.jamcollsurg.2015.12.004. Epub 2015 Dec 18.

  PMID: 26776357 BACKGROUND

• Melnitchouk N, Scully RE, Davids JS. Barriers to Breastfeeding for US Physicians Who Are Mothers. JAMA Intern Med. 2018 Aug 1;178(8):1130-1132. doi: 10.1001/jamainternmed.2018.0320.

  PMID: 29554184 BACKGROUND

• Peters GW, Kuczmarska-Haas A, Holliday EB, Puckett L. Lactation challenges of resident physicians- results of a national survey. BMC Pregnancy Childbirth. 2020 Dec 9;20(1):762. doi: 10.1186/s12884-020-03436-3.

  PMID: 33297993 BACKGROUND

• Kancherla BS, Upender R, Collen JF, Rishi MA, Sullivan SS, Ahmed O, Berneking M, Flynn-Evans EE, Peters BR, Gurubhagavatula I. What is the role of sleep in physician burnout? J Clin Sleep Med. 2020 May 15;16(5):807-810. doi: 10.5664/jcsm.8412. Epub 2020 Feb 28.

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  PMID: 19699775 BACKGROUND

• Lyu HG, Davids JS, Scully RE, Melnitchouk N. Association of Domestic Responsibilities With Career Satisfaction for Physician Mothers in Procedural vs Nonprocedural Fields. JAMA Surg. 2019 Aug 1;154(8):689-695. doi: 10.1001/jamasurg.2019.0529.

  PMID: 30969336 BACKGROUND

• Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.

  PMID: 3651732 BACKGROUND

• Livingston-Rosanoff D, Shubeck SP, Kanters AE, Dossett LA, Minter RM, Wilke LG. Got Milk? Design and Implementation of a Lactation Support Program for Surgeons. Ann Surg. 2019 Jul;270(1):31-32. doi: 10.1097/SLA.0000000000003269. No abstract available.

  PMID: 30921050 BACKGROUND

• Trockel MT, Menon NK, Rowe SG, Stewart MT, Smith R, Lu M, Kim PK, Quinn MA, Lawrence E, Marchalik D, Farley H, Normand P, Felder M, Dudley JC, Shanafelt TD. Assessment of Physician Sleep and Wellness, Burnout, and Clinically Significant Medical Errors. JAMA Netw Open. 2020 Dec 1;3(12):e2028111. doi: 10.1001/jamanetworkopen.2020.28111.

  PMID: 33284339 BACKGROUND

MeSH Terms

Conditions

Burnout, Professional; Psychological Well-Being; Burnout, Psychological; Depression, Postpartum; Breast Feeding

Condition Hierarchy (Ancestors)

Occupational Stress; Occupational Diseases; Stress, Psychological; Behavioral Symptoms; Behavior; Personal Satisfaction; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Feeding Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Surgeon, Assistant Professor of Surgery

Model Details: This study is designed as a prospective randomized open-labeled study. We plan to enroll 152 trainees who are pregnant or immediately post-partum. Participants will undergo stratified randomization to an intervention or no intervention arm in a 1 to 1 ratio based on training specialty (either procedural or non-procedural) and training site (MGH, BWH, BCH, or BIDMC). Procedural specialties are defined as specialties that spend a significant portion of their training performing procedures: this includes all surgical specialties, anesthesiologists, gastroenterologists, obstetricians-gynecologists, interventional-radiologist, interventional-pulmonologists, interventional-cardiologists, emergency physicians. All other training programs are considered non-procedural specialties.

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 28, 2023
• Study Start: May 25, 2023
• Primary Completion: January 25, 2026
• Study Completion: January 25, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)