Parental Support Package for Pregnant Trainees' Wellbeing

Not currently recruiting at 3 trial locations

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Cardiopulmonary, Gastrointestinal, Neurologic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a parental support package designed to assist new trainee mothers by offering mentorship, lactation support, sleep aids, and access to perinatal care. The goal is to determine if these tools and support systems can enhance wellbeing and reduce medical errors among participants. Those currently pregnant and working in residency or fellowship programs at specific hospitals, who will remain clinically active until six months postpartum, are ideal candidates for this study. Participants will either receive the new support package, known as The 4th Trimester Initiative, or continue with the usual support. Researchers will compare their wellbeing, professional satisfaction, and error rates. As an unphased trial, this study provides a unique opportunity to contribute to innovative support systems for new mothers in medical training.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on providing support for new trainee mothers, so it's best to consult with the trial coordinators or your healthcare provider for guidance.

What prior data suggests that this parental support package is safe for new trainee mothers?

Research shows that the components of the parental support package in this trial have been thoroughly studied for safety. The Snoo smart sleep bassinet, an FDA-approved device, improves infant sleep and safety. Many families have used it without serious problems. The Willow wearable breast pump, also FDA-approved, allows for discreet, hands-free pumping and has been widely used safely by mothers.

The Maven Clinic provides 24/7 care for new mothers, crucial for their health and support. This telehealth service is generally safe, offering professional health support whenever needed. Additionally, having a faculty mentor provides professional and emotional support, enhancing overall well-being.

Overall, these supports have been well-received in the past, with no major safety issues reported. This initiative focuses on enhancing support rather than introducing new medical treatments, which increases safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Parental Support Package for Pregnant Trainees' Wellbeing because it offers a comprehensive approach to supporting new parents in medical training. Unlike standard care, which often lacks tailored support, this initiative includes a Snoo smart sleep bassinet to help infants sleep better, a Willow wearable breast pump for convenience and mobility, and 24/7 access to Maven Clinic for perinatal care. Additionally, each participant is paired with a faculty mentor in their department, providing personalized guidance and support. These resources aim to improve wellbeing and balance for pregnant trainees, setting it apart from existing options.

What evidence suggests that this parental support package is effective for improving trainee wellbeing?

This trial will compare the effectiveness of a parental support package with the current standard in the residency training program. Research has shown that the parental support package, provided to participants in the intervention arm, can improve the wellbeing of new trainee mothers. Studies indicate that smart sleep bassinets, such as the Snoo, help babies sleep longer, allowing parents to rest more. Wearable breast pumps, like the Willow, offer convenience and assist mothers in achieving their breastfeeding goals. Access to 24/7 perinatal care, such as that from Maven Clinic, is linked to better health by providing timely support and advice. Mentorship programs have reduced job burnout and increased job satisfaction. Together, these tools aim to reduce tiredness, support breastfeeding, and enhance the overall wellbeing of new mothers. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for pregnant trainees at MGH, BWH, BCH, or BIDMC who will stay clinically active until 6 months after giving birth. It's not for those on research electives or with serious health issues in themselves or their fetus.

Inclusion Criteria

Currently pregnant

Clinically active and will remain clinically active until 6 months postpartum

Part of a residency or fellowship training program at MGH, BWH, BCH, or BIDMC during pregnancy and for 6 months postpartum

Exclusion Criteria

On research elective or dedicated research time from time of enrollment until 6 months postpartum.

I or my fetus have serious heart, lung, stomach, or nerve health issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Pre-Intervention Assessment

Participants complete an electronic pre-intervention assessment survey and are randomized into control or intervention groups

1 week

Intervention

Intervention group receives a Snoo smart sleep bassinet, a Willow wearable breast pump, access to Maven Clinic for 24/7 on-demand perinatal care, and a faculty mentor. Control group receives standard support.

6 months

Daily monitoring with wearable device

Follow-up

Participants are monitored for outcomes such as burnout, professional fulfillment, and medical errors through surveys at various postpartum intervals

12 months

Surveys at 4, 12, 16, 20, 24, and 52 weeks postpartum

What Are the Treatments Tested in This Trial?

Interventions

• The 4th Trimester Initiative

Trial Overview The study tests if a support package including a smart bassinet, wearable breast pump, perinatal care access via Maven Clinic, and faculty mentorship can improve wellbeing and reduce medical errors among new trainee mothers.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 4 Interventions

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

Group II: Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

Boston Children's Hospital

Collaborator

Trials

801

Recruited

5,584,000+

Beth Israel Deaconess Medical Center

Collaborator

Trials

872

Recruited

12,930,000+

Published Research Related to This Trial

A structured parent-to-parent support program can effectively help parents cope with the stress of having a baby in the neonatal intensive care unit (NICU) by providing essential resources and emotional support.

Successful implementation of such a program requires commitment from hospital staff, recruitment and training of volunteer parents, and continuous collaboration between parents and professionals to ensure the program's sustainability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent partners: a parent-to-parent support program in the NICU. Part II: Program implementation. Jarrett, MH.[2004]

The pregnancy program significantly reduced postpartum depression scores in older first-time mothers, indicating improved mental health after participation.

Husbands' awareness of their wives' physical burdens increased after the program, which contributed to better satisfaction with housework support and potentially strengthened marital relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a pregnancy programme to enhance older primiparas' physical and mental health and marital relationships after childbirth: A non-randomized clinical trial. Nakajima, K., Hirose, A., Nameda, T.[2023]

The 'early support' intervention program, Babylotse-Plus, significantly reduced the incidence of depression in mothers facing high psychosocial burdens, with an adjusted odds ratio of 0.25 after 12 months.

Mothers in the intervention group also reported lower stress levels related to their child's demands and improved relationships with their parenting partners, indicating the program's effectiveness in enhancing maternal well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How effective is the early support program Babylotse-Plus for psychosocially burdened mothers and their infants? A comparative intervention study. Klapp, C., Fisch, S., Keller, T., et al.[2022]

A pilot study involving 126 expectant parents found that adding an 'inspirational lecture' to ordinary antenatal classes may improve certain aspects of the birth experience and enhance relationship quality, particularly for partners.

Despite some positive outcomes, both groups reported a decrease in social support during the first 6 months after birth, indicating that more comprehensive support may be needed for new parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the "Inspirational Lecture" in Combination With "Ordinary Antenatal Parental Classes" as Professional Support for Expectant Parents: A Pilot Study as a Randomized Controlled Trial. Thorstensson, S., Ekström-Bergström, A., Bäckström, C.[2021]

Staff in a Mother and Baby Unit found the Baby Triple P Positive Parenting Programme to be an acceptable and feasible intervention for mothers with severe mental illness, based on a study involving 16 staff members using Q-methodology.

The results suggest that mothers in the unit would likely be open to participating in the Baby Triple P programme, indicating potential for broader implementation in similar settings, although further research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of a Positive Parenting Programme on a Mother and Baby Unit: Q-Methodology with Staff. Butler-Coyne, H., Hare, D., Walker, S., et al.[2020]

The 'Growing Together' parenting education kit, developed by the Royal Women's Hospital, aims to improve maternal health and wellbeing by providing comprehensive information to new parents from conception to one year after birth.

This study will evaluate the kit's effectiveness through a cluster randomized controlled trial involving 1000 mothers, measuring outcomes like maternal health using the experience of motherhood questionnaire and assessing parental attachment and infant health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the effect of the 'Growing Together' parenting education kit on early parenting - study protocol for a cluster randomised controlled trial. Shafiei, T., McLachlan, HL., Nicholson, JM., et al.[2020]

Group-based antenatal education programs that focus on building relationships and social support are most effective in helping couples transition to parenthood, according to a review of existing studies.

The Preparation for Birth and Beyond (PBB) program, designed by an Expert Reference Group, incorporates evidence from various fields to enhance parental strengths and motivation, aiming to improve outcomes for both parents and their children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Before we begin. The importance of antenatal education. Nolan, M.[2012]

Citations

1. withpower.com withpower.com/trial/phase-burnout-psychological-4-2023-13750

Parental Support Package for Pregnant Trainees' Wellbeing A structured parent-to-parent support program can effectively help parents cope with the stress of having a baby in the neonatal intensive care unit (NICU) by ...

2. the4thtrimesterinitiative.com the4thtrimesterinitiative.com/

The 4th Trimester Initiative It is designed to address fatigue and lactation challenges while improving mentorship and your ability to take care of yourself and your baby. The study is ...

3. the4thtrimesterinitiative.com the4thtrimesterinitiative.com/study-overview/

Study Overview The 4th Trimester Initiative is a multicenter prospective, randomized trial seeking to improve wellbeing of expectant and new trainee childbearing mothers. We ...

4. childrenshospital.org childrenshospital.org/clinical-trials/nct06014892

NCT06014892 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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7159799/

A Fourth Trimester Action Plan for Wellness - PMC A wellness plan approach to enable expectant mothers/couples to be proactive in preparing for their physical and emotional needs after the arrival of their ...

6. hrsa.gov hrsa.gov/sites/default/files/hrsa/about/hrsa-enhancing-maternal-health-initiative-impact-report.pdf

Enhancing Maternal Health Initiative Healthy Start funding will better support moms and babies to improve health in communities experiencing high disparities in maternal and infant health outcomes.

7. the4thtrimesterinitiative.com the4thtrimesterinitiative.com/wp-content/uploads/2023/02/safe-and-supported.pdf

Safe and Supported Pregnancy Rotating shifts. (combination of day and night work) are associated with 75% increased odds of developing pre-eclampsia, while fixed night shifts and long work ...