Doula Support for Postpartum Care

(PeliCaN Trial)

Overseen By Niesha Darden

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Under 16, Unable to consent, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how doula support can assist mothers with newborns in a neonatal intensive care unit (NICU), particularly in high-risk situations. It will compare usual care with additional support from doulas, who are trained to assist new parents both in the hospital and at home. The trial seeks English-speaking mothers who gave birth at the Hospital of the University of Pennsylvania to preterm infants (born before 34 weeks). Participants should be prepared to engage in postpartum care after leaving the NICU. As an unphased trial, this study offers a unique opportunity for mothers to receive additional support and contribute to research that could enhance care for future families.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this doula support model is safe for postpartum care?

Research has shown that having a doula can lead to better outcomes for new parents and their babies. Studies have found that doulas enhance the birth experience, although further research continues. Importantly, no studies have reported safety concerns or harmful effects from having a doula. Doulas provide emotional and physical support, which many find helpful during and after childbirth. Overall, doula support is considered safe and well-received by those who choose it. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about doula support for postpartum care because it offers a personalized, continuous support system that is not typically part of standard postpartum care. Unlike the usual care, which often ends after hospital discharge, this approach includes a warm handoff to a community doula, ensuring ongoing support and care coordination. This method is particularly beneficial for mothers with infants in the NICU, as it helps bridge the gap between hospital and home care, potentially improving both mental and medical health outcomes for new mothers.

What evidence suggests that doula support is effective for postpartum care?

This trial will compare usual postpartum care with an intervention involving doula support. Studies have shown that having a doula can lead to better outcomes for both mothers and babies. Research indicates that doulas can lower the chances of needing a cesarean section and can help make labor shorter. One study found that doula care is linked to fewer early births and less pain during delivery. Additionally, evidence suggests that doulas help organize care, which can be especially helpful for new mothers after they leave the hospital with their babies. Overall, while more research could be beneficial, early findings suggest doulas make a positive difference in care after childbirth. ^{1 2 6 7 8}

Who Is on the Research Team?

Heather Burris, MD MPH

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for new mothers experiencing postpartum depression, anxiety, or PTSD after giving birth prematurely. Participants should be from a high-risk, low-income background and will receive care in the NICU of the Hospital of the University of Pennsylvania.

Inclusion Criteria

Infant born at HUP

Preterm birth <34 weeks

English language speaking

Exclusion Criteria

Unable to read or sign informed consent

Parents of infants transferred into HUP NICU

If the medical team believes that the infant may not live or be transferred to another hospital in upcoming weeks

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive doula support and healthcare coordination in the NICU, with a warm handoff to a community doula for continued support post-discharge

6 months

Follow-up

Participants are monitored for PTSD and depression symptoms, and attendance with a primary care provider is assessed

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Doula Support

Trial Overview

The study tests a support program involving doulas (trained companions for new mothers) who provide emotional and practical support during and after NICU stay. It's randomized, meaning by chance some get doula support while others don't.

How Is the Trial Designed?

Group I: Doula Intervention Experimental Treatment 1 Intervention

Participants randomized to the intervention will be offered doula support including care coordination to mental and medical health services in the neonatal intensive care unit (NICU), with a warm handoff to a community doula to continue the support once infants leave the Hospital of the University of Pennsylvania (HUP) NICU.

Group II: Control Active Control 1 Intervention

Participants randomized to usual care will get the same care they normally would with their own provider, outside of research enrollment, and receive a resource guide with information about the importance of postpartum follow-up care.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

Postpartum doulas provide comprehensive support across 11 domains, including emotional support, infant care, and household organization, which help new mothers develop responsiveness and competence in caring for their infants.

The study highlights that emotional support is a key component that enhances other areas of care, particularly in resolving infant feeding issues and integrating the infant into the family, ultimately fostering better attachment and developmental care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Domains of postpartum doula care and maternal responsiveness and competence. McComish, JF., Visger, JM.[2018]

Postpartum doulas play a crucial role in supporting new mothers and families during the transition to parenthood, emphasizing empowerment and understanding the mother's perspective.

The study highlights the importance of postpartum doulas in filling care gaps after hospital discharge, suggesting that their integration into maternal care can enhance support for new families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postpartum doulas: motivations and perceptions of practice. Campbell-Voytal, K., Fry McComish, J., Visger, JM., et al.[2023]

Continuous support from a lay woman, or doula, during labor and delivery significantly reduces the need for medical interventions such as cesarean sections and the use of pain relief methods.

Doula care enhances the overall birth experience for mothers, improving their memory of the event, strengthening mother-infant bonding, and increasing the likelihood of successful breastfeeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous female companionship during childbirth: a crucial resource in times of stress or calm. Pascali-Bonaro, D., Kroeger, M.[2014]

Continuous support from a trained doula during childbirth significantly shortens labor and reduces the need for interventions like cesarean deliveries and pain relief, based on evidence from 12 randomized trials.

Doula support not only improves immediate childbirth experiences but also leads to long-term benefits such as reduced postpartum depression and increased breastfeeding rates, highlighting the importance of emotional and physical support during labor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The obstetrical and postpartum benefits of continuous support during childbirth. Scott, KD., Klaus, PH., Klaus, MH.[2007]

Doulas provide essential support during the perinatal period, leading to improved outcomes such as decreased preterm births and increased rates of breastfeeding initiation, based on a review of 34 articles.

Doula support is particularly beneficial for Black patients, showing promise in reducing racial disparities in maternal and infant health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Doula Care: A Review of Outcomes and Impact on Birth Experience. Ramey-Collier, K., Jackson, M., Malloy, A., et al.[2023]

Many new mothers leave the hospital unprepared for postpartum care, often facing a lack of support during the critical 6-week period after childbirth in the U.S.

Postpartum doulas play a vital role in providing support and identifying health issues for new mothers, helping them navigate the challenges of early parenthood and improve their overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Postpartum Support in the Home: A Vital Link to Healthy and Safe Postpartum Recovery in the United States. Graves, J.[2023]

In a study involving 600 low-risk first-time mothers, those who received doula support reported more positive feelings about childbirth, their infants, and their own self-worth compared to those who received standard care.

Doula-supported mothers were more likely to breastfeed and expressed higher satisfaction with their hospital care, suggesting that having a supportive friend or relative during labor can significantly enhance postpartum well-being at a low cost.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Female relatives or friends trained as labor doulas: outcomes at 6 to 8 weeks postpartum. Campbell, D., Scott, KD., Klaus, MH., et al.[2015]

In a pilot study involving 12 women who received doula support during hospital births, participants reported that doulas provided significant emotional and practical support, enhancing their overall birthing experience.

Key themes from the interviews included the doulas' ability to offer reassurance, encouragement, and tailored support, which fulfilled the women's desire for guidance from an experienced individual, indicating the positive impact of doula support in the perinatal period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Women's Perceptions of Their Doula Support. Koumouitzes-Douvia, J., Carr, CA.[2020]

Community doulas at SisterWeb San Francisco spend about half of their time providing direct client care, but they also dedicate significant time (2.15 hours for every hour of direct care) to communication and support activities, highlighting their extensive role in pregnancy and postpartum support.

The study emphasizes the need for recognition and appropriate compensation for the diverse activities community doulas engage in, as this is crucial for promoting health equity in maternal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What, when, and how long? Doula time use in a community doula program in San Francisco, California. Arcara, J., Cuentos, A., Abdallah, O., et al.[2023]

A study involving 47 maternity care practitioners revealed that while many support the role of doulas in providing emotional and physical support during childbirth, there are mixed feelings about their integration into hospital teams, often due to cultural differences between traditional medical practices and natural birth philosophies.

To improve collaboration between doulas and hospital staff, it is essential to provide training on the doula model of care, clearly define roles, and foster mutual respect, which can enhance maternal health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospital-based maternity care practitioners' perceptions of doulas. Neel, K., Goldman, R., Marte, D., et al.[2020]

Citations

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The purpose of this review is to characterize the research on doula utilization among birthing people of color, identify gaps in the field, and provide ...

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Postpartum Care in the NICU (PeliCaN) Transitions

This is a randomized controlled trial of a dyad-centered, doula support and healthcare coordination model of care in a large urban neonatal intensive care unit ...