Doula Support for Postpartum Care

(PeliCaN Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Heather Burris, MD MPH

Age: Any Age

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Pennsylvania

Disqualifiers: Under 16, Unable to consent, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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 (NICU), which serves a high-risk, low-income, majority Black population. In addition to doula support and coordination of care in the NICU, there will be a warm handoff to a community doula to continue the support once infants leave the Hospital of the University of Pennsylvania (HUP) NICU.

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 data supports the effectiveness of the treatment Doula Support for Postpartum Care?

Research shows that doula support during the perinatal period (the time shortly before and after birth) is linked to better outcomes for mothers and babies, such as fewer early births, more mothers starting to breastfeed, and higher satisfaction with the birth experience. Doulas also help reduce health differences among different racial groups, making them a valuable support for new mothers. ^{1 2 3 4 5}

Is doula support safe for postpartum care?

Research shows that doula support is generally safe and beneficial for mothers and infants, improving outcomes like reduced medical interventions and increased breastfeeding success. Doulas provide emotional and physical support, which can lead to a more positive birth experience and better postpartum recovery. ^{1 4 6 7 8}

How is Doula Support different from other postpartum treatments?

Doula Support is unique because it provides personalized, nonclinical support from an experienced woman during and after childbirth, focusing on emotional and physical assistance, which is not typically offered by standard medical postpartum care. ^{2 3 7 9 10}

Research Team

Heather Burris, MD MPH

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Doula Support (Behavioural Intervention)

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.

Participant Groups

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+

Dr. Joan Lau

University of Pennsylvania

Chief Executive Officer since 2020

PhD in Neuroscience from the University of Cincinnati College of Medicine, MBA from the Wharton School of Business, BS in Bioengineering from the University of Pennsylvania

Dr. Robert Iannone

University of Pennsylvania

Chief Medical Officer since 2019

MD from Yale University, MSCE from the University of Pennsylvania

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Hospital-based maternity care practitioners' perceptions of doulas. [2020]

2. Scotland pubmed.ncbi.nlm.nih.gov

Postpartum doulas: motivations and perceptions of practice. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

What, when, and how long? Doula time use in a community doula program in San Francisco, California. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Doula Care: A Review of Outcomes and Impact on Birth Experience. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Female relatives or friends trained as labor doulas: outcomes at 6 to 8 weeks postpartum. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Continuous female companionship during childbirth: a crucial resource in times of stress or calm. [2014]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

The obstetrical and postpartum benefits of continuous support during childbirth. [2007]

9. United States pubmed.ncbi.nlm.nih.gov

Women's Perceptions of Their Doula Support. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Domains of postpartum doula care and maternal responsiveness and competence. [2018]