Doula Support for Postpartum Care
(PeliCaN Trial)
Recruiting in Palo Alto (17 mi)
Overseen byHeather 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.12345
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.14678
How is Doula Support different from other postpartum treatments?
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
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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
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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 OverviewThe 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
2Treatment groups
Experimental Treatment
Active Control
Group I: Doula InterventionExperimental Treatment1 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: ControlActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Hospital of the University of PennsylvaniaPhiladelphia, PA
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Who Is Running the Clinical Trial?
University of PennsylvaniaLead Sponsor
References
Hospital-based maternity care practitioners' perceptions of doulas. [2020]A birth doula provides continuous informational, physical, and emotional support during pregnancy, labor, and immediately postpartum. Existing data on the benefits of doulas, especially for low-resource, high-need patients, do not address how and why individual practitioners decide to recommend this model of care. This project aims to describe best practices of integrating doulas into hospital-based maternity care teams to facilitate access to this evidence-based service for improving maternal health outcomes.
Postpartum doulas: motivations and perceptions of practice. [2023]To describe the perceptions of a US cohort of experienced birth doulas who were among the first in the country to be trained to provide postpartum support.
What, when, and how long? Doula time use in a community doula program in San Francisco, California. [2023]Community doulas, who provide culturally concordant, nonclinical support during and after pregnancy, are increasingly promoted as an evidence-based intervention to advance birth equity. As valued members of their communities, community doulas often provide extensive physical and emotional pregnancy, birth, and postpartum support at low or no cost to clients. However, neither community doulas' scope of work nor the distribution of time among their different work activities has been clearly defined or enumerated; therefore, this project sought to describe the work activities and time use of doulas in one community-based doula organization.
Doula Care: A Review of Outcomes and Impact on Birth Experience. [2023]Doulas are trained professionals that provide comprehensive support during the perinatal period. Doula-supported care is associated with improved maternal and infant outcomes including decreased preterm birth, increased breastfeeding initiation, and higher patient satisfaction. In addition, research suggests that doula support is a promising strategy to mitigate racial disparities in maternal and infant health outcomes.
Female relatives or friends trained as labor doulas: outcomes at 6 to 8 weeks postpartum. [2015]Data collected on more than 12,000 women in 15 randomized controlled trials provide robust evidence of the beneficial effects of doula support on medical outcomes to childbirth. The objective of this paper was to examine the association between doula support and maternal perceptions of the infant, self, and support from others at 6 to 8 weeks postpartum. The doula was a minimally trained close female relative or friend.
Continuous female companionship during childbirth: a crucial resource in times of stress or calm. [2014]Continuous support by a lay woman during labor and delivery facilitates birth, enhances the mother's memory of the experience, strengthens mother-infant bonding, increases breastfeeding success, and significantly reduces many forms of medical intervention, including cesarean delivery and the use of analgesia, anesthesia, vacuum extraction, and forceps. The contribution of doula care has become increasingly available in industrial countries and is beginning to be adopted in hospitals in underdeveloped countries. Research continues to demonstrate the far-reaching value of supportive companionship as a corollary to professional health care during birth. Mothers who are at risk because of medical or social factors and those delivering in situations of stress, including disasters, can benefit greatly from labor support.
Early Postpartum Support in the Home: A Vital Link to Healthy and Safe Postpartum Recovery in the United States. [2023]Many newly postpartum women and birthing people are sent home from the hospital with their newborn babies, ill-prepared to care for themselves with little to no capacity to learn about newborn care and parenting. Women are often left to fend for themselves in the "black hole" of health care in 6 weeks post-birth that the United States calls postpartum care. Postpartum doulas can be the first line of defense, helping people identify potential postpartum physical and mental health issues, and in many places, they are doing it on the front lines and in the homes of newly postpartum women and families. In this guest opinion piece, the author discusses her personal experience with birth and how it led her to become an advocate for postpartum doulas.
The obstetrical and postpartum benefits of continuous support during childbirth. [2007]The purpose of this article is to review the evidence regarding the effectiveness of continuous support provided by a trained laywoman (doula) during childbirth on obstetrical and postpartum outcomes. Twelve individual randomized trials have compared obstetrical and postpartum outcomes between doula-supported women and women who did not receive doula support during childbirth. Three meta-analyses, which used different approaches, have been performed on the results of the clinical trials. Emotional and physical support significantly shortens labor and decreases the need for cesarean deliveries, forceps and vacuum extraction, oxytocin augmentation, and analgesia. Doula-supported mothers also rate childbirth as less difficult and painful than do women not supported by a doula. Labor support by fathers does not appear to produce similar obstetrical benefits. Eight of the 12 trials report early or late psychosocial benefits of doula support. Early benefits include reductions in state anxiety scores, positive feelings about the birth experience, and increased rates of breastfeeding initiation. Later postpartum benefits include decreased symptoms of depression, improved self-esteem, exclusive breastfeeding, and increased sensitivity of the mother to her child's needs. The results of these 12 trials strongly suggest that doula support is an essential component of childbirth. A thorough reorganization of current birth practices is in order to ensure that every woman has access to continuous emotional and physical support during labor.
Women's Perceptions of Their Doula Support. [2020]The pilot qualitative study presented in this article explored women's perceptions of the doula support they received in the perinatal period, with the aim of describing details of their experiences. Study participants were 12 women who had hospital births with the support of a certified doula. In-depth interviews were conducted postpartum with all 12 participants. Interview topics included specific categories and aspects of doula support and whether participants would use and/or recommend doulas in the future. Transcripts were analyzed using content analysis. Emerging themes included support for husbands, tailored approaches, reassurance and encouragement, fulfillment of the women's desire for support from an experienced woman, and praise for the doula. The findings suggest that the doulas were beneficial in multiple areas for their clients.
Domains of postpartum doula care and maternal responsiveness and competence. [2018]To describe the domains of postpartum doula care and illustrate how doulas facilitate development of maternal responsiveness and competence.