What is the mechanism of action of this treatment?

The Dyad-Centered, Doula-Coordinated, Midwife-Delivered Postpartum Care model integrates emotional, physical, and clinical support to enhance postpartum recovery. Doulas provide continuous emotional and physical support, reducing stress and improving maternal outcomes. Midwives offer clinical expertise, ensuring medical needs are met and promoting natural recovery processes. This holistic approach addresses both psychological and physiological aspects, crucial for the well-being of both mother and child.

What side effects are associated with this type of intervention?

Common treatments for postpartum care, such as those involving integrated support and clinical expertise like dyad-centered, doula-coordinated, midwife-delivered care, generally have minimal side effects. Emotional support and counseling can occasionally lead to emotional discomfort as sensitive topics are discussed. Lactation consulting may sometimes result in temporary nipple pain or discomfort as breastfeeding techniques are adjusted. Physical recovery exercises are usually safe but can lead to mild soreness or fatigue as the body heals. Overall, these treatments are designed to be supportive and have a low risk of adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for postpartum conditions, particularly focusing on postpartum depression. Notably, brexanolone (marketed as Zulresso) was approved in 2019 as the first drug specifically for postpartum depression. Additionally, selective serotonin reuptake inhibitors (SSRIs) like sertraline and fluoxetine are commonly prescribed for postpartum depression. While there are no specific FDA approvals for integrated care models like dyad-centered, doula-coordinated, midwife-delivered postpartum care, these treatments are often part of a broader, multidisciplinary approach to postpartum care.

What other types of research exist?

Promising alternatives to Dyad-Centered, Doula-Coordinated, Midwife-Delivered Postpartum Care include: 1) Telehealth-based postpartum care, which provides remote monitoring and support through virtual consultations with healthcare providers. 2) Community-based postpartum care programs that involve home visits by trained healthcare professionals to offer personalized care and support. 3) Integrated postpartum care models that combine obstetric and pediatric care, ensuring continuous and coordinated care for both mother and baby. 4) Group-based postpartum care, where new mothers receive support and education in a group setting, fostering community and shared experiences.

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Postpartum Care in the NICU (PeliCaN Trial)

N/A

Waitlist Available

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months postpartum

Awards & highlights

Summary

This trial tests a new postpartum care model where a doula and a midwife work together to support mothers and their babies in the NICU. The doula offers emotional and practical help, while the midwife provides medical care. This approach aims to enhance the health and well-being of both mother and baby during their critical time in the NICU.

Who is the study for?

This trial is for mothers who have given birth prematurely (before 34 weeks) and are in the NICU of a large urban hospital. They must be able to sign a medical record release form. Mothers cannot participate if they can't read or consent to the study, or if their baby might pass away or be moved to another hospital soon.

What is being tested?

The trial is testing a new way of caring for mother-baby pairs after birth with services coordinated by doulas and delivered by midwives right in the NICU. It's designed to see how well this approach works in a real-world setting.

What are the potential side effects?

Since this intervention involves non-medical support, there may not be direct side effects like those seen with medications; however, emotional distress or dissatisfaction with care could potentially occur.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months postpartum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to receipt of postpartum care

Secondary study objectives

Comparison of effectiveness of intervention for mothers with infants less than 29 weeks gestational age vs those 29 weeks or older.

Comparison of effectiveness of intervention for mothers with public vs private insurance

Receipt of Postpartum care

Other study objectives

Breastfeeding- age at stopping breastmilk

Breastfeeding- ever

Breastfeeding- length of time exclusive breastmilk

+6 more

Trial Design

2Treatment groups

Active Control

Group I: Standard Postpartum Care ArmActive Control1 Intervention

In this arm participants will receive usual postpartum care. They will be discharged from the hospital while their baby is still in the NICU and a plan will be made to for follow-up with their provider as an outpatient at some point in the next 6 weeks. The study coordinator will provide the participant with a community postpartum resources list.

Group II: Doula Coordinated-Care ArmActive Control1 Intervention

Postpartum care will be doula-coordinated. The doula will meet with the mother at least once a week during their infant's NICU stay, with a minimum of 3 meetings. Participants will be given the option of seeing the study nurse midwife or their own provider. If the participant opts to see the nurse midwife, they can meet in a private office located in the NICU. The doula, as typical of the doula role, will coordinate any needed community services in the transition to home.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Dyad-Centered, Doula-Coordinated, Midwife-Delivered Postpartum Care model integrates emotional, physical, and clinical support to enhance postpartum recovery. Doulas provide continuous emotional and physical support, reducing stress and improving maternal outcomes. Midwives offer clinical expertise, ensuring medical needs are met and promoting natural recovery processes. This holistic approach addresses both psychological and physiological aspects, crucial for the well-being of both mother and child.

Woman-centred care: An integrative review of the empirical literature.The ARRIVE Trial: Interpretation from an Epidemiologic Perspective.

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,053 Previous Clinical Trials

43,013,090 Total Patients Enrolled

Media Library

Doula-coordinated, midwife-delivered postpartum care Clinical Trial Eligibility Overview. Trial Name: NCT05510284 — N/A

Postpartum Research Study Groups: Standard Postpartum Care Arm, Doula Coordinated-Care Arm

Postpartum Clinical Trial 2023: Doula-coordinated, midwife-delivered postpartum care Highlights & Side Effects. Trial Name: NCT05510284 — N/A

Doula-coordinated, midwife-delivered postpartum care 2023 Treatment Timeline for Medical Study. Trial Name: NCT05510284 — N/A

~13 spots leftby Sep 2025

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