Postpartum PeriodPeliCaNNCT05510284
Post-partum Care in the NICU
A study testing Doula-coordinated, midwife-delivered postpartum care in people with Postpartum Period, run by University of Pennsylvania at 1 site in United States.
Trial summary
This is a pilot randomized control trial to demonstrate the feasibility of a novel model of dyad-centered, doula-coordinated, midwife-delivered postpartum care located in the NICU in a large urban hospital. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postpartum Period
- What is being tested?
- Doula-coordinated, midwife-delivered postpartum care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2022to 14 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Preterm birth <34 weeks
- Signed medical record release form
Who cannot join
- Unable to read or sign informed consent
- If the medical team believes that the infant may die or be transferred to another hospital in upcoming weeks
- PI Discretion
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
This is a pilot randomized control trial to demonstrate the feasibility of a novel model of dyad-centered, doula-coordinated, midwife-delivered postpartum care located in the NICU in a large urban hospital.
- Conditions
- Postpartum Period
- Being tested
- Doula-coordinated, midwife-delivered postpartum care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doula-coordinated, midwife-delivered postpartum careOther
A doula will coordinate all postpartum care and provide support to the participant. A midwife will be available on-site in the NICU to provide postpartum care.
| Study group | Role | What they receive |
|---|---|---|
| Doula Coordinated-Care Arm | Active comparator | 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. Receives: Other: Doula-coordinated, midwife-delivered postpartum care |
| Standard Postpartum Care Arm | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to receipt of postpartum care
To be analyzed using a wilcoxin rank sum test
Measured: birth until 6 weeks post-partum
Secondary outcomes (3)
Comparison of effectiveness of intervention for mothers with public vs private insurance
Time to receipt of postpartum care will be compared between mothers with public vs private insurance
Measured: birth until 6 weeks post-partum
Comparison of effectiveness of intervention for mothers with infants less than 29 weeks gestational age vs those 29 weeks or older.
Time to receipt of postpartum care will be compared between mothers with infants with a gestational age of less than or equal to 28 6/7 weeks vs a gestational age greater than or equal to 29 weeks
Measured: birth until 6 weeks post-partum
Receipt of Postpartum care
Binary (yes/no), fishers exact test
Measured: birth until 6 weeks post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start29 Nov 2022
- Primary completion14 May 2024
- Study completion14 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum PeriodStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Burris, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510284
- Sponsor's protocol ID
- 851606
- Acronym
- PeliCaN
- Status last verified
- Jul 2024
- First submitted
- 17 Aug 2022
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zafman KB, Darden N, Walker L, Power M, Ledyard R, Kornfield SL, Shanmugan S, Durnwald C, Burris HH. Six-month mental health outcomes among participants in a postpartum care in the NICU (PeliCaN) trial: secondary analysis of a randomized controlled trial. Matern Health Neonatol Perinatol. 2026 Sep 24;12(1):54. doi: 10.1186/s40748-026-00303-5.
PubMed 42786527
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-partum Care in the NICU
- ClinicalTrials.gov ID
- NCT05510284
- Acronym / sponsor ID
- PeliCaN / 851606
- Conditions
- Postpartum Period
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 14 May 2024 (actual)
- Study completion
- 14 May 2024 (actual)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot randomized control trial to demonstrate the feasibility of a novel model of dyad-centered, doula-coordinated, midwife-delivered postpartum care located in the NICU in a large urban hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doula Coordinated-Care Arm | Active comparator | Other: Doula-coordinated, midwife-delivered postpartum carePostpartum 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. |
| Standard Postpartum Care Arm | No 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Preterm birth <34 weeks
- Signed medical record release form
Key exclusion criteria (3 listed)
- Unable to read or sign informed consent
- If the medical team believes that the infant may die or be transferred to another hospital in upcoming weeks
- PI Discretion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doula-coordinated, midwife-delivered postpartum careA doula will coordinate all postpartum care and provide support to the participant. A midwife will be available on-site in the NICU to provide postpartum care. | Other | Doula Coordinated-Care Arm |
Primary outcome
Time to receipt of postpartum care
Time frame: birth until 6 weeks post-partum
To be analyzed using a wilcoxin rank sum test
3 secondary outcomes
Comparison of effectiveness of intervention for mothers with public vs private insurance
Time frame: birth until 6 weeks post-partum
Comparison of effectiveness of intervention for mothers with infants less than 29 weeks gestational age vs those 29 weeks or older.
Time frame: birth until 6 weeks post-partum
Receipt of Postpartum care
Time frame: birth until 6 weeks post-partum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Derived from this study: PubMed 42786527Zafman KB, Darden N, Walker L, Power M, Ledyard R, Kornfield SL, Shanmugan S, Durnwald C, Burris HH. Six-month mental health outcomes among participants in a postpartum care in the NICU (PeliCaN) trial: secondary analysis of a randomized controlled trial. Matern Health Neonatol Perinatol. 2026 Sep 24;12(1):54. doi: 10.1186/s40748-026-00303-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doula-coordinated, midwife-delivered postpartum care in people with Postpartum Period, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to receipt of postpartum care (time frame: birth until 6 weeks post-partum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05510284, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.