Health Care UtilizationNEST-RuralNCT06682520
Evaluation of a Health System Integrated Model for Postpartum Education and Support in Rural Populations
A study testing Postpartum NEST-Rural Program (Hospital based service model) in people with Health Care Utilization, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This study was designed to evaluate the implementation of the Nurse Education and Support Team (NEST) Program for postpartum women who reside in 5 rural counties in North Carolina. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health Care Utilization
- What is being tested?
- Postpartum NEST-Rural Program (Hospital based service model)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,300 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2024to Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women that deliver an infant(s) at The Birth Center at Atrium Health Wake Forest Baptist and currently reside in Davidson, Davie, Stokes, Wilkes or Yadkin County in North Carolina
- Women that delivered an infant(s) at home, were transported to Atrium Health Wake Forest Baptist and received postpartum care at The Birth Center and currently reside in Davidson, Davie, Stokes, Wilkes or Yadkin County in North Carolina
- Ages 18 years or older
Who cannot join
- Women that delivered an infant(s) and did not receive postpartum care at The Birth Center at Atrium Health Wake Forest Baptist.
- Women that currently reside outside of Davidson, Davie, Stokes, Wilkes or Yadkin County in North Carolina
- Under 18 years of age
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
Angie Almond, MEd, 336-713-4524, angie.almond@advocatehealth.org
About this study
Official title: Evaluation of a Health System Integrated Model for Postpartum Education and Support in Rural Populations - NEST-Rural
This study was designed to evaluate the implementation of the Nurse Education and Support Team (NEST) Program for postpartum women who reside in 5 rural counties in North Carolina. Overarching Hypothesis: Mothers and infants residing in rural communities, randomized to the NEST-Rural care model over the 3-year course of the project will: 1. Receive more coordinated care for addressing social, mental and physical health needs. 2. Experience fewer postpartum hospital readmissions and decreased utilization of emergency departments (ED) for healthcare. 3. Experience higher adherence to American College of Obstetricians and Gynecologists (ACOG) and American Academy of Pediatrics (AAP) guidelines for preventive care, including recently updated ongoing postpartum care, serial well-child visits and vaccinations compared to those assigned to usual care. This group will be compared to those assigned to usual care,
Read the detailed description
This is a Randomized Control Trial (RCT) designed study evaluating the implementation of the Nurse Education and Support Team (NEST) Program for postpartum women who reside in 5 rural counties (Davie, Davidson, Yadkin, Wilkes and Stokes counties) in North Carolina. The study cohort will be for all mothers residing in these rural counties and delivering their infant(s) in the Atrium Health Wake Forest Baptist Birth Center. It is anticipated that 1,300 mother-infant dyads will be enrolled and randomized to either usual care [visit 4-6 weeks postpartum] (~650) or NEST-Rural care (~650).
The NEST model is unique in that it supports both maternal and infant health, with an emphasis on using strategies aligned with evidence-based guidelines for postpartum and infant healthcare. Another important feature of NEST is integration of service delivery in the healthcare system. This integration facilitates reaching mother-infant dyads and bi-directional communication with the mother's and infant's healthcare providers to enable appropriate, timely healthcare. For example, as part of NEST, mothers are discharged from the hospital with a remote blood pressure monitor. Blood pressures are transmitted to a service hub through an app that is downloaded onto her phone prior to hospital discharge. The hub alerts the healthcare team, which follows-up with her to determine appropriate care.
Randomization to NEST-Rural services will include 3-5 nurse encounters with mothers and their infants in the postpartum period, postpartum remote blood pressure monitoring, breastfeeding support, infant weight checks, linking mothers and infants to needed social, behavioral, and health-related resources, and integration of service delivery with healthcare providers. Services will initiate in the postpartum hospital unit, with a NEST Coordinator introducing the program and identifying and making referrals and/or providing resources for emergent needs (e.g. pack-n-play, diapers), and offering and scheduling a follow-up nurse visit (home or telehealth-based, depending on needs) 2-3 weeks postpartum. Up to two additional nurse and/or social worker home/virtual visits will be provided, depending on the family's needs. At six weeks postpartum, the NEST Coordinator will contact the family to inquire whether any referrals were made and assess for continuing gaps in support. Following nurse encounters, a note will be sent to the mother's and infant's healthcare providers. If acute concerns are identified, the nurse will contact the provider immediately for additional care.
- Conditions
- Health Care Utilization
- Being tested
- Postpartum NEST-Rural Program (Hospital based service model)
- Keywords
- Remote blood pressure monitoring, Postpartum Nurse home visiting, Postpartum Health Care Services, Postpartum Hospital Program Service Model, Maternal Health, Newborn Health
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postpartum NEST-Rural Program (Hospital based service model)Other
NEST-Rural services will include 3-5 nurse encounters and, if indicated, up to 3 social work encounters with mothers and their infants in the postpartum period, postpartum remote blood pressure monitoring, breastfeeding support, infant weight checks, linking mothers and infants to needed social, behavioral, and health-related resources, and integration of service delivery with healthcare providers.
| Study group | Role | What they receive |
|---|---|---|
| Postpartum NEST-Rural Program Group | Experimental | Postpartum women randomized to this group will receive the usual postpartum care from an Obstetrics provider and the following NEST-Rural Program:
* Information about services and resources available in your community
* A blood pressure monitor.
* Access to the Babyscripts smartphone app.
* A nurse visit(s) at home or via telehealth.
* A visit(s) from a Family Outreach Specialist, if needed.
* A follow-up phone call from a Coordinator in about 6 weeks Receives: Other: Postpartum NEST-Rural Program (Hospital based service model) |
| Postpartum Usual Care Group | No intervention | Postpartum women randomized to this group will receive the usual postpartum care from an Obstetrics provider and the following: * Information about services and resources available in your community * A follow-up phone call from a Coordinator in about 6 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median number of hospital readmissions - Maternal
Number of hospital readmissions in the 4th trimester
Measured: Baseline through 30 days postpartum
Median number of hospital readmissions - Maternal
Number of hospital readmissions in the 4th trimester
Measured: Baseline through 90 days postpartum
Median number of encounters for urgent or emergent care - Maternal
Number of visits to Urgent Care or the Emergency Room in the 4th trimester
Measured: Baseline through 30 days postpartum
Median number of encounters for urgent or emergent care - Maternal
To determine number of visits to Urgent Care or the Emergency Room in the 4th trimester
Measured: Baseline through 90 days postpartum
Proportion of women that attend recommended postpartum visits
Percentage of women that attended recommended visits to their obstetrician after delivery.
Measured: Baseline through 90 days postpartum
Median number of hospital readmissions - Infant
Number of hospital readmissions after birth following hospital discharge.
Measured: Baseline through 30 days postpartum
Median number of hospital readmissions - Infant
Number of hospital readmissions after birth following hospital discharge.
Measured: Baseline through 90 days postpartum
Median number of encounters for urgent or emergent care - Infant
Number of visits to Urgent Care or the Emergency Room following hospital discharge.
Measured: Baseline through 30 days postpartum
Median number of encounters for urgent or emergent care - Infant
Number of visits to Urgent Care or the Emergency Room following hospital discharge.
Measured: Baseline through 90 days postpartum
Proportion of infants receiving a visit with an ambulatory care provider
Percentage of infants that attended recommended visits to their pediatric care provider within 21 days following hospital discharge
Measured: Baseline through 21 days postpartum
Proportion of infants that received >/= 4 well-child care visits with an ambulatory care provider
Percentage of infants that attended recommended visits to their pediatric care provider within the first 9 months following hospital discharge
Measured: Baseline through 274 days postpartum
Secondary outcomes (17)
Median number of days with >/= 1 remote blood pressure obtained - Maternal
Number of days that patients checked and remotely reported their blood pressure readings following hospital discharge.
Measured: Baseline through 21 days postpartum
Proportion of women with a diagnosis of hypertensive disorders of pregnancy with at least one blood pressure obtained
Percentage of women diagnosed with hypertensive disorders that checked and remotely reported at least one blood pressure reading.
Measured: Baseline through 10 days postpartum
Proportion of women with preeclampsia with severe features with at least one blood pressure obtained
Percentage of women with preeclampsia with severe features checked and remotely reported at least one blood pressure reading.
Measured: Baseline through 3 days postpartum
Proportion of women exceeding 3 days length of stay in hospital after delivery
Percentage of women that remain hospitalized for more than 3 days following delivery.
Measured: Baseline through date of hospital discharge
Median length of stay for hospital readmissions after delivery
Number of days mothers are readmitted and remain hospitalized after delivery.
Measured: Baseline through 90 days postpartum
Proportion of women that attend a follow-up encounter with their primary care physician
Percentage of women that have a follow-up visit with their primary care physician within the first year after giving birth.
Measured: Baseline through 365 days postpartum
Proportion of women who receive a nurse home visit
Percentage of women who receive a nurse home visit within 30 days of discharge
Measured: Baseline through 30 days postpartum
Proportion of women eligible for an in-person home visit that received the in-person nurse visit
Percentage of women eligible for an in-person nurse home visit that received the in-person home visit.
Measured: Baseline through 30 days postpartum
Proportion of women eligible for an in-person social work home visit that received the in-person social work visit
Percentage of women eligible for an in-person social work home visit that received the in-person social work visit
Measured: Baseline through 45 days postpartum
Median number of hospital readmissions - Maternal
Number of hospital readmissions within the first 2 years following delivery
Measured: Baseline through 365 days postpartum
Median number of hospital readmissions - Maternal
Number of hospital readmissions within the first 2 years following delivery
Measured: Baseline through 730 days postpartum
Proportion of women scheduled for a mood check provider visit who received a mood check provider visit
Number of women scheduled for a mood check visit and attended their mood check visit within 21 days of discharge after delivery
Measured: Baseline through 21 days postpartum
Proportion of infants that received recommended immunizations
Percentage of infants that received 3 hepatitis B, 2-3 rotavirus (depending on which one is given), 3 diphtheria/tetanus/pertussis, 3 haemophilus influenzae type B, 3 pneumococcal conjugate vaccines, 3 inactivated polio, and 1 flu vaccine within the first 9 months after discharge
Measured: Baseline through Day 274
Proportion of infants exclusively receiving breastmilk at nurse encounter
Percentage of infants exclusively breastfeeding at the time of the nurse home visit within the first 3 weeks after discharge.
Measured: Baseline through Day 21
Proportion of infants receiving any amount of breastmilk at nurse encounter
Percentage of infants receiving any breastmilk at the time of the nurse home visit within the first 3 weeks after discharge
Measured: Baseline through Day 21
Median number of hospital readmissions - Infant
Number of hospital readmissions within the first 2 years following discharge.
Measured: Baseline through day 365
Median number of hospital readmissions - Infant
Number of hospital readmissions within the first 2 years following discharge.
Measured: Baseline through day 730
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start4 Dec 2024
- Primary completionOct 2027 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Care UtilizationStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization to one of two study arms: Postpartum Standard of Care (Control arm). Postpartum NEST-Rural Program Service model (Experimental arm).
- Masking
- None (open label)
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- The Duke Endowment
- Responsible party
- Sponsor
- Investigators
- Elizabeth T. Jensen, MPH PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682520
- Sponsor's protocol ID
- IRB00113575
- Acronym
- NEST-Rural
- Status last verified
- Sep 2026
- First submitted
- 6 Nov 2024
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Health System Integrated Model for Postpartum Education and Support in Rural Populations - NEST-Rural
- ClinicalTrials.gov ID
- NCT06682520
- Acronym / sponsor ID
- NEST-Rural / IRB00113575
- Conditions
- Health Care Utilization
- Keywords
- Remote blood pressure monitoring, Postpartum Nurse home visiting, Postpartum Health Care Services, Postpartum Hospital Program Service Model, Maternal Health, Newborn Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- The Duke Endowment
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 12 Nov 2024 (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 study was designed to evaluate the implementation of the Nurse Education and Support Team (NEST) Program for postpartum women who reside in 5 rural counties in North Carolina. Overarching Hypothesis: Mothers and infants residing in rural communities, randomized to the NEST-Rural care model over the 3-year course of the project will: 1. Receive more coordinated care for addressing social, mental and physical health needs. 2. Experience fewer postpartum hospital readmissions and decreased utilization of emergency departments (ED) for healthcare. 3. Experience higher adherence to American College of Obstetricians and Gynecologists (ACOG) and American Academy of Pediatrics (AAP) guidelines for preventive care, including recently updated ongoing postpartum care, serial well-child visits and vaccinations compared to those assigned to usual care. This group will be compared to those assigned to usual care,
Detailed description
This is a Randomized Control Trial (RCT) designed study evaluating the implementation of the Nurse Education and Support Team (NEST) Program for postpartum women who reside in 5 rural counties (Davie, Davidson, Yadkin, Wilkes and Stokes counties) in North Carolina. The study cohort will be for all mothers residing in these rural counties and delivering their infant(s) in the Atrium Health Wake Forest Baptist Birth Center. It is anticipated that 1,300 mother-infant dyads will be enrolled and randomized to either usual care [visit 4-6 weeks postpartum] (~650) or NEST-Rural care (~650).
The NEST model is unique in that it supports both maternal and infant health, with an emphasis on using strategies aligned with evidence-based guidelines for postpartum and infant healthcare. Another important feature of NEST is integration of service delivery in the healthcare system. This integration facilitates reaching mother-infant dyads and bi-directional communication with the mother's and infant's healthcare providers to enable appropriate, timely healthcare. For example, as part of NEST, mothers are discharged from the hospital with a remote blood pressure monitor. Blood pressures are transmitted to a service hub through an app that is downloaded onto her phone prior to hospital discharge. The hub alerts the healthcare team, which follows-up with her to determine appropriate care.
Randomization to NEST-Rural services will include 3-5 nurse encounters with mothers and their infants in the postpartum period, postpartum remote blood pressure monitoring, breastfeeding support, infant weight checks, linking mothers and infants to needed social, behavioral, and health-related resources, and integration of service delivery with healthcare providers. Services will initiate in the postpartum hospital unit, with a NEST Coordinator introducing the program and identifying and making referrals and/or providing resources for emergent needs (e.g. pack-n-play, diapers), and offering and scheduling a follow-up nurse visit (home or telehealth-based, depending on needs) 2-3 weeks postpartum. Up to two additional nurse and/or social worker home/virtual visits will be provided, depending on the family's needs. At six weeks postpartum, the NEST Coordinator will contact the family to inquire whether any referrals were made and assess for continuing gaps in support. Following nurse encounters, a note will be sent to the mother's and infant's healthcare providers. If acute concerns are identified, the nurse will contact the provider immediately for additional care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization to one of two study arms: Postpartum Standard of Care (Control arm). Postpartum NEST-Rural Program Service model (Experimental arm).
| Arm | Type | Receives |
|---|---|---|
| Postpartum NEST-Rural Program Group | Experimental | Other: Postpartum NEST-Rural Program (Hospital based service model)Postpartum women randomized to this group will receive the usual postpartum care from an Obstetrics provider and the following NEST-Rural Program: * Information about services and resources available in your community * A blood pressure monitor. * Access to the Babyscripts smartphone app. * A nurse visit(s) at home or via telehealth. * A visit(s) from a Family Outreach Specialist, if needed. * A follow-up phone call from a Coordinator in about 6 weeks |
| Postpartum Usual Care Group | No intervention | –Postpartum women randomized to this group will receive the usual postpartum care from an Obstetrics provider and the following: * Information about services and resources available in your community * A follow-up phone call from a Coordinator in about 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women that deliver an infant(s) at The Birth Center at Atrium Health Wake Forest Baptist and currently reside in Davidson, Davie, Stokes, Wilkes or Yadkin County in North Carolina
- Women that delivered an infant(s) at home, were transported to Atrium Health Wake Forest Baptist and received postpartum care at The Birth Center and currently reside in Davidson, Davie, Stokes, Wilkes or Yadkin County in North Carolina
- Ages 18 years or older
Key exclusion criteria (3 listed)
- Women that delivered an infant(s) and did not receive postpartum care at The Birth Center at Atrium Health Wake Forest Baptist.
- Women that currently reside outside of Davidson, Davie, Stokes, Wilkes or Yadkin County in North Carolina
- Under 18 years of age
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 |
|---|---|---|
| Postpartum NEST-Rural Program (Hospital based service model)NEST-Rural services will include 3-5 nurse encounters and, if indicated, up to 3 social work encounters with mothers and their infants in the postpartum period, postpartum remote blood pressure monitoring, breastfeeding support, infant weight checks, linking mothers and infants to needed social, behavioral, and health-related resources, and integration of service delivery with healthcare providers. | Other | Postpartum NEST-Rural Program Group |
Primary outcome
Median number of hospital readmissions - Maternal
Time frame: Baseline through 30 days postpartum
Number of hospital readmissions in the 4th trimester
Median number of hospital readmissions - Maternal
Time frame: Baseline through 90 days postpartum
Number of hospital readmissions in the 4th trimester
Median number of encounters for urgent or emergent care - Maternal
Time frame: Baseline through 30 days postpartum
Number of visits to Urgent Care or the Emergency Room in the 4th trimester
Median number of encounters for urgent or emergent care - Maternal
Time frame: Baseline through 90 days postpartum
To determine number of visits to Urgent Care or the Emergency Room in the 4th trimester
Proportion of women that attend recommended postpartum visits
Time frame: Baseline through 90 days postpartum
Percentage of women that attended recommended visits to their obstetrician after delivery.
Median number of hospital readmissions - Infant
Time frame: Baseline through 30 days postpartum
Number of hospital readmissions after birth following hospital discharge.
Median number of hospital readmissions - Infant
Time frame: Baseline through 90 days postpartum
Number of hospital readmissions after birth following hospital discharge.
Median number of encounters for urgent or emergent care - Infant
Time frame: Baseline through 30 days postpartum
Number of visits to Urgent Care or the Emergency Room following hospital discharge.
Median number of encounters for urgent or emergent care - Infant
Time frame: Baseline through 90 days postpartum
Number of visits to Urgent Care or the Emergency Room following hospital discharge.
Proportion of infants receiving a visit with an ambulatory care provider
Time frame: Baseline through 21 days postpartum
Percentage of infants that attended recommended visits to their pediatric care provider within 21 days following hospital discharge
Proportion of infants that received >/= 4 well-child care visits with an ambulatory care provider
Time frame: Baseline through 274 days postpartum
Percentage of infants that attended recommended visits to their pediatric care provider within the first 9 months following hospital discharge
17 secondary outcomes
Median number of days with >/= 1 remote blood pressure obtained - Maternal
Time frame: Baseline through 21 days postpartum
Proportion of women with a diagnosis of hypertensive disorders of pregnancy with at least one blood pressure obtained
Time frame: Baseline through 10 days postpartum
Proportion of women with preeclampsia with severe features with at least one blood pressure obtained
Time frame: Baseline through 3 days postpartum
Proportion of women exceeding 3 days length of stay in hospital after delivery
Time frame: Baseline through date of hospital discharge
Median length of stay for hospital readmissions after delivery
Time frame: Baseline through 90 days postpartum
Proportion of women that attend a follow-up encounter with their primary care physician
Time frame: Baseline through 365 days postpartum
Proportion of women who receive a nurse home visit
Time frame: Baseline through 30 days postpartum
Proportion of women eligible for an in-person home visit that received the in-person nurse visit
Time frame: Baseline through 30 days postpartum
Proportion of women eligible for an in-person social work home visit that received the in-person social work visit
Time frame: Baseline through 45 days postpartum
Median number of hospital readmissions - Maternal
Time frame: Baseline through 365 days postpartum
Median number of hospital readmissions - Maternal
Time frame: Baseline through 730 days postpartum
Proportion of women scheduled for a mood check provider visit who received a mood check provider visit
Time frame: Baseline through 21 days postpartum
Proportion of infants that received recommended immunizations
Time frame: Baseline through Day 274
Proportion of infants exclusively receiving breastmilk at nurse encounter
Time frame: Baseline through Day 21
Proportion of infants receiving any amount of breastmilk at nurse encounter
Time frame: Baseline through Day 21
Median number of hospital readmissions - Infant
Time frame: Baseline through day 365
Median number of hospital readmissions - Infant
Time frame: Baseline through day 730
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- 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.
Elizabeth T. Jensen, MPH PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postpartum NEST-Rural Program (Hospital based service model) in people with Health Care Utilization, run by Wake Forest University Health Sciences 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 3 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: looking for participants now, as of the sponsor's last update on 28 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth T. Jensen, MPH PhD (336-713-3132, elizabeth.jensen@wfusm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median number of hospital readmissions - Maternal (time frame: Baseline through 30 days postpartum). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2026.