Postpartum HealthNNM2NCT03922334
Navigating New Motherhood 2
A study testing Patient Navigation Program in people with Postpartum Health and Breastfeeding, run by Northwestern University at 1 site in United States.
Trial summary
The primary aim of this study is to determine whether implementation of a postpartum patient navigation program improves health outcomes among low-income women. Patient navigation is a barrier focused, long-term patient-centered intervention that offers support for a defined set of health services. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Health, Breastfeeding, Contraception
- What is being tested?
- Patient Navigation Program
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2020to 31 Dec 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 16 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant (any plurality) delivering at or after 20 weeks of gestation OR postpartum (during hospitalization), regardless of perinatal outcome
- 16 years or older
- Low-income socioeconomic status (publicly funded prenatal care)
- Ability to speak and read English or Spanish
- Established patient at the Northwestern Medicine Prentice Ambulatory Care clinical site (at least one antenatal clinical visit).
Who cannot join
- Intent to transfer care to an outside institution
- HIV (as these patients already receive intensive social support and navigation-like services at this institution)
- Prior pregnancy in which individual declined participation
- Prior enrollment in NNM2
- Enrollment in a concurrent research study that poses a potential conflict to the aims of either NNM2 or the other study
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: Navigating New Motherhood 2: Patient Navigation to Improve Outcomes Among Low-income Women in the Postpartum Period
The primary aim of this study is to determine whether implementation of a postpartum patient navigation program improves health outcomes among low-income women. Patient navigation is a barrier focused, long-term patient-centered intervention that offers support for a defined set of health services. The intervention under investigation is a comprehensive postpartum patient navigator program. Women who are randomized to receive patient navigation will be compared to women who are randomized to receive usual care. Navigators will support women through one year postpartum. The NNM2 program will be grounded in understanding and addressing social determinants of health in order to promote self-efficacy, enhance access, and sustain long-term engagement. Participants will undergo surveys, interviews, and medical record review at 4-12 weeks and 11-13 months postpartum. The investigators will additionally conduct focus groups and surveys with clinical providers.
Read the detailed description
The postpartum period - often called the "fourth trimester" - is a time of rapid and intense change in the life of a woman and her family, and uptake of health care during this transition is critical to optimizing women's long-term health and the health of their subsequent pregnancies. The importance of postpartum care has been reinforced by professional organizations, yet postpartum care in the United States remains inadequate. Substantial racial/ethnic and socioeconomic disparities in health care uptake, quality, and outcomes exist. Improving health for all women requires the development of new, more comprehensive approaches to postpartum and interconceptional care. One potential model may be patient navigation, which is a barrier-focused, longitudinal, patient-centered intervention that offers support for a defined set of health services.
This protocol is to evaluate whether implementation of a postpartum patient navigation program improves health outcomes among low-income women. The investigators previously developed a postpartum patient navigation program, called Navigating New Motherhood (NNM), which introduced a clinic-level intervention in which a patient navigator assumed postpartum supportive and logistical responsibilities for low-income women. Navigation was associated with improvements in outcomes (retention in care, contraception uptake, vaccination, and depression screening) compared to those of a historical cohort. The investigators now propose to test the efficacy of the updated NNM model - called "NNM2" - via a randomized trial. The study will randomize 400 pregnant or postpartum women (1:1) with publicly-funded prenatal care to NNM2 versus usual care. Women randomized to navigation will be provided intensive, individualized, one-on-one navigation services through 12 weeks postpartum and, based on individual needs, ongoing, tapered navigation through one year postpartum. The NNM2 program will be grounded in understanding and addressing social determinants of health in order to promote self-efficacy, enhance access, and sustain long-term engagement. Participants will undergo surveys, interviews, and medical record review at 4-12 weeks and 11-13 months postpartum.
Aim 1 will evaluate whether the navigation program improves clinical outcomes at 4-12 weeks postpartum as measured via a composite of health status that includes retention in care, receipt of recommended counseling ("anticipatory guidance"), receipt of desired family planning method, postpartum depression screening/care, breastfeeding initiation/maintenance, and receipt of indicated vaccinations. Sub-Aims will include investigation of relevant outcomes at 11-13 months postpartum. Aim 2 will evaluate whether NNM2 improves patient-reported outcomes. Aim 3 additionally involves examining obstetric and primary care provider perspectives on the navigation program and on optimizing the postpartum transition. Completion of this study will fill an evidence gap by demonstrating whether postpartum patient navigation is an effective mechanism to improve women's short- and long-term health, enhance health care utilization, and improve patient and provider satisfaction.
NNM2 suspended enrollment due to COVID-19 beginning March 16, 2020. For already enrolled individuals, study visits and patient navigation activities were converted to tele-research and tele-navigation. Recruitment was planned to resume when the COVID-19 pandemic resolves and normal outpatient care has resumed. For individuals already recruited and whose care occurred during the early phases of the pandemic, the outcomes definitions were appropriately modified for the conduct of telemedicine during the pandemic. Recruitment resumed on June 8, 2020, with continued use of telemedicine or tele-research when appropriate. Given the ongoing pandemic, the modified outcomes definitions for telemedicine provision of care were retained.
- Conditions
- Postpartum Health, Breastfeeding, Contraception, Preventive Care / Anticipatory Guidance, Retention in Care
- Being tested
- Patient Navigation Program
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Navigation ProgramBehavioural
A postpartum patient navigation program is designed to reduce barriers to care, enhance access, and improve multiple postpartum health outcomes, including retention in care, contraception uptake, vaccination, and depression screening.
| Study group | Role | What they receive |
|---|---|---|
| Navigation Group | Experimental | Women who are randomized into NNM2 will be assigned to a patient navigator. The patient navigator will meet with the patient during pregnancy and after delivery occurs for introductions and education. The patient navigator will offer support and resources (transportation, community referrals, support for your mental health, connection to your doctors, etc.). The navigator will also help to schedule postpartum medical appointments, and will remind the patients of these appointments via text, email, or phone calls. The navigator will continue to provide psychosocial support, social needs support, and continued linkage to resources through one-year postpartum. Receives: Behavioral: Patient Navigation Program |
| Non-navigation cohort | No intervention | No navigation will be provided; women will receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum health at 4-12 weeks after delivery
Number of women who achieve a composite measure of health status that includes retention in care, receipt of recommended counseling (anticipatory guidance), receipt of desired family planning method, postpartum depression screening and linkage, breastfeeding initiation and maintenance, and receipt of indicated vaccination. Components of the primary outcome composite will also be examined as a score and individually as secondary outcomes (see below). (Outcome is modified to include receipt telemedicine when appropriate for health care for women who require postpartum care during the pandemic)
Measured: 4-12 weeks postpartum
Secondary outcomes (15)
Retention in care (component of primary outcome)
Number of participants who return for comprehensive medical care at least once between 4 and 12 weeks postpartum.
Measured: 4-12 weeks postpartum
Receipt of recommended counseling/anticipatory guidance (component of primary outcome)
Number of participants who have been counseled about indicated topics recommended for postpartum care/health
Measured: 4-12 weeks and 1 year postpartum
Receipt of desired family planning method (component of primary outcome)
Number of participants who received their desired family planning method
Measured: 4-12 weeks and 1 year postpartum
Postpartum depression screening and care (component of primary outcome)
Number of participants who undergo appropriate screening for postpartum depression with either 1) screening that indicates no depressive symptoms, or 2) if depressive symptoms are identified, patient receives linkage to further care
Measured: 4-12 weeks and 1 year postpartum
Breastfeeding initiation and maintenance (component of primary outcome)
Number of participants who have initiated and maintained exclusive or partial breastfeeding
Measured: 4-12 weeks postpartum
Receipt of indicated vaccinations (component of primary outcome)
Number of participants who received indicated vaccines (e.g. influenza, TDaP, HPV, MMR; based on individual need)
Measured: 4-12 weeks postpartum
Postpartum diabetes screening
Among women with gestational diabetes mellitus (GDM), number of women with completion of a 2-hour oral glucose tolerance test by 12 weeks postpartum and any other diabetes screening tests by 1 year postpartum
Measured: 4-12 weeks and 1 year postpartum
Postpartum atherosclerotic cardiovascular disease screening
Overall and among women with ASCVD-associated adverse pregnancy outcomes, number of women who undergo indicated clinical assessments for blood pressure, lipids, weight, nutrition, activity
Measured: 4-12 weeks and 1 year postpartum
Gestational weight retention
Difference between weight at delivery and 1) weight at early postpartum (4-12 weeks) and 2) weight at 1 year postpartum
Measured: 4-12 weeks and 1 year postpartum
Breastfeeding duration
Total duration of exclusive or partial breastfeeding among women who initated breastfeeding
Measured: 4-12 weeks and 1 year postpartum
Postpartum transition to primary care
Number of women with appointment made and kept for primary care by 1 year postpartum
Measured: 1 year postpartum
Patient-reported outcomes - self-efficacy, activation, engagement, quality of life, and other PROs
Differences in self-efficacy, activation, quality of life, engagement, and other PROs between women who are randomized to navigation versus usual care, using the DHHS PROMIS and other validated measures of PROs.
PROs to be measured include global health status (PROMIS Global Health), health literacy (Newest Vital Sign), depressive symptoms (Patient Health Questionnaire-9), pregnancy experience and pregnancy-related stress (Pregnancy Experience Scale - Brief, at 4-12 weeks only), patient activation (Patient Activation Measure), health-related self-efficacy (PROMIS Self-Efficacy - general), informational support (PROMIS Informational Support), perceived stress (Perceived Stress Scale), breastfeeding self-efficacy (Breastfeeding Self-Efficacy Scale), postpartum preparedness (Postpartum Preparedness Checklist), and satisfaction with prenatal and postpartum care (original and adaptation of Prenatal Care Satisfaction Scale).
Measured: 4-12 weeks and 1 year postpartum
Patient-reported outcomes - experiences with navigation (survey)
Navigated participants' experiences with navigation as assessed through PRO surveys (Patient Satisfaction with Interpersonal Relationship with Navigator Scale and Patient Satisfaction with Logistical Aspects of Navigation Scale).
Measured: 4-12 weeks and 1 year postpartum
Experiences with navigation (qualitative)
Qualitative perspectives on experiences with the navigation program, based on interviews with women who received navigation
Measured: 3-6 months postpartum and 1 year postpartum
Pregnancy/postpartum experiences during the pandemic
Qualitative perspective of participants' experiences during the COVID-19 pandemic, utilizing a semi-structured interview guide developed by the research team, as it relates to their receipt of health care, experiences as a pregnant person and new parent, and the role of patient navigation in this time period
Measured: At any point during the COVID-19 pandemic, up to 3 months after the end of the pandemic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start21 Jan 2020
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Postpartum HealthStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be two cohorts: One cohort will be provided intensive, individualized, one-on-one navigation services through 12 weeks postpartum and, based on individual needs, ongoing, tapered navigation through one year (11-13 months) postpartum. The second cohort will receive usual care.
- Masking
- None (open label)
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Lynn M Yee, Northwestern University
- Investigators
- Lynn M Yee, MD, MPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922334
- Sponsor's protocol ID
- STU002096009
- Other IDs
- 1R01HD098178
- Acronym
- NNM2
- Status last verified
- Jan 2026
- First submitted
- 15 Apr 2019
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yee LM, Williams B, Green HM, Carmona-Barrera V, Diaz L, Davis K, Kominiarek MA, Feinglass J, Zera CA, Grobman WA. Bridging the postpartum gap: best practices for training of obstetrical patient navigators. Am J Obstet Gynecol. 2021 Aug;225(2):138-152. doi: 10.1016/j.ajog.2021.03.038. Epub 2021 Apr 1.
PubMed 33812809Ruderman RS, Dahl EC, Williams BR, Davis K, Feinglass JM, Grobman WA, Kominiarek MA, Yee LM. Provider Perspectives on Barriers and Facilitators to Postpartum Care for Low-Income Individuals. Womens Health Rep (New Rochelle). 2021 Jul 16;2(1):254-262. doi: 10.1089/whr.2021.0009. eCollection 2021.
PubMed 34318295Filicko A, Huennekens K, Davis K, Dolan BM, Williams BR, Feinglass J, Grobman WA, Kominiarek MA, Yee LM. Primary Care Clinician Perspectives on Patient Navigation to Improve Postpartum Care for Patients with Low Income. Womens Health Rep (New Rochelle). 2022 Dec 15;3(1):1006-1015. doi: 10.1089/whr.2022.0064. eCollection 2022.
PubMed 36636317Green HM, Diaz L, Carmona-Barrera V, Grobman WA, Yeh C, Williams B, Davis K, Kominiarek MA, Feinglass J, Zera C, Yee LM. Mapping the Postpartum Experience Through Obstetric Patient Navigation for Low-Income Individuals. J Womens Health (Larchmt). 2024 Jul;33(7):975-985. doi: 10.1089/jwh.2023.0459. Epub 2024 Jan 23.
PubMed 38265478Green HM, Carmona-Barrera V, Diaz L, Yeh C, Williams B, Davis K, Kominiarek MA, Feinglass J, Grobman WA, Zera C, Yee LM. Implementation of postpartum navigation for low-income individuals at an urban academic medical center. PLoS One. 2023 Feb 23;18(2):e0282048. doi: 10.1371/journal.pone.0282048. eCollection 2023.
PubMed 36821597Ruderman RS, Dahl EC, Williams BR, Feinglass JM, Kominiarek MA, Grobman WA, Yee LM. Obstetric Provider Perspectives on Postpartum Patient Navigation for Low-Income Patients. Health Educ Behav. 2023 Apr;50(2):260-267. doi: 10.1177/10901981211043117. Epub 2021 Oct 12.
PubMed 34636273Yee LM, Feinglass J, Williams BR, Diaz L, Carmona-Barrera V, Cheung Y, Davis K, Yeh C, Niznik CM, Kominiarek MA, Grobman WA. Patient Navigation and Postpartum Health Care Outcomes: A Randomized Clinical Trial. JAMA Health Forum. 2026 Oct 2;7(10):e263338. doi: 10.1001/jamahealthforum.2026.3338.
PubMed 42826032Green HM, Williams B, Diaz L, Carmona-Barrera V, Davis K, Feinglass J, Kominiarek MA, Dolan BM, Grobman WA, Yee LM. Evaluating feedback from an implementation advisory board to assess the rollout of a postpartum patient navigation program. Implement Sci Commun. 2024 May 3;5(1):50. doi: 10.1186/s43058-024-00589-6.
PubMed 38702751Davis KM, Lu L, Williams B, Roas-Gomez MV, Leziak K, Jackson J, Feinglass J, Yee LM. The Stress of Parenting in the Postpartum Period During the COVID-19 Pandemic. Womens Health Rep (New Rochelle). 2022 Nov 9;3(1):895-903. doi: 10.1089/whr.2022.0029. eCollection 2022.
PubMed 36479375
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Navigating New Motherhood 2: Patient Navigation to Improve Outcomes Among Low-income Women in the Postpartum Period
- ClinicalTrials.gov ID
- NCT03922334
- Acronym / sponsor ID
- NNM2 / STU002096009
- Conditions
- Postpartum Health, Breastfeeding, Contraception, Preventive Care / Anticipatory Guidance, Retention in Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 19 Apr 2019 (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.
The primary aim of this study is to determine whether implementation of a postpartum patient navigation program improves health outcomes among low-income women. Patient navigation is a barrier focused, long-term patient-centered intervention that offers support for a defined set of health services. The intervention under investigation is a comprehensive postpartum patient navigator program. Women who are randomized to receive patient navigation will be compared to women who are randomized to receive usual care. Navigators will support women through one year postpartum. The NNM2 program will be grounded in understanding and addressing social determinants of health in order to promote self-efficacy, enhance access, and sustain long-term engagement. Participants will undergo surveys, interviews, and medical record review at 4-12 weeks and 11-13 months postpartum. The investigators will additionally conduct focus groups and surveys with clinical providers.
Detailed description
The postpartum period - often called the "fourth trimester" - is a time of rapid and intense change in the life of a woman and her family, and uptake of health care during this transition is critical to optimizing women's long-term health and the health of their subsequent pregnancies. The importance of postpartum care has been reinforced by professional organizations, yet postpartum care in the United States remains inadequate. Substantial racial/ethnic and socioeconomic disparities in health care uptake, quality, and outcomes exist. Improving health for all women requires the development of new, more comprehensive approaches to postpartum and interconceptional care. One potential model may be patient navigation, which is a barrier-focused, longitudinal, patient-centered intervention that offers support for a defined set of health services.
This protocol is to evaluate whether implementation of a postpartum patient navigation program improves health outcomes among low-income women. The investigators previously developed a postpartum patient navigation program, called Navigating New Motherhood (NNM), which introduced a clinic-level intervention in which a patient navigator assumed postpartum supportive and logistical responsibilities for low-income women. Navigation was associated with improvements in outcomes (retention in care, contraception uptake, vaccination, and depression screening) compared to those of a historical cohort. The investigators now propose to test the efficacy of the updated NNM model - called "NNM2" - via a randomized trial. The study will randomize 400 pregnant or postpartum women (1:1) with publicly-funded prenatal care to NNM2 versus usual care. Women randomized to navigation will be provided intensive, individualized, one-on-one navigation services through 12 weeks postpartum and, based on individual needs, ongoing, tapered navigation through one year postpartum. The NNM2 program will be grounded in understanding and addressing social determinants of health in order to promote self-efficacy, enhance access, and sustain long-term engagement. Participants will undergo surveys, interviews, and medical record review at 4-12 weeks and 11-13 months postpartum.
Aim 1 will evaluate whether the navigation program improves clinical outcomes at 4-12 weeks postpartum as measured via a composite of health status that includes retention in care, receipt of recommended counseling ("anticipatory guidance"), receipt of desired family planning method, postpartum depression screening/care, breastfeeding initiation/maintenance, and receipt of indicated vaccinations. Sub-Aims will include investigation of relevant outcomes at 11-13 months postpartum. Aim 2 will evaluate whether NNM2 improves patient-reported outcomes. Aim 3 additionally involves examining obstetric and primary care provider perspectives on the navigation program and on optimizing the postpartum transition. Completion of this study will fill an evidence gap by demonstrating whether postpartum patient navigation is an effective mechanism to improve women's short- and long-term health, enhance health care utilization, and improve patient and provider satisfaction.
NNM2 suspended enrollment due to COVID-19 beginning March 16, 2020. For already enrolled individuals, study visits and patient navigation activities were converted to tele-research and tele-navigation. Recruitment was planned to resume when the COVID-19 pandemic resolves and normal outpatient care has resumed. For individuals already recruited and whose care occurred during the early phases of the pandemic, the outcomes definitions were appropriately modified for the conduct of telemedicine during the pandemic. Recruitment resumed on June 8, 2020, with continued use of telemedicine or tele-research when appropriate. Given the ongoing pandemic, the modified outcomes definitions for telemedicine provision of care were retained.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There will be two cohorts: One cohort will be provided intensive, individualized, one-on-one navigation services through 12 weeks postpartum and, based on individual needs, ongoing, tapered navigation through one year (11-13 months) postpartum. The second cohort will receive usual care.
| Arm | Type | Receives |
|---|---|---|
| Navigation Group | Experimental | Behavioral: Patient Navigation ProgramWomen who are randomized into NNM2 will be assigned to a patient navigator. The patient navigator will meet with the patient during pregnancy and after delivery occurs for introductions and education. The patient navigator will offer support and resources (transportation, community referrals, support for your mental health, connection to your doctors, etc.). The navigator will also help to schedule postpartum medical appointments, and will remind the patients of these appointments via text, email, or phone calls. The navigator will continue to provide psychosocial support, social needs support, and continued linkage to resources through one-year postpartum. |
| Non-navigation cohort | No intervention | –No navigation will be provided; women will receive usual care. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Pregnant (any plurality) delivering at or after 20 weeks of gestation OR postpartum (during hospitalization), regardless of perinatal outcome
- 16 years or older
- Low-income socioeconomic status (publicly funded prenatal care)
- Ability to speak and read English or Spanish
- Established patient at the Northwestern Medicine Prentice Ambulatory Care clinical site (at least one antenatal clinical visit).
Key exclusion criteria (5 listed)
- Intent to transfer care to an outside institution
- HIV (as these patients already receive intensive social support and navigation-like services at this institution)
- Prior pregnancy in which individual declined participation
- Prior enrollment in NNM2
- Enrollment in a concurrent research study that poses a potential conflict to the aims of either NNM2 or the other study
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 |
|---|---|---|
| Patient Navigation ProgramA postpartum patient navigation program is designed to reduce barriers to care, enhance access, and improve multiple postpartum health outcomes, including retention in care, contraception uptake, vaccination, and depression screening. | Behavioural | Navigation Group |
Primary outcome
Postpartum health at 4-12 weeks after delivery
Time frame: 4-12 weeks postpartum
Number of women who achieve a composite measure of health status that includes retention in care, receipt of recommended counseling (anticipatory guidance), receipt of desired family planning method, postpartum depression screening and linkage, breastfeeding initiation and maintenance, and receipt of indicated vaccination. Components of the primary outcome composite will also be examined as a score and individually as secondary outcomes (see below). (Outcome is modified to include receipt telemedicine when appropriate for health care for women who require postpartum care during the pandemic)
15 secondary outcomes
Retention in care (component of primary outcome)
Time frame: 4-12 weeks postpartum
Receipt of recommended counseling/anticipatory guidance (component of primary outcome)
Time frame: 4-12 weeks and 1 year postpartum
Receipt of desired family planning method (component of primary outcome)
Time frame: 4-12 weeks and 1 year postpartum
Postpartum depression screening and care (component of primary outcome)
Time frame: 4-12 weeks and 1 year postpartum
Breastfeeding initiation and maintenance (component of primary outcome)
Time frame: 4-12 weeks postpartum
Receipt of indicated vaccinations (component of primary outcome)
Time frame: 4-12 weeks postpartum
Postpartum diabetes screening
Time frame: 4-12 weeks and 1 year postpartum
Postpartum atherosclerotic cardiovascular disease screening
Time frame: 4-12 weeks and 1 year postpartum
Gestational weight retention
Time frame: 4-12 weeks and 1 year postpartum
Breastfeeding duration
Time frame: 4-12 weeks and 1 year postpartum
Postpartum transition to primary care
Time frame: 1 year postpartum
Patient-reported outcomes - self-efficacy, activation, engagement, quality of life, and other PROs
Time frame: 4-12 weeks and 1 year postpartum
Patient-reported outcomes - experiences with navigation (survey)
Time frame: 4-12 weeks and 1 year postpartum
Experiences with navigation (qualitative)
Time frame: 3-6 months postpartum and 1 year postpartum
Pregnancy/postpartum experiences during the pandemic
Time frame: At any point during the COVID-19 pandemic, up to 3 months after the end of the pandemic
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 29 Jan 2026.
- Background: PubMed 33812809Yee LM, Williams B, Green HM, Carmona-Barrera V, Diaz L, Davis K, Kominiarek MA, Feinglass J, Zera CA, Grobman WA. Bridging the postpartum gap: best practices for training of obstetrical patient navigators. Am J Obstet Gynecol. 2021 Aug;225(2):138-152. doi: 10.1016/j.ajog.2021.03.038. Epub 2021 Apr 1.
- Results publication: PubMed 34318295Ruderman RS, Dahl EC, Williams BR, Davis K, Feinglass JM, Grobman WA, Kominiarek MA, Yee LM. Provider Perspectives on Barriers and Facilitators to Postpartum Care for Low-Income Individuals. Womens Health Rep (New Rochelle). 2021 Jul 16;2(1):254-262. doi: 10.1089/whr.2021.0009. eCollection 2021.
- Results publication: PubMed 36636317Filicko A, Huennekens K, Davis K, Dolan BM, Williams BR, Feinglass J, Grobman WA, Kominiarek MA, Yee LM. Primary Care Clinician Perspectives on Patient Navigation to Improve Postpartum Care for Patients with Low Income. Womens Health Rep (New Rochelle). 2022 Dec 15;3(1):1006-1015. doi: 10.1089/whr.2022.0064. eCollection 2022.
- Results publication: PubMed 38265478Green HM, Diaz L, Carmona-Barrera V, Grobman WA, Yeh C, Williams B, Davis K, Kominiarek MA, Feinglass J, Zera C, Yee LM. Mapping the Postpartum Experience Through Obstetric Patient Navigation for Low-Income Individuals. J Womens Health (Larchmt). 2024 Jul;33(7):975-985. doi: 10.1089/jwh.2023.0459. Epub 2024 Jan 23.
- Results publication: PubMed 36821597Green HM, Carmona-Barrera V, Diaz L, Yeh C, Williams B, Davis K, Kominiarek MA, Feinglass J, Grobman WA, Zera C, Yee LM. Implementation of postpartum navigation for low-income individuals at an urban academic medical center. PLoS One. 2023 Feb 23;18(2):e0282048. doi: 10.1371/journal.pone.0282048. eCollection 2023.
- Results publication: PubMed 34636273Ruderman RS, Dahl EC, Williams BR, Feinglass JM, Kominiarek MA, Grobman WA, Yee LM. Obstetric Provider Perspectives on Postpartum Patient Navigation for Low-Income Patients. Health Educ Behav. 2023 Apr;50(2):260-267. doi: 10.1177/10901981211043117. Epub 2021 Oct 12.
- Derived from this study: PubMed 42826032Yee LM, Feinglass J, Williams BR, Diaz L, Carmona-Barrera V, Cheung Y, Davis K, Yeh C, Niznik CM, Kominiarek MA, Grobman WA. Patient Navigation and Postpartum Health Care Outcomes: A Randomized Clinical Trial. JAMA Health Forum. 2026 Oct 2;7(10):e263338. doi: 10.1001/jamahealthforum.2026.3338.
- Derived from this study: PubMed 38702751Green HM, Williams B, Diaz L, Carmona-Barrera V, Davis K, Feinglass J, Kominiarek MA, Dolan BM, Grobman WA, Yee LM. Evaluating feedback from an implementation advisory board to assess the rollout of a postpartum patient navigation program. Implement Sci Commun. 2024 May 3;5(1):50. doi: 10.1186/s43058-024-00589-6.
- Derived from this study: PubMed 36479375Davis KM, Lu L, Williams B, Roas-Gomez MV, Leziak K, Jackson J, Feinglass J, Yee LM. The Stress of Parenting in the Postpartum Period During the COVID-19 Pandemic. Womens Health Rep (New Rochelle). 2022 Nov 9;3(1):895-903. doi: 10.1089/whr.2022.0029. eCollection 2022.
- 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.
Lynn M Yee, MD, MPH principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigation Program in people with Postpartum Health and Breastfeeding, run by Northwestern University 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 5 inclusion and 5 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 29 Jan 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?
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?
Postpartum health at 4-12 weeks after delivery (time frame: 4-12 weeks postpartum). 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 NCT03922334, which also lists 9 linked publications.
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 29 Jan 2026.