Severe Maternal MorbidityMOMs-CCNCT06335381
MOMs Chat and Care Study
A study testing Maternal Health Education Resources, Prenatal Telehealth Visits and Postpartum Telehealth Visits in people with Severe Maternal Morbidity, run by Northwell Health at 1 site in United States.
Trial summary
The purpose of this study is to test the effectiveness of an integrated care model approach at two different levels of intensity designed to facilitate timely, appropriate care to reduce risk for SMM. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Severe Maternal Morbidity
- What is being tested?
- Maternal Health Education Resources, Prenatal Telehealth Visits and Postpartum Telehealth Visits
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 674 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2024to 30 Jun 2028
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 or older,
- Self-identify as Black/African American or Hispanic/Latina (includes Black + another race; Black or Afro Hispanic/Latina; or Hispanic/Latina),
- Pregnant, less than 17 weeks gestational age,
- OB-CMI risk score ≥ 2 and/or history or preeclampsia,
- English or Spanish as primary language, and
- Receive care at Northwell Health Physician Partners obstetrics practice site.
Who cannot join
- Pregnant women who are not able to provide informed consent due to cognitive or psychiatric impairment.
- If interested in participating in the study, please visit https://www.momschatandcare.com/
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
Northwell Health
Manhasset, New York, 11030
Stephanie L Fitzpatrick, PhD
About this study
Official title: Maternal OutcoMes (MOMs) Program: Testing Integrated Maternal Care Model Approaches to Reduce Risk of Severe Maternal Morbidity
The purpose of this study is to test the effectiveness of an integrated care model approach at two different levels of intensity designed to facilitate timely, appropriate care to reduce risk for SMM. Black and Hispanic pregnant patients with an Obstetrics-Comorbidity Index Score ³ greater than or equal to 2 and/or a history of pre-eclampsia will be identified via the electronic health record and 674 will be recruited and randomized early during pregnancy to one of two study arms: MOMs High-Touch (MOMs-HT) vs. MOMs Low-Touch (MOMs-LT). The two study arms will be compared on incidence of SMM at labor and delivery (Aim 1), incidence rate of SMM-related hospitalizations at 1-month and 1-year postpartum (Aim 1a), time to preeclampsia diagnosis and initiation of treatment (Aim 2), change in perceived social support domains (Aim 3), and physical activity trajectories (exploratory Aim 4). Mixed methods will also be used to examine facilitators and barriers to implementation (Aim 5). Findings from this study will help to determine how to feasibly implement an effective and sustainable integrated care approach to reduce risk for SMM.
Read the detailed description
The purpose of this study is to test the effectiveness of an integrated care model approach at two different levels of intensity designed to facilitate timely, appropriate care to reduce risk for SMM. Black and Hispanic pregnant patients with an Obstetrics-Comorbidity Index Score ³ greater than or equal to 2 and/or a history of pre-eclampsia will be identified via the electronic health record and 674 will be recruited and randomized early during pregnancy to one of two study arms: MOMs High-Touch (MOMs-HT) vs. MOMs Low-Touch (MOMs-LT). MOMs-HT will consist of access to maternal health education resources, along with navigation to timely care and services by the MOMs team throughout the prenatal and postpartum periods; 12 bi-weekly self-management support calls with the MOMs team during the prenatal period; and 5 bi-weekly postpartum clinical check-in calls with navigation by the MOMs team up to 6 weeks postpartum. MOMs-LT will also include access to maternal health education resources, along with navigation to services by the MOMs team as needed and 5 bi-weekly postpartum clinical check-in calls with navigation. Participants in both study arms will receive a Fitbit to track engagement in physical activity. SMM at labor and delivery (primary) and SMM-related hospitalizations at 1-month and 1-year postpartum (secondary) will be based on the CDC's 21 indicators with diagnoses extracted from the EHR. Diagnosis of preeclampsia and initiation of treatment (secondary) will also be captured using the EHR. Questionnaires will be administered to measure domains of social support (secondary). Physical activity behaviors (exploratory) will be assessed via survey and wearable activity monitor (i.e., Fitbit). Determinants of implementation will be captured via semi-structured qualitative interviews and discrete process measures.
- Conditions
- Severe Maternal Morbidity
- Being tested
- Maternal Health Education Resources, Prenatal Telehealth Visits, Postpartum Telehealth Visits, Home Blood Pressure Monitor, Fitbit
- Keywords
- Maternal health, Severe maternal morbidity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal Health Education ResourcesOther
Maternal health education will be provided via digital applications that participants can access on their smart phone, tablet, or computer. One of the maternal health education resources will be the Northwell Pregnancy \& Peds Chats, a personalized care digital chatbot delivered via the Conversa platform and accessible on a smartphone, tablet, and computer. During the prenatal and postpartum periods, participants will receive a weekly chat via text message or email with a link to the platform. The chats provide timely, brief educational tools and resources. They are also designed to capture clinical, behavioral health, and social health concerns that alert the 24/7 nurse-led call center who follows up to connect the participant to services as needed. The other education resource that participants will be encouraged to use is the Pregnancy+ app, a publicly available application where participants can view educational videos and articles as well as a list of community resources.
Prenatal Telehealth VisitsBehavioural
The MOMs CMC/RN (interventionists) will deliver up to 12 bi-weekly self-management support telehealth visits during the prenatal period. The first telehealth visit will be 30-45 minutes in duration and follow-up visits will be 15-20 minutes. These telehealth visits will involve clinical and behavioral health check-ins; navigation to clinical, behavioral health, and social services as needed; screening for social needs during the initial telehealth visit; follow-up on referrals to resources to address social needs; and self-management support. MOMs CMCs/RNs will assess progress with engagement in self-management behaviors including asking about minutes and type of physical activity, self-monitoring (blood pressure, blood sugar, weight), and taking medications. The MOMs CMC/RN will provide brief maternal health education and support the participant in establishing behavior change goals and facilitating problem solving to address barriers to achieving goals each session.
Postpartum Telehealth VisitsOther
The MOMs CMC/RN will conduct a telehealth visit (with navigation as needed) by phone 24 and 72 hours after labor and delivery. After the 72-hour call, telehealth visits with navigation will occur bi-weekly until 6 weeks postpartum. These telehealth visits will be 15-20 minutes in duration. Telehealth visits will include a brief clinical and behavioral health check-in, screening for social needs, navigation to clinical, behavioral health, and social services as needed, and follow-up on referrals to community resources and social services. During each visit, participants will be asked if they have experienced any signs or symptoms of concern (e.g., pain, discomfort, headaches, bleeding), screened for depression and anxiety, and be reminded about upcoming medical appointments. The CMC or RN will navigate the participant to the appropriate provider (e.g., OB, cardiologist, behavioral health) or services (e.g., emergency, social, community-based resources) as needed in a timely manner.
Home Blood Pressure MonitorOther
Participants will receive an Omron 10 home blood pressure monitor to use throughout the study period. Along with the cuff, participants will receive written (postcard) and video instructions (https://youtu.be/p9UEDv6nvwU) on how to accurately measure their blood pressure. Participants with diagnosed chronic hypertension or preeclampsia during the prenatal period will be encouraged to measure their blood pressure twice a day; participants without these conditions will be encouraged to measure their blood pressure twice a week. During the postpartum period, participants will be encouraged to follow their provider recommendations in terms of how often they should measure their blood pressure. Participants will be allowed to keep the blood pressure monitor after the study has completed.
FitbitOther
Participants will receive a Fitbit to use during the study period. Participants will be asked to wear the Fitbit on their wrist throughout the day to track all activity (e.g., walking, other physical activity, sedentary activity, and sleep). All data including minutes of activity and step counts will be stored on a secure web-based platform that aggregates data from the Fitbit device. Participants will be encouraged to sync their Fitbit device every 5 days with their phone to ensure data is up to date. Participants will be allowed to keep the Fitbit after the study has completed.
| Study group | Role | What they receive |
|---|---|---|
| MOMs High Touch (MOMs-HT) | Experimental | Participants randomized to the MOMs-HT arm will receive access to maternal health education resources via digital applications available on their phone, tablet, or computer as well as navigation to timely clinical, behavioral health, and/or social care services by the MOMs team throughout the prenatal and postpartum periods; 12 bi-weekly self-management support telehealth visits with a MOMs care management coordinator (CMC) or registered nurse (RN) during the prenatal period; home blood pressure monitor to measure their blood pressure regularly; Fitbit to track physical activity; and 5 bi-weekly telehealth visits with navigation to clinical, behavioral, and social services as needed by the MOMs team up to 6 weeks postpartum. Receives: Other: Maternal Health Education Resources; Behavioral: Prenatal Telehealth Visits; Other: Postpartum Telehealth Visits; Other: Home Blood Pressure Monitor; Other: Fitbit |
| MOMs Low Touch (MOMs-LT) | Active comparator | Participants randomized to the MOMs-LT arm will receive access to maternal health education resources via digital applications available on their phone, tablet, or computer as well as navigation to timely clinical, behavioral health, and/or social care services by the MOMs team throughout the prenatal and postpartum periods; 5 bi-weekly telehealth visits with navigation to clinical, behavioral, and social services as needed by the MOMs team up to 6 weeks postpartum; and a Fitbit to track physical activity. Receives: Other: Maternal Health Education Resources; Other: Postpartum Telehealth Visits; Other: Fitbit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe maternal morbidity (SMM)
The Centers for Disease Control \& Prevention define SMM as having ≥ 1 ICD-10 diagnosis codes that correspond to 21 SMM indicators. SMM indicator diagnoses that occur at labor and delivery, from delivery to 1-month postpartum during a hospital admission, or from delivery to 1-year postpartum during a hospital admission will be extracted from the electronic health record.
Measured: Labor and delivery; 1-month postpartum; 1-year postpartum
Secondary outcomes (4)
Preeclampsia
We will use the electronic health record to capture date preeclampsia diagnosis is documented at any time between study enrollment and labor and delivery (i.e., during the prenatal period) in both study arms. The following ICD-10 codes will be used to determine preeclampsia diagnosis: O14.1, O14.10, O14.12, O14.13, O14.14, or O14.15. Also, using the electronic health record and surveys, we will assess when treatment for preeclampsia (i.e., low-dose aspirin) has been initiated.
Measured: During prenatal period (from study enrollment to labor and delivery), estimated 9 months.
Informational Support
The PROMIS 10-item Informational Support measure will be administered to all participants to assess degree of support in terms of having someone to provide information or offer advice. The validated measure is on a 5-point Likert scale (ranging from 'never' to 'always') and is available in English and Spanish.
Measured: Baseline; 1-month postpartum; 1-year postpartum
Emotional Support
The PROMIS 12-item Emotional Support measure will be administered to all participants to assess degree of feeling like they have someone who cares and expresses concern. The validated measure is on a 5-point Likert scale (ranging from 'never' to 'always') and is available in English and Spanish.
Measured: Baseline; 1-month postpartum; 1-year postpartum
Tangible Support
This is a newly developed 8-item measure based on findings from qualitative interview with previous MOMs Program participants. The measure is designed to assess the degree to which patients feel supported in accessing clinical care and social services.
Measured: Baseline; 1-month postpartum; 1-year postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start28 May 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
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 Severe Maternal MorbidityStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to one of two groups in parallel for the duration of the study.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 674 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Stephanie L Fitzpatrick, PhD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335381
- Sponsor's protocol ID
- 24-0131
- Other IDs
- 1R01NR021134-01
- Acronym
- MOMs-CC
- Status last verified
- May 2026
- First submitted
- 15 Mar 2024
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant data related to the outcomes will be shared with scientists on the Open Science Framework (OSF) repository. This will include the 21 severe maternal morbidity indicators, preeclampsia diagnosis, and responses to the perceived social support domain measures. We will also include data relating to physical activity and data for variables which may moderate the primary analyses (e.g., sociodemographics, comorbidity). Data will be redacted to strip all individual identifiers, and effective strategies will be adopted to minimize risk of disclosing a participant's identity. Whenever possible, raw participant-level data will be shared along with documentation of how variables were cleaned, coded, or summarized. In cases where participant-level data could be used to identify individuals, summary data will be presented rather than raw data. Information about how summary data was generated will be provided in the data dictionary.
Publications
Fitzpatrick SL, Polo J, Ephraim P, Vrany E, Chiuzan C, Basile M, Friel CP, Moon KC, Silvia E, Bleau H, Nicholson W, Lewis D; MOMs Chat Care Research Group. MOMs Chat & Care Study: Rationale and design of a pragmatic randomized clinical trial to prevent severe maternal morbidity among Black birthing people. Contemp Clin Trials. 2025 May;152:107850. doi: 10.1016/j.cct.2025.107850. Epub 2025 Feb 21.
PubMed 39987957
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal OutcoMes (MOMs) Program: Testing Integrated Maternal Care Model Approaches to Reduce Risk of Severe Maternal Morbidity
- ClinicalTrials.gov ID
- NCT06335381
- Acronym / sponsor ID
- MOMs-CC / 24-0131
- Conditions
- Severe Maternal Morbidity
- Keywords
- Maternal health, Severe maternal morbidity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 674 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 28 May 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 28 Mar 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.
The purpose of this study is to test the effectiveness of an integrated care model approach at two different levels of intensity designed to facilitate timely, appropriate care to reduce risk for SMM. Black and Hispanic pregnant patients with an Obstetrics-Comorbidity Index Score ³ greater than or equal to 2 and/or a history of pre-eclampsia will be identified via the electronic health record and 674 will be recruited and randomized early during pregnancy to one of two study arms: MOMs High-Touch (MOMs-HT) vs. MOMs Low-Touch (MOMs-LT). The two study arms will be compared on incidence of SMM at labor and delivery (Aim 1), incidence rate of SMM-related hospitalizations at 1-month and 1-year postpartum (Aim 1a), time to preeclampsia diagnosis and initiation of treatment (Aim 2), change in perceived social support domains (Aim 3), and physical activity trajectories (exploratory Aim 4). Mixed methods will also be used to examine facilitators and barriers to implementation (Aim 5). Findings from this study will help to determine how to feasibly implement an effective and sustainable integrated care approach to reduce risk for SMM.
Detailed description
The purpose of this study is to test the effectiveness of an integrated care model approach at two different levels of intensity designed to facilitate timely, appropriate care to reduce risk for SMM. Black and Hispanic pregnant patients with an Obstetrics-Comorbidity Index Score ³ greater than or equal to 2 and/or a history of pre-eclampsia will be identified via the electronic health record and 674 will be recruited and randomized early during pregnancy to one of two study arms: MOMs High-Touch (MOMs-HT) vs. MOMs Low-Touch (MOMs-LT). MOMs-HT will consist of access to maternal health education resources, along with navigation to timely care and services by the MOMs team throughout the prenatal and postpartum periods; 12 bi-weekly self-management support calls with the MOMs team during the prenatal period; and 5 bi-weekly postpartum clinical check-in calls with navigation by the MOMs team up to 6 weeks postpartum. MOMs-LT will also include access to maternal health education resources, along with navigation to services by the MOMs team as needed and 5 bi-weekly postpartum clinical check-in calls with navigation. Participants in both study arms will receive a Fitbit to track engagement in physical activity. SMM at labor and delivery (primary) and SMM-related hospitalizations at 1-month and 1-year postpartum (secondary) will be based on the CDC's 21 indicators with diagnoses extracted from the EHR. Diagnosis of preeclampsia and initiation of treatment (secondary) will also be captured using the EHR. Questionnaires will be administered to measure domains of social support (secondary). Physical activity behaviors (exploratory) will be assessed via survey and wearable activity monitor (i.e., Fitbit). Determinants of implementation will be captured via semi-structured qualitative interviews and discrete process measures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Participants will be assigned to one of two groups in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| MOMs High Touch (MOMs-HT) | Experimental | Other: Maternal Health Education Resources, Behavioral: Prenatal Telehealth Visits, Other: Postpartum Telehealth Visits, Other: Home Blood Pressure Monitor, Other: FitbitParticipants randomized to the MOMs-HT arm will receive access to maternal health education resources via digital applications available on their phone, tablet, or computer as well as navigation to timely clinical, behavioral health, and/or social care services by the MOMs team throughout the prenatal and postpartum periods; 12 bi-weekly self-management support telehealth visits with a MOMs care management coordinator (CMC) or registered nurse (RN) during the prenatal period; home blood pressure monitor to measure their blood pressure regularly; Fitbit to track physical activity; and 5 bi-weekly telehealth visits with navigation to clinical, behavioral, and social services as needed by the MOMs team up to 6 weeks postpartum. |
| MOMs Low Touch (MOMs-LT) | Active comparator | Other: Maternal Health Education Resources, Other: Postpartum Telehealth Visits, Other: FitbitParticipants randomized to the MOMs-LT arm will receive access to maternal health education resources via digital applications available on their phone, tablet, or computer as well as navigation to timely clinical, behavioral health, and/or social care services by the MOMs team throughout the prenatal and postpartum periods; 5 bi-weekly telehealth visits with navigation to clinical, behavioral, and social services as needed by the MOMs team up to 6 weeks postpartum; and a Fitbit to track physical activity. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18 or older,
- Self-identify as Black/African American or Hispanic/Latina (includes Black + another race; Black or Afro Hispanic/Latina; or Hispanic/Latina),
- Pregnant, less than 17 weeks gestational age,
- OB-CMI risk score ≥ 2 and/or history or preeclampsia,
- English or Spanish as primary language, and
Key exclusion criteria (2 listed)
- Pregnant women who are not able to provide informed consent due to cognitive or psychiatric impairment.
- If interested in participating in the study, please visit https://www.momschatandcare.com/
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 |
|---|---|---|
| Maternal Health Education ResourcesMaternal health education will be provided via digital applications that participants can access on their smart phone, tablet, or computer. One of the maternal health education resources will be the Northwell Pregnancy \& Peds Chats, a personalized care digital chatbot delivered via the Conversa platform and accessible on a smartphone, tablet, and computer. During the prenatal and postpartum periods, participants will receive a weekly chat via text message or email with a link to the platform. The chats provide timely, brief educational tools and resources. They are also designed to capture clinical, behavioral health, and social health concerns that alert the 24/7 nurse-led call center who follows up to connect the participant to services as needed. The other education resource that participants will be encouraged to use is the Pregnancy+ app, a publicly available application where participants can view educational videos and articles as well as a list of community resources. | Other | MOMs High Touch (MOMs-HT), MOMs Low Touch (MOMs-LT) |
| Prenatal Telehealth VisitsThe MOMs CMC/RN (interventionists) will deliver up to 12 bi-weekly self-management support telehealth visits during the prenatal period. The first telehealth visit will be 30-45 minutes in duration and follow-up visits will be 15-20 minutes. These telehealth visits will involve clinical and behavioral health check-ins; navigation to clinical, behavioral health, and social services as needed; screening for social needs during the initial telehealth visit; follow-up on referrals to resources to address social needs; and self-management support. MOMs CMCs/RNs will assess progress with engagement in self-management behaviors including asking about minutes and type of physical activity, self-monitoring (blood pressure, blood sugar, weight), and taking medications. The MOMs CMC/RN will provide brief maternal health education and support the participant in establishing behavior change goals and facilitating problem solving to address barriers to achieving goals each session. | Behavioural | MOMs High Touch (MOMs-HT) |
| Postpartum Telehealth VisitsThe MOMs CMC/RN will conduct a telehealth visit (with navigation as needed) by phone 24 and 72 hours after labor and delivery. After the 72-hour call, telehealth visits with navigation will occur bi-weekly until 6 weeks postpartum. These telehealth visits will be 15-20 minutes in duration. Telehealth visits will include a brief clinical and behavioral health check-in, screening for social needs, navigation to clinical, behavioral health, and social services as needed, and follow-up on referrals to community resources and social services. During each visit, participants will be asked if they have experienced any signs or symptoms of concern (e.g., pain, discomfort, headaches, bleeding), screened for depression and anxiety, and be reminded about upcoming medical appointments. The CMC or RN will navigate the participant to the appropriate provider (e.g., OB, cardiologist, behavioral health) or services (e.g., emergency, social, community-based resources) as needed in a timely manner. | Other | MOMs High Touch (MOMs-HT), MOMs Low Touch (MOMs-LT) |
| Home Blood Pressure MonitorParticipants will receive an Omron 10 home blood pressure monitor to use throughout the study period. Along with the cuff, participants will receive written (postcard) and video instructions (https://youtu.be/p9UEDv6nvwU) on how to accurately measure their blood pressure. Participants with diagnosed chronic hypertension or preeclampsia during the prenatal period will be encouraged to measure their blood pressure twice a day; participants without these conditions will be encouraged to measure their blood pressure twice a week. During the postpartum period, participants will be encouraged to follow their provider recommendations in terms of how often they should measure their blood pressure. Participants will be allowed to keep the blood pressure monitor after the study has completed. | Other | MOMs High Touch (MOMs-HT) |
| FitbitParticipants will receive a Fitbit to use during the study period. Participants will be asked to wear the Fitbit on their wrist throughout the day to track all activity (e.g., walking, other physical activity, sedentary activity, and sleep). All data including minutes of activity and step counts will be stored on a secure web-based platform that aggregates data from the Fitbit device. Participants will be encouraged to sync their Fitbit device every 5 days with their phone to ensure data is up to date. Participants will be allowed to keep the Fitbit after the study has completed. | Other | MOMs High Touch (MOMs-HT), MOMs Low Touch (MOMs-LT) |
Primary outcome
Severe maternal morbidity (SMM)
Time frame: Labor and delivery; 1-month postpartum; 1-year postpartum
The Centers for Disease Control \& Prevention define SMM as having ≥ 1 ICD-10 diagnosis codes that correspond to 21 SMM indicators. SMM indicator diagnoses that occur at labor and delivery, from delivery to 1-month postpartum during a hospital admission, or from delivery to 1-year postpartum during a hospital admission will be extracted from the electronic health record.
4 secondary outcomes
Preeclampsia
Time frame: During prenatal period (from study enrollment to labor and delivery), estimated 9 months.
Informational Support
Time frame: Baseline; 1-month postpartum; 1-year postpartum
Emotional Support
Time frame: Baseline; 1-month postpartum; 1-year postpartum
Tangible Support
Time frame: Baseline; 1-month postpartum; 1-year postpartum
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 7 May 2026.
- Derived from this study: PubMed 39987957Fitzpatrick SL, Polo J, Ephraim P, Vrany E, Chiuzan C, Basile M, Friel CP, Moon KC, Silvia E, Bleau H, Nicholson W, Lewis D; MOMs Chat Care Research Group. MOMs Chat & Care Study: Rationale and design of a pragmatic randomized clinical trial to prevent severe maternal morbidity among Black birthing people. Contemp Clin Trials. 2025 May;152:107850. doi: 10.1016/j.cct.2025.107850. Epub 2025 Feb 21.
- Individual participant dataSharing planned: Yes. Participant data related to the outcomes will be shared with scientists on the Open Science Framework (OSF) repository. This will include the 21 severe maternal morbidity indicators, preeclampsia diagnosis, and responses to the perceived social support domain measures. We will also include data relating to physical activity and data for variables which may moderate the primary analyses (e.g., sociodemographics, comorbidity). Data will be redacted to strip all individual identifiers, and effective strategies will be adopted to minimize risk of disclosing a participant's identity. Whenever possible, raw participant-level data will be shared along with documentation of how variables were cleaned, coded, or summarized. In cases where participant-level data could be used to identify individuals, summary data will be presented rather than raw data. Information about how summary data was generated will be provided in the data dictionary.
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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.
Stephanie L Fitzpatrick, PhD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maternal Health Education Resources, Prenatal Telehealth Visits and Postpartum Telehealth Visits in people with Severe Maternal Morbidity, run by Northwell Health 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 6 inclusion and 2 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 7 May 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 Stephanie L Fitzpatrick, PhD (646-766-7167, sfitzpatrick1@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe maternal morbidity (SMM) (time frame: Labor and delivery; 1-month postpartum; 1-year 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 NCT06335381, 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 7 May 2026.