Pregnancy RelatedNCT05499507
The Path to Optimal Black Maternal Heart Health: Comparing Two CVD Risk Reduction Interventions (Change of HEART)
A study testing COH and COH+ in people with Pregnancy Related and Hypertension, run by Temple University at 1 site in United States.
Trial summary
The overarching goal of our proposal is to reduce disparities in perinatal cardiovascular disease risk factors among Black women utilizing a community-driven, social ecological framework. 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
- Pregnancy Related, Hypertension, Obesity
- What is being tested?
- COH and COH+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2023to 9 Jan 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
- age ≥18 years
- baseline BMI ≥30 kg/m2 and/or diagnosis of HTN (≥130/80 x 2)
- gestational age ≤28 weeks by last menstrual period
- smartphone ownership
- self-identification as Black or African American
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Temple University/Temple Health
Philadelphia, Pennsylvania, 19140
About this study
The overarching goal of our proposal is to reduce disparities in perinatal cardiovascular disease risk factors among Black women utilizing a community-driven, social ecological framework.
Read the detailed description
What is this research about? Heart disease (e.g., heart attack, stroke) is a major threat to safe motherhood and is the leading cause of maternal death in the United States, responsible for nearly 50 percent of pregnancy-related deaths among Black women, three times the rate of white women, and is largely preventable. It is well established that eating healthy foods and monitoring blood pressure can help prevent heart disease. While prior studies addressing these individual behaviors have led to some success, a single individual-level approach has not been enough to stop the rising rate of Black maternal mortality. Researchers have also established that depression, social isolation, and stress from racism lead to poor heart outcomes. But few studies have treated these psychosocial and structural factors in addition to individual behaviors to ensure optimal Black maternal heart health, particularly for mothers at higher risk (e.g., those with high blood pressure and/or obesity). To meet this need, the research team plans to compare two approaches that treat multiple factors leading to heart disease among patients age 18 and older who self-identify as Black or African American, have either obesity and/or high blood pressure, are less than 28 weeks pregnant, and have a smart phone. Both approaches address individual behaviors through nutrition and physical activity text messages and home blood pressure self-monitoring as well as provide training to medical care providers in order to reduce patients' experiences of racism or mistreatment. But only one of the approaches being studied also adds supports for Black women by Black women (community doula care, mental health services, and lactation consultation) during their pregnancy, birth, and postpartum in order to learn if these supports lead to lower blood pressure and also treat social isolation, depression, and increase experiences of respectful maternity care.
Who can this research help? This study will increase Black mothers' understanding of the many influences on their heart health. Findings from this study will help Black women with obesity and/or high blood pressure make informed decisions about the use of community doulas, lactation professionals, and psychotherapists as part of their care to reduce risks for heart disease during pregnancy or in the first year after their baby is born. Results may also strengthen health systems' commitment to anti-racism training as part of their efforts to provide quality health care for Black pregnant and postpartum people. And further, this research may provide evidence to insurance companies that coverage of this study's package of supports is needed.
What outcomes are being studied? The primary outcomes are changes in maternal blood pressure and body weight at six weeks and one year after giving birth. The team will also evaluate how well the treatments are implemented and able to reach patients, be adopted into practice consistently, and lead to healthcare provider and patient satisfaction. The team will analyze outcomes that patient partners have identified as important. These include perinatal mood and anxiety disorders (e.g., postpartum depression), emotional and informational support, stress, and experiences of respectful maternity care. In addition, the study team will look at clinical outcomes including if and for how long patients breastfeed, blood pressure disorders of pregnancy, how the patient gave birth (e.g., vaginal or cesarean), baby's birth weight, and how many weeks pregnant mothers were at the time of birth.
How long does this study last? Final follow-up of primary outcomes is at one year postpartum (i.e., approximately 18 months from enrollment).
How are stakeholders involved? The research team believes that efforts to improve Black maternal heart health will be most effective when partnered with patients and community leaders that have shared lived experience. Study leadership is an equitable partnership by an academic physician-researcher and community-based Black provider who herself experienced heart health complications in her pregnancy. There are three other patient investigators who will also be involved in all aspects of the planning, delivery, and evaluation of the treatments, including serving as lead doulas, therapists, and lactation professionals. Patient representatives will make up the majority of the study's advisory board to give feedback and further guide the team's efforts throughout the five years of the project. Finally, patient, health system, and community provider stakeholders will provide feedback and guidance through focus groups over the entire study duration to ensure adoption of treatments.
- Conditions
- Pregnancy Related, Hypertension, Obesity, Racism
- Being tested
- COH, COH+
- Medical subject headings
- Hypertension, Obesity, Racism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COHBehavioural
Incorporates two, evidence-based individual-level interventions (home blood pressure telemonitoring coupled with the interactive obesity treatment approach, that includes nutrition and physical activity text messages with tailored feedback) and an institutional-level intervention (anti-racism training of providers and staff along with patient feedback to inform respectful care).
COH+Behavioural
Includes all components of COH plus interpersonal support for Black women by Black women (community doula care, mental health services, and lactation support).
| Study group | Role | What they receive |
|---|---|---|
| Change of Heart (COH) | Active comparator | Incorporates two, evidence-based individual-level interventions (home blood pressure telemonitoring coupled with the interactive obesity treatment approach, that includes nutrition and physical activity text messages with tailored feedback) and an institutional-level intervention (anti-racism training of providers and staff along with patient feedback to inform respectful care). Receives: Behavioral: COH |
| Change of Heart Plus (COH+) | Experimental | Includes all components of COH plus the addition of interpersonal support for Black women by Black women (community doula care, mental health services, and lactation support). Receives: Behavioral: COH+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure at 6-weeks postpartum.
Blood pressure will be measured at each time point on the upper arm three times at one-minute intervals after five minutes of quiet sitting. The investigators will use the validated Omron HEM-907XL and the appropriate size cuff. The investigators will average the three measures for analysis.
Measured: At baseline and 6-weeks postpartum
Change in blood pressure at 12-months postpartum.
Blood pressure will be measured at each time point on the upper arm three times at one-minute intervals after five minutes of quiet sitting. The investigators will use the validated Omron HEM-907XL and the appropriate size cuff. The investigators will average the three measures for analysis.
Measured: At baseline and 12-months postpartum
Change in body weight at 6-weeks postpartum.
Body weight will be measured in duplicate and recorded to the nearest 0.1kg using calibrated SECA scales at each time point.
Measured: At baseline and 6-weeks postpartum
Change in body weight at 12-months postpartum.
Body weight will be measured in duplicate and recorded to the nearest 0.1kg using calibrated SECA scales at each time point.
Measured: At baseline and 12-months postpartum
Secondary outcomes (23)
Change in emotional support at 6-weeks postpartum.
The investigators will use the 8-item emotional support PROMIS instrument to measure perceived feelings of being cared for at each time point. The lowest possible raw score is 8; the highest possible raw score is 40. Higher scores indicate greater emotional support.
Measured: At baseline and 6-weeks postpartum
Change in emotional support at 12-months postpartum.
The investigators will use the 8-item emotional support PROMIS instrument to measure perceived feelings of being cared for at each time point. The lowest possible raw score is 8; the highest possible raw score is 40. Higher scores indicate greater emotional support.
Measured: At baseline and 12-months postpartum
Change in informational support at 6-weeks postpartum.
The investigators will use the 8-item informational support PROMIS instruments to measure perceived availability of helpful information or advice at each time point. The lowest possible raw score is 8; the highest possible raw score is 40. Higher scores indicate greater informational support.
Measured: At baseline and 6-weeks postpartum
Change in informational support at 12-months postpartum.
The investigators will use the 8-item informational support PROMIS instruments to measure perceived availability of helpful information or advice at each time point. The lowest possible raw score is 8; the highest possible raw score is 40. Higher scores indicate greater informational support.
Measured: At baseline and 12-months postpartum
Change in Perinatal Mood and Anxiety Disorders (PMADs) at 6-weeks postpartum.
PMADs will be assessed using the Beck Depression Inventory II (BDI-II), a 21-item screening tool. The BDI-II has demonstrated concurrent validity with other postpartum depression scales and validated cut points for mild/moderate depressive symptoms in Black women of low-socioeconomic position. The lowest possible raw score is 1; the highest possible raw score is 40. Higher scores indicate greater depressive symptoms.
Measured: At baseline and 6-weeks postpartum
Change in PMADs at 12-months postpartum.
PMADs will be assessed using the Beck Depression Inventory II (BDI-II), a 21-item screening tool. The BDI-II has demonstrated concurrent validity with other postpartum depression scales and validated cut points for mild/moderate depressive symptoms in Black women of low-socioeconomic position. The lowest possible raw score is 1; the highest possible raw score is 40. Higher scores indicate greater depressive symptoms.
Measured: At baseline and 12-months postpartum
Mothers autonomy in decision making at baseline.
The 7-item Mothers Autonomy in Decision Making scale rates patients' level of agency and autonomy experienced during conversations with a maternity provider. The range of scores is 7-42, with higher scores indicating more opportunities to take an active role and lead decisions.
Measured: Baseline
Mothers autonomy in decision making at 6-weeks postpartum.
The 7-item Mothers Autonomy in Decision Making scale rates patients' level of agency and autonomy experienced during conversations with a maternity provider. The range of scores is 7-42, with higher scores indicating more opportunities to take an active role and lead decisions.
Measured: 6-weeks postpartum
Respectful maternity care at baseline.
Respectful maternity care will be assessed by the 14-item Mothers on Respect Index, which examines the nature of provider-patient relationships and access to person-centered care. The range of scores is 14-84, with higher scores indicating more respectful care.
lead decisions.
Measured: Baseline
Respectful maternity care at 6-weeks postpartum.
Respectful maternity care will be assessed by the 14-item Mothers on Respect Index, which examines the nature of provider-patient relationships and access to person-centered care. The range of scores is 14-84, with higher scores indicating more respectful care.
Measured: 6-weeks postpartum
Obstetric mistreatment at baseline.
The 8-item Mistreatment Index queries patients' experience of dimensions of mistreatment (e.g., physical abuse, discrimination). To describe the overall prevalence of mistreatment, the investigators will calculate the proportion of women who experienced each of the seven types of mistreatment and what proportion experience any mistreatment (i.e. any of the seven indicators).
Measured: Baseline
Obstetric mistreatment at 6-weeks postpartum
The 8-item Mistreatment Index queries patients' experience of dimensions of mistreatment (e.g., physical abuse, discrimination). To describe the overall prevalence of mistreatment, the investigators will calculate the proportion of women who experienced each of the seven types of mistreatment and what proportion experience any mistreatment (i.e. any of the seven indicators).
Measured: 6-weeks postpartum
Blood pressure control at 6-weeks postpartum for patients with hypertension (HTN) at baseline.
Blood pressure control will be assessed at each time point for patients with HTN at enrollment (proportion with mean systolic BP ≥ 130mm/Hg or mean diastolic BP ≥ 80mm/Hg).
Measured: 6-weeks postpartum
Blood pressure control at 12-months postpartum for patients with hypertension at baseline.
Blood pressure control will be assessed at each time point for patients with HTN at enrollment (proportion with mean systolic BP ≥ 130mm/Hg or mean diastolic BP ≥ 80mm/Hg).
Measured: 12-months postpartum
Incident hypertension at 6-weeks postpartum for patients who were normotensive at baseline.
Data will be collected about incident HTN at 6-weeks and 1-year postpartum for normotensive patients at enrollment (proportion with mean systolic BP ≥130 mm/Hg or mean diastolic BP ≥ 80mm/Hg).
Measured: 6-weeks postpartum
Incident hypertension at 12-months postpartum for patients who were normotensive at baseline.
Data will be collected about incident HTN at 6-weeks and 1-year postpartum for normotensive patients at enrollment (proportion with mean systolic BP ≥130 mm/Hg or mean diastolic BP ≥ 80mm/Hg).
Measured: 12-months postpartum
Breast/Chestfeeding initiation.
Breast/chestfeeding initiation will be assessed via questions adapted from the Infant Feeding Practices Study II.
Measured: 6-weeks postpartum
Breast/Chestfeeding duration.
Breast/chestfeeding duration will be assessed via questions adapted from the Infant Feeding Practices Study II.
Measured: 12-months postpartum
Breastfeeding support/self-efficacy at 6-weeks postpartum.
Breast/chestfeeding self-efficacy will be assessed via questions adapted from the Breastfeeding Self-Efficacy Scale. The range of scores is 14-70, with higher scores indicating greater self-efficacy.
Measured: 6-weeks postpartum
Breastfeeding support/self-efficacy at 12-months postpartum.
Breast/chestfeeding self-efficacy will be assessed via questions adapted from the Breastfeeding Self-Efficacy Scale. he range of scores is 14-70, with higher scores indicating greater self-efficacy.
Measured: 12-months postpartum
Mode of delivery.
Mode of delivery will be abstracted from the electronic health record and categorized as either operative delivery (cesarean section) or non-operative (vaginal delivery), stratified by birth history.
Measured: 6-weeks postpartum
Infant birth weight.
Infant birth weight will be abstracted from electronic health record. The investigators will calculate sex-specific birth weight for gestational age percentile based on national data.
Measured: 6-weeks postpartum
Preterm birth.
To determine rates of preterm birth, gestational length will be calculated from last menstrual period (LMP) unless ultrasound dating differs ≥10 days from LMP dating. Pregnancy loss will be assessed by self-report, verified by electronic health record.
Measured: 6-weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start24 Jan 2023
- Primary completion15 Jul 2027 (estimated)
- Study completion9 Jan 2029 (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 Pregnancy RelatedStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Sharon J Herring, MD, MPH, Principal investigator, Temple University, Philadelphia, Pennsylvania, United States, 19140
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499507
- Sponsor's protocol ID
- 27919
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2022
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Descriptions of the study dataset, including codebooks and documentation of the programming code used for creating the final study population, variable definitions, and descriptive and outcome analyses will be provided at the end of the final funding year. The investigators will make these materials, as well as the final dataset, available via the Inter-university Consortium for Political and Social Research (ICPSR, https://www.icpsr.umich.edu/web/pages/) of which Temple University is a member.
Publications
Wycoff KL, Coleman JG, Santoro CM, Zullig LL, Darden N, Holland PM, Cruice JF, Mitchell S, Smith M, McNeil SJ, Herring SJ. Multilevel Community Engagement to Inform a Randomized Clinical Trial. Obstet Gynecol. 2023 Oct 1;142(4):929-939. doi: 10.1097/AOG.0000000000005344. Epub 2023 Sep 7.
PubMed 37734093
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Path to Optimal Black Maternal Heart Health: Comparing Two CVD Risk Reduction Interventions (Change of HEART)
- ClinicalTrials.gov ID
- NCT05499507
- Acronym / sponsor ID
- 27919
- Conditions
- Pregnancy Related, Hypertension, Obesity, Racism
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 345 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 9 Jan 2029 (estimated)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overarching goal of our proposal is to reduce disparities in perinatal cardiovascular disease risk factors among Black women utilizing a community-driven, social ecological framework.
Detailed description
What is this research about? Heart disease (e.g., heart attack, stroke) is a major threat to safe motherhood and is the leading cause of maternal death in the United States, responsible for nearly 50 percent of pregnancy-related deaths among Black women, three times the rate of white women, and is largely preventable. It is well established that eating healthy foods and monitoring blood pressure can help prevent heart disease. While prior studies addressing these individual behaviors have led to some success, a single individual-level approach has not been enough to stop the rising rate of Black maternal mortality. Researchers have also established that depression, social isolation, and stress from racism lead to poor heart outcomes. But few studies have treated these psychosocial and structural factors in addition to individual behaviors to ensure optimal Black maternal heart health, particularly for mothers at higher risk (e.g., those with high blood pressure and/or obesity). To meet this need, the research team plans to compare two approaches that treat multiple factors leading to heart disease among patients age 18 and older who self-identify as Black or African American, have either obesity and/or high blood pressure, are less than 28 weeks pregnant, and have a smart phone. Both approaches address individual behaviors through nutrition and physical activity text messages and home blood pressure self-monitoring as well as provide training to medical care providers in order to reduce patients' experiences of racism or mistreatment. But only one of the approaches being studied also adds supports for Black women by Black women (community doula care, mental health services, and lactation consultation) during their pregnancy, birth, and postpartum in order to learn if these supports lead to lower blood pressure and also treat social isolation, depression, and increase experiences of respectful maternity care.
Who can this research help? This study will increase Black mothers' understanding of the many influences on their heart health. Findings from this study will help Black women with obesity and/or high blood pressure make informed decisions about the use of community doulas, lactation professionals, and psychotherapists as part of their care to reduce risks for heart disease during pregnancy or in the first year after their baby is born. Results may also strengthen health systems' commitment to anti-racism training as part of their efforts to provide quality health care for Black pregnant and postpartum people. And further, this research may provide evidence to insurance companies that coverage of this study's package of supports is needed.
What outcomes are being studied? The primary outcomes are changes in maternal blood pressure and body weight at six weeks and one year after giving birth. The team will also evaluate how well the treatments are implemented and able to reach patients, be adopted into practice consistently, and lead to healthcare provider and patient satisfaction. The team will analyze outcomes that patient partners have identified as important. These include perinatal mood and anxiety disorders (e.g., postpartum depression), emotional and informational support, stress, and experiences of respectful maternity care. In addition, the study team will look at clinical outcomes including if and for how long patients breastfeed, blood pressure disorders of pregnancy, how the patient gave birth (e.g., vaginal or cesarean), baby's birth weight, and how many weeks pregnant mothers were at the time of birth.
How long does this study last? Final follow-up of primary outcomes is at one year postpartum (i.e., approximately 18 months from enrollment).
How are stakeholders involved? The research team believes that efforts to improve Black maternal heart health will be most effective when partnered with patients and community leaders that have shared lived experience. Study leadership is an equitable partnership by an academic physician-researcher and community-based Black provider who herself experienced heart health complications in her pregnancy. There are three other patient investigators who will also be involved in all aspects of the planning, delivery, and evaluation of the treatments, including serving as lead doulas, therapists, and lactation professionals. Patient representatives will make up the majority of the study's advisory board to give feedback and further guide the team's efforts throughout the five years of the project. Finally, patient, health system, and community provider stakeholders will provide feedback and guidance through focus groups over the entire study duration to ensure adoption of treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Change of Heart (COH) | Active comparator | Behavioral: COHIncorporates two, evidence-based individual-level interventions (home blood pressure telemonitoring coupled with the interactive obesity treatment approach, that includes nutrition and physical activity text messages with tailored feedback) and an institutional-level intervention (anti-racism training of providers and staff along with patient feedback to inform respectful care). |
| Change of Heart Plus (COH+) | Experimental | Behavioral: COH+Includes all components of COH plus the addition of interpersonal support for Black women by Black women (community doula care, mental health services, and lactation support). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age ≥18 years
- baseline BMI ≥30 kg/m2 and/or diagnosis of HTN (≥130/80 x 2)
- gestational age ≤28 weeks by last menstrual period
- smartphone ownership
- self-identification as Black or African American
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| COHIncorporates two, evidence-based individual-level interventions (home blood pressure telemonitoring coupled with the interactive obesity treatment approach, that includes nutrition and physical activity text messages with tailored feedback) and an institutional-level intervention (anti-racism training of providers and staff along with patient feedback to inform respectful care). | Behavioural | Change of Heart (COH) |
| COH+Includes all components of COH plus interpersonal support for Black women by Black women (community doula care, mental health services, and lactation support). | Behavioural | Change of Heart Plus (COH+) |
Primary outcome
Change in blood pressure at 6-weeks postpartum.
Time frame: At baseline and 6-weeks postpartum
Blood pressure will be measured at each time point on the upper arm three times at one-minute intervals after five minutes of quiet sitting. The investigators will use the validated Omron HEM-907XL and the appropriate size cuff. The investigators will average the three measures for analysis.
Change in blood pressure at 12-months postpartum.
Time frame: At baseline and 12-months postpartum
Blood pressure will be measured at each time point on the upper arm three times at one-minute intervals after five minutes of quiet sitting. The investigators will use the validated Omron HEM-907XL and the appropriate size cuff. The investigators will average the three measures for analysis.
Change in body weight at 6-weeks postpartum.
Time frame: At baseline and 6-weeks postpartum
Body weight will be measured in duplicate and recorded to the nearest 0.1kg using calibrated SECA scales at each time point.
Change in body weight at 12-months postpartum.
Time frame: At baseline and 12-months postpartum
Body weight will be measured in duplicate and recorded to the nearest 0.1kg using calibrated SECA scales at each time point.
23 secondary outcomes
Change in emotional support at 6-weeks postpartum.
Time frame: At baseline and 6-weeks postpartum
Change in emotional support at 12-months postpartum.
Time frame: At baseline and 12-months postpartum
Change in informational support at 6-weeks postpartum.
Time frame: At baseline and 6-weeks postpartum
Change in informational support at 12-months postpartum.
Time frame: At baseline and 12-months postpartum
Change in Perinatal Mood and Anxiety Disorders (PMADs) at 6-weeks postpartum.
Time frame: At baseline and 6-weeks postpartum
Change in PMADs at 12-months postpartum.
Time frame: At baseline and 12-months postpartum
Mothers autonomy in decision making at baseline.
Time frame: Baseline
Mothers autonomy in decision making at 6-weeks postpartum.
Time frame: 6-weeks postpartum
Respectful maternity care at baseline.
Time frame: Baseline
Respectful maternity care at 6-weeks postpartum.
Time frame: 6-weeks postpartum
Obstetric mistreatment at baseline.
Time frame: Baseline
Obstetric mistreatment at 6-weeks postpartum
Time frame: 6-weeks postpartum
Blood pressure control at 6-weeks postpartum for patients with hypertension (HTN) at baseline.
Time frame: 6-weeks postpartum
Blood pressure control at 12-months postpartum for patients with hypertension at baseline.
Time frame: 12-months postpartum
Incident hypertension at 6-weeks postpartum for patients who were normotensive at baseline.
Time frame: 6-weeks postpartum
Incident hypertension at 12-months postpartum for patients who were normotensive at baseline.
Time frame: 12-months postpartum
Breast/Chestfeeding initiation.
Time frame: 6-weeks postpartum
Breast/Chestfeeding duration.
Time frame: 12-months postpartum
Breastfeeding support/self-efficacy at 6-weeks postpartum.
Time frame: 6-weeks postpartum
Breastfeeding support/self-efficacy at 12-months postpartum.
Time frame: 12-months postpartum
Mode of delivery.
Time frame: 6-weeks postpartum
Infant birth weight.
Time frame: 6-weeks postpartum
Preterm birth.
Time frame: 6-weeks 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 5 Aug 2026.
- Derived from this study: PubMed 37734093Wycoff KL, Coleman JG, Santoro CM, Zullig LL, Darden N, Holland PM, Cruice JF, Mitchell S, Smith M, McNeil SJ, Herring SJ. Multilevel Community Engagement to Inform a Randomized Clinical Trial. Obstet Gynecol. 2023 Oct 1;142(4):929-939. doi: 10.1097/AOG.0000000000005344. Epub 2023 Sep 7.
- Individual participant dataSharing planned: Yes. Descriptions of the study dataset, including codebooks and documentation of the programming code used for creating the final study population, variable definitions, and descriptive and outcome analyses will be provided at the end of the final funding year. The investigators will make these materials, as well as the final dataset, available via the Inter-university Consortium for Political and Social Research (ICPSR, https://www.icpsr.umich.edu/web/pages/) of which Temple University is a member.
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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.
Sharon J Herring, MD, MPH principal investigator
Temple University, Philadelphia, Pennsylvania, United States, 19140
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COH and COH+ in people with Pregnancy Related and Hypertension, run by Temple 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 0 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: under way, not looking for participants, as of the sponsor's last update on 5 Aug 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?
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?
Change in blood pressure at 6-weeks postpartum. (time frame: At baseline and 6-weeks postpartum). The study lists 4 primary outcomes in all. 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 NCT05499507, 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 5 Aug 2026.