Hypertensive Disorder of PregnancysheMATTERSNCT04580927
Breastfeeding and Postpartum Cardiovascular Health
A study testing Breastfeeding self-efficacy (BSE) in people with Hypertensive Disorder of Pregnancy and Pregnancy Complications, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 4 sites in Canada.
Trial summary
Hypertensive disorders of pregnancy (HDP) are increasingly recognized sex-specific risk factors for premature cardiovascular disease (CVD) in women. HDP, including preeclampsia and gestational hypertension, confer a 2- to 3-fold increase in the risk of chronic hypertension and ischemic heart disease 10-15 years after… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypertensive Disorder of Pregnancy, Pregnancy Complications, Pre-Eclampsia
- What is being tested?
- Breastfeeding self-efficacy (BSE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 4 sitesCanada
- Study dates
- 15 Mar 2021to Nov 2025
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years.
- Singleton live birth delivered at >34 weeks gestation.
- Mother intends to breastfeed (randomized portion)
- Breastfeeding initiated before postpartum hospital discharge (randomized portion)
- Participant speaks and understands English or French.
- Participant has a valid Medicare card (RAMQ, OHIP) at time of recruitment.
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- Participant has access to a cellular telephone to receive text messages and install a Blood Pressure Monitoring Application, and internet access to receive emails and to complete online questionnaires.
- Be available to attend in-person visits if COVID restrictions allow (resides in Montreal, Kingston or surrounding areas)
- Have AT LEAST ONE OR MORE of the criteria listed below related to the diagnosis of HDP:
- Pregnancy at or beyond 20 weeks gestation with: Two (2) recorded seated BPs taken at least 15 minutes apart during one medical visit measuring >140 mmHg systolic AND/OR >90 mmHg diastolic AND Recorded elevated BP is present at more than one consecutive medical visit ii. Women who during antenatal visits were prescribed antihypertensive medication, OR received a diagnosis of chronic or gestational hypertension iii. Women who during labor and delivery, had two (2) or more BP measurements >140 mmHg systolic or >90 mmHg diastolic at least 15 minutes apart or who were prescribed antihypertensive medication iv. Women who during labor and delivery received a diagnosis of preeclampsia v. Women with new-onset hypertension as defined above, and/or preeclampsia and/or pre-existing hypertension readmitted within 1 week of postnatal hospital discharge with elevated blood pressure.
Who cannot join
- Exclusion criteria from randomized trial portion of the study:
- Maternal absolute contraindication to breastfeeding (e.g., mother taking medication for which breastfeeding is contraindicated , or mother is infected with human immunodeficiency virus, HTLV-1, active tuberculosis, active herpes simplex on the breast, or Ebola, or mother is a cocaine or phencyclidine user).
- Maternal condition that interferes with breastfeeding (e.g., breast reduction, or breast augmentation surgery due to hypoplastic mammary tissue. Uncomplicated breast augmentation surgery is not an exclusion criterion).
- Neonatal absolute contraindication to breastfeeding (Galactosemia)
- Neonatal condition that interferes with breastfeeding (e.g., cleft palate).
- Exclusion criteria from randomized OR observational portion of the study (including non-randomized arm):
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- Infant born before 34 weeks gestation.
- Maternal intensive care unit (ICU) admission lasting >24 hours.
- Severe or uncontrolled psychiatric illness in the mother that would preclude active engagement in the study. These include schizophrenia or other psychotic disorder; uncontrolled bipolar disorder; major depressive episode within the last year, or history of major depressive disorder requiring hospitalization at any point; substance abuse disorder; any previous suicide attempt.
- Mother has active COVID-19 infection (confirmed by positive COVID test) at time of postpartum hospitalization.
- Previous BP-MOM participant (ISRCTN85493925, www.isrctn.com)
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Kingston General Hospital
Kingston, Ontario, K7L 2V7
Jewish General Hospital
Montreal, Quebec, H3T 1E2
St Mary's Hospital
Montreal, Quebec, H3T 1M5
Muhc-Rimuhc
Montreal, Quebec, H4A 3S9
About this study
Official title: Improving Cardiovascular Health in New Mothers: Multi-Centre Open-Label Randomized Trial of a Breastfeeding Intervention to Improve Breastfeeding Practices and Lower Blood Pressure in Women With Hypertensive Disorders of Pregnancy
Hypertensive disorders of pregnancy (HDP) are increasingly recognized sex-specific risk factors for premature cardiovascular disease (CVD) in women. HDP, including preeclampsia and gestational hypertension, confer a 2- to 3-fold increase in the risk of chronic hypertension and ischemic heart disease 10-15 years after delivery. Observational data suggest that breastfeeding can lower maternal blood pressure (BP), risk of metabolic syndrome, and other markers of cardiovascular risk in the short term and long term, possibly by helping to re-set the metabolic changes of pregnancy. The investigators recently demonstrated an 11% reduction in the risk of metabolic syndrome among postpartum women with a variety of complications in pregnancy, including HDP, who breastfed for > 6 months, compared to those who did not breastfeed and those who breastfed for shorter durations. An analysis of 622 postpartum women at Kingston General Hospital showed that breastfeeding women had nearly a 6-mmHg lower systolic BP than women who did not breastfeed with an apparent dose-response effect of breastfeeding duration. Women with pregnancy complications including HDP are vulnerable to early weaning. Interactive, multi-modal approaches targeting a mother's breastfeeding self-efficacy (i.e., confidence about breastfeeding) have been effective in healthy postpartum women. However, these have not yet been tested specifically in HDP women, who stand to derive substantial benefit from breastfeeding. This is an important area to study since nurse-led breastfeeding supportive interventions can be widely applied to the postpartum care of women with HDP and can be integrated into comprehensive CVD risk reduction programs for these women. The primary outcome is postpartum BP, since hypertension is a key mediating factor in women's heart health. The investigators conducted a feasibility study of a breastfeeding self-efficacy intervention to enhance breastfeeding outcomes among women with HDP achieving pre-defined targets of a recruitment rate of >50% , attrition rates of < 30%, and > 70% participant satisfaction with the intervention, measured at the 6-month time point. Additionally, data showed trends in both systolic and diastolic BP favoring the intervention group. The current study is a multi-site open-label randomized trial to assess for a difference in blood pressure and breastfeeding between groups, and to serve as a cohort of HDP women for longitudinal follow-up.
Read the detailed description
The present study aims to assess a nurse-led self-efficacy enhancing breastfeeding intervention in women who have HDP. The investigators will examine whether this intervention reduces postpartum blood pressure and improves breastfeeding outcomes in these women. In the long-term, the investigators will observe to see whether breastfeeding helps to lower the chance of chronic hypertension or other cardiovascular risk factors, as well as heart disease or stroke.
Outcomes:
As per study protocol amendment approved by the RI-MUHC Research Ethics Board on July 2023, all study aims (with the exception of the exploratory ones such as Objective 8, Biomarkers) now address an active 6-months follow up period, and a passive 12-months follow up allowing a shorter time for data analysis and study completion. This modification will align the end of study with the availability of funding resources.
Previously, it was stated that "All outcomes will be ascertained at the end of the study, which is at 12 months postpartum."
The primary study endpoint is systolic and/or diastolic BP, in mmHg.
Secondary study endpoints:
- Breastfeeding outcomes: i. Duration of exclusive breastfeeding (weeks); ii. The proportion who breastfeed (exclusive or non-exclusive) at 6 months;
- The presence of metabolic syndrome.
Additional objectives:
-to evaluate whether women who breastfeed for longer are more likely to engage in cardiovascular protective behaviors such as weight reduction, healthy eating and higher levels of physical activity at 12 months postpartum; to explore the biological and psychosocial determinants of breastfeeding behaviour within 12 months postpartum, measured at the time of delivery; to assess the risk of future hospitalization or emergency room visit for any cardiovascular event or procedure within 15 years after delivery, according to: (a) breastfeeding intervention, (b) total duration of breastfeeding, and (c) other novel determinants of cardiovascular risk; to collect biosamples among women who recently had HDP, in order to advance on the understanding of the different phenotypes of women and their associated cardio-metabolic risk in the short and long-term.
Women who had HDP will be recruited from three participating centers. In Quebec there will be three (previously two) centers: (1) McGill University Health Centre-Royal Victoria Hospital (MUHC-RVH) and (2) St. Mary's Hospital Centre (SMHC) and the Jewish General Hospital (JGH), the fourth (previously third) site will be in Ontario at the (3) Kingston General Hospital (KGH). Participants that plan to breastfeed will be randomly divided into two groups: usual postpartum care + BSE intervention or usual postpartum care. Participants with HDP who are not planning to breastfeed will also be invited to participate as an additional observational comparison group. Study outcomes for all participants will be assessed by completion of questionnaires, home and in-office blood pressure measurement, basic metabolic biochemical testing and long-term follow-up via linkage with administrative health data.
NOTE: The pandemic and other factors have led to delays in approvals at different sites, and associated challenges with recruitment. Due to these delays and funding deadlines, we revised sample size calculation with more realistic and less stringent assumptions. Sample size was modified from 323 to 221. This modification was approved by the RI-MUHC Research Ethics Board on July 2023
- Conditions
- Hypertensive Disorder of Pregnancy, Pregnancy Complications, Pre-Eclampsia, Hypertension, Pregnancy-Induced, Breastfeeding
- Being tested
- Breastfeeding self-efficacy (BSE)
- Medical subject headings
- Toxemia, Pregnancy Complications, Pre-Eclampsia, Hypertension, Pregnancy-Induced, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breastfeeding self-efficacy (BSE)Behavioural
Self-efficacy is determined by factors such as prior experience, vicarious learning, persuasion of others and physiological state, which in turn impact on one's behaviours and actions. One's sense of self-efficacy is modifiable, and can be readily targeted for intervention. An increasingly studied key determinant of breastfeeding outcomes is breastfeeding confidence, also referred to as breastfeeding self-efficacy (BSE). The investigators will use a nurse-administered validated BSE intervention tool.
| Study group | Role | What they receive |
|---|---|---|
| Randomized to breastfeeding self-efficacy enhancing intervention with nurse | Experimental | Participants receiving breastfeeding self-efficacy enhancing nurse-led intervention plus postpartum standard of care consisting of postpartum medical visits with their obstetrics care provider and for cardiovascular risk assessment, routine postpartum hospital breastfeeding support, as-needed community breastfeeding support, and postpartum medical visits with their obstetrics care provider and for cardiovascular risk assessment. Receives: Behavioral: Breastfeeding self-efficacy (BSE) |
| Randomized to usual postpartum care | No intervention | Participants receiving postpartum standard of care consisting of postpartum medical visits with their obstetrics care provider and for cardiovascular risk assessment, routine postpartum hospital breastfeeding support, as-needed community breastfeeding support, and postpartum medical visits with their obstetrics care provider and for cardiovascular risk assessment. |
| Non-randomized observational arm | No intervention | Participants who are not planning to breastfeed receiving postpartum standard of care consisting of postpartum medical visits with their obstetrics care provider and for cardiovascular risk assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Lower Systolic and/or diastolic BP, in mmHg.
Evaluate whether a nurse-led BSE intervention will result in a lower systolic and/or diastolic BP 6 months (and passive follow up to 12 months) postpartum
Measured: 6 months and passive follow up until 12 months
Number of Participants Using Antihypertensive Therapy
Evaluate whether a nurse-led BSE intervention will result in a lower need for antihypertensive therapy
Measured: 6 months and passive follow up until 12 months
Secondary outcomes (3)
Number of Participants Providing Exclusive Breastfeeding (weeks)
Evaluate whether a nurse-led BSE intervention will result in longer duration of exclusive breastfeeding
Measured: 6 months and passive follow up until 12 months
Proportion of Participants who Breastfeed (exclusive or non-exclusive)
Evaluate whether a nurse-led BSE intervention will result in higher rates of any continued breastfeeding at 6 months
Measured: 6 months and passive follow up until 12 months
Number of Participants that Develop Metabolic Syndrome
Evaluate whether a nurse-led BSE intervention will result in lower metabolic syndrome
Measured: 6 months and passive follow up until 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start15 Mar 2021
- Primary completionAug 2024 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hypertensive Disorder of PregnancyStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-site open-label, randomized control trial, evaluating a nurse-led breastfeeding self-efficacy enhancing intervention for women who had hypertensive disorders of pregnancy recruited at three sites in Canada. Participants that plan to breastfeed will be randomly divided into two groups: one will be given the BSE intervention, the other will not. Both groups will receive same standard postpartum care: routine postpartum hospital breastfeeding support, community breastfeeding support, and postpartum medical visits with obstetrics care provider and cardiovascular risk assessment. Participants who had high blood pressure in pregnancy and are not planning to breastfeed will not be randomized and will receive standard postpartum care excluding breastfeeding care. Outcomes for all participants will be assessed by completion of questionnaires, collecting blood pressure measurements and blood tests and long-term follow-up via linkage with administrative health data.
- Masking
- None (open label)
- Enrolment
- 221 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, McGill University
- Responsible party
- Principal investigator, Natalie Dayan, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Natalie Dayan, MD, MSc, Study director, McGill University Health Center- Research Institute of the McGill University Health CenterSonia Semenic, N, PhD, Principal investigator, Associate Professor and PhD Program Ingram School of Nursing, McGill UniversityGraeme Smith, MD, PhD, Principal investigator, Prof. Head Dept Obstetrics - Gynaecology, Dept. Biomedical and Molecular Sciences Queen's UniversityAtanas Nedelchev, MD, Principal investigator, Assistant Professor, Department of Obstetrics and GynecologyHaim Abenhaim, MD, MPH, Principal investigator, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580927
- Sponsor's protocol ID
- MP-37-2021-7201: she MATTERS
- Acronym
- sheMATTERS
- Status last verified
- Mar 2024
- First submitted
- 2 Oct 2020
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The plan to share is not defined yet
Publications
Yu J, Pudwell J, Dayan N, Smith GN. Postpartum Breastfeeding and Cardiovascular Risk Assessment in Women Following Pregnancy Complications. J Womens Health (Larchmt). 2020 May;29(5):627-635. doi: 10.1089/jwh.2019.7894. Epub 2019 Dec 3.
PubMed 31800357Smith GN, Pudwell J, Roddy M. The Maternal Health Clinic: a new window of opportunity for early heart disease risk screening and intervention for women with pregnancy complications. J Obstet Gynaecol Can. 2013 Sep;35(9):831-839. doi: 10.1016/S1701-2163(15)30841-0. No abstract available.
PubMed 24099450Dennis CL. Theoretical underpinnings of breastfeeding confidence: a self-efficacy framework. J Hum Lact. 1999 Sep;15(3):195-201. doi: 10.1177/089033449901500303. No abstract available.
PubMed 10578797Dennis CL, McQueen K. The relationship between infant-feeding outcomes and postpartum depression: a qualitative systematic review. Pediatrics. 2009 Apr;123(4):e736-51. doi: 10.1542/peds.2008-1629.
PubMed 19336362Grand'Maison S, Pilote L, Okano M, Landry T, Dayan N. Markers of Vascular Dysfunction After Hypertensive Disorders of Pregnancy: A Systematic Review and Meta-Analysis. Hypertension. 2016 Dec;68(6):1447-1458. doi: 10.1161/HYPERTENSIONAHA.116.07907. Epub 2016 Oct 17.
PubMed 27754864Dayan N, Smith G, Nedelchev A, Abenhaim H, Brown R, Da Costa D, Ali S, Perlman J, Nguyen TV, Dennis CL, Abdelmageed W, Semenic S. Study protocol for the sheMATTERS study (iMproving cArdiovascular healTh in new moThERS): a randomized behavioral trial assessing the effect of a self-efficacy enhancing breastfeeding intervention on postpartum blood pressure and breastfeeding continuation in women with hypertensive disorders of pregnancy. BMC Pregnancy Childbirth. 2023 Jan 26;23(1):68. doi: 10.1186/s12884-022-05325-3.
PubMed 36703104
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Cardiovascular Health in New Mothers: Multi-Centre Open-Label Randomized Trial of a Breastfeeding Intervention to Improve Breastfeeding Practices and Lower Blood Pressure in Women With Hypertensive Disorders of Pregnancy
- ClinicalTrials.gov ID
- NCT04580927
- Acronym / sponsor ID
- sheMATTERS / MP-37-2021-7201: she MATTERS
- Conditions
- Hypertensive Disorder of Pregnancy, Pregnancy Complications, Pre-Eclampsia, Hypertension, Pregnancy-Induced, Breastfeeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 221 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, McGill University
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 9 Oct 2020 (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.
Hypertensive disorders of pregnancy (HDP) are increasingly recognized sex-specific risk factors for premature cardiovascular disease (CVD) in women. HDP, including preeclampsia and gestational hypertension, confer a 2- to 3-fold increase in the risk of chronic hypertension and ischemic heart disease 10-15 years after delivery. Observational data suggest that breastfeeding can lower maternal blood pressure (BP), risk of metabolic syndrome, and other markers of cardiovascular risk in the short term and long term, possibly by helping to re-set the metabolic changes of pregnancy. The investigators recently demonstrated an 11% reduction in the risk of metabolic syndrome among postpartum women with a variety of complications in pregnancy, including HDP, who breastfed for > 6 months, compared to those who did not breastfeed and those who breastfed for shorter durations. An analysis of 622 postpartum women at Kingston General Hospital showed that breastfeeding women had nearly a 6-mmHg lower systolic BP than women who did not breastfeed with an apparent dose-response effect of breastfeeding duration. Women with pregnancy complications including HDP are vulnerable to early weaning. Interactive, multi-modal approaches targeting a mother's breastfeeding self-efficacy (i.e., confidence about breastfeeding) have been effective in healthy postpartum women. However, these have not yet been tested specifically in HDP women, who stand to derive substantial benefit from breastfeeding. This is an important area to study since nurse-led breastfeeding supportive interventions can be widely applied to the postpartum care of women with HDP and can be integrated into comprehensive CVD risk reduction programs for these women. The primary outcome is postpartum BP, since hypertension is a key mediating factor in women's heart health. The investigators conducted a feasibility study of a breastfeeding self-efficacy intervention to enhance breastfeeding outcomes among women with HDP achieving pre-defined targets of a recruitment rate of >50% , attrition rates of < 30%, and > 70% participant satisfaction with the intervention, measured at the 6-month time point. Additionally, data showed trends in both systolic and diastolic BP favoring the intervention group. The current study is a multi-site open-label randomized trial to assess for a difference in blood pressure and breastfeeding between groups, and to serve as a cohort of HDP women for longitudinal follow-up.
Detailed description
The present study aims to assess a nurse-led self-efficacy enhancing breastfeeding intervention in women who have HDP. The investigators will examine whether this intervention reduces postpartum blood pressure and improves breastfeeding outcomes in these women. In the long-term, the investigators will observe to see whether breastfeeding helps to lower the chance of chronic hypertension or other cardiovascular risk factors, as well as heart disease or stroke.
Outcomes:
As per study protocol amendment approved by the RI-MUHC Research Ethics Board on July 2023, all study aims (with the exception of the exploratory ones such as Objective 8, Biomarkers) now address an active 6-months follow up period, and a passive 12-months follow up allowing a shorter time for data analysis and study completion. This modification will align the end of study with the availability of funding resources.
Previously, it was stated that "All outcomes will be ascertained at the end of the study, which is at 12 months postpartum."
The primary study endpoint is systolic and/or diastolic BP, in mmHg.
Secondary study endpoints:
- Breastfeeding outcomes: i. Duration of exclusive breastfeeding (weeks); ii. The proportion who breastfeed (exclusive or non-exclusive) at 6 months;
- The presence of metabolic syndrome.
Additional objectives:
-to evaluate whether women who breastfeed for longer are more likely to engage in cardiovascular protective behaviors such as weight reduction, healthy eating and higher levels of physical activity at 12 months postpartum; to explore the biological and psychosocial determinants of breastfeeding behaviour within 12 months postpartum, measured at the time of delivery; to assess the risk of future hospitalization or emergency room visit for any cardiovascular event or procedure within 15 years after delivery, according to: (a) breastfeeding intervention, (b) total duration of breastfeeding, and (c) other novel determinants of cardiovascular risk; to collect biosamples among women who recently had HDP, in order to advance on the understanding of the different phenotypes of women and their associated cardio-metabolic risk in the short and long-term.
Women who had HDP will be recruited from three participating centers. In Quebec there will be three (previously two) centers: (1) McGill University Health Centre-Royal Victoria Hospital (MUHC-RVH) and (2) St. Mary's Hospital Centre (SMHC) and the Jewish General Hospital (JGH), the fourth (previously third) site will be in Ontario at the (3) Kingston General Hospital (KGH). Participants that plan to breastfeed will be randomly divided into two groups: usual postpartum care + BSE intervention or usual postpartum care. Participants with HDP who are not planning to breastfeed will also be invited to participate as an additional observational comparison group. Study outcomes for all participants will be assessed by completion of questionnaires, home and in-office blood pressure measurement, basic metabolic biochemical testing and long-term follow-up via linkage with administrative health data.
NOTE: The pandemic and other factors have led to delays in approvals at different sites, and associated challenges with recruitment. Due to these delays and funding deadlines, we revised sample size calculation with more realistic and less stringent assumptions. Sample size was modified from 323 to 221. This modification was approved by the RI-MUHC Research Ethics Board on July 2023
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Multi-site open-label, randomized control trial, evaluating a nurse-led breastfeeding self-efficacy enhancing intervention for women who had hypertensive disorders of pregnancy recruited at three sites in Canada. Participants that plan to breastfeed will be randomly divided into two groups: one will be given the BSE intervention, the other will not. Both groups will receive same standard postpartum care: routine postpartum hospital breastfeeding support, community breastfeeding support, and postpartum medical visits with obstetrics care provider and cardiovascular risk assessment. Participants who had high blood pressure in pregnancy and are not planning to breastfeed will not be randomized and will receive standard postpartum care excluding breastfeeding care. Outcomes for all participants will be assessed by completion of questionnaires, collecting blood pressure measurements and blood tests and long-term follow-up via linkage with administrative health data.
| Arm | Type | Receives |
|---|---|---|
| Randomized to breastfeeding self-efficacy enhancing intervention with nurse | Experimental | Behavioral: Breastfeeding self-efficacy (BSE)Participants receiving breastfeeding self-efficacy enhancing nurse-led intervention plus postpartum standard of care consisting of postpartum medical visits with their obstetrics care provider and for cardiovascular risk assessment, routine postpartum hospital breastfeeding support, as-needed community breastfeeding support, and postpartum medical visits with their obstetrics care provider and for cardiovascular risk assessment. |
| Randomized to usual postpartum care | No intervention | –Participants receiving postpartum standard of care consisting of postpartum medical visits with their obstetrics care provider and for cardiovascular risk assessment, routine postpartum hospital breastfeeding support, as-needed community breastfeeding support, and postpartum medical visits with their obstetrics care provider and for cardiovascular risk assessment. |
| Non-randomized observational arm | No intervention | –Participants who are not planning to breastfeed receiving postpartum standard of care consisting of postpartum medical visits with their obstetrics care provider and for cardiovascular risk assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age >18 years.
- Singleton live birth delivered at >34 weeks gestation.
- Mother intends to breastfeed (randomized portion)
- Breastfeeding initiated before postpartum hospital discharge (randomized portion)
- Participant speaks and understands English or French.
Key exclusion criteria (11 listed)
- Maternal absolute contraindication to breastfeeding (e.g., mother taking medication for which breastfeeding is contraindicated , or mother is infected with human immunodeficiency virus, HTLV-1, active tuberculosis, active herpes simplex on the breast, or Ebola, or mother is a cocaine or phencyclidine user).
- Maternal condition that interferes with breastfeeding (e.g., breast reduction, or breast augmentation surgery due to hypoplastic mammary tissue. Uncomplicated breast augmentation surgery is not an exclusion criterion).
- Neonatal absolute contraindication to breastfeeding (Galactosemia)
- Neonatal condition that interferes with breastfeeding (e.g., cleft palate).
- Exclusion criteria from randomized OR observational portion of the study (including non-randomized arm):
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 |
|---|---|---|
| Breastfeeding self-efficacy (BSE)Self-efficacy is determined by factors such as prior experience, vicarious learning, persuasion of others and physiological state, which in turn impact on one's behaviours and actions. One's sense of self-efficacy is modifiable, and can be readily targeted for intervention. An increasingly studied key determinant of breastfeeding outcomes is breastfeeding confidence, also referred to as breastfeeding self-efficacy (BSE). The investigators will use a nurse-administered validated BSE intervention tool. | Behavioural | Randomized to breastfeeding self-efficacy enhancing intervention with nurse |
Primary outcome
Number of Participants with Lower Systolic and/or diastolic BP, in mmHg.
Time frame: 6 months and passive follow up until 12 months
Evaluate whether a nurse-led BSE intervention will result in a lower systolic and/or diastolic BP 6 months (and passive follow up to 12 months) postpartum
Number of Participants Using Antihypertensive Therapy
Time frame: 6 months and passive follow up until 12 months
Evaluate whether a nurse-led BSE intervention will result in a lower need for antihypertensive therapy
3 secondary outcomes
Number of Participants Providing Exclusive Breastfeeding (weeks)
Time frame: 6 months and passive follow up until 12 months
Proportion of Participants who Breastfeed (exclusive or non-exclusive)
Time frame: 6 months and passive follow up until 12 months
Number of Participants that Develop Metabolic Syndrome
Time frame: 6 months and passive follow up until 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Results publication: PubMed 31800357Yu J, Pudwell J, Dayan N, Smith GN. Postpartum Breastfeeding and Cardiovascular Risk Assessment in Women Following Pregnancy Complications. J Womens Health (Larchmt). 2020 May;29(5):627-635. doi: 10.1089/jwh.2019.7894. Epub 2019 Dec 3.
- Results publication: PubMed 24099450Smith GN, Pudwell J, Roddy M. The Maternal Health Clinic: a new window of opportunity for early heart disease risk screening and intervention for women with pregnancy complications. J Obstet Gynaecol Can. 2013 Sep;35(9):831-839. doi: 10.1016/S1701-2163(15)30841-0. No abstract available.
- Results publication: PubMed 10578797Dennis CL. Theoretical underpinnings of breastfeeding confidence: a self-efficacy framework. J Hum Lact. 1999 Sep;15(3):195-201. doi: 10.1177/089033449901500303. No abstract available.
- Results publication: PubMed 19336362Dennis CL, McQueen K. The relationship between infant-feeding outcomes and postpartum depression: a qualitative systematic review. Pediatrics. 2009 Apr;123(4):e736-51. doi: 10.1542/peds.2008-1629.
- Results publication: PubMed 27754864Grand'Maison S, Pilote L, Okano M, Landry T, Dayan N. Markers of Vascular Dysfunction After Hypertensive Disorders of Pregnancy: A Systematic Review and Meta-Analysis. Hypertension. 2016 Dec;68(6):1447-1458. doi: 10.1161/HYPERTENSIONAHA.116.07907. Epub 2016 Oct 17.
- Derived from this study: PubMed 36703104Dayan N, Smith G, Nedelchev A, Abenhaim H, Brown R, Da Costa D, Ali S, Perlman J, Nguyen TV, Dennis CL, Abdelmageed W, Semenic S. Study protocol for the sheMATTERS study (iMproving cArdiovascular healTh in new moThERS): a randomized behavioral trial assessing the effect of a self-efficacy enhancing breastfeeding intervention on postpartum blood pressure and breastfeeding continuation in women with hypertensive disorders of pregnancy. BMC Pregnancy Childbirth. 2023 Jan 26;23(1):68. doi: 10.1186/s12884-022-05325-3.
- Individual participant dataSharing planned: No. The plan to share is not defined yet
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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.
Natalie Dayan, MD, MSc study director
McGill University Health Center- Research Institute of the McGill University Health Center
Sonia Semenic, N, PhD principal investigator
Associate Professor and PhD Program Ingram School of Nursing, McGill University
Graeme Smith, MD, PhD principal investigator
Prof. Head Dept Obstetrics - Gynaecology, Dept. Biomedical and Molecular Sciences Queen's University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breastfeeding self-efficacy (BSE) in people with Hypertensive Disorder of Pregnancy and Pregnancy Complications, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 4 sites in Canada.
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 10 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. 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?
Results are not available in the source record.
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?
Number of Participants with Lower Systolic and/or diastolic BP, in mmHg. (time frame: 6 months and passive follow up until 12 months). The study lists 2 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 NCT04580927, which also lists 6 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 25 Mar 2024.