- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04580927
Breastfeeding and Postpartum Cardiovascular Health (sheMATTERS)
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Natalie Dayan, MD, MSC
- Phone Number: 76125 514-934-1934
- Email: natalie.dayan@rimuhc.ca
Study Contact Backup
- Name: Sonia Semenic, PhD
- Phone Number: 514-398-1281
- Email: sonia.semenic@mcgill.ca
Study Locations
-
-
Ontario
-
Kingston, Ontario, Canada, K7L 2V7
- Kingston General Hospital
-
-
Quebec
-
Montreal, Quebec, Canada, H3T 1E2
- Jewish General Hospital
-
Montreal, Quebec, Canada, H3T 1M5
- St Mary's Hospital
-
Montreal, Quebec, Canada, H4A 3S9
- Muhc-Rimuhc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
- 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:
i. 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.
Exclusion Criteria:
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):
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Randomized to breastfeeding self-efficacy enhancing intervention with nurse
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.
|
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.
|
No Intervention: Randomized to usual postpartum care
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.
|
|
No Intervention: Non-randomized observational arm
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 months and passive follow up until 12 months
|
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
|
6 months and passive follow up until 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Providing Exclusive Breastfeeding (weeks)
Time Frame: 6 months and passive follow up until 12 months
|
Evaluate whether a nurse-led BSE intervention will result in longer duration of exclusive breastfeeding
|
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
|
Evaluate whether a nurse-led BSE intervention will result in higher rates of any continued breastfeeding at 6 months
|
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
|
Evaluate whether a nurse-led BSE intervention will result in lower metabolic syndrome
|
6 months and passive follow up until 12 months
|
Collaborators and Investigators
Investigators
- Study Director: Natalie Dayan, MD, MSc, McGill University Health Center- Research Institute of the McGill University Health Center
- Principal Investigator: Sonia Semenic, N, PhD, Associate Professor and PhD Program Ingram School of Nursing, McGill University
- Principal Investigator: Graeme Smith, MD, PhD, Prof. Head Dept Obstetrics - Gynaecology, Dept. Biomedical and Molecular Sciences Queen's University
- Principal Investigator: Atanas Nedelchev, MD, Assistant Professor, Department of Obstetrics and Gynecology
- Principal Investigator: Haim Abenhaim, MD, MPH, Jewish General Hospital
Publications and helpful links
General 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.
- Smith 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.
- Dennis 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.
- Dennis 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.
- Grand'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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MP-37-2021-7201: she MATTERS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pregnancy Complications
-
The Cooper Health SystemRecruitingPregnancy,Neoplastic ComplicationsUnited States
-
Northwestern UniversityTerminatedPregnancy Related | Labor ComplicationUnited States
-
The George Washington University Biostatistics...Eunice Kennedy Shriver National Institute of Child Health and Human Development...Terminated
-
Oslo University HospitalRecruitingPregnancy Related | Labor Complication | Induced; BirthNorway
-
Jazz PharmaceuticalsRecruitingPregnancy | Pregnancy Complication | Maternal Complications | Birth Outcomes, AdverseUnited States
-
Washington University School of MedicineUniversity of MichiganRecruiting
-
Egas Moniz - Cooperativa de Ensino Superior, CRLCompleted
-
Thomas Jefferson UniversityCompleted
-
University Hospital Center of MartiniqueCompletedLabor Complication | CervixMartinique
-
PerspectumUniversity of Oxford; Fetal Medicine FoundationCompletedPregnancy Complications | Fetal Growth ComplicationsUnited Kingdom
Clinical Trials on Breastfeeding self-efficacy (BSE)
-
The University of Hong KongRecruiting
-
Ondokuz Mayıs UniversityNot yet recruitingSelf Efficacy | Nurse's Role | Breastfeeding, Exclusive
-
Ataturk UniversityCompleted
-
University of Maryland, College ParkCompletedChronic Pain
-
University of ZurichCompletedStress | Self EfficacySwitzerland
-
Karamanoğlu Mehmetbey UniversityKaraman Training and Research HospitalCompletedCoronary Artery DiseaseTurkey
-
Hospital for Special Surgery, New YorkRecruitingLumbar Spine Degenerative ChangesUnited States
-
Radboud University Medical CenterCompleted
-
University of British ColumbiaCompleted
-
Alexandria UniversityRecruiting