Breastfeeding Support for High Blood Pressure Postpartum

(sheMATTERS Trial)

Recruiting at 3 trial locations

Overseen By Sonia Semenic, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Must be taking: Antihypertensives

Must not be taking: Cocaine, Phencyclidine

Disqualifiers: HIV, Tuberculosis, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

221 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking medication that makes breastfeeding unsafe, you may not be eligible to participate.

Is breastfeeding self-efficacy intervention safe for humans?

The research on breastfeeding self-efficacy interventions focuses on improving mothers' confidence and success in breastfeeding, and there are no reports of safety concerns for humans in the studies reviewed. ^{1 2 3 4 5}

How does the breastfeeding support treatment for high blood pressure postpartum differ from other treatments?

This treatment is unique because it focuses on increasing breastfeeding self-efficacy (confidence in one's ability to breastfeed), which can indirectly help manage high blood pressure postpartum by promoting sustained breastfeeding. Unlike traditional medical treatments for high blood pressure, this approach emphasizes psychological support and education to improve breastfeeding success. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Breastfeeding self-efficacy (BSE) for high blood pressure postpartum?

Research shows that interventions to boost breastfeeding self-efficacy help mothers breastfeed more successfully, which can improve overall health. While not directly linked to high blood pressure, better breastfeeding practices may contribute to improved postpartum health. ^{2 3 6 7 11}

Who Is on the Research Team?

Natalie Dayan, MD, MSc

Principal Investigator

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

Atanas Nedelchev, MD

Principal Investigator

Assistant Professor, Department of Obstetrics and Gynecology

Haim Abenhaim, MD, MPH

Principal Investigator

Jewish General Hospital

Are You a Good Fit for This Trial?

This trial is for women over 18 who've given birth to a single baby at or after 34 weeks, plan and have started breastfeeding, speak English or French, have health coverage (RAMQ/OHIP), can use a cellphone with internet for BP monitoring and live near Montreal/Kingston. It's not for those with conditions that prevent breastfeeding, severe mental illness, substance abuse issues, COVID-19 during hospitalization or specific neonatal complications.

Inclusion Criteria

Mother intends to breastfeed (randomized portion)

Breastfeeding initiated before postpartum hospital discharge (randomized portion)

I am older than 18 years.

Exclusion Criteria

You have participated in a previous study with the identifier ISRCTN85493925.

I have a condition that prevents me from breastfeeding, not including simple breast augmentation.

You have a condition that makes it hard for you to breastfeed as a newborn, like a cleft palate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a nurse-led breastfeeding self-efficacy intervention to improve breastfeeding practices and lower blood pressure

6 months

Regular postpartum medical visits and breastfeeding support

Follow-up

Participants are monitored for blood pressure and breastfeeding outcomes, with passive follow-up for cardiovascular risk factors

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Breastfeeding self-efficacy (BSE)

Trial Overview The study tests if boosting mothers' confidence in breastfeeding (breastfeeding self-efficacy) can help lower blood pressure postpartum among women who had high blood pressure disorders during pregnancy. The goal is to see if this intervention could be part of heart disease risk reduction programs.

How Is the Trial Designed?

Group I: Randomized to breastfeeding self-efficacy enhancing intervention with nurse Experimental Treatment 1 Intervention

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.

Group II: Randomized to usual postpartum care Active Control 1 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.

Group III: Non-randomized observational arm Active Control 1 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 Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

Trials

476

Recruited

170,000+

McGill University

Collaborator

Trials

421

Recruited

1,017,000+

Heart and Stroke Foundation of Canada

Collaborator

Trials

131

Recruited

72,600+

Citations

1. Pakistan pubmed.ncbi.nlm.nih.gov

The effectiveness of breastfeeding self-efficacy intervention on implementation of breastfeeding in low-birth-weight infants: A systematic review. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Effectiveness of an integrated breastfeeding education program to improve self-efficacy and exclusive breastfeeding rate: A single-blind, randomised controlled study. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness of theory-based educational interventions on breastfeeding self-efficacy and exclusive breastfeeding: A systematic review and meta-analysis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Predictors of Breastfeeding Confidence in the Early Postpartum Period. [2018]

5. Brazil pubmed.ncbi.nlm.nih.gov

Telephone intervention in the promotion of self-efficacy, duration and exclusivity of breastfeeding: randomized controlled trial. [2022]

6. Scotland pubmed.ncbi.nlm.nih.gov

Translation and psychometric assessment of the Breast-feeding Self-Efficacy Scale-Short Form among pregnant and postnatal women in Turkey. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The Effect of Educational Intervention on Improvement of Breastfeeding Self-Efficacy: A Systematic Review and Meta-Analysis. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Interventions to Improve Breastfeeding Self-Efficacy and Resultant Breastfeeding Rates: A Systematic Review and Meta-Analysis. [2022]

9. England pubmed.ncbi.nlm.nih.gov

The significance of early breastfeeding experiences on breastfeeding self-efficacy one week postpartum. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Effectiveness of a brief motivational intervention to increase the breastfeeding duration in the first 6 months postpartum: Randomized controlled trial. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Psychometric properties of the Breastfeeding Self-Efficacy Scale-Short Form in an ethnically diverse U.K. sample. [2022]