Breastfeeding Support for High Blood Pressure Postpartum

(sheMATTERS Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if supporting new moms with breastfeeding can lower high blood pressure after pregnancy. It focuses on moms who experienced conditions like preeclampsia or gestational hypertension. Participants are divided into groups to receive either usual care or additional support from nurses to enhance their breastfeeding confidence (breastfeeding self-efficacy). This trial is ideal for moms who have recently given birth, intend to breastfeed, and have experienced high blood pressure during or after pregnancy. As an unphased trial, it offers new moms a unique opportunity to contribute to important research that could improve postpartum care.

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.

What prior data suggests that this breastfeeding self-efficacy intervention is safe for postpartum women with high blood pressure?

Research has shown that breastfeeding can lower a mother's blood pressure and reduce the risk of heart-related issues. Studies have found that women who breastfed had a systolic blood pressure nearly 6 mmHg lower than those who did not, with benefits increasing the longer they breastfed.

In one study of new mothers with high blood pressure during pregnancy, a program designed to boost confidence in breastfeeding led to a drop of 5.3 mmHg in systolic blood pressure and 3.6 mmHg in diastolic blood pressure. This suggests that increasing confidence in breastfeeding can positively affect blood pressure for these women.

Overall, encouraging breastfeeding through confidence-building programs appears safe and may help manage blood pressure after pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the breastfeeding self-efficacy (BSE) enhancing intervention because it offers a unique approach to managing high blood pressure postpartum by empowering new mothers with confidence and skills in breastfeeding. Unlike traditional methods focused solely on postpartum medical visits and routine care, this intervention involves nurse-led support that aims to strengthen mothers' belief in their ability to breastfeed effectively. This could potentially improve cardiovascular health outcomes by promoting breastfeeding, which is known to have various health benefits for both mothers and infants. By focusing on boosting self-efficacy, this approach may lead to a more holistic improvement in postpartum health.

What evidence suggests that breastfeeding self-efficacy is effective for lowering postpartum blood pressure in women with hypertensive disorders of pregnancy?

Research has shown that breastfeeding can help lower blood pressure in women who experienced high blood pressure during pregnancy. In this trial, participants may be randomized to receive a breastfeeding self-efficacy enhancing intervention with a nurse, designed to boost confidence in breastfeeding. A study in the US found that women who received support to increase their breastfeeding confidence experienced a 5.3 mmHg drop in systolic blood pressure. This is significant because lower blood pressure can reduce the risk of heart problems later on. Another study found that breastfeeding for more than six months lowered the risk of metabolic syndrome by 11%, which also helps reduce heart disease risk. These findings suggest that increasing confidence in breastfeeding might help manage blood pressure and improve heart health in new mothers with pregnancy-related high blood pressure. ^{2 3 4 5 6}

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9878496/

a randomized behavioral trial assessing the effect of a self ... A US study of 246 individuals with early or late-onset HDP who were 4 to 6 weeks postpartum found a mean decrease of 5.3 mmHg systolic (p = .03) and 3.6 mmHg ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2836562

Hypertensive Disorders of Pregnancy and Breastfeeding A few observational studies have found worse breastfeeding outcomes for women with HDP, with most of these studies conducted outside the US, ...

3. journals.sagepub.com journals.sagepub.com/doi/10.1177/08903344251369419

A Descriptive Qualitative Study of Breastfeeding ... This study aimed to explore breastfeeding challenges, enablers, and factors influencing breastfeeding confidence among individuals with ...

4. news.yale.edu news.yale.edu/2025/07/18/study-finds-link-between-hypertension-and-breastfeeding-outcomes

Study finds link between hypertension and breastfeeding ... A new Yale study suggests women with high blood pressure before and during pregnancy may benefit from targeted interventions to support breastfeeding.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12295525/

Breastfeeding Self-Efficacy in Postpartum Woman - PMC A high level of breastfeeding self-efficacy was observed in 93.7% (n = 89) of the sample, 6.3% (n = 6) exhibited a medium level, and no ...

6. withpower.com withpower.com/trial/phase-hypertension-pregnancy-induced-2-2021-9c925

Breastfeeding Support for High Blood Pressure Postpartum ... Observational data suggest that breastfeeding can lower maternal blood pressure (BP), risk of metabolic syndrome, and other markers of cardiovascular risk ...