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Breastfeeding Support for High Blood Pressure Postpartum (sheMATTERS Trial)

N/A

Waitlist Available

Led By Atanas Nedelchev, MD

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

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >18 years

Participant speaks and understands English or French

Must not have

Mother has active COVID-19 infection (confirmed by positive COVID test) at time of postpartum hospitalization

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months and passive follow up until 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a breastfeeding self-efficacy intervention to improve breastfeeding outcomes and lower blood pressure in women with hypertensive disorders of pregnancy.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the intervention focuses on educational support rather than medication or medical procedures, there are no direct side effects from the treatment itself. However, general challenges related to breastfeeding may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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I can speak and understand English or French.

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I gave birth to one baby at more than 34 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My mother tested positive for COVID-19 during her postpartum hospital stay.

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I do not have a severe psychiatric illness that would stop me from participating fully in the study.

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I cannot breastfeed due to a health condition or medication I am taking.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months and passive follow up until 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months and passive follow up until 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months and passive follow up until 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants Using Antihypertensive Therapy

Number of Participants with Lower Systolic and/or diastolic BP, in mmHg.

Secondary study objectives

Number of Participants Providing Exclusive Breastfeeding (weeks)

Number of Participants that Develop Metabolic Syndrome

Proportion of Participants who Breastfeed (exclusive or non-exclusive)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Randomized to breastfeeding self-efficacy enhancing intervention with nurseExperimental Treatment1 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 careActive Control1 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 armActive Control1 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.

0 / 6Eligibility criteria met