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Breastfeeding Support for High Blood Pressure Postpartum (sheMATTERS Trial)

N/A
Recruiting
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 has a valid Medicare card (RAMQ, OHIP) at time of recruitment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

sheMATTERS Trial 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.Check my eligibility
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.See study design
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.

sheMATTERS Trial 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 have a valid Medicare card.
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I can speak and understand English or French.
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I meet one or more criteria for high blood pressure during pregnancy.
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I gave birth to one baby at more than 34 weeks.

sheMATTERS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Using Antihypertensive Therapy
Number of Participants with Lower Systolic and/or diastolic BP, in mmHg.
Secondary outcome measures
Number of Participants Providing Exclusive Breastfeeding (weeks)
Number of Participants that Develop Metabolic Syndrome
Proportion of Participants who Breastfeed (exclusive or non-exclusive)

sheMATTERS 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: 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.
Group III: 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.

Find a Location

Who is running the clinical trial?

McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
440 Previous Clinical Trials
158,795 Total Patients Enrolled
Heart and Stroke Foundation of CanadaOTHER
122 Previous Clinical Trials
71,885 Total Patients Enrolled
McGill UniversityOTHER
392 Previous Clinical Trials
984,286 Total Patients Enrolled

Media Library

Breastfeeding self-efficacy (BSE) Clinical Trial Eligibility Overview. Trial Name: NCT04580927 — N/A
Pre-eclampsia Research Study Groups: Non-randomized observational arm, Randomized to breastfeeding self-efficacy enhancing intervention with nurse, Randomized to usual postpartum care
Breastfeeding self-efficacy (BSE) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04580927 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do you currently have any openings for participants in this research project?

"Affirmative. Information posted on clinicaltrials.gov indicates that this medical research project is presently recruiting participants, having been initially published on March 15th 2021 and edited lastly on August 27th 2021. 323 individuals are needed to be enrolled across two sites."

Answered by AI

What is the current patient capacity of this medical research study?

"Affirmative. According to the listings on clinicaltrials.gov, this medical experiment is recruiting now - it was initially posted on March 15th 2021 and last edited on August 27th 2021. The study requires 323 participants from 2 different locations."

Answered by AI
Recent research and studies
~81 spots leftby Mar 2025