Breastfeeding and Postpartum Cardiovascular Health

Summary

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.

Conditions

• Hypertensive Disorder of Pregnancy
• Pregnancy Complications
• Pre-Eclampsia
• Hypertension, Pregnancy-Induced
• Breastfeeding

Interventions

BEHAVIORAL

Breastfeeding self-efficacy (BSE)

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.

Sponsors & Collaborators

• Heart and Stroke Foundation of Canada

  collaborator OTHER

• McGill University

  collaborator OTHER

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

  lead OTHER

Principal Investigators

• Natalie Dayan, MD, MSc · McGill University Health Center- Research Institute of the McGill University Health Center

• Sonia Semenic, N, PhD · Associate Professor and PhD Program Ingram School of Nursing, McGill University

• Graeme Smith, MD, PhD · Prof. Head Dept Obstetrics - Gynaecology, Dept. Biomedical and Molecular Sciences Queen's University

• Atanas Nedelchev, MD · Assistant Professor, Department of Obstetrics and Gynecology

• Haim Abenhaim, MD, MPH · Jewish General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-15

Primary Completion

2024-08-31

Completion

2025-11-30

Countries

• Canada

Study Locations