Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Breastfeeding
  • Hypertension Pregnancy-induced
  • Hypertensive Disorder of Pregnancy
  • Pre Eclampsia
  • Pregnancy Complications
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Multi-site open-label, randomized control trial, evaluating a nurse-led breastfeeding self-efficacy enhancing intervention for women who had hypertensive disorders of pregnancy recruited at three sites in Canada. Participants that plan to breastfeed will be randomly divided into two groups: one will be given the BSE intervention, the other will not. Both groups will receive same standard postpartum care: routine postpartum hospital breastfeeding support, community breastfeeding support, and postpartum medical visits with obstetrics care provider and cardiovascular risk assessment. Participants who had high blood pressure in pregnancy and are not planning to breastfeed will not be randomized and will receive standard postpartum care excluding breastfeeding care. Outcomes for all participants will be assessed by completion of questionnaires, collecting blood pressure measurements and blood tests and long-term follow-up via linkage with administrative health data.Masking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

The present study aims to assess a nurse-led self-efficacy enhancing breastfeeding intervention in women who have HDP. We will examine whether this intervention reduces postpartum blood pressure and improves breastfeeding outcomes in these women. In the long-term, we will observe to see whether brea...

The present study aims to assess a nurse-led self-efficacy enhancing breastfeeding intervention in women who have HDP. We will examine whether this intervention reduces postpartum blood pressure and improves breastfeeding outcomes in these women. In the long-term, we will observe to see whether breastfeeding helps to lower the chance of chronic hypertension or other cardiovascular risk factors, as well as heart disease or stroke. Outcomes: All outcomes will be ascertained at the end of the study, which is at 12 months postpartum. Our primary study endpoint is systolic and/or diastolic BP, in mmHg. Secondary study endpoints: Breastfeeding outcomes: i. Duration of exclusive breastfeeding (weeks); ii. The proportion who breastfeed (exclusive or non-exclusive) at 6 months; The presence of metabolic syndrome. Additional objectives: -to evaluate whether women who breastfeed for longer are more likely to engage in cardiovascular protective behaviors such as weight reduction, healthy eating and higher levels of physical activity at 12 months postpartum; to explore the biological and psychosocial determinants of breastfeeding behaviour within 12 months postpartum, measured at the time of delivery; to assess the risk of future hospitalization or emergency room visit for any cardiovascular event or procedure within 15 years after delivery, according to: (a) breastfeeding intervention, (b) total duration of breastfeeding, and (c) other novel determinants of cardiovascular risk; to collect biosamples among women who recently had HDP, in order to advance our understanding of the different phenotypes of women and their associated cardio-metabolic risk in the short and long-term. Women who had HDP will be recruited from three participating centers. In Quebec there will be two centers: (1) McGill University Health Centre-Royal Victoria Hospital (MUHC-RVH) and (2) St. Mary's Hospital Centre (SMHC) and the third site will be in Ontario at the (3) Kingston General Hospital (KGH). Participants that plan to breastfeed will be randomly divided into two groups: usual postpartum care + BSE intervention or usual postpartum care. Participants with HDP who are not planning to breastfeed will also be invited to participate as an additional observational comparison group. Study outcomes for all participants will be assessed by completion of questionnaires, home and in-office blood pressure measurement, basic metabolic biochemical testing and long-term follow-up via linkage with administrative health data.

Tracking Information

NCT #
NCT04580927
Collaborators
  • Heart and Stroke Foundation of Canada
  • McGill University
Investigators
Study Director: Natalie Dayan, MD, MSc McGill University Health Center- Research Institute of the McGill University Health Center Principal Investigator: Sonia Semenic, N, PhD Associate Professor and PhD Program Ingram School of Nursing, McGill University Principal Investigator: Graeme Smith, MD, PhD Prof. Head Dept Obstetrics - Gynaecology, Dept. Biomedical and Molecular Sciences Queen's University Principal Investigator: Robert Hemmings, MD Associate Professor, Department of Obstetrics and Gynecology