Breastfeeding and Postpartum Cardiovascular Health

NCT04580927 | Active Not Recruiting

• 1 other identifier: MP-37-2021-7201: she MATTERS
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 4

Brief 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

Outcome Measures

Primary Outcomes (2)

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

  Evaluate whether a nurse-led BSE intervention will result in a lower systolic and/or diastolic BP 6 months (and passive follow up to 12 months) postpartum

  6 months and passive follow up until 12 months

• Number of Participants Using Antihypertensive Therapy

  Evaluate whether a nurse-led BSE intervention will result in a lower need for antihypertensive therapy

  6 months and passive follow up until 12 months

Secondary Outcomes (3)

• Number of Participants Providing Exclusive Breastfeeding (weeks)

  6 months and passive follow up until 12 months

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

  6 months and passive follow up until 12 months

• Number of Participants that Develop Metabolic Syndrome

  6 months and passive follow up until 12 months

Study Arms (3)

Randomized to breastfeeding self-efficacy enhancing intervention with nurse

EXPERIMENTAL

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.

Behavioral: Breastfeeding self-efficacy (BSE)

Randomized to usual postpartum care

NO 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.

Non-randomized observational arm

NO 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.

Interventions

Breastfeeding self-efficacy (BSE) BEHAVIORAL

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.

Randomized to breastfeeding self-efficacy enhancing intervention with nurse

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women who had high blood pressure in pregnancy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years.
• Singleton live birth delivered at \>34 weeks gestation.
• Mother intends to breastfeed (randomized portion)
• Breastfeeding initiated before postpartum hospital discharge (randomized portion)
• Participant speaks and understands English or French.
• Participant has a valid Medicare card (RAMQ, OHIP) at time of recruitment.
• Participant has access to a cellular telephone to receive text messages and install a Blood Pressure Monitoring Application, and internet access to receive emails and to complete online questionnaires.
• Be available to attend in-person visits if COVID restrictions allow (resides in Montreal, Kingston or surrounding areas)
• Have AT LEAST ONE OR MORE of the criteria listed below related to the diagnosis of HDP:
• i. Pregnancy at or beyond 20 weeks gestation with: Two (2) recorded seated BPs taken at least 15 minutes apart during one medical visit measuring \>140 mmHg systolic AND/OR \>90 mmHg diastolic AND Recorded elevated BP is present at more than one consecutive medical visit ii. Women who during antenatal visits were prescribed antihypertensive medication, OR received a diagnosis of chronic or gestational hypertension iii. Women who during labor and delivery, had two (2) or more BP measurements \>140 mmHg systolic or \>90 mmHg diastolic at least 15 minutes apart or who were prescribed antihypertensive medication iv. Women who during labor and delivery received a diagnosis of preeclampsia v. Women with new-onset hypertension as defined above, and/or preeclampsia and/or pre-existing hypertension readmitted within 1 week of postnatal hospital discharge with elevated blood pressure.

You may not qualify if:

• Maternal absolute contraindication to breastfeeding (e.g., mother taking medication for which breastfeeding is contraindicated , or mother is infected with human immunodeficiency virus, HTLV-1, active tuberculosis, active herpes simplex on the breast, or Ebola, or mother is a cocaine or phencyclidine user).
• Neonatal absolute contraindication to breastfeeding (Galactosemia)
• Neonatal condition that interferes with breastfeeding (e.g., cleft palate).
• Infant born before 34 weeks gestation.
• Maternal intensive care unit (ICU) admission lasting \>24 hours.
• 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.
• Mother has active COVID-19 infection (confirmed by positive COVID test) at time of postpartum hospitalization.
• Previous BP-MOM participant (ISRCTN85493925, www.isrctn.com)

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Heart and Stroke Foundation of Canada: collaborator
• McGill University: collaborator

Study Sites (4)

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

St Mary's Hospital

Montreal, Quebec, H3T 1M5, Canada

Location

Muhc-Rimuhc

Montreal, Quebec, H4A 3S9, Canada

Location

Related Publications (6)

• Yu J, Pudwell J, Dayan N, Smith GN. Postpartum Breastfeeding and Cardiovascular Risk Assessment in Women Following Pregnancy Complications. J Womens Health (Larchmt). 2020 May;29(5):627-635. doi: 10.1089/jwh.2019.7894. Epub 2019 Dec 3.

  PMID: 31800357 RESULT

• Smith GN, Pudwell J, Roddy M. The Maternal Health Clinic: a new window of opportunity for early heart disease risk screening and intervention for women with pregnancy complications. J Obstet Gynaecol Can. 2013 Sep;35(9):831-839. doi: 10.1016/S1701-2163(15)30841-0. No abstract available.

  PMID: 24099450 RESULT

• Dennis CL. Theoretical underpinnings of breastfeeding confidence: a self-efficacy framework. J Hum Lact. 1999 Sep;15(3):195-201. doi: 10.1177/089033449901500303. No abstract available.

  PMID: 10578797 RESULT

• Dennis CL, McQueen K. The relationship between infant-feeding outcomes and postpartum depression: a qualitative systematic review. Pediatrics. 2009 Apr;123(4):e736-51. doi: 10.1542/peds.2008-1629.

  PMID: 19336362 RESULT

• Grand'Maison S, Pilote L, Okano M, Landry T, Dayan N. Markers of Vascular Dysfunction After Hypertensive Disorders of Pregnancy: A Systematic Review and Meta-Analysis. Hypertension. 2016 Dec;68(6):1447-1458. doi: 10.1161/HYPERTENSIONAHA.116.07907. Epub 2016 Oct 17.

  PMID: 27754864 RESULT

• Dayan N, Smith G, Nedelchev A, Abenhaim H, Brown R, Da Costa D, Ali S, Perlman J, Nguyen TV, Dennis CL, Abdelmageed W, Semenic S. Study protocol for the sheMATTERS study (iMproving cArdiovascular healTh in new moThERS): a randomized behavioral trial assessing the effect of a self-efficacy enhancing breastfeeding intervention on postpartum blood pressure and breastfeeding continuation in women with hypertensive disorders of pregnancy. BMC Pregnancy Childbirth. 2023 Jan 26;23(1):68. doi: 10.1186/s12884-022-05325-3.

  PMID: 36703104 DERIVED

MeSH Terms

Conditions

Toxemia; Pregnancy Complications; Pre-Eclampsia; Hypertension, Pregnancy-Induced; Breast Feeding

Condition Hierarchy (Ancestors)

Infections; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Feeding Behavior; Behavior

Study Officials

• Natalie Dayan, MD, MSc

  McGill University Health Center- Research Institute of the McGill University Health Center

  STUDY DIRECTOR

• 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

• Atanas Nedelchev, MD

  Assistant Professor, Department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

• Haim Abenhaim, MD, MPH

  Jewish General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician and Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: October 9, 2020
• Study Start: March 15, 2021
• Primary Completion: August 1, 2024
• Study Completion: November 1, 2025
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)