Breastfeeding and Postpartum Cardiovascular Health (sheMATTERS)
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| ClinicalTrials.gov Identifier: NCT04580927 |
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Recruitment Status :
Recruiting
First Posted : October 9, 2020
Last Update Posted : September 2, 2021
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| Condition or disease | Intervention/treatment | Phase |
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| Hypertensive Disorder of Pregnancy Pregnancy Complications Pre-Eclampsia Hypertension, Pregnancy-Induced Breastfeeding | Behavioral: Breastfeeding self-efficacy (BSE) | Not Applicable |
The present study aims to assess a nurse-led self-efficacy enhancing breastfeeding intervention in women who have HDP. The investigators will examine whether this intervention reduces postpartum blood pressure and improves breastfeeding outcomes in these women. In the long-term, the investigators 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.
The 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 on the 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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 323 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention 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 |
| Official Title: | Improving Cardiovascular Health in New Mothers: Multi-Centre Open-Label Randomized Trial of a Breastfeeding Intervention to Improve Breastfeeding Practices and Lower Blood Pressure in Women With Hypertensive Disorders of Pregnancy |
| Actual Study Start Date : | March 15, 2021 |
| Estimated Primary Completion Date : | November 2022 |
| Estimated Study Completion Date : | November 2024 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Randomized to breastfeeding self-efficacy enhancing intervention with nurse
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.
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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. |
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No Intervention: Randomized to usual postpartum care
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.
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No Intervention: Non-randomized observational arm
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.
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- Number of Participants with Lower Systolic and/or diastolic BP, in mmHg. [ Time Frame: 12 months ]Evaluate whether a nurse-led BSE intervention will result in a lower systolic and/or diastolic BP 12 months postpartum
- Number of Participants Using Antihypertensive Therapy [ Time Frame: 12 months ]Evaluate whether a nurse-led BSE intervention will result in a lower need for antihypertensive therapy
- Number of Participants Providing Exclusive Breastfeeding (weeks) [ Time Frame: 12 months ]Evaluate whether a nurse-led BSE intervention will result in longer duration of exclusive breastfeeding
- Proportion of Participants who Breastfeed (exclusive or non-exclusive) [ Time Frame: 12 months ]Evaluate whether a nurse-led BSE intervention will result in higher rates of any continued breastfeeding at 6 months
- Number of Participants that Develop Metabolic Syndrome [ Time Frame: 12 months ]Evaluate whether a nurse-led BSE intervention will result in lower metabolic syndrome
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | Women who had high blood pressure in pregnancy |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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)
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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.
Exclusion Criteria:
Exclusion criteria from randomized trial portion of the study:
- 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).
- Maternal condition that interferes with breastfeeding (e.g., breast reduction, or breast augmentation surgery due to hypoplastic mammary tissue. Uncomplicated breast augmentation surgery is not an exclusion criterion).
- Neonatal absolute contraindication to breastfeeding (Galactosemia)
- Neonatal condition that interferes with breastfeeding (e.g., cleft palate).
Exclusion criteria from randomized OR observational portion of the study (including non-randomized arm):
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04580927
| Contact: Natalie Dayan, MD, MSC | 514-934-1934 ext 76125 | natalie.dayan@rimuhc.ca | |
| Contact: Sonia Semenic, PhD | 514-398-1281 | sonia.semenic@mcgill.ca |
| Canada, Ontario | |
| Kingston General Hospital | Recruiting |
| Kingston, Ontario, Canada, K7L 2V7 | |
| Contact: Jessica Pudwell, MSc, MPH jessica.pudwell@queensu.ca | |
| Principal Investigator: Graeme Smith, MD, PhD | |
| Canada, Quebec | |
| Muhc-Rimuhc | Recruiting |
| Montreal, Quebec, Canada, H4A 3S9 | |
| Contact: Natalie Dayan, MD, MSc 514-934-1934 ext 76125 natalie.dayan@mcgill.ca | |
| Contact: Sonia Semenic, N, PhD 514-398-1281 sonia.semenic@mcgill.ca | |
| Principal Investigator: natalie Dayan, MD, MSc | |
| Principal Investigator: Sonia Semenic, N, PhD | |
| Sub-Investigator: Graeme Smith, MD, PhD | |
| Sub-Investigator: Hélène Weibel, MD | |
| 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: | Atanas Nedelchev, MD | Assistant Professor, Department of Obstetrics and Gynecology |
| Responsible Party: | Natalie Dayan, Physician and Principal Investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre |
| ClinicalTrials.gov Identifier: | NCT04580927 |
| Other Study ID Numbers: |
MP-37-2021-7201: she MATTERS |
| First Posted: | October 9, 2020 Key Record Dates |
| Last Update Posted: | September 2, 2021 |
| Last Verified: | August 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | The plan to share is not defined yet |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Toxemia Eclampsia Pre-Eclampsia Pregnancy Complications Hypertension, Pregnancy-Induced |
Hypertension Vascular Diseases Cardiovascular Diseases Infections |