Breastfeeding Support for High Blood Pressure Postpartum
(sheMATTERS Trial)

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen bySonia Semenic, N, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

Mother intends to breastfeed (randomized portion)

Breastfeeding initiated before postpartum hospital discharge (randomized portion)

I am older than 18 years.

+6 more

Exclusion Criteria

You have participated in a previous study with the identifier ISRCTN85493925.

I have a condition that prevents me from breastfeeding, not including simple breast augmentation.

You have a condition that makes it hard for you to breastfeed as a newborn, like a cleft palate.

+6 more

Participant Groups

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.

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: 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.

Group III: 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.