Breastfeeding and blood Pressure patterns in MOthers with recent hypertensive coMplications of pregnancy - BP-MOM Study
| ISRCTN | ISRCTN18352227 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18352227 |
| Secondary identifying numbers | 2019-4726 |
- Submission date
- 18/01/2019
- Registration date
- 29/01/2019
- Last edited
- 14/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Women with hypertensive (high blood pressure) disorders of pregnancy including preeclampsia and gestational hypertension are at increased risk for later cardiovascular (heart) disease. Breastfeeding may lower maternal blood pressure and other cardiovascular risk factors, and interventions designed to improve mothers’ breastfeeding self-efficacy (i.e., confidence about breastfeeding) have been helpful for healthy postpartum women. However, such breastfeeding support interventions have not yet been tested specifically in women who have had hypertensive disorders of pregnancy, a group who may benefit substantially from breastfeeding. This study tests a nurse-led self-efficacy based breastfeeding intervention in women with hypertensive disorders of pregnancy, to measure whether the intervention is feasible in this population and whether it improves breastfeeding rates and/or lowers maternal blood pressure.
Who can participate?
Women at least 18 years old who have been diagnosed with a hypertensive disorder of pregnancy (preeclampsia or gestational hypertension), have given birth to a live-born single infant delivered at 34 weeks gestation or later, who intend to breastfeed and have started breastfeeding before hospital discharge, speak and understand English or French, and have access to a telephone.
What does the study involve?
Participants are randomly allocated to receive either usual postpartum care, or usual postpartum care plus additional breastfeeding support. Additional breastfeeding support will include the nurse-led intervention designed to improve women’s confidence about breastfeeding.
What are the possible benefits and risks of participating?
Participants who receive additional breastfeeding support may benefit from the nurse-led breastfeeding intervention. The study involves collection of test results from blood draws that are part of routine postpartum care. Blood draws may cause temporary discomfort, minor bleeding, light-headedness, and rarely, fainting.
Where is the study run from?
McGill University Health Centre (MUHC), Montreal (Canada)
When is the study starting and how long is it expected to run for?
May 2018 to December2021
Who is funding the study?
The study is supported by startup funds of the principal investigator, Natalie Dayan
Who is the main contact?
Natalie Dayan
Natalie.Dayan@mcgill.ca
Contact information
Scientific
McGill University Health Center- Research Institute (MUHC-RI)
Center for Outcomes Research and Evaluation (CORE)
5252 de Maisonneuve West
2nd Floor
Suite 2B.40
Montreal
H4A 3S5
Canada
| Phone | +1 (0)514 934 1934 ext. 76125 |
|---|---|
| Natalie.dayan@mcgill.ca |
Study information
| Study design | Single-centre pilot randomized open-label trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Scientific title | Pilot randomized trial of a nurse-led self-efficacy based breastfeeding intervention in women with hypertensive disorders of pregnancy |
| Study acronym | BP-MOM |
| Study objectives | The trialists hypothesize that a self-efficacy based breastfeeding intervention in women with hypertensive disorders of pregnancy will be feasible in this population. They further hypothesize that there will be a trend toward protective effects on maternal health as measured by blood pressure, weight, and continued breastfeeding, at 6 months postpartum, with continued but dampened protective effects at 12 months postpartum. |
| Ethics approval(s) | Research Ethics Board of the McGill University Health Centre (MUHC), 2155 Guy Street, 2nd floor, Montreal, Quebec, H3H 2R9, Tel: +1 (0)514 934 1934 ext. 36077, Email: sheldon.levy@muhc.mcgill.ca, 20/11/2018, protocol number: 2019-4726 |
| Health condition(s) or problem(s) studied | Hypertensive disorders of pregnancy, including preeclampsia and gestational hypertension |
| Intervention | Nurse-led breastfeeding enhancing intervention, including a maternal assessment followed by the provision of tailored lactation management strategies to enhance breastfeeding self-efficacy and support exclusive breastfeeding. Participants are randomized 1:1 to the intervention or usual postpartum care. |
| Intervention type | Behavioural |
| Primary outcome measure | Feasibility, including recruitment, retention and participant satisfaction with the intervention: 1. Recruitment rate is defined as the number of eligible women who consented/number of eligible women who were approached, calculated at baseline 2. Retention rate is defined as the number of women who complete 12-month follow-up for the study/all women who consent to participate, calculated at 12-month follow-up 3. Participant satisfaction with the breastfeeding intervention will be measured using a self-administered questionnaire that includes quantitative and qualitative items on participants' satisfaction with the support received from the study nurse, measured at 3 months and 6 months postpartum |
| Secondary outcome measures | 1. Exclusive breastfeeding assessed by self-report at 6 months and 12 months postpartum 2. Total breastfeeding duration assessed by self-report at 6 months and 12 months postpartum 3. Blood pressure measured by the study nurse at 12 months postpartum 4. Use of anti-hypertensive medication as ascertained from the participant's medical chart at 12 months postpartum |
| Overall study start date | 01/05/2018 |
| Completion date | 01/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 75 |
| Total final enrolment | 45 |
| Key inclusion criteria | 1. Age >18 years 2. Diagnosis of hypertensive disorder of pregnancy (preeclampsia or gestational hypertension) 3. Singleton live birth delivered at >34 weeks gestation 4. Mother intends to breastfeed and breastfeeding initiated before hospital discharge 5. Patient speaks and understands English or French 6. Patient has telephone access |
| Key exclusion criteria | 1. Maternal contraindication to breastfeeding 2. Maternal condition that interferes with breastfeeding 3. Neonatal condition that interferes with breastfeeding 4. Infant born before 34 weeks gestation 5. Maternal ICU admission lasting >24 hours |
| Date of first enrolment | 02/01/2019 |
| Date of final enrolment | 21/11/2019 |
Locations
Countries of recruitment
- Canada
Study participating centre
Montreal
H4A 3J1
Canada
Sponsor information
Hospital/treatment centre
1001 Boulevard Décarie
Montreal
H4A 3J1
Canada
"ROR" |
https://ror.org/04cpxjv19 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 30/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The study protocol will be available on request. The trialists will disseminate their findings to: 1. Members of the general public via press releases to local, national, and international media organizations, and via commercial and community organizations dedicated to women’s health such as Nourri-Source, La Leche, the Preeclampsia Foundation, and Johnson & Johnson 2. Clinicians involved in perinatal care, e.g., knowledge users from the Society of Obstetricians and Gynaecologists of Canada (SOGC), Canadian Association of Women’s Health, and Canadian Lactation Consultant Association 3. Policy makers, in particular the World Health Organization and American Academy of Pediatrics as they relate to breastfeeding recommendations, and the SOGC, Hypertension Canada, and the Canadian Cardiovascular Society as they relate to hypertension and cardiovascular risk management |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
14/10/2022: The intention to publish date was changed from 25/02/2022 to 30/12/2022.
07/12/2021: The intention to publish date was changed from 01/10/2021 to 25/02/2022.
26/07/2021: The following changes have been made:
1. The overall trial end date has been changed from 01/06/2021 to 01/12/2021 and the plain English summary updated accordingly.
2. The intention to publish date has been changed from 02/01/2021 to 01/10/2021.
19/02/2020: The following changes have been made:
1. The recruitment start date has been changed from 06/01/2019 to 02/01/2019.
2. The recruitment end date has been changed from 06/01/2020 to 21/11/2019.
3. The total final enrolment number has been added.
4. The public title has been changed from "Breastfeeding and blood pressure patterns in mothers with recent hypertensive complications of pregnancy (BP-MOM)" to "Breastfeeding and blood Pressure patterns in MOthers with recent hypertensive coMplications of pregnancy - BP-MOM Study".
5. The scientific contact has been updated.
18/02/2019: The following changes were made:
1. The recruitment start date was changed from 01/07/2019 to 06/01/2019.
2. The recruitment end date was changed from 01/06/2020 to 06/01/2020.
