Rehabilitation Program for Postpartum Hypertension

Overseen By Rafael O Fernandes, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Must not be taking: Beta-blockers

Disqualifiers: Chronic hypertension, Musculoskeletal injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking beta-blockers or have received antihypertensive drug therapy after 6 weeks postpartum.

What data supports the effectiveness of the treatment Postpartum Cardio-obstetric Rehabilitation Program for postpartum hypertension?

Research suggests that lifestyle interventions, such as healthy eating and physical activity, can help reduce blood pressure in the postpartum period. These components are part of the Postpartum Cardio-obstetric Rehabilitation Program, indicating its potential effectiveness for managing postpartum hypertension. ^{1 2 3 4 5}

Is the Postpartum Cardio-obstetric Rehabilitation Program safe for humans?

The research discusses various interventions for postpartum cardiovascular care, including lifestyle coaching and education, which are generally safe and focus on healthy behaviors like diet and exercise. However, specific safety data for the Postpartum Cardio-obstetric Rehabilitation Program itself is not detailed in the available studies. ^{1 4 6 7 8}

How is the Postpartum Cardio-obstetric Rehabilitation Program treatment different from other treatments for postpartum hypertension?

The Postpartum Cardio-obstetric Rehabilitation Program is unique because it focuses on a comprehensive approach that includes lifestyle coaching and education to help new mothers adopt healthy behaviors, which is not typically emphasized in standard treatments for postpartum hypertension. ^{1 2 3 4 8}

What is the purpose of this trial?

Some women who develop high blood pressure during pregnancy, such as gestational hypertension or preeclampsia, may continue to have slightly or moderately high blood pressure after giving birth. This can increase their risk of heart disease later in life. Managing blood pressure and adopting a healthy lifestyle after pregnancy could help lower this risk. Right now, the investigators don't know much about how postpartum rehabilitation programs focused on heart and pregnancy-related health could help women with these conditions. However, a feasibility study suggests that exercise programs might help reduce blood pressure and encourage healthier lifestyles in these women. In this study, the investigators are testing an 8-week exercise program to see how it affects blood pressure, fitness, and blood vessel health. The investigators will compare the results with a group of women who receive usual healthcare, which includes verbal advice on healthy living but no supervised exercise sessions. This type of program, called cardio-obstetric rehabilitation, combines exercises for heart health with specialized care for women's health.

Eligibility Criteria

This trial is for women who had high blood pressure issues during pregnancy, like gestational hypertension or preeclampsia, and continue to have high blood pressure postpartum. The study aims to help them reduce the risk of heart disease.

Inclusion Criteria

Participants are 3 to 6 months postpartum, willing, and able to give informed consent for participation

I am over 18 years old.

Participants are able to access and use a computer, mobile phone, and internet for online sessions

Exclusion Criteria

I took blood pressure medication before getting pregnant or after 6 weeks post-birth.

Participants have chronic (pre-existing) hypertension (BP > 139/89 mmHg pre-pregnancy, <20 weeks' gestation, or after 6 weeks postpartum)

Participants participated in exercise activity programs regularly before 3-month postpartum (more than 2 hours of moderate-to-vigorous exercise per week)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-week rehabilitation program combining aerobic exercise with obstetric rehabilitation, including online education courses about healthy lifestyle.

8 weeks

1 in-person session, 1 online session, 1 pre-recorded video per week

Follow-up

Participants are monitored for safety and effectiveness after treatment, with evaluations at baseline, immediately post-intervention, and 6-month post-intervention.

6 months

Treatment Details

Interventions

• Postpartum Cardio-obstetric Rehabilitation Program

Trial Overview The trial is testing an 8-week cardio-obstetric rehabilitation program that includes exercise tailored for heart health and post-pregnancy recovery. It will be compared with usual care which involves general advice on healthy living.

Participant Groups

Group I: Rehabilitation Group Experimental Treatment 1 Intervention

The rehabilitation Group will be submitted to an 8-week exercise and education program with a hybrid format, delivered by a professional physiotherapist at the Centre Jean-Jacques Gauthier (CJJG). Briefly, one in-person session (60 minutes of aerobic exercise and full-body strength exercise), one online session (30-35 minutes - focus on pelvic floor muscle training, core/abdominals, balance, and stretching exercises), and one pre-recorded video (30 minutes - exercise instructions) will be delivered per week. Participants will use Fitbit Charge-6 to progressively reach daily 10,000 steps throughout the intervention period. Four online educational workshops on healthy lifestyle will be delivered.

Group II: Control group Active Control 1 Intervention

Control group participants will received the usual care, together with information about the guidelines for physical activity practice, nutritional and risk factor monitoring instructions, pelvic floor exercise instructions, and recommendations to progressively reach daily 10,000 steps according to guidelines . Participants will also receive a Fitbit device.

Who Is Running the Clinical Trial?

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Lead Sponsor

Trials

17

Recruited

4,600+

Findings from Research

Postpartum hypertension can either continue from pregnancy or develop after delivery, posing significant risks to maternal health, especially due to reduced medical monitoring after discharge.

There is a lack of clear guidelines for managing postpartum hypertension, which can lead to misdiagnosis and inappropriate treatment, highlighting the need for hypertension specialists to be involved in postpartum care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypertension in the postpartum woman: clinical update for the hypertension specialist. Ghuman, N., Rheiner, J., Tendler, BE., et al.[2022]

In a study of 1,829 women, those with hypertensive disorders in pregnancy (HDP) showed similar levels of physical and psychological health at 3 months postpartum compared to women without HDP, despite having higher immediate postnatal needs.

Women with HDP had a higher rate of re-admission within 3 months after birth (13.1%) compared to those without HDP (5.5%), indicating a need for better postnatal care and support for this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postnatal health and care following hypertensive disorders in pregnancy: a prospective cohort study (BPiPP study). Ashworth, DC., Bowen, L., Maule, SP., et al.[2022]

A systematic review of 39 studies involving 2901 postnatal women with hypertensive disorders of pregnancy found that while calcium-channel blockers, vasodilators, and beta-blockers can lower blood pressure postpartum, there is insufficient evidence to recommend any specific pharmacological intervention due to variability in effectiveness.

Uterine curettage was shown to significantly reduce blood pressure in the first 48 hours postpartum compared to standard care, but safety data was limited, preventing a strong recommendation for its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postpartum management of hypertensive disorders of pregnancy: a systematic review. Cairns, AE., Pealing, L., Duffy, JMN., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Timing of outpatient postpartum care utilization among women with chronic hypertension and hypertensive disorders of pregnancy. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Hypertension in the postpartum woman: clinical update for the hypertension specialist. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

The effect of postpartum lifestyle interventions on blood pressure: a systematic literature review. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Optimising mothers' health behaviour after hypertensive disorders of pregnancy: a qualitative study of a postnatal intervention. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Postnatal health and care following hypertensive disorders in pregnancy: a prospective cohort study (BPiPP study). [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The Fourth Trimester: a Time for Enhancing Transitions in Cardiovascular Care. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Cardiovascular Health After Preeclampsia: Patient and Provider Perspective. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Postpartum management of hypertensive disorders of pregnancy: a systematic review. [2023]