Rehabilitation Program for Postpartum Hypertension

MB
RO
Overseen ByRafael 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
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an 8-week exercise program designed to help women reduce high blood pressure that developed during pregnancy, which can persist after childbirth and increase the risk of heart disease. The program, called the Postpartum Cardio-obstetric Rehabilitation Program, combines heart health exercises with postpartum care and will be compared to usual care, which includes advice but no supervised exercise. Women who are 3 to 6 months postpartum and experienced high blood pressure during pregnancy may be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance postpartum care for women.

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 prior data suggests that this postpartum cardio-obstetric rehabilitation program is safe?

Research has shown that exercise programs might help lower blood pressure in women with high blood pressure after pregnancy. Early results suggest these programs can be part of a healthy lifestyle change, potentially reducing the risk of heart disease later on.

Specific information about safety concerns or side effects related to the postpartum cardio-obstetric rehabilitation program is not available. However, exercise is generally safe and often recommended after pregnancy to improve health. This program includes accessible activities like aerobic and strength exercises, as well as online and video sessions, which most people manage well.

While direct evidence about negative effects is lacking, the program is expected to be quite safe. Participants should follow the instructions and consult their healthcare providers if they have any concerns.12345

Why are researchers excited about this trial?

Researchers are excited about the Postpartum Cardio-obstetric Rehabilitation Program because it offers a comprehensive and hybrid approach to managing postpartum hypertension, which is often managed with medication and lifestyle changes alone. This program uniquely combines in-person and online exercise sessions tailored to new mothers, focusing on aerobic, strength, and pelvic floor exercises. Additionally, it incorporates the use of wearable technology like Fitbit to track and encourage 10,000 daily steps, making it an engaging and personalized way to promote healthy lifestyle habits. By integrating education and technology, this method has the potential to enhance recovery and well-being in ways traditional options might not.

What evidence suggests that the Postpartum Cardio-obstetric Rehabilitation Program might be an effective treatment for postpartum hypertension?

Research has shown that high blood pressure after giving birth, known as postpartum hypertension, can be managed with lifestyle changes and exercise. This trial will compare a Postpartum Cardio-obstetric Rehabilitation Program with usual care. Studies have found that postpartum clinics offering heart health check-ups and lifestyle advice can help lower blood pressure. Specifically, one study found that women in a postpartum rehab program lowered their diastolic blood pressure by about 4.5 mmHg up to 6 months after giving birth. This suggests that structured exercise and education programs, like the one being tested in this trial, could help new mothers reduce their blood pressure and improve their long-term heart health.12346

Are You a Good Fit for This Trial?

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
Participants are able to access and use a computer, mobile phone, and internet for online sessions
I am over 18 years old.
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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)
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Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Rehabilitation GroupExperimental Treatment1 Intervention
Group II: Control groupActive Control1 Intervention

Find a Clinic Near You

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+

Published Research Related to This Trial

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.
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.
Postpartum management of hypertensive disorders of pregnancy: a systematic review.Cairns, AE., Pealing, L., Duffy, JMN., et al.[2023]
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.
Hypertension in the postpartum woman: clinical update for the hypertension specialist.Ghuman, N., Rheiner, J., Tendler, BE., et al.[2022]

Citations

Feasibility of Postpartum Blood Pressure Monitoring for ...Among those with normal BP at enrollment, 87% had elevated BP on at least 1 day during the 12-week monitoring period. These findings highlight ...
Cardiovascular Screening Rates With Establishment of ...Our preliminary pilot data demonstrate the feasibility and benefit of establishing a postpartum cardiovascular care pathway in increasing rates ...
Advances in postpartum hypertension managementPostpartum hypertension clinics providing cardiovascular assessment, lifestyle counseling, and medication management have emerged as one such ...
Hypertension in Pregnancy and PostpartumHypertension in pregnancy contributes substantially to maternal morbidity and mortality, persistent hypertension, and rehospitalization.
Clinical Outcomes Associated With a Remote Postpartum ...Both studies found improvements in diastolic blood pressure with a lowering of 4.5mmHg seen in the intervention group up to 6 months postpartum, ...
Management of Postpartum Preeclampsia and ...Tighter blood pressure control was associated with reduced postpartum Emergency Department visits for hypertensive disorders.
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