Optimal BP Treatment Thresholds for Postpartum High Blood Pressure

Overseen By Sila Yavan, MS

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Alisse Hauspurg

Disqualifiers: Pre-pregnancy hypertension, diabetes, cardiac disease, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of this research project is to conduct a single-site pilot trial within our institution's clinical remote blood pressures (BP) management program to assess the feasibility and effect of tight blood pressure control versus usual care in the immediate postpartum period after a hypertensive disorder of pregnancy (HDP). The investigators' central hypothesis is that tight blood pressure control will be feasible and acceptable to postpartum individuals and will result in lower BP at six months postpartum and a reduction in postpartum hospital readmissions. Subjects will undergo 3 study visits (1 in-person and 2 remote) involving BP measurements, blood draws, and/or questionnaires. Up to 60 adult subjects will be enrolled at Magee-Women's Hospital.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the idea that Optimal BP Treatment Thresholds for Postpartum High Blood Pressure is an effective treatment?

The available research shows that using a standardized clinical assessment and management plan for postpartum hypertension can reduce hospital readmissions and emergency department visits. This suggests that tight blood pressure control is effective in managing postpartum high blood pressure. Additionally, postpartum home blood pressure monitoring is found to be effective compared to clinic-based follow-ups, indicating that close monitoring and management of blood pressure at home can be beneficial. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Tight Blood Pressure Control for postpartum high blood pressure?

The research on postpartum home blood pressure monitoring suggests that closely watching blood pressure at home can be effective in managing postpartum high blood pressure, which aligns with the idea of tight blood pressure control. Additionally, a standardized clinical assessment and management plan has been shown to reduce hospital readmissions for postpartum hypertension, indicating that structured and careful management of blood pressure can be beneficial. ^{1 2 3 4 5}

What safety data exists for postpartum high blood pressure treatment?

The SNAP-HT Trial provides some safety data on postpartum hypertension treatment. It was a randomized controlled trial that evaluated the feasibility and effects of self-management of postpartum hypertension. The trial included 91 women and showed that self-management resulted in better diastolic blood pressure control up to 6 months postpartum. The study reported high retention and compliance rates, indicating that the intervention was feasible and safe for participants. ^{2 3 6 7 8}

Is tight blood pressure control safe for postpartum high blood pressure?

The SNAP-HT trial found that self-management of postpartum high blood pressure, which includes tight blood pressure control, was safe and feasible. Participants who managed their own blood pressure had better control without any reported safety issues. ^{2 3 6 7 8}

Is Tight Blood Pressure Control a promising treatment for postpartum high blood pressure?

Yes, Tight Blood Pressure Control is a promising treatment for postpartum high blood pressure. Research shows that self-managing blood pressure at home can lead to better control of blood pressure levels, especially in the weeks following childbirth. This approach helps maintain lower blood pressure, which is important for the health of new mothers. ^{1 2 3 4 8}

How is the Tight Blood Pressure Control treatment different from other treatments for postpartum high blood pressure?

Tight Blood Pressure Control is unique because it involves self-management, where patients monitor their blood pressure at home daily and adjust their medication through telemonitoring, leading to better blood pressure control compared to usual care. ^{1 2 3 4 8}

Research Team

Alisse Hauspurg, MD

Principal Investigator

UPMC Magee Women's Hospital

Eligibility Criteria

This trial is for postpartum individuals over 18 who were diagnosed with preeclampsia or gestational hypertension. Participants must be enrolled in a remote blood pressure management program.

Inclusion Criteria

I am over 18, had high blood pressure during pregnancy, and am in a remote blood pressure program.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive tight blood pressure control or usual care postpartum

6 weeks

1 visit (in-person), 1 visit (remote)

Follow-up

Participants are monitored for blood pressure and medication use

6 months

1 visit (remote)

Treatment Details

Interventions

• Tight Blood Pressure Control

Trial Overview The study is testing whether tight control of blood pressure after giving birth (using specific medication thresholds) leads to better outcomes than usual care, including lower BP at six months and fewer hospital readmissions.

Participant Groups

Group I: Intervention (Tight Blood Pressure Control) Group Experimental Treatment 1 Intervention

BP medication will be started if a subject's hospital BP consistently exceeds 140/90 mmHg or her home BP consistently exceeds 135/85 mmHg.

Group II: Usual Care Group Active Control 1 Intervention

Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point.

Who Is Running the Clinical Trial?

Alisse Hauspurg

Lead Sponsor

Trials

3

Recruited

230+

Findings from Research

In a study of 235 women with chronic hypertension, 12.8% were diagnosed with postpartum severe hypertension (PHTN), which was linked to higher blood pressure levels and the number of antihypertensive medications required after delivery.

The median time to diagnosis of PHTN was 10 days postpartum, indicating that monitoring blood pressure and medication needs during this period is crucial for early detection and management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence and Risk Factors for Postpartum Severe Hypertension in Women with Underlying Chronic Hypertension. Glover, AV., Tita, A., Biggio, JR., et al.[2020]

In a study of 460 women with hypertensive disorders in pregnancy, 88.7% experienced a return to normal blood pressure levels by 42 days postpartum, indicating a generally positive recovery trend after delivery.

Risk factors that may hinder the recovery of postpartum blood pressure include advanced maternal age, a higher severity of hypertensive disorders during pregnancy, and having both high systolic and diastolic blood pressures, suggesting that these women require closer monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Postpartum change of blood pressure and its risk factors in patients with hypertensive disorders in pregnancy]. Shen, L., Tan, H., Zhou, S., et al.[2018]

In a study of 1,964 women, 2.9% developed a postpartum-onset hypertensive disorder, highlighting the need for awareness of this condition after delivery.

Key risk factors for developing postpartum hypertension include assisted reproductive technology, high pre-pregnancy body mass index, chronic nephritis, hypothyroidism, elevated blood pressure during pregnancy, and cesarean delivery, suggesting that women with these factors should be closely monitored for blood pressure changes post-delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical features and antenatal risk factors for postpartum-onset hypertensive disorders. Takaoka, S., Ishii, K., Taguchi, T., et al.[2022]

Postpartum home blood pressure monitoring significantly increases the likelihood of obtaining BP measurements in the first 10 days after delivery compared to clinic-based follow-up, with a relative risk of 2.11, indicating it may enhance early detection of hypertension.

Home BP monitoring is associated with reduced unplanned hypertension-related hospital admissions (adjusted relative risk 0.12), and it helps to reduce racial disparities in BP ascertainment by about 50%, although it does not appear to affect treatment initiation rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postpartum Home Blood Pressure Monitoring: A Systematic Review. Steele, DW., Adam, GP., Saldanha, IJ., et al.[2023]

Implementing a standardized clinical assessment and management plan for postpartum hypertension significantly reduced readmissions and emergency department visits, with only 2.8% of patients in the postintervention group experiencing these outcomes compared to 11.0% in the historical control group.

Outpatient remote blood pressure monitoring and timely medication adjustments were crucial for managing hypertension after discharge, particularly for high-risk groups, highlighting the importance of follow-up care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardized Clinical Assessment and Management Plan to Reduce Readmissions for Postpartum Hypertension. Mei, JY., Corry-Saavedra, K., Nguyen, TA., et al.[2023]

A study involving 256 postpartum women found that starting antihypertensive treatment at a lower threshold of 140/90 mm Hg did not reduce maternal morbidity compared to a higher threshold of 150/95 mm Hg.

Both groups experienced similar rates of complications and secondary outcomes, indicating that the lower threshold may not provide additional benefits in managing postpartum hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tight vs liberal control of mild postpartum hypertension: a randomized controlled trial. Aderibigbe, OA., Hackney, DN., Ranzini, AC., et al.[2023]

In a study of 129 individuals with hypertensive disorders of pregnancy, 58% developed persistent hypertension by one year postpartum, indicating a significant risk for long-term hypertension after pregnancy.

While blood pressure trajectories during pregnancy were similar for those who normalized and those who developed hypertension, the postpartum trajectories were significantly different, suggesting that monitoring blood pressure in the first year after delivery is crucial for identifying individuals at risk for persistent hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Pressure Trajectories Through the First Year Postpartum in Overweight or Obese Individuals Following a Hypertensive Disorder of Pregnancy. Hauspurg, A., Bryan, S., Jeyabalan, A., et al.[2023]

This randomized controlled trial involving 186 women with postpartum hypertension demonstrated that self-management, which included daily blood pressure monitoring and telemonitoring for medication adjustments, was feasible and led to better blood pressure control compared to usual care.

The intervention group showed significantly lower blood pressure, particularly diastolic pressure, at 6 weeks and maintained better control up to 6 months, suggesting that self-management could be an effective strategy for managing postpartum hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-Management of Postnatal Hypertension: The SNAP-HT Trial. Cairns, AE., Tucker, KL., Leeson, P., et al.[2021]

References

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

Incidence and Risk Factors for Postpartum Severe Hypertension in Women with Underlying Chronic Hypertension. [2020]

2. China pubmed.ncbi.nlm.nih.gov

[Postpartum change of blood pressure and its risk factors in patients with hypertensive disorders in pregnancy]. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Clinical features and antenatal risk factors for postpartum-onset hypertensive disorders. [2022]

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

Postpartum Home Blood Pressure Monitoring: A Systematic Review. [2023]

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

Standardized Clinical Assessment and Management Plan to Reduce Readmissions for Postpartum Hypertension. [2023]

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

Tight vs liberal control of mild postpartum hypertension: a randomized controlled trial. [2023]

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

Blood Pressure Trajectories Through the First Year Postpartum in Overweight or Obese Individuals Following a Hypertensive Disorder of Pregnancy. [2023]

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

Self-Management of Postnatal Hypertension: The SNAP-HT Trial. [2021]