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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether tighter blood pressure control immediately after pregnancy can lower blood pressure and reduce hospital visits six months later. It focuses on women who experienced high blood pressure during pregnancy. Participants will be divided into two groups: one receiving usual care and the other receiving tight blood pressure control. Those diagnosed with preeclampsia or gestational hypertension and enrolled in a remote blood pressure management program might be suitable candidates. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand how it can benefit more patients.

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 is the safety track record for tight blood pressure control?

Research has shown that carefully managing blood pressure in women after childbirth is generally safe. One study found that maintaining blood pressure below 130/80 mm Hg did not cause major safety issues, indicating that most women tolerated the treatment well.

Another study discovered that stricter blood pressure control reduced emergency room visits for high blood pressure after childbirth. This suggests that tighter control might not only be safe but also help prevent complications.

Overall, while more research is always beneficial, current evidence indicates that this approach is safe for postpartum women with high blood pressure. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the trial for optimal blood pressure (BP) treatment thresholds in postpartum women because it could redefine how high BP is managed after childbirth. Unlike the standard care, which typically starts medication when BP consistently exceeds 150/100 mmHg, the trial explores a tighter control approach by initiating medication at lower BP levels of 140/90 mmHg in the hospital or 135/85 mmHg at home. This could potentially lead to better outcomes by preventing complications earlier and providing more personalized care for new mothers.

What evidence suggests that tight blood pressure control is effective for postpartum high blood pressure?

Research has shown that controlling blood pressure after childbirth greatly benefits women with high blood pressure. This trial compares two approaches: the Usual Care Group, where standard BP medication begins if blood pressure exceeds 150/100 mmHg, and the Intervention Group, which employs Tight Blood Pressure Control, starting medication at lower thresholds. Studies have found that managing blood pressure can reduce emergency room visits by 68% for new mothers with high blood pressure issues. Careful management of blood pressure after giving birth is crucial, as many serious problems can arise during this time. Monitoring blood pressure from home has also been shown to save money and improve health outcomes compared to regular care. This method helps lower blood pressure and reduces the risk of hospital readmission. ^{1 2 3 6 7}

Who Is on the Research Team?

Alisse Hauspurg, MD

Principal Investigator

UPMC Magee Women's Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2772963X25000341

Management of Postpartum Preeclampsia and ... Tighter blood pressure control was associated with reduced postpartum emergency department visits for hypertensive disorders.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12150216/

Remote blood pressure management for postpartum ... CONCLUSION: Remote blood pressure management for postpartum hypertension is cost saving and has better outcomes than usual care. Our data can ...

3. acc.org acc.org/Latest-in-Cardiology/Journal-Scans/2025/02/06/16/20/Tighter-Blood-Pressure-Control

Tighter Blood Pressure Control Reduces ED Visits in ... Results showed that tighter BP control reduced the primary outcome of ED visits by 68% postpartum. Overall, 10 patients (3.6%) in the ...

4. jacc.org jacc.org/doi/10.1016/j.jacadv.2025.101617

Postpartum Tight vs Standard Blood Pressure Control Tighter blood pressure control was associated with reduced postpartum Emergency Department visits for hypertensive disorders.

5. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.073302

Hypertension in Pregnancy and Postpartum Postpartum blood pressure (BP) control is equally crucial, because the majority of hypertension-related maternal deaths occur after delivery, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8673186/

Hypertension in the Postpartum Woman: Clinical Update ... In a study of preeclamptic women by Podymow and colleagues, 43% of patients had BPs that normalized by the end of the first postpartum month, but 57% remained ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2589933322002488

Tight vs liberal control of mild postpartum hypertension Recent data from Ohio demonstrate that 12% of maternal deaths were caused by HDP, of which 68% occurred in the postpartum period. ... Emerging evidence suggests ...