Optimal BP Treatment Thresholds for Postpartum High Blood Pressure

Recruiting in Palo Alto (17 mi)

Overseen by Alisse Hauspurg, MD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Alisse Hauspurg

No Placebo Group

Prior Safety Data

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.

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 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 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}

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.

Treatment Details

Interventions

• Tight Blood Pressure Control (Other)

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Pittsburgh Magee-Womens Hospital Pittsburgh, PA

Who Is Running the Clinical Trial?

Alisse Hauspurg Lead Sponsor

References

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

Incidence and Risk Factors for Postpartum Severe Hypertension in Women with Underlying Chronic Hypertension. [2020] To determine risk factors and time to diagnosis of postpartum severe hypertension (PHTN) in women with chronic hypertension (CHTN).

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

[Postpartum change of blood pressure and its risk factors in patients with hypertensive disorders in pregnancy]. [2018] To investigate the change of blood pressure in patients with hypertensive disorders in pregnancy after delivery and the risk factors.

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

Clinical features and antenatal risk factors for postpartum-onset hypertensive disorders. [2022] To identify the clinical features and risk factors for diagnosis of a postpartum-onset hypertensive disorder.

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

Postpartum Home Blood Pressure Monitoring: A Systematic Review. [2023] To assess the effectiveness of postpartum home blood pressure (BP) monitoring compared with clinic-based follow-up and the comparative effectiveness of alternative home BP-monitoring regimens.

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

Standardized Clinical Assessment and Management Plan to Reduce Readmissions for Postpartum Hypertension. [2023] To evaluate the effect of a postpartum hypertension standardized clinical assessment and management plan on postpartum readmissions and emergency department (ED) visits.

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

Tight vs liberal control of mild postpartum hypertension: a randomized controlled trial. [2023] High-quality evidence to inform the management of postpartum hypertension, including the optimal blood pressure threshold to initiate therapy, is lacking. Randomized trials have been conducted in pregnancy, but there are no published trials to guide management in the postpartum period.

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] Hypertensive disorders of pregnancy are associated with cardiovascular disease; however, patterns of blood pressure (BP) recovery are understudied. We compared pregnancy and postpartum BP trajectories among individuals with hypertensive disorders of pregnancy who developed persistent hypertension at 1-year postpartum compared with individuals with normalization of BP.

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

Self-Management of Postnatal Hypertension: The SNAP-HT Trial. [2021] Hypertension affects 1 in 10 pregnancies, often persisting postpartum, when antihypertensive requirements may vary substantially. This unmasked, randomized controlled trial evaluated the feasibility and effects on blood pressure (BP) of self-management of postpartum hypertension. Women with gestational hypertension or preeclampsia, requiring postnatal antihypertensive treatment, were randomized to self-management or usual care. Self-management entailed daily home BP monitoring and automated medication reduction via telemonitoring. Women attended 5 follow-up visits during 6 months. The primary outcome was feasibility: specifically recruitment, retention, and compliance with follow-up rates. Secondary outcomes included BP control and safety, analyzed on an intention-to-treat basis. Forty-nine percent (91/186) of those women approached were randomized (45 intervention, 46 control), and 90% (82/91) finished follow-up. The groups had similar baseline characteristics. After randomization, BP was lower in the intervention group, most markedly at 6 weeks: intervention group mean (SD), systolic 121.6 (8.7)/diastolic 80.5 (6.6) mm Hg; control group, systolic 126.6 (11.0)/diastolic 86.0 (9.7) mm Hg; adjusted differences (95% confidence interval), systolic -5.2 (-9.3 to -1.2)/diastolic -5.8 (-9.1 to -2.5) mm Hg. Diastolic BP remained significantly lower in those self-managing to 6 months: adjusted difference -4.5 (-8.1 to -0.8) mm Hg. This is the first randomized evaluation of BP self-management postpartum and indicates it would be feasible to trial this intervention in larger studies. Self-management resulted in better diastolic BP control to 6 months, even beyond medication cessation.