NCT05849103

Comprehensive Postpartum Management for Women With Hypertensive Disorders of Pregnancy

Completed NA Results posted Last updated 12 March 2026

What this trial tests

NA trial testing Blood Pressure Control Targets in Hypertension, Pregnancy-Induced in 343 participants. Completed in 1 August 2024.

Timeline

8 May 2023

Primary endpoint
1 August 2024

1 August 2024

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	health services research
Enrollment	343
Start date	8 May 2023
Primary completion	1 August 2024
Estimated completion	1 August 2024
Sites	1 location across United States

Drugs / interventions tested

• Blood Pressure Control Targets
• Hypertension Management

Conditions studied

• Hypertension, Pregnancy-Induced — all drugs for Hypertension, Pregnancy-Induced →
• Postpartum Preeclampsia — all drugs for Postpartum Preeclampsia →
• Hypertension; Maternal — all drugs for Hypertension; Maternal →

Sponsor

Vanderbilt University Medical Center

Who can join

18 and older, female only, with Hypertension, Pregnancy-Induced or Postpartum Preeclampsia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Participants With Recorded Blood Pressure Values in Office Primary · 7-10 days post delivery

Proportion of participants with blood pressure values recorded in the office

Group	Value	95% CI
A) Standard BP Control, Clinician Monitoring	43
B) Tight BP Control, Clinician Monitoring	44
C) Standard BP Control, Care Navigation	49
D) Tight BP Control, Care Navigation	56

Proportion of Participants With Recorded Blood Pressure Values, Any Reporting Secondary · 7-10 days post delivery

Proportion of participants with blood pressure values recorded through any means

Group	Value	95% CI
A) Standard BP Control, Clinician Monitoring	48
B) Tight BP Control, Clinician Monitoring	47
C) Standard BP Control, Care Navigation	76
D) Tight BP Control, Care Navigation	78

Systolic Blood Pressure, 7-10 Days Secondary · 7-10 days post delivery

Mean difference in systolic blood pressure from baseline, 7-10 days

Group	Value	95% CI
A) Standard BP Control, Clinician Monitoring	130	122 – 139
B) Tight BP Control, Clinician Monitoring	132	125 – 138
C) Standard BP Control, Care Navigation	128	123 – 136
D) Tight BP Control, Care Navigation	128	120 – 137

Diastolic Blood Pressure Secondary · 7-10 days post delivery

Mean difference in diastolic blood pressure from baseline, 7-10 days

Group	Value	95% CI
A) Standard BP Control, Clinician Monitoring	84	78 – 90
B) Tight BP Control, Clinician Monitoring	82	78 – 90
C) Standard BP Control, Care Navigation	84	78 – 89
D) Tight BP Control, Care Navigation	84	78 – 90

Systolic Blood Pressure, 4-6 Weeks Secondary · 4-6 weeks post delivery

Mean systolic blood pressure, 4-6 weeks

Group	Value	95% CI
A) Standard BP Control, Clinician Monitoring	125.1	± 12.0
B) Tight BP Control, Clinician Monitoring	124.1	± 9.4
C) Standard BP Control, Care Navigation	121.1	± 10.0
D) Tight BP Control, Care Navigation	124.2	± 11.8

Diastolic Blood Pressure, 4-6 Weeks Secondary · 4-6 weeks post delivery

Mean diastolic blood pressure, 4-6 weeks

Group	Value	95% CI
A) Standard BP Control, Clinician Monitoring	78.2	± 9.3
B) Tight BP Control, Clinician Monitoring	79.9	± 9.9
C) Standard BP Control, Care Navigation	78.6	± 9.9
D) Tight BP Control, Care Navigation	78.7	± 9.4

Initiated New Medications Secondary · 7-10 days

Initiated new antihypertensive medications by 7-10 days postpartum

Group	Value	95% CI
A) Standard BP Control, Clinician Monitoring	9
B) Tight BP Control, Clinician Monitoring	7
C) Standard BP Control, Care Navigation	4
D) Tight BP Control, Care Navigation	17

Sustained Severe Hypertension, 7-10 Days Secondary · 7-10 days postpartum

Proportion of participants with two blood pressures \>=160/100 at least 15 minutes apart

Group	Value	95% CI
A) Standard BP Control, Clinician Monitoring	6
B) Tight BP Control, Clinician Monitoring	5
C) Standard BP Control, Care Navigation	6
D) Tight BP Control, Care Navigation	9

Unplanned Visits Secondary · 7-10 days

Proportion of patients with obstetric triage visits, emergency department visits, or hospital readmission

Group	Value	95% CI
A) Standard BP Control, Clinician Monitoring	13
B) Tight BP Control, Clinician Monitoring	10
C) Standard BP Control, Care Navigation	10
D) Tight BP Control, Care Navigation	12

Postpartum Visit Attendance Secondary · 3-6 weeks post delivery

Proportion of patients with postpartum visit attendance

Group	Value	95% CI
A) Standard BP Control, Clinician Monitoring	66
B) Tight BP Control, Clinician Monitoring	66
C) Standard BP Control, Care Navigation	67
D) Tight BP Control, Care Navigation	71

Primary Care Visit Attendance Secondary · 3 months post delivery

Proportion of patients with primary care visit attendance

Group	Value	95% CI
A) Standard BP Control, Clinician Monitoring	29
B) Tight BP Control, Clinician Monitoring	20
C) Standard BP Control, Care Navigation	44
D) Tight BP Control, Care Navigation	48

Felt That They Were Treated With Respect Secondary · 2 weeks post delivery

Proportion of participants who responded "good", "very good", or "excellent" to the prompt "My health care team treated me with respect"

Group	Value	95% CI
A) Standard BP Control, Clinician Monitoring	82
B) Tight BP Control, Clinician Monitoring	80
C) Standard BP Control, Care Navigation	82
D) Tight BP Control, Care Navigation	83

Sponsor's own description

Investigators propose a comprehensive management program for postpartum patients with HDP who are at risk for severe maternal morbidity and mortality. Our program will emphasize three key components: 1) self-monitoring of blood pressures with app-based reporting connected to our electronic health record, 2) blood pressure management directed by a program navigator with guideline and physician support and 3) facilitated transitions of care to primary care clinicians for hypertension management. Investigators will randomize 300 patents with HDP on postpartum day one with follow up through 3 months postpartum. Primary outcome will be blood pressure reporting at 7-10 postpartum. Secondary outcomes include blood pressure control at 7-10 days postpartum, identification and treatment of severe blood pressures, severe maternal morbidity, hospital readmission, triage visits for hypertension, postpartum and primary care visit attendance, and multiple patient-reported outcome measures. All outcomes will be stratified by race (Black and non-Black) to evaluate disparities and by tight versus usual blood pressure control to evaluate the impact of strict postpartum blood pressure control on outcomes. Investigators hypothesize that a comprehensive postpartum HDP management program will improve hypertension control for all patients and reduce disparities that affect Black patients, and that stricter blood pressure control will be associated with fewer adverse outcomes.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comprehensive blood pressure management to improve early postpartum blood pressure parameters: A randomized controlled trial.
   Phelps AJD, Liu J, Lindley KJ, Phillippi JC, et al · · 2026 · PMID 41648074 · DOI 10.1002/pmf2.70145