An interventional study of Collaborative care and Standard of Care (SOC) in Hypertensive Disorders of Pregnancy (HDP), Hypertension, Pregnancy Induced and Severe Maternal Morbidity, sponsored by University of Nebraska. Not yet recruiting. Open to female participants aged 19 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by University of Nebraska · Not applicable, Interventional, and Supportive care
The goal of this randomized clinical trial is to evaluate the effectiveness of a collaborative care intervention, consisting of remote blood pressure monitoring and support from community health workers, in improving blood pressure control and reducing postpartum complications among Black women with hypertensive disorders of pregnancy (HDP). The primary objectives are to determine whether the intervention leads to improved blood pressure control at 12 months postpartum compared to standard care, and whether it reduces the incidence of serious maternal morbidity, including hospitalizations and cardiovascular events. Secondary objectives include examining whether patient activation and trust in the healthcare system mediate the relationship between the intervention and clinical outcomes. Participants will be enrolled at approximately 6 weeks postpartum and randomized to either the collaborative care intervention or standard postpartum care. All participants will self-monitor blood pressure using a provided device, receive guidance on hypertension management, and complete study assessments at multiple time points. Participants assigned to the intervention arm will additionally receive ongoing support from community health workers, including health education, care coordination, and assistance with healthcare navigation. Clinical outcomes and patient-reported measures will be assessed over a 12-month follow-up period.
262 studies on the registry are indexed under Hypertension, Pregnancy-Induced; 71 are open to participants now.
This study's planned enrollment of 404 is above the median of 147 across 174 interventional studies indexed under Hypertension, Pregnancy-Induced.
Browse Hypertension, Pregnancy-Induced studies →University of Nebraska is the lead sponsor of 496 studies on the registry; 67 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 53 (64%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants assigned to this arm will receive a collaborative care intervention that includes home blood pressure monitoring using a provided device and support from community health workers. The intervention includes education on hypertension management, assistance with care coordination, and support with healthcare navigation. Participants will regularly measure blood pressure and receive ongoing guidance throughout the 12-month postpartum follow-up period.
Other: Collaborative care
Participants assigned to this arm will receive standard postpartum care. In addition, participants will be provided with a home blood pressure monitoring device and instructed to measure their blood pressure regularly. No additional community health worker support will be provided.
Other: Standard of Care (SOC)
Bluetooth-enabled Remote Patient Monitoring (RPM) with algorithm-driven Community Health Worker (CHW) support. CHWs provide support (averaging 2.3 contacts/week) to facilitate medication titration and address social determinants of health. Treatment follows a standardized protocol using guideline-directed medical therapy targeting a blood pressure of \<130/80 mmHg.
Traditional clinical management consisting of manual blood pressure monitoring and clinic-based medication titration. Treatment follows the same standardized protocol as the intervention arm, using guideline-directed medical therapy targeting a blood pressure of \<130/80 mmHg.
Blood Pressure Control (BP <130/80 mmHg)
Primary endpoint - The proportion of patients achieving a target blood pressure of less than 130/80 mmHg. Blood pressure will be analyzed both as a dichotomous variable (normal \<130/80 mmHg vs. elevated) and as a continuous variable (mean systolic and diastolic readings).
Time frame: Baseline (6 weeks) postpartum to 12 months postpartum
Patient Activation Measure (PAM-13)
Evaluation of survey-based mechanisms of action to determine if they mediate the impact of the Collaborative Care intervention on blood pressure outcome. It assesses patient engagement and activation. A 13-item survey instrument with scores ranging from a minimum of 0 to a maximum of 100. Higher scores indicate a better outcome (greater patient engagement and activation).
Time frame: At Baseline (6 weeks) postpartum, 6 months postpartum and 12 months (1 year) postpartum
Trust in Physician Scale
An 11-item exploratory survey instrument used to evaluate trust in the health care system and determine if it mediates the impact of the Collaborative Care intervention on blood pressure outcome. Scores range from a minimum of 11 to a maximum of 55, where higher scores indicate a better outcome (greater trust in the healthcare provider).
Time frame: At Baseline (6 weeks) postpartum, 6 months postpartum, and 12 months (1 year) postpartum.
Severe Maternal Morbidity (SMM) Composite Rate
Composite Endpoint - Incidence rates of severe maternal morbidity events to assess the efficacy of the Collaborative Care model in reducing overall maternal risk. This composite variable tracks the occurrence of any unplanned emergency department (ED) visit, unplanned hospitalization, or the presence of a severe morbidity event. Severe morbidity events are strictly defined as the clinical occurrence of severe hypertension, acute heart failure, pulmonary edema, eclampsia, acute renal failure, shock, sepsis, cardiac arrest, arrhythmias, myocardial infarction, pulmonary embolism, stroke, or death.
Time frame: Baseline (6weeks) postpartum to 12 months (1 year) postpartum
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Start is estimated for Oct 2026; primary completion for Jun 2031, 56 months later.
Of 90 non-industry interventional studies with no phase under Hypertension, Pregnancy-Induced, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 34. This study's planned 56 months is above that.
Counting every sponsor, half of 91 studies reached it within 23 months; a quarter within 9 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Hypertension, Pregnancy-Induced →