An interventional study of Intensive Education and Enhanced Virtual Care in Postpartum Complication, sponsored by University of Texas Southwestern Medical Center. Recruiting at 2 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Prevention
The purpose of this study is to compare two complex, multi-component evidence-based postpartum interventions in underserved populations of lower socioeconomic status in an effort to reduce maternal morbidity and mortality.
This large, multi-center randomized controlled trial will compare two multi-component postpartum care models via hybrid type 1 design conducted in two phases. An initial phase (phase 1) will collect baseline data and ensure patient input into final study. In phase 2, women will be randomized. Comparators are evidenced- based approaches: (1) an intensive in-person education with virtual education via push notifications using an electronic health record web portal; (2) a telehealth model using serial encounters. The "push" approach using notifications directly contrasts with the "pull" approach using telehealth visits. Both models include home visit programs. The study population includes patients delivering in two urban, inner-city health systems: Parkland (Dallas, TX) under the direction of Drs. Duryea and Nelson (UT Southwestern PIs) and Grady Memorial (Atlanta, GA) under the direction of Dr. Newton-Levinson (Emory PI). The primary outcome is time from hospital discharge to diagnosis and treatment of a composite of complications in the first 6 weeks. Based upon pilot data, 2349 women will demonstrate a 40% reduction (9 to 5.4 days) with 80% power and two-sided alpha of 0.05. 3500 women will be enrolled (1000 in phase 1; 2500 in phase 2) with anticipated \<5% attrition at 6 weeks. Inclusion will be women who deliver liveborn infants. Secondary outcomes include mental health disorders, emergency room visits, hospital admissions, patient knowledge, quality of life and satisfaction, provider satisfaction, and social determinants of health. Women will be followed for one year postpartum.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 3,500 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →University of Texas Southwestern Medical Center is the lead sponsor of 1,010 studies on the registry; 199 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women enrolled in the intensive education care model participate in intensive in-person education as well as ongoing virtual education via the electronic health record web portal in the form of strategically timed "pushes" of relevant and digestible educational elements via a "Care Companion." These virtual education "pushes" will include "to do" list reminders to check vital signs and submit them for review to the care team. Positive reinforcement will be provided when tasks are completed.
Other: Intensive Education
Women in the enhanced virtual care model will receive scheduled telehealth visits on the platform of their choice - either via video or audio-only synchronous visits. Patients in the virtual care model will check vital signs with home devices during the telehealth visit and report them directly to the provider. This "pull" approach to data collection directly contrasts with the "push" approach of comparator #1.
Other: Enhanced Virtual Care
Intervention will consist of virtual education and communication through scheduled push notifications
Intervention will utilize a telehealth model consisting of "pull" approach of patient engagement.
Composite Healthcare Outcome - time to diagnosis and treatment of postpartum complications after hospital discharge
Time to diagnosis and treatment of postpartum complications including hypertension, wound infection, and venous thromboembolism, measured in days. Lower value is considered better, representing timely care.
Time frame: Up to one year postpartum
Edinburgh Postnatal Depression Scale
screening continuous, numerical; higher value consistent with great risk of postpartum depression
Time frame: enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum
Generalized Anxiety Disorder 7
screening tool, continuous, numerical, higher value consistent with higher risk of anxiety disorder
Time frame: enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum
Number of patients requiring emergency room visits, % preventable
continuous variable, preventability to be determined by preventability panel
Time frame: Up to one year postpartum
Number of patients requiring hospital admissions, % preventable
continuous variable, preventability to be determined by preventability panel
Time frame: Up to one year postpartum
Postpartum warning signs knowledge assessment, based on AWOHHN criteria
Percent scored correct out of 10 total questions
Time frame: enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum
PROMIS-29 questionnaire v 2.1
Scales 1-10 for each independent question, with numerical summary score
Time frame: 6 weeks and 1 year postpartum
Healthy People 2030 questionnaire
categorical variables selected by the participant
Time frame: 6 weeks and 1 year postpartum
PRAPARE questionnaire
categorical and dichotomous variables
Time frame: 6 weeks and 1 year postpartum
Short Assessment of Patient Satisfaction (SAPS)
Scale: Extremely dissatisfied to extremely satisfied Score Range is 0-28.
Time frame: 6 weeks and 1 year postpartum
Provider Satisfaction Survey (Quantitative)
Scale: Strong agree to strongly disagree; very good to very bad; often to never
Time frame: Every 6 months throughout the study period
Systolic Blood Pressure
numerical, continuous
Time frame: enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum
Diastolic Blood Pressure
numerical, continuous
Time frame: enrollment, 1 week, 6 weeks, 3 months, 6 months, 1 year postpartum
Social Determinants of Health - Healthy People 2030 and PRAPARE questionnaire
qualitative data, each questions treated as dichotomous or categorical variables
Time frame: enrollment, 6 weeks, 1 year postpartum
Long-term disease control - diabetes - hemoglobin A1c, LDL, HDL, total cholesterol, triglycerides
laboratory value - continuous variables
Time frame: enrollment, 6 weeks, 3 months, and 1 year postpartum
Long-term disease control - hypertension - serum creatinine
laboratory value - continuous variable
Time frame: enrollment, 6 weeks, 3 months, and 1 year postpartum
Long-term disease control - liver function test (AST, ALT)
laboratory value - continuous variables
Time frame: enrollment, 6 weeks, 3 months, and 1 year postpartum
Long-term disease control - anemia - hemoglobin and hematocrit
laboratory value - continuous variables
Time frame: enrollment, 6 weeks, 3 months, and 1 year postpartum
Plan to share: No
Started Mar 2024 (actual). Primary completion is estimated for Sep 2027, 42 months after the start.
Of 1,403 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 42 months is above that.
Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Texas Southwestern Medical Center →