Pregnancy-Related Hypertension: Adherence to a New Type of Monitoring

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-15

Study Completion Date

2022-01-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A large segment of our patient population is diagnosed with hypertensive disorders of pregnancy, including gestational hypertension and pre-eclampsia. New guidelines from the American College of Obstetricians and Gynecologists recommend postpartum monitoring of blood pressures via blood pressure checks on day 3 postpartum and between days 7-10 postpartum. Our purpose is to compare the effectiveness of using a Bluetooth-enabled home blood pressure monitoring platform to the standard postpartum office-based blood pressure monitoring in performing the recommended postpartum follow-up for patients with hypertensive disorders of pregnancy.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Innovation in Postpartum Care for Women With Hypertensive Disorders of Pregnancy

NCT03613714

Hypertension in Pregnancy Hypertension, Pregnancy-Induced Postpartum Preeclampsia +1 more

COMPLETED NA

Use of a Cloud-connected Remote Blood Pressure Monitoring Program During the Postpartum Period for Hypertensive Women

NCT06096701

Hypertensive Disorder

RECRUITING

Blood Pressure Monitoring in High Risk Pregnancy to Improve the Detection and Monitoring of Hypertension

NCT03334149

Pregnancy, High Risk Pre-Eclampsia Hypertension +1 more

COMPLETED NA

Hypertensive Pregnant Women Monitored by Teletransmitted Self-measurements of Blood Pressure

NCT03648645

Hypertension in Pregnancy

UNKNOWN NA

Premom: Pregnancy Remote Monitoring

NCT03246737

Pregnancies, Cardiovascular Complications

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

While inpatient during the postpartum period, patients will be identified who were diagnosed with hypertensive disorders of pregnancy antepartum, intrapartum, or postpartum. These patients will be recruited prior to discharge home. This will be a randomized control trial, non-blinded. The study group will receive a mobile app for postpartum education and an integrated Wi-Fi connected blood pressure cuff for at-home monitoring for 16 days postpartum. The home BP monitoring will occur twice a day and study team will check the BPs twice a day and intervene by phone or text if necessary. The control group will be scheduled for blood pressure checks at the clinic between days 7-10. These groups will be compared with regard to adherence to guidelines from the American College of Obstetricians and Gynecologists for blood pressure monitoring, antihypertensive initiation after discharge, unscheduled visits, readmission, and attendance of postpartum visit.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gestational Hypertension Preeclampsia Chronic Hypertension With Pre-Eclampsia Complicating Childbirth HELLP Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Control arm: will be scheduled an in-office blood pressure check 7-10 days postpartum Intervention arm: will receive a blood pressure cuff and app with which to monitor their blood pressures at home for 16 days postpartum

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard care

Patient will be scheduled for a blood pressure check in the office 7-10 days postpartum

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

Patient will receive a Babyscripts blood pressure cuff(brand: A\&D Medical) and Babyscripts MyJourney phone app with which to monitor their blood pressures twice daily for 16 days after discharge

Group Type EXPERIMENTAL

Home blood pressure monitoring

Intervention Type DEVICE

See arm description

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Home blood pressure monitoring

See arm description

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient must have delivered an infant either at Greenville Memorial Hospital or MUSC and be willing and able to follow-up with her respective institution.
* Patient must have been diagnosed with a hypertensive disorder of pregnancy in the antepartum, intrapartum, or postpartum period.

Exclusion Criteria

* \<18 years of age
* BMI \>50 (due to limitations in blood pressure cuff size through BabyScripts)
* non English-speaking
* not able to receive phone calls and unlimited texts on cell phone
* not able to download and use Babyscripts phone application

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No