Centering HER for Preeclampsia

Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: University of Kansas Medical Center
Must be taking: Aspirin

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a telehealth program called Centering HER to determine if it helps pregnant women better monitor their blood pressure and adhere to aspirin regimens, potentially reducing early-onset preeclampsia, a serious pregnancy condition. It compares this approach with regular doula care to assess its effectiveness. The trial also examines its ease of use and practicality in community clinics. Women less than 13 weeks pregnant, at moderate or high risk for preeclampsia, and receiving prenatal care might be suitable candidates. As an unphased trial, this study offers a chance to contribute to innovative research that could enhance prenatal care for many women.

What prior data suggests that the Centering HER telehealth program is safe for pregnant participants?

Research has shown that the Centering HER program, which includes online group sessions and tools like a Bluetooth blood pressure cuff, is under study for its potential benefits in prenatal care. Participants in similar programs have experienced positive results. Specifically, studies found that women in group prenatal care programs like Centering HER did not face a higher risk of severe preeclampsia, a condition related to high blood pressure during pregnancy.

These programs aim to provide respectful and supportive care, which is crucial for managing high blood pressure during pregnancy. While specific data for Centering HER is still being collected, its approach has been linked to fewer negative outcomes in other studies.

The program's safety appears promising because it focuses on monitoring and preventive care, rather than introducing new medications or invasive procedures. This suggests that the Centering HER program is well-tolerated and poses minimal risk to participants.12345

Why are researchers excited about this trial?

Researchers are excited about Centering HER for preeclampsia because it introduces a unique approach that combines traditional prenatal care with modern technology and support systems. Unlike standard treatments that focus on monitoring and medication, this method incorporates virtual group sessions led by doulas, adding a personalized touch to patient care. The inclusion of a Bluetooth blood pressure cuff and scale, and optionally an Apple Watch, allows for real-time health tracking and remote monitoring, potentially leading to earlier detection and management of symptoms. This holistic approach empowers expectant mothers with tools and support, aiming to improve both health outcomes and patient experience.

What evidence suggests that the Centering HER program is effective for improving hypertension monitoring and aspirin adherence in pregnant participants?

Research has shown that exercise can lower the risk of gestational hypertension and preeclampsia by 30% to 40%. Treating high blood pressure before pregnancy reduces complications by about 20%. Taking low-dose aspirin between the 12th and 16th weeks of pregnancy also helps prevent preeclampsia. Managing very high blood pressure early can stop problems from developing. This trial will compare usual doula care with the Centering HER program, which includes routine prenatal care and additional doula-led virtual group sessions. These findings suggest that monitoring and preventive steps, like those in the Centering HER program, effectively reduce issues related to high blood pressure during pregnancy.16789

Are You a Good Fit for This Trial?

This trial is for pregnant women in Kansas who are less than 13 weeks along, at least 18 years old, speak English or Spanish, and have a moderate or high risk of developing high blood pressure during pregnancy.

Inclusion Criteria

English or Spanish speaking
Moderate or high risk for hypertensive disorders in pregnancy
Less than 13 weeks gestation
See 1 more

Exclusion Criteria

No risk factors for hypertensive disorders in pregnancy
Not receiving prenatal care
I am younger than 18 years old.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive routine prenatal care and attend 7 doula-led 90-minute virtual group sessions with OB/GYN fellow oversight, using a Bluetooth BP cuff/scale ± Apple Watch for self-monitoring

12 weeks
7 virtual group sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Centering HER

Trial Overview

The study compares standard prenatal care with an enhanced program called Centering HER. This program adds seven virtual group sessions led by doulas to routine care, aiming to improve blood pressure checks and aspirin use.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: Behavioral: Experimental: Centering HER (routine prenatal care + 7 doula-led 90-minute virtual groupActive Control1 Intervention
Group II: usual doula care + routine prenatal carePlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials
527
Recruited
181,000+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials
315
Recruited
251,000+

Citations

High Blood Pressure During Pregnancy

Preeclampsia occurs when a woman who previously had normal blood pressure suddenly develops high blood pressure and protein is found in her ...

Hypertension in Pregnancy: Diagnosis, Blood Pressure Goals ...

Exercise may reduce gestational hypertension and preeclampsia risk by approximately 30 and 40%, respectively.72,

Hypertension in Pregnancy and Postpartum

Hypertension in pregnancy contributes substantially to maternal morbidity and mortality, persistent hypertension, and rehospitalization.

Study shows treating preexisting high blood pressure in ...

There was an almost 20 percent decrease in pregnancy complications for women treated with medication compared to the standard group.

Severe Hypertension In Pregnancy | AIM

Monitor outcomes and process data related to severe hypertension with disaggregated data to support analysis. RESPECTFUL, SUPPORTIVE & PATIENT-CENTERED CARE.

Improving Prenatal Care

Centering HER and collect feasibility and intermediate outcome data. Centering HER may be a low cost, sustainable, translatable option to prevent preeclampsia ...

Preeclampsia: Recent Advances in Predicting, Preventing ...

Chronic hypertension accounts for approximately 4% of pregnancies and is often associated with adverse gestational outcomes such as preeclampsia, preterm

Best Practices

To assist healthcare providers in achieving this goal, this patient safety bundle provides guidance to coordinate and standardize the care provided to women ...

Participation in the CenteringPregnancy Program and ...

However, CenteringPregnancy participants did not experience significantly higher odds of mild pre-eclampsia (OR=1.06, 95% CI=0.65, 1.78) and severe pre- ...