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Remote Patient Monitoring for Chronic Hypertension During Pregnancy (REACH)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 55 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Heart tracing (ECG), Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "An EKG is also part of the standard of care for patients with chronic hypertension in pregnancy."
  • "Patients randomized to the remote patient monitoring system will be set up with a Bluetooth-enabled tablet and blood pressure cuff through the HRS system synced with electronic medical records."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This pilot study is for pregnant adults with mild, long-term high blood pressure. It tests whether daily blood pressure checks at home, with prompt medicine changes, can be studied in a larger trial compared with checks at office visits. The blood pressure goal is below 140/90.

We hypothesize that frequent remote monitoring of blood pressure and real-time antihypertensive medication titration will optimize pregnancy outcomes in a clinically meaningful and cost-effective manner compared to the current standard of care. Therefore, this pilot study, as part of the K12 training support, will evaluate the feasibility of a randomized clinical trial to treat mild chronic hypertension with medication therapy to a blood pressure goal of less than 140/90 mmHg based on remote daily patient monitoring compared to in-office blood pressure readings.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Less than 23 weeks pregnant, with a pregnancy that is still developing.
  • Already being treated for high blood pressure, or have a top reading of 140 or higher or a bottom reading of 90 or higher before 20 weeks of pregnancy.
  • Able to follow directions.
  • Able to agree to take part in the study.
  • Speak English or Spanish.

Who can't join

  • High blood pressure has a known underlying cause.
  • The baby has a known major birth defect, has died, or may not be growing as expected.
  • Your water has broken, or you plan to end the pregnancy.
  • You plan to give birth outside the RWJ Barnabas Health system.
  • Known sensitivity to labetalol or nifedipine, medicines for high blood pressure.
  • Study staff think you are unlikely to return for follow-up care.
  • Your care team thinks a medical condition makes the study's treatment plan unsafe for you.
  • You are unwilling to check your blood pressure at home.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Age 18 or older * Patients with a viable pregnancy \<23 weeks of gestation * Chronic hypertension is defined as: 1) Currently receiving treatment for hypertensive disorders OR 2) Newly diagnosed or untreated chronic hypertension is defined as systolic blood pressure \>=140 mm Hg or diastolic blood pressure \>=90 mm Hg prior to 20 weeks of gestation * Viable pregnancy \<23 weeks of gestation * Ability to follow directions * Ability to consent * Speak English or Spanish Exclusion Criteria: * Known secondary cause of hypertension * Known major fetal anomaly * Known fetal demise * Suspected fetal growth restriction * Membrane rupture * Planned termination * Plan to deliver outside of the RWJ Barnabas Health system * Known sensitivity to labetalol or nifedipine * Unlikely to follow up, in the opinion of the study staff. * Any medical condition that the providers feel is a contraindication to the REACH algorithm. * Unwillingness to take blood pressure at home

Study sites (1)

NJ