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80 Participants NeededMy employer runs this trial

Breathing Exercises for High Blood Pressure in Pregnancy

EE
LW
Overseen ByLily Woods, MA
Age: 18 - 65
Sex: Female
Trial Phase: Phase < 1
Sponsor: University of Arizona
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This is an interventional study that will test whether a breathing exercise called Inspiratory Muscle Strength Training (IMST) can safely and effectively lower blood pressure during late pregnancy. The goal is to see if a home-based breathing training can help prevent or reduce high blood pressure disorders in pregnancy. The main objectives are to make sure the training is safe and tolerable for pregnant women and to examine blood pressure and blood vessel health. Participants in their third trimester will be randomly assigned to either do moderate resistance IMST or a minimal resistance sham IMST, for 5 to 8 minutes a day over six weeks.

Are You a Good Fit for This Trial?

This trial is for pregnant women in their third trimester who want to help manage or prevent high blood pressure during pregnancy. Participants should not have any conditions that would make breathing exercises unsafe, but specific exclusions are not listed.

Inclusion Criteria

Not planning delivery for at least one month at time of enrollment (< 38 weeks of gestation)
Lower-Risk Pregnancy Cohort: No history or evidence of hypertensive disorders of pregnancy
Lower-Risk Pregnancy Cohort: May be undergoing antenatal testing for conception via in vitro fertilization, BMI ≥ 35, advanced maternal age (≥35), or other condition not listed in exclusion criteria or higher risk for HDP group but recommended for antenatal testing
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Exclusion Criteria

Signs of labor
Placenta previa or other placental abnormalities including placental cyst or abruption
Current substance use disorder
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What Are the Treatments Tested in This Trial?

Trial Overview

The study tests a home-based breathing exercise called Inspiratory Muscle Strength Training (IMST) at either moderate or minimal resistance. Women are randomly assigned to one of the two groups and do daily sessions for six weeks.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: Moderate-Resistance IMSTActive Control1 Intervention
Group II: Low-Resistance IMSTPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials
545
Recruited
161,000+

Banner University Medical Center

Collaborator

Trials
10
Recruited
3,200+

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