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NCT07687745RecruitingEarly phase 1

Breathing for Two: Inspiratory Muscle Strength Training for Supporting Healthy Blood Pressure in Pregnancy

Source: ClinicalTrials.gov · Last updated 7 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Early phase 1
Study type
Interventional
Enrollment
80 (estimated)
First submitted
8 Jun 2026
Start date
8 Jun 2026
Primary completion date
30 Jun 2027
Lead sponsor
University of Arizona
NCT number
NCT07687745

What you commit to

  • Study type: Interventional · Early phase 1
  • Planned participants: 80
  • From 8 Jun 2026 to the primary completion date, 30 Jun 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Organ transplant

Other illness

  • Any contraindication for moderate exercise (e.g., cardiomyopathy, congenital cardiac conditions)
  • Deep vein thrombosis
  • Active vaginal bleeding, or history of coagulopathy
  • Current substance use disorder
  • History of neurological, respiratory, head/neck, or thoracic surgeries, or conditions such as collapsed lung or perforated eardrum
  • Chronic obstructive pulmonary disorder (COPD)
  • Severe ischemic heart disease
  • Left-sided heart failure
  • Latent or active tuberculosis
  • Neurological problems (e.g. seizure disorder)
  • Severe scoliosis with no history of surgical correction or management.
  • HIV or other immunocompromising conditions
  • Autoimmune disease with possible vascular complications (e.g. Lupus)
  • Significant respiratory compromise (e.g., severe dyspnea, O₂ saturation \<95%, uncontrolled asthma, history of pneumothorax)

Age

  • Younger than 18 or older than 55 years of age

Other

  • Multiple gestation (twin or higher-order pregnancy)
  • Fetal chromosomal abnormalities or major anatomical anomalies
  • Planning to deliver earlier than 38 weeks or within 4 weeks of study enrollment
  • Complications in current pregnancy including intrauterine growth restriction (IUGR), oligohydramnios, preeclampsia, or severe-range blood pressures (\>/=160/110 or \<100/60)
  • Placenta previa or other placental abnormalities (including placental cyst or abruption)
  • Signs of labor
  • Individuals with any of the following:
  • Severe asthma
  • Chronic laryngitis, chronic bronchitis, emphysema, pneumonia
  • Chronic cough

Who the study is looking for

  • Female sex
  • Pregnant (32 to 34 weeks of gestation, confirmed by ultrasound, at the time of first training session, eligible patients may consent/enrolled earlier in pregnancy)
  • Singleton pregnancy
  • Age 18 to 55
  • Able to read English and provide consent
  • Possess smartphone for syncing the AiroFit and Omron devices using Bluetooth and completing online surveys
  • Smartphone updated to iOS 12+ or Android 11+
  • No contraindication for moderate exercise at time of enrollment
  • Not planning delivery for at least one month at time of enrollment (\< 38 weeks of gestation)
  • Willing to adhere to AiroFit device use throughout study period
  • Must already be scheduled, or in the process of scheduling, for weekly NST appointments by 32 to 34 weeks gestational age (per provider order / due to obstetric indication)
    • Lower-Risk Pregnancy Cohort Inclusion Criteria:
  • No history or evidence of hypertensive disorders of pregnancy
  • May be undergoing antenatal testing for:
  • Conception via in vitro fertilization, BMI ≥ 35, an advanced maternal age (age \>/=35), or other condition not listed in exclusion criteria or 'higher risk for HDP group' but is recommended for antenatal testing.
    • Higher-Risk Pregnancy Cohort Inclusion Criteria:
  • Conditions associated with higher risk of developing HDP, including:
  • Gestational diabetes mellitus, chronic hypertension, gestational hypertension, or a history of preeclampsia in a previous pregnancy

Age in the registry: 18 years to 55 years · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Banner University Medical Center
Coordinator of this site? Confirm its status
TucsonUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.