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New treatment option for Hypertension Disorders in Pregnancy
Official title Breathing for Two: Inspiratory Muscle Strength Training for Supporting Healthy Blood Pressure in Pregnancy
ClinicalTrials.gov ID: NCT07687745
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Singleton pregnancy
- Age 18 to 55
- Able to read English and provide consent
You likely can't join if
- 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 Exclusion...
- Younger than 18 or older than 55 years of age
- Multiple gestation (twin or higher-order pregnancy)
- Fetal chromosomal abnormalities or major anatomical anomalies
See the full eligibility criteria
- 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
- 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
- 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 Exclusion Criteria:
- Younger than 18 or older than 55 years of age
- 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
- Any contraindication for moderate exercise (e.g., cardiomyopathy, congenital cardiac conditions)
- Deep vein thrombosis
- Complications in current pregnancy including intrauterine growth restriction (IUGR), oligohydramnios, preeclampsia, or severe-range blood pressures (\>/=160/110 or \<100/60)
- Active vaginal bleeding, or history of coagulopathy
- Placenta previa or other placental abnormalities (including placental cyst or abruption)
- Signs of labor
- Current substance use disorder
- History of neurological, respiratory, head/neck, or thoracic surgeries, or conditions such as collapsed lung or perforated eardrum
- Individuals with any of the following:
- Chronic obstructive pulmonary disorder (COPD)
- Severe asthma
- Severe ischemic heart disease
- Left-sided heart failure
- Chronic laryngitis, chronic bronchitis, emphysema, pneumonia
- Latent or active tuberculosis
- Chronic cough
- Neurological problems (e.g. seizure disorder)
- Severe scoliosis with no history of surgical correction or management.
- Organ transplant
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.