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New treatment option for High-risk Pregnancy
Official title Leg Heating in Pregnant Women With Obesity
ClinicalTrials.gov ID: NCT06932250
What this study is testing
- What it's testing
- Obesity is a major risk factor for hypertensive disorders of pregnancy (HDP). The underlying mechanisms are largely unclear, but maternal vascular endothelial dysfunction is likely involved.
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 45, women only. Healthy volunteers may be eligible.
You may be able to join if
- Women with overweight or obesity (self-reported pre-pregnancy body mass index ≥25 kg/m2) between 10-14 weeks of gestation and aged 18-45 years old...
- Both normotensive and hypertensive (office sitting systolic BP 140-150 mmHg and/or diastolic BP 90-100 mmHg) pregnant women will be enrolled if they...
- We will enroll both nulliparous and multiparous women.
- There is no restriction regarding race/ethnicity and socioeconomic status.
- Women with a history of HDP will be allowed to participate.
You likely can't join if
- Current multiple pregnancies (e.g., twins, triplets, etc.).
- Known major fetal chromosomal or anatomical abnormalities diagnosed during the study.
- Recurrent miscarriage (three or more, to avoid antiphospholipid antibody syndrome).
- Office sitting BP \ 150/100 mmHg (for safety reasons).
- Evidence of cardiovascular, pulmonary, or neurological diseases.
- Diabetes mellitus (to avoid its effects on vascular endothelial function and sympathetic vasoconstriction).
See the full eligibility criteria
- Women with overweight or obesity (self-reported pre-pregnancy body mass index ≥25 kg/m2) between 10-14 weeks of gestation and aged 18-45 years old will be enrolled.
- Both normotensive and hypertensive (office sitting systolic BP 140-150 mmHg and/or diastolic BP 90-100 mmHg) pregnant women will be enrolled if they are not on any antihypertensive drug treatment.
- We will enroll both nulliparous and multiparous women.
- There is no restriction regarding race/ethnicity and socioeconomic status.
- Women with a history of HDP will be allowed to participate.
- Women taking low-dose aspirin will be allowed to participate and aspirin use will be documented.
- Current multiple pregnancies (e.g., twins, triplets, etc.).
- Known major fetal chromosomal or anatomical abnormalities diagnosed during the study.
- Recurrent miscarriage (three or more, to avoid antiphospholipid antibody syndrome).
- Office sitting BP \ 150/100 mmHg (for safety reasons).
- Evidence of cardiovascular, pulmonary, or neurological diseases.
- Diabetes mellitus (to avoid its effects on vascular endothelial function and sympathetic vasoconstriction).
- Kidney disease (serum creatinine \>0.9 mg/dL).
- Clinical known deep vein thrombosis, clinical symptoms and history of deep vein thrombosis, or dermatological lesions.
- History of drug or alcohol abuse within the last 2 years.
- Current tobacco use.
- Pregnant women who do not have air conditioning at home during summer (for safety reasons).
The study team makes the final eligibility decision.
Where it's taking place
- Dallas, Texas, 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 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dallas, Texas, 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.