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Pregnancy Salt Substitution Trial for Hypertensive Disorders of Pregnancy Prevention (PREG-Salt)

RecruitingNAAges 18 Years - anyFemalePeking University
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In plain words

What the trial is, and whether it could suit you

The PREG-Salt study is to evaluate the effect, safety and cost-effectiveness of low-sodium salt in reducing blood pressure and preventing hypertensive disorders in pregnant women at high risk in China. The study will recruit about 3,200 participants from approximately 100 hospitals across multiple provinces in China. Eligible pregnant women (≤16 weeks of gestation) will be randomly assigned in a 1:1 ratio to the following 2 groups: 1. Salt subsittute(intervention); 2. Usual salt (control) . The intervention will last until delivery. The study employs an adaptive two-phase design. An interim analysis after the first phase (n=400) will inform whether the trial continues into the second phase and if any adjustments to the sample size are needed. The primary outcomes are: Phase 1: The mean systolic blood pressure across antenatal visits (excluding the last week before delivery). Phase 2:

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Singleton pregnancy with a viable fetus at ≤16 weeks of gestation. 2. Meets at least one of the following criteria (enrolled sequentially): 1. Systolic Blood Pressure (SBP) ≥130 mmHg and \<160 mmHg at enrollment, OR current monotherapy with antihypertensive medications such as labetalol or nifedipine (priority enrollment). 2. At least one of the following 4 items: advanced maternal age (≥35 years), pre-pregnancy obesity (BMI ≥28 kg/m²), history of preeclampsia, or pre-existing type 1 or type 2 diabetes. 3. At least two of the following 5 items: history of adverse pregnancy outcome (e.g., fetal death, placental abruption, fetal growth restriction), personal history of gestational hypertension or family history of preeclampsia (mother or sister), history of gestational diabetes, obstructive sleep apnea, or pre-pregnancy overweight (BMI 24-28 kg/m²). 3. Routinely eats at least two meals per day at home (including meals brought from home). 4. Able to attend regular antenatal check-ups and is expected to complete the study follow-up. 5. Provides written informed consent. - Exclusion Criteria: 1. SBP ≥160 mmHg or Diastolic Blood Pressure (DBP) ≥110 mmHg at enrollment. 2. Conditions or history associated with high uterine tension (e.g., polyhydramnios, macrosomia, hydatidiform mole); autoimmune diseases (e.g., systemic lupus erythematosus, antiphospholipid syndrome). 3. History of chronic kidney disease, OR any antenatal check-up with a confirmed estimated Glomerular Filtration Rate (eGFR) \<70 ml/min/1.73m², OR dipstick urine protein ≥2+. 4. Diagnosed hyperkalemia. 5. History of hypotension or syncope. 6. A household member who shares meals has a confirmed diagnosis of chronic kidney disease or hyperkalemia.
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What it tests

  • Potassium-enriched salt substitute
  • Usual salt
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Where

110 sites
Chongqing Bishan District Maternal and Child Health Care Hospital
Bishan, China
Chongqing Fuling District Maternal and Child Health Care Hospital
Fuling, China
Chongqing Qijiang District People's Hospital
Gunan, China
Chongqing Hechuan District Maternal and Child Health Care Hospital
Hechuan, China
Chongqing Jiangjin District Maternal and Child Health Care Hospital
Jiangjin, China
Chongqing Qianjiang District Maternal and Child Health Care Hospital
Qianjiang, China
The First Affiliated Hospital of Army Medical University (Xinan Hospital)
Shapingba, China
The Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
Shapingba, China

…and 102 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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