Salt substitute to prevent hypertensive disorders in high-risk pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized study in China will compare a potassium-enriched salt substitute to ordinary salt in pregnant women at high risk for hypertensive disorders, enrolling about 3,200 participants up to 16 weeks gestation. The trial uses a two-phase adaptive design to assess effectiveness, safety, and cost-effectiveness, with interim analyses guiding continuation and sample size adjustments. Primary outcomes include mean systolic blood pressure during antenatal care and the incidence of hypertensive disorders of pregnancy from randomization to delivery. The intervention lasts until delivery, with follow-up through all antenatal visits and delivery to capture blood pressure data and adverse pregnancy outcomes. Salt substitute is provided free of charge; adherence and safety are monitored across multiple centers in Chongqing and surrounding regions.

Why it matters

Who can join: the full rules

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.

Where it's running

• Chongqing Wulong District Maternal and Child Health Care Hospital
  Wulong, Chongqing Municipality, China Recruiting
• Chongqing Wushan County People's Hospital
  Wushan, Chongqing Municipality, China Recruiting
• Chongqing Maternal and Child Health Care Hospital
  Yubei, Chongqing Municipality, China Recruiting
• Chongqing Yunyang County People's Hospital
  Yunyang, Chongqing Municipality, China Recruiting
• Army Specialty Medical Center (Daping Hospital)
  Yuzhong, Chongqing Municipality, China Recruiting
• The First Affiliated Hospital of Chongqing Medical University
  Yuzhong, Chongqing Municipality, China Recruiting

+60 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Jie Qiao — Peking University
• Study coordinator: Yifang Yuan
• Email: yuanyf_pucri@bjmu.edu.cn
• Phone: 0086-17310387323

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.