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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Peking University • ClinicalTrials.gov ID: NCT07294807

Registry updated: 2026-08-28
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Description

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: New-onset hypertensive disorders of pregnancy and related adverse events from randomization to delivery.

Interventions

  • Potassium-enriched salt substitute (Other)
    replace usual salt with potassium-enriched salt containing 25% potassium chloride
  • Usual salt (Other)
    Usual salt (NaCl \>99%)

Eligibility criteria

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.

Conditions

Hypertensive Disorders of Pregnancy

Locations

  • Chongqing Bishan District Maternal and Child Health Care Hospital — Bishan, Chongqing Municipality, China
  • Chongqing Fuling District Maternal and Child Health Care Hospital — Fuling, Chongqing Municipality, China
  • Chongqing Qijiang District People's Hospital — Gunan, Chongqing Municipality, China
  • Chongqing Hechuan District Maternal and Child Health Care Hospital — Hechuan, Chongqing Municipality, China
  • Chongqing Jiangjin District Maternal and Child Health Care Hospital — Jiangjin, Chongqing Municipality, China
  • Chongqing Qianjiang District Maternal and Child Health Care Hospital — Qianjiang, Chongqing Municipality, China
  • The First Affiliated Hospital of Army Medical University (Xinan Hospital) — Shapingba, Chongqing Municipality, China
  • The Second Affiliated Hospital of Army Medical University (Xinqiao Hospital) — Shapingba, Chongqing Municipality, China
  • University Town Hospital of Chongqing Medical University — Shapingba, Chongqing Municipality, China
  • Chongqing Wulong District Maternal and Child Health Care Hospital — Wulong, Chongqing Municipality, China
  • Chongqing Wushan County People's Hospital — Wushan, Chongqing Municipality, China
  • Chongqing Yongchuan District Maternal and Child Health Care Hospital — Yongchuan, Chongqing Municipality, China
  • Chongqing Maternal and Child Health Care Hospital — Yubei, Chongqing Municipality, China
  • Chongqing Yubei District Maternal and Child Health Care Hospital — Yubei, Chongqing Municipality, China
  • Chongqing Yunyang County People's Hospital — Yunyang, Chongqing Municipality, China
  • Army Specialty Medical Center (Daping Hospital) — Yuzhong, Chongqing Municipality, China
  • The First Affiliated Hospital of Chongqing Medical University — Yuzhong, Chongqing Municipality, China
  • The Second Affiliated Hospital of Chongqing Medical University — Yuzhong, Chongqing Municipality, China
  • Affiliated Hospital of Hebei University — Baoding, Hebei, China
  • Baoding Maternal and Child Health Hospital — Baoding, Hebei, China
  • Yixian Maternal and Child Health Hospital — Baoding, Hebei, China
  • Cangzhou Central Hospital — Cangzhou, Hebei, China
  • Cangzhou Maternal and Child Health Hospital — Cangzhou, Hebei, China
  • Huanghua People's Hospital — Cangzhou, Hebei, China
  • Gucheng County Hospital — Hengshui, Hebei, China
  • Hengshui Fourth Hospital — Hengshui, Hebei, China
  • Hengshui Maternal and Child Health Care Hospital — Hengshui, Hebei, China
  • China Petroleum Central Hospital (Hebei) — Langfang, Hebei, China
  • Hebei Yanda Hospital — Langfang, Hebei, China
  • Langfang People's Hospital — Langfang, Hebei, China
  • Qinhuangdao Changli County Maternal and Child Health Hospital — Qinhuangdao, Hebei, China
  • Qinhuangdao Maternal and Child Health Hospital — Qinhuangdao, Hebei, China
  • Qinhuangdao Qinglong County People's Hospital — Qinhuangdao, Hebei, China
  • Shijiazhuang Maternity & Child Healthcare Hospital — Shijiazhuang, Hebei, China
  • Xinle City Hospital — Shijiazhuang, Hebei, China
  • Linxi County People's Hospital — Xingtai, Hebei, China
  • Weixian County People's Hospital — Xingtai, Hebei, China
  • Xingtai People's Hospital — Xingtai, Hebei, China
  • The First People's Hospital of Changde — Changde, Hunan, China
  • Changsha Hospital for Maternal and Child Health Care — Changsha, Hunan, China
  • Xiangya Hospital of Central South University — Changsha, Hunan, China
  • Guyuan Maternal and Child Health Care Hospital — Guyuan, Ningxia, China
  • Guyuan People's Hospital — Guyuan, Ningxia, China
  • Lingwu People's Hospital — Lingwu, Ningxia, China
  • Pingluo County People's Hospital — Pingluo Chengguanzhen, Ningxia, China
  • Shizuishan First People's Hospital — Shizuishan, Ningxia, China
  • Wuzhong People's Hospital — Wuzhong, Ningxia, China
  • Ningxia Hui Autonomous Region Hospital of Traditional Chinese Medicine — Xixia, Ningxia, China
  • Ningxia Hui Autonomous Region People's Hospital — Yinchuan, Ningxia, China
  • Peking University First Hospital Ningxia Women and Children's Hospital — Yinchuan, Ningxia, China
  • Yinchuan First People's Hospital — Yinchuan, Ningxia, China
  • Yinchuan Maternal and Child Health Care Hospital — Yinchuan, Ningxia, China
  • Tongxin County People's Hospital — Yuhai, Ningxia, China
  • Zhongning County People's Hospital — Zhongwei, Ningxia, China
  • Zhongwei People's Hospital — Zhongwei, Ningxia, China
  • Binzhou Medical University Hospital — Binzhou, Shandong, China
  • Qilu Hospital of Shandong University (Dezhou Hospital) — Dezhou, Shandong, China
  • Dongying Second People's Hospital — Dongying, Shandong, China
  • Dong'e County People's Hospital — Dong’e, Shandong, China
  • Feicheng People's Hospital — Feicheng, Shandong, China
  • Heze Municipal Hospital — Heze, Shandong, China
  • Jinan Maternal and Child Health Care Hospital — Jinan, Shandong, China
  • Qilu Hospital of Shandong University — Jinan, Shandong, China
  • Shandong Provincial Hospital — Jinan, Shandong, China
  • Shandong Provincial Maternal and Child Health Care Hospital — Jinan, Shandong, China
  • The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital) — Jinan, Shandong, China
  • The Second Hospital of Shandong University — Jinan, Shandong, China
  • The Second Jinan Maternal and Child Health Care Hospital — Jinan, Shandong, China
  • Jining First People's Hospital — Jining, Shandong, China
  • The Affiliated Hospital of Jining Medical University — Jining, Shandong, China
  • Laizhou Maternal and Child Health Hospital — Laizhou, Shandong, China
  • Lanling County People's Hospital — Lanling, Shandong, China
  • Liaocheng People's Hospital — Liaocheng, Shandong, China
  • Linyi People's Hospital — Linyi, Shandong, China
  • Qingdao Chengyang District People's Hospital — Qingdao, Shandong, China
  • Qingdao Women and Children's Hospital (Peking University People's Hospital Qingdao Branch) — Qingdao, Shandong, China
  • Rizhao People's Hospital — Rizhao, Shandong, China
  • Taian Central Hospital — Taian, Shandong, China
  • Weifang Maternal and Child Health Hospital — Weifang, Shandong, China
  • Weihai Maternal and Child Health Hospital — Weihai, Shandong, China
  • Yantai Yeda Hospital — Yantai, Shandong, China
  • Yantai Yuhuangding Hospital — Yantai, Shandong, China
  • Rongcheng Maternal and Child Health Hospital — Yatou, Shandong, China
  • Zaozhuang Maternal and Child Health Hospital — Zaozhuang, Shandong, China
  • Huantai County Maternal and Child Health Hospital — Zibo, Shandong, China
  • Zibo Maternal and Child Health Hospital — Zibo, Shandong, China
  • Zoucheng People's Hospital — Zoucheng, Shandong, China
  • Zouping People's Hospital — Zouping, Shandong, China
  • Xinjiang Military Region General Hospital — Ürümqi, Xingjiang, China
  • The First People's Hospital of Aksu Prefecture — Aksu, Xinjiang, China
  • Altay Prefecture People's Hospital — Altay, Xinjiang, China
  • Kizilsu Kirgiz Autonomous Prefecture People's Hospital — Artux, Xinjiang, China
  • Bortala Mongolian Autonomous Prefecture People's Hospital — Bole, Xinjiang, China
  • Changji Hui Autonomous Prefecture People's Hospital — Changji, Xinjiang, China
  • The First Affiliated Hospital of Xinjiang Medical University (Changji Branch) — Changji, Xinjiang, China
  • Hami Central Hospital — Hami, Xinjiang, China
  • Hotan Prefecture People's Hospital — Hotan, Xinjiang, China
  • Karamay Central Hospital — Karamay, Xinjiang, China
  • The First People's Hospital of Kashi — Kashgar, Xinjiang, China
  • The Second People's Hospital of Kashi Prefecture — Kashgar, Xinjiang, China
  • Bayingolin Mongolian Autonomous Prefecture People's Hospital — Korla, Xinjiang, China
  • The First Affiliated Hospital of Shihezi University — Shihezi, Xinjiang, China
  • Turpan Gaochang District People's Hospital — Turpan, Xinjiang, China
  • Turpan People's Hospital — Turpan, Xinjiang, China
  • People's Hospital of Xinjiang Uygur Autonomous Region — Ürümqi, Xinjiang, China
  • The First Affiliated Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China
  • Urumqi First People's Hospital (Railway Bureau Campus) — Ürümqi, Xinjiang, China
  • Urumqi Maternal and Child Health Care Hospital (Urumqi You'ai Hospital) — Ürümqi, Xinjiang, China
  • Yili Prefecture Friendship Hospital — Yining, Xinjiang, China
  • Chongqing Wanzhou District Maternal and Child Health Care Hospital — Wanzhou, China
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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