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Pregnancy Salt Substitution Trial for Hypertensive Disorders of Pregnancy Prevention (PREG-Salt)
Sponsor: Peking University
Summary
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.
Official title: Effectiveness, Safety, and Cost-effectiveness of Salt Substitution in High-risk Pregnant Women for the Prevention of Hypertensive Disorders of Pregnancy
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
3200
Start Date
2025-12-25
Completion Date
2027-12-25
Last Updated
2025-12-29
Healthy Volunteers
No
Conditions
Interventions
Potassium-enriched salt substitute
replace usual salt with potassium-enriched salt containing 25% potassium chloride
Usual salt
Usual salt (NaCl \>99%)
Locations (107)
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
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