Pregnancy Salt Substitution Trial for Hypertensive Disorders of Pregnancy Prevention (PREG-Salt)
NCT ID: NCT07294807
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
3200 participants
INTERVENTIONAL
2025-12-25
2027-12-25
Brief Summary
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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.
Detailed Description
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1. to evaluate whether salt substitute significantly reduces mean blood pressure, while observing adherence and safety, in a high-risk population for hypertensive disorders of pregnancy.
2. to further evaluate whether salt substitute significantly reduces the incidence of hypertensive disorders of pregnancy, while assessing its safety and cost-effectiveness.
The study is a two-phase, multicenter, randomized, double-blind, parallel-group controlled study. High-risk pregnant women at ≤16 weeks of gestation will be enrolled and randomly assigned in a 1:1 ratio to either the salt substitute(intervention) group or the usual salt (control) group. The study salt will be provided free of charge until delivery. Follow-up will be conducted through all antenatal visits and delivery to collect blood pressure data and information on the incidence of hypertensive disorders of pregnancy (including gestational hypertension, preeclampsia, eclampsia, death, stillbirth, preterm birth, etc.). The study employs an adaptive design. An interim analysis will be conducted after the completion of the first phase. Based on pre-specified efficacy and safety criteria, a decision will be made regarding the continuation of the study and potential adjustments to the subsequent sample size and randomization ratio.
The study will recruit about 3,200 participants(400 participants in the first phase) from approximately 100 hospitals (with an annual delivery volume of \>1,000) at the county level or above, across multiple provinces in China.
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. A confirmed diagnosis of hyperkalemia.
5. History of hypotension or syncope.
6. A household member who shares meals has a confirmed diagnosis of chronic kidney disease or hyperkalemia.
Outcome Measures:
Primary outcomes:
Phase 1: Mean change in systolic blood pressure. Phase 2: New-onset Hypertensive Disorders of Pregnancy and Related Maternal Adverse Events
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Potassium-Enriched Salt substitutes
Participants will use a potassium-enriched salt substitute in place of usual salt for home-prepared meals. The study salt substitute consists of 25% potassium chloride and 75% sodium chloride.
Potassium-enriched salt substitute
replace usual salt with potassium-enriched salt containing 25% potassium chloride
Usual salt
Participants will continue to use usual salt (≥99% sodium chloride) in the preparation of home meals.
Usual salt
Usual salt (NaCl \>99%)
Interventions
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Potassium-enriched salt substitute
replace usual salt with potassium-enriched salt containing 25% potassium chloride
Usual salt
Usual salt (NaCl \>99%)
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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Peking University
OTHER
Responsible Party
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Principal Investigators
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Jie Qiao
Role: PRINCIPAL_INVESTIGATOR
Peking University
Yangfeng Wu
Role: PRINCIPAL_INVESTIGATOR
Peking University
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Li Liu
Role: primary
Xuejuan Xiao
Role: primary
Xiaojun Wang
Role: primary
Chongwen Xia
Role: primary
Zhaoning Ding
Role: primary
Min Huang
Role: primary
Dan Wang
Role: primary
Zhengqiong Chen
Role: primary
Jing Tian
Role: primary
Xianmei Li
Role: primary
Laqiong Tan
Role: primary
Li Luo
Role: primary
Lan Wang
Role: primary
Xian Che
Role: primary
Hong Tang
Role: primary
Xiuhui Zheng
Role: primary
Xin Luo
Role: primary
Yingya Xu
Role: primary
Hongli Zhang
Role: primary
Jing Zhang
Role: primary
Jianxue Gao
Role: primary
Dandan Shi
Role: primary
Xinyan Wang
Role: primary
Jing Zhang
Role: primary
Fang Liu
Role: primary
Chunyan Wang
Role: primary
Lihua Bai
Role: primary
Zhimin Gao
Role: primary
Zhenyan Wang
Role: primary
Jing Zhang
Role: primary
Jing Wang
Role: primary
Chunyu Zhang
Role: primary
Li Tong
Role: primary
Lulu Sun
Role: primary
Yuxia Guo
Role: primary
Guizhen Dou
Role: primary
Juncai Guo
Role: primary
Zongxu Qiao
Role: primary
Lin Hu
Role: primary
Liping Liu
Role: primary
Wenhua Zhang
Role: primary
Jinmei Wang
Role: primary
Ling Zhang
Role: primary
Tao Wang
Role: primary
Lifang Li
Role: primary
Yang Fan
Role: primary
Ling He
Role: primary
Xin Qi
Role: primary
Yingchun Ha
Role: primary
Jinlian Ma
Role: primary
Jianping Li
Role: primary
Lihua Wang
Role: primary
Kexin Lu
Role: primary
Peng Yu
Role: primary
Caixia Zhou
Role: primary
Yan Jiang
Role: primary
Qiuyun Guo
Role: primary
Cuili Zou
Role: primary
Fengchun Gao
Role: primary
Xia Luo
Role: primary
Xietong Wang
Role: primary
Yan Lian
Role: primary
Wei Guo
Role: primary
Fanzhen Hong
Role: primary
Yan Wu
Role: primary
Yingjie Han
Role: primary
Dongmei Man
Role: primary
Xuxia Wu
Role: primary
Wenhui Sun
Role: primary
Xiaobing Wang
Role: primary
Ying Chen
Role: primary
Jinli Liang
Role: primary
Dongmei Fan
Role: primary
Yongjing Lai
Role: primary
Ling Huang
Role: primary
Yong Guo
Role: primary
Qiongqiong Wu
Role: primary
Xiangna Wan
Role: primary
Hongmei Qu
Role: primary
Hailing Yu
Role: primary
Chengwen Liu
Role: primary
Caiqin Jin
Role: primary
Yingchun Yu
Role: primary
Qi Chen
Role: primary
Shujian Xing
Role: primary
Zerong Tu
Role: primary
Kebinuer Maimaiti
Role: primary
Huimei Tian
Role: primary
Xinxin Zhang
Role: primary
Yonghui Dai
Role: primary
Weiwei Li
Role: primary
Ping Li
Role: primary
Yan Ma
Role: primary
Maihebureti Maimaitinuer
Role: primary
Jing Lv
Role: primary
Maihefuzaimu Abudukade
Role: primary
Baharguli Abulaiti
Role: primary
Hui Zhao
Role: primary
Yajuan Gu
Role: primary
Xue Xia
Role: primary
Juan Li
Role: primary
Ying Huang
Role: primary
Qiying Zhu
Role: primary
Lei Dai
Role: primary
Li Yan
Role: primary
Zonglin Lu
Role: primary
Xianbing Wang
Role: primary
Other Identifiers
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XMHEJH-WU
Identifier Type: -
Identifier Source: org_study_id