Pregnancy Salt Substitution Trial for Hypertensive Disorders of Pregnancy Prevention (PREG-Salt)
PREG-Salt
Effectiveness, Safety, and Cost-effectiveness of Salt Substitution in High-risk Pregnant Women for the Prevention of Hypertensive Disorders of Pregnancy
1 other identifier
interventional
3,200
1 country
107
Brief 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) .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2025
Typical duration for not_applicable
107 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2025
CompletedFirst Posted
Study publicly available on registry
December 19, 2025
CompletedStudy Start
First participant enrolled
December 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 25, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 25, 2027
December 29, 2025
November 1, 2025
2 years
December 7, 2025
December 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Systolic Blood Pressure
Mean change in systolic blood pressure across antenatal visits (excluding the week before delivery) during the follow-up period.
from baseline to 36-37 weeks of gestation
Incidence of new-onset hypertensive disorders of pregnancy and related maternal adverse events
A prespecified hierarchical composite endpoint including the first occurrence of any of the following events from randomization to delivery: 1）Maternal death or pregnancy loss; 2）New-onset preeclampsia, eclampsia, or placental abruption; 3）New-onset gestational hypertension or clinically meaningful elevation in blood pressure meeting diagnostic criteria.
from randomization to delivery
Secondary Outcomes (21)
Change in Diastolic Blood Pressure
from baseline to 36-37 weeks of gestation
Incidence of new-onset hypertensive disorders of pregnancy
from randomization to delivery
Incidence of clinically meaningful increase in blood pressure
from randomization to delivery
Incidence of preeclampsia or eclampsia
from randomization to delivery
Incidence of maternal death
from randomization to delivery
- +16 more secondary outcomes
Study Arms (2)
Potassium-Enriched Salt substitutes
EXPERIMENTALParticipants 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.
Usual salt
PLACEBO COMPARATORParticipants will continue to use usual salt (≥99% sodium chloride) in the preparation of home meals.
Interventions
replace usual salt with potassium-enriched salt containing 25% potassium chloride
Eligibility Criteria
You may qualify if:
- Singleton pregnancy with a viable fetus at ≤16 weeks of gestation.
- Meets at least one of the following criteria (enrolled sequentially):
- Systolic Blood Pressure (SBP) ≥130 mmHg and \<160 mmHg at enrollment, OR current monotherapy with antihypertensive medications such as labetalol or nifedipine (priority enrollment).
- 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.
- 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).
- Routinely eats at least two meals per day at home (including meals brought from home).
- Able to attend regular antenatal check-ups and is expected to complete the study follow-up.
- Provides written informed consent. -
You may not qualify if:
- SBP ≥160 mmHg or Diastolic Blood Pressure (DBP) ≥110 mmHg at enrollment.
- Conditions or history associated with high uterine tension (e.g., polyhydramnios, macrosomia, hydatidiform mole); autoimmune diseases (e.g., systemic lupus erythematosus, antiphospholipid syndrome).
- 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+.
- Diagnosed hyperkalemia.
- History of hypotension or syncope.
- A household member who shares meals has a confirmed diagnosis of chronic kidney disease or hyperkalemia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
Study Officials
- PRINCIPAL INVESTIGATOR
Jie Qiao
Peking University
- PRINCIPAL INVESTIGATOR
Yangfeng Wu
Peking University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2025
First Posted
December 19, 2025
Study Start
December 25, 2025
Primary Completion (Estimated)
December 25, 2027
Study Completion (Estimated)
December 25, 2027
Last Updated
December 29, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share