Hypertensive Disorders of PregnancyPREG-SaltNCT07294807

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

A study testing Potassium-enriched salt substitute and Usual salt in people with Hypertensive Disorders of Pregnancy, run by Peking University at 110 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Hypertensive Disorders of Pregnancy
What is being tested?: Potassium-enriched salt substitute and Usual salt
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 3,200 participants
Where: 110 sitesChina
Study dates: 6 Jan 2026to 25 Dec 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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. -

Who cannot join

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.

Trial locations and contacts

110 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yifang Yuan contact

0086-17310387323

yuanyf_pucri@bjmu.edu.cn

Jie Yuan contact

0086-15222768336

yuanjie_pucri@bjmu.edu.cn

City, postcode or hospital

Sites recruiting now only

110 sites in 1 country

China110 sites, 102 recruiting

The First People's Hospital of Aksu Prefecture
Aksu, Xinjiang
Kebinuer Maimaiti, 0086-13369888102, 2137772698.@qq.com
Not yet recruiting
Altay Prefecture People's Hospital
Altay, Xinjiang
Huimei Tian, 0086-13699945255, 247964937@qq.com
Not yet recruiting
Kizilsu Kirgiz Autonomous Prefecture People's Hospital
Artux, Xinjiang
Xinxin Zhang, 0086-18199723554, 515690839@qq.com
Not yet recruiting
Affiliated Hospital of Hebei University
Baoding, Hebei
Hongli Zhang, 0086-13931351958, fyckwhl@163.com
Not yet recruiting
Baoding Maternal and Child Health Hospital
Baoding, Hebei
Jing Zhang, 0086-15832205811, zhangjing101125@126.com
Recruiting
Yixian Maternal and Child Health Hospital
Baoding, Hebei
Jianxue Gao, 0086-15930475408, 2483985975@qq.com
Not yet recruiting
Binzhou Medical University Hospital
Binzhou, Shandong
Withdrawn
Chongqing Bishan District Maternal and Child Health Care Hospital
Bishan, Chongqing Municipality
Li Liu, 0086-15923155063, 1341409605@qq.com
Not yet recruiting
Bortala Mongolian Autonomous Prefecture People's Hospital
Bole, Xinjiang
Yonghui Dai, 0086-18609092773, 71710227@qq.com
Not yet recruiting
Cangzhou Central Hospital
Cangzhou, Hebei
Dandan Shi, 0086-13315703200, 2479793756@qq.com
Not yet recruiting
Cangzhou Maternal and Child Health Hospital
Cangzhou, Hebei
Xinyan Wang, 0086-17603171778, xuyalingfch@163.com
Not yet recruiting
Huanghua People's Hospital
Cangzhou, Hebei
Jing Zhang, 0086-13722745821, zhangjing925@163.com
Recruiting
The First People's Hospital of Changde
Changde, Hunan
Jing Zhang, 0086-13873614102, zhang.jing254x@163.com
Recruiting
Changji Hui Autonomous Prefecture People's Hospital
Changji, Xinjiang
Weiwei Li, 0086-13999559070, 2747871145@qq.com
Not yet recruiting
The First Affiliated Hospital of Xinjiang Medical University (Changji Branch)
Changji, Xinjiang
Ping Li, 0086-17767629867, 49920461@qq.com
Not yet recruiting
Changsha Hospital for Maternal and Child Health Care
Changsha, Hunan
Lihui Huang, 0086-13637424928, m13637424928_2@163.com
Not yet recruiting
Xiangya Hospital of Central South University
Changsha, Hunan
Ping Li, 0086-13975139809, 3559468545@qq.com
Not yet recruiting
Qilu Hospital of Shandong University (Dezhou Hospital)
Dezhou, Shandong
Peng Yu, 0086-15589184004, yu.acool@163.com
Not yet recruiting
Dong'e County People's Hospital
Dong’e, Shandong
Yan Jiang, 0086-13780719366, jy0635@163.com
Not yet recruiting
Dongying Second People's Hospital
Dongying, Shandong
Withdrawn
Feicheng People's Hospital
Feicheng, Shandong
Qiuyun Guo, 0086-13954857116, fcjiz@163.com
Recruiting
Chongqing Fuling District Maternal and Child Health Care Hospital
Fuling, Chongqing Municipality
Xuejuan Xiao, 0086-15923669991, xiaoxuejuanck@163.com
Not yet recruiting
Chongqing Qijiang District People's Hospital
Gunan, Chongqing Municipality
Xiaojun Wang, 0086-18983851503, 401796106@qq.com
Not yet recruiting
Guyuan Maternal and Child Health Care Hospital
Guyuan, Ningxia
Lin Hu, 0086-13995347979, hulin7979@163.com
Not yet recruiting
Guyuan People's Hospital
Guyuan, Ningxia
Liping Liu, 0086-13995141619, LLP4011492@163.com
Not yet recruiting
Hami Central Hospital
Hami, Xinjiang
Yan Ma, 0086-13899336150, 594973356@qq.com
Not yet recruiting
Chongqing Hechuan District Maternal and Child Health Care Hospital
Hechuan, Chongqing Municipality
Chongwen Xia, 0086-18983968213, 154242693@qq.com
Not yet recruiting
Gucheng County Hospital
Hengshui, Hebei
Fang Liu, 0086-16631836573, 1923924684@qq.com
Recruiting
Hengshui Fourth Hospital
Hengshui, Hebei
Withdrawn
Hengshui Maternal and Child Health Care Hospital
Hengshui, Hebei
Lihua Bai, 0086-13903288236, hsfybailihua@126.com
Recruiting
Heze Municipal Hospital
Heze, Shandong
Cuili Zou, 0086-15965802856, 155219533@qq.com
Not yet recruiting
Hotan Prefecture People's Hospital
Hotan, Xinjiang
Maihebureti Maimaitinuer, 0086-13899476897, 45139633@qq.com
Not yet recruiting
Chongqing Jiangjin District Maternal and Child Health Care Hospital
Jiangjin, Chongqing Municipality
Zhaoning Ding, 0086-13617628861, 1373678156@qq.com
Not yet recruiting
Jinan Maternal and Child Health Care Hospital
Jinan, Shandong
Fengchun Gao, 0086-18053155218, gfc15806794062@163.com
Not yet recruiting
Qilu Hospital of Shandong University
Jinan, Shandong
Xia Luo, 0086-18560081722, luoxia0311@163.com
Not yet recruiting
Shandong Provincial Hospital
Jinan, Shandong
Xietong Wang, 0086-15168888928, wxt65@vip.163.com
Recruiting
Shandong Provincial Maternal and Child Health Care Hospital
Jinan, Shandong
Yan Lian, 0086-18615671220, lianyan73@126.com
Not yet recruiting
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital)
Jinan, Shandong
Wei Guo, 0086-13954166880, gwei19@163.com
Not yet recruiting
The Second Hospital of Shandong University
Jinan, Shandong
Fanzhen Hong, 0086-17660082720, hongfanzhen@hotmail.com
Recruiting
The Second Jinan Maternal and Child Health Care Hospital
Jinan, Shandong
Yan Wu, 0086-15163499078, 920558224@qq.com
Recruiting
Jining First People's Hospital
Jining, Shandong
Yingjie Han, 0086-13515377806, hyjkzh@126.com
Recruiting
The Affiliated Hospital of Jining Medical University
Jining, Shandong
Dongmei Man, 0086-15588733702, 344193468@qq.com
Not yet recruiting
Karamay Central Hospital
Karamay, Xinjiang
Jing Lv, 0086-13519901719, 13519903702@163.com
Not yet recruiting
The First People's Hospital of Kashi
Kashgar, Xinjiang
Maihefuzaimu Abudukade, 0086-13899107165, 2696410913@qq.com
Not yet recruiting
The Second People's Hospital of Kashi Prefecture
Kashgar, Xinjiang
Baharguli Abulaiti, 13657539889, 381385250@qq.com
Not yet recruiting
Bayingolin Mongolian Autonomous Prefecture People's Hospital
Korla, Xinjiang
Hui Zhao, 0086-18196219988, 2272759103@qq.com
Not yet recruiting
Laizhou Maternal and Child Health Hospital
Laizhou, Shandong
Xuxia Wu, 0086-15866357170, 15866357170@163.com
Recruiting
China Petroleum Central Hospital (Hebei)
Langfang, Hebei
Zhimin Gao, 0086-15931665603, syckgzmys@163.com
Recruiting
Hebei Yanda Hospital
Langfang, Hebei
Zhenyan Wang, 0086-18831608557, 1340956146@qq.com
Not yet recruiting
Langfang People's Hospital
Langfang, Hebei
Jing Zhang, 0086-18003368611, 13473161185@163.com
Not yet recruiting
Lanling County People's Hospital
Lanling, Shandong
Withdrawn
Liaocheng People's Hospital
Liaocheng, Shandong
Xiaobing Wang, 0086-13346258358, 13346258358@163.com
Recruiting
Lingwu People's Hospital
Lingwu, Ningxia
Wenhua Zhang, 0086-18995009229, zhangwenhua9901@126.com
Not yet recruiting
Linyi People's Hospital
Linyi, Shandong
Ying Chen, 0086-13954490267, duqilin68@163.com
Recruiting
Pingluo County People's Hospital
Pingluo Chengguanzhen, Ningxia
Jinmei Wang, 0086-18909526380, pllcb@163.com
Not yet recruiting
Chongqing Qianjiang District Maternal and Child Health Care Hospital
Qianjiang, Chongqing Municipality
Min Huang, 0086-18315246634, 308660049@qq.com
Not yet recruiting
Qingdao Chengyang District People's Hospital
Qingdao, Shandong
Jinli Liang, 0086-18561880330, 18561880330@163.com
Not yet recruiting
Qingdao Women and Children's Hospital (Peking University People's Hospital Qingdao Branch)
Qingdao, Shandong
Dongmei Fan, 0086-18553262800, 18553262800@163.com
Not yet recruiting
Qinhuangdao Changli County Maternal and Child Health Hospital
Qinhuangdao, Hebei
Jing Wang, 0086-13231386178, 323473546@qq.com
Not yet recruiting
Qinhuangdao Maternal and Child Health Hospital
Qinhuangdao, Hebei
Withdrawn
Qinhuangdao Qinglong County People's Hospital
Qinhuangdao, Hebei
Li Tong, 0086-18503311052, 3156612249@qq.com
Not yet recruiting
Rizhao People's Hospital
Rizhao, Shandong
Yongjing Lai, 0086-13963335562, laiyongjing@126.com
Not yet recruiting
The First Affiliated Hospital of Army Medical University (Xinan Hospital)
Shapingba, Chongqing Municipality
Dan Wang, 0086-13708391535, 61126575@qq.com
Not yet recruiting
The Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
Shapingba, Chongqing Municipality
Withdrawn
University Town Hospital of Chongqing Medical University
Shapingba, Chongqing Municipality
Jing Tian, 0086-13368067070, 9571088@qq.com
Not yet recruiting
The First Affiliated Hospital of Shihezi University
Shihezi, Xinjiang
Yajuan Gu, 0086-18703096536, 2584049853@qq.com
Recruiting
Shijiazhuang Maternity & Child Healthcare Hospital
Shijiazhuang, Hebei
Lulu Sun, 0086-13661512044, yfguoqing@163.com
Not yet recruiting
Xinle City Hospital
Shijiazhuang, Hebei
Yuxia Guo, 0086-18931197317, 18931197317@189.cn
Not yet recruiting
Shizuishan First People's Hospital
Shizuishan, Ningxia
Ling Zhang, 0086-13995365383, haozhangling@163.com
Not yet recruiting
Taian Central Hospital
Taian, Shandong
Ling Huang, 0086-13375386336, 13375386336@163.com
Not yet recruiting
Turpan Gaochang District People's Hospital
Turpan, Xinjiang
Xue Xia, 0086-18609959807, 708881739@qq.com
Recruiting
Turpan People's Hospital
Turpan, Xinjiang
Juan Li, 0086-13999693639, 280211408@qq.com
Not yet recruiting
Xinjiang Military Region General Hospital
Ürümqi, Xingjiang
Zerong Tu, 0086-15276760286, tt72rose@126.com
Not yet recruiting
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang
Ying Huang, 0086-13999986366, 1360305781@qq.com
Not yet recruiting
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
Qiying Zhu, 0086-13009647166, 541951517@qq.com
Not yet recruiting
Urumqi First People's Hospital (Railway Bureau Campus)
Ürümqi, Xinjiang
Lei Dai, 0086-18160699876, 122089667@qq.com
Not yet recruiting
Urumqi Maternal and Child Health Care Hospital (Urumqi You'ai Hospital)
Ürümqi, Xinjiang
Withdrawn
Chongqing Wanzhou District Maternal and Child Health Care Hospital
Wanzhou
Xianbing Wang, 0086-15084362480, 1341409605@qq.com
Not yet recruiting
Weifang Maternal and Child Health Hospital
Weifang, Shandong
Yong Guo, 0086-13589169026, 1483583108@qq.com
Not yet recruiting
Weihai Maternal and Child Health Hospital
Weihai, Shandong
Qiongqiong Wu, 0086-15216311556, Wuqiongqiong1982@163.com
Recruiting
Chongqing Wulong District Maternal and Child Health Care Hospital
Wulong, Chongqing Municipality
Xianmei Li, 0086-13983583223, 940717544@qq.com
Recruiting
Chongqing Wushan County People's Hospital
Wushan, Chongqing Municipality
Laqiong Tan, 0086-18323679059, 281080281@qq.com
Recruiting
Wuzhong People's Hospital
Wuzhong, Ningxia
Tao Wang, 0086-13895256305, 815529898@qq.com
Not yet recruiting
Linxi County People's Hospital
Xingtai, Hebei
Guizhen Dou, 0086-13831974138, 1026163152@qq.com
Recruiting
Weixian County People's Hospital
Xingtai, Hebei
Juncai Guo, 0086-15383196518, 1687493582@qq.com
Not yet recruiting
Xingtai People's Hospital
Xingtai, Hebei
Zongxu Qiao, 0086-13184950055, 13363730599@163.com
Not yet recruiting
Ningxia Hui Autonomous Region Hospital of Traditional Chinese Medicine
Xixia, Ningxia
Lifang Li, 0086-13909587255, lilifang_7901@163.com
Not yet recruiting
Yantai Yeda Hospital
Yantai, Shandong
Withdrawn
Yantai Yuhuangding Hospital
Yantai, Shandong
Hongmei Qu, 0086-15953505180, qhm791015@126.com
Recruiting
Rongcheng Maternal and Child Health Hospital
Yatou, Shandong
Hailing Yu, 0086-15666307352, rcnxwd@sina.com
Recruiting
Ningxia Hui Autonomous Region People's Hospital
Yinchuan, Ningxia
Yang Fan, 0086-13895319858, fangy0803@126.com
Recruiting
Peking University First Hospital Ningxia Women and Children's Hospital
Yinchuan, Ningxia
Ling He, 0086-13639586032, 2358440766@qq.com
Not yet recruiting
Yinchuan First People's Hospital
Yinchuan, Ningxia
Xin Qi, 0086-13895637793, 15924682@qq.com
Recruiting
Yinchuan Maternal and Child Health Care Hospital
Yinchuan, Ningxia
Yingchun Ha, 0086-13014298895, hayc1217@163.com
Not yet recruiting
Yili Prefecture Friendship Hospital
Yining, Xinjiang
Zonglin Lu, 0086-13779557203, 66270273@qq.com
Not yet recruiting
Chongqing Yongchuan District Maternal and Child Health Care Hospital
Yongchuan, Chongqing Municipality
Li Luo, 0086-15310837070, 223242955@qq.com
Not yet recruiting
Chongqing Maternal and Child Health Care Hospital
Yubei, Chongqing Municipality
Lan Wang, 0086-13002310769, xwanglan@163.com
Recruiting
Chongqing Yubei District Maternal and Child Health Care Hospital
Yubei, Chongqing Municipality
Xian Che, 0086-15310319813, 79947192@qq.com
Not yet recruiting
Tongxin County People's Hospital
Yuhai, Ningxia
Jinlian Ma, 0086-13909555338, 346854001@qq.com
Recruiting
Chongqing Yunyang County People's Hospital
Yunyang, Chongqing Municipality
Hong Tang, 0086-13983516862, 70386349@qq.com
Recruiting
Army Specialty Medical Center (Daping Hospital)
Yuzhong, Chongqing Municipality
Xiuhui Zheng, 0086-15823495993, lph1972@163.com
Recruiting
The First Affiliated Hospital of Chongqing Medical University
Yuzhong, Chongqing Municipality
Xin Luo, 0086-15826109160, 14802315@qq.com
Recruiting
The Second Affiliated Hospital of Chongqing Medical University
Yuzhong, Chongqing Municipality
Yingya Xu, 0086-13635428066, 315820503@qq.com
Not yet recruiting
Zaozhuang Maternal and Child Health Hospital
Zaozhuang, Shandong
Chengwen Liu, 0086-13863292856, liss1975@126.com
Not yet recruiting
Zhongning County People's Hospital
Zhongwei, Ningxia
Jianping Li, 0086-13739512389, 23855970@qq.com
Not yet recruiting
Zhongwei People's Hospital
Zhongwei, Ningxia
Lihua Wang, 0086-13723338701, Daohuaxiang969@163.com
Recruiting
Huantai County Maternal and Child Health Hospital
Zibo, Shandong
Caiqin Jin, 0086-13953363923, 13953363923@163.com
Not yet recruiting
Zibo Maternal and Child Health Hospital
Zibo, Shandong
Yingchun Yu, 0086-13589592528, 529115528@qq.com
Recruiting
Zoucheng People's Hospital
Zoucheng, Shandong
Qi Chen, 0086-15863750377, cqlsx2002@163.com
Recruiting
Zouping People's Hospital
Zouping, Shandong
Shujian Xing, 0086-13793890607, xsj_311@163.com
Recruiting

Other trials in China

About this study

Official title: Effectiveness, Safety, and Cost-effectiveness of Salt Substitution in High-risk Pregnant Women for the Prevention of Hypertensive Disorders of Pregnancy

Salt subsittute(intervention);
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.

Read the detailed description

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.
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:

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.

Exclusion Criteria:

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+.
A confirmed diagnosis of hyperkalemia.
History of hypotension or syncope.
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: Hypertensive Disorders of Pregnancy
Being tested: Potassium-enriched salt substitute, Usual salt
Keywords: Sodium reduction, Pregnancy disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Potassium-enriched salt substituteOther
replace usual salt with potassium-enriched salt containing 25% potassium chloride
Usual saltOther
Usual salt (NaCl >99%)

Study groups in NCT07294807
Study group	Role	What they receive
Potassium-Enriched Salt substitutes	Experimental	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. Receives: Other: Potassium-enriched salt substitute
Usual salt	Placebo comparator	Participants will continue to use usual salt (≥99% sodium chloride) in the preparation of home meals. Receives: Other: Usual salt

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Systolic Blood Pressure
Mean change in systolic blood pressure across antenatal visits (excluding the week before delivery) during the follow-up period.
Measured: 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.
Measured: from randomization to delivery

Secondary outcomes (21)

Change in Diastolic Blood Pressure
Mean change in diastolic blood pressure across antenatal visits (excluding the week before delivery) during the follow-up period.
Measured: from baseline to 36-37 weeks of gestation
Incidence of new-onset hypertensive disorders of pregnancy
hypertensive disorders of pregnancy is defined as a baseline blood pressure <140/90 mmHg without antihypertensive medication, followed by any two consecutive measurements of systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg during follow-up, or the initiation of antihypertensive medication under a physician's guidance.
Measured: from randomization to delivery
Incidence of clinically meaningful increase in blood pressure
Clinically meaningful increase in blood pressure is defined as an average systolic blood pressure increase of >10 mmHg from baseline, measured at any two consecutive follow-up visits, in participants with a baseline blood pressure ≥140/90 mmHg or those receiving antihypertensive therapy.
Measured: from randomization to delivery
Incidence of preeclampsia or eclampsia
Preeclampsia is defined as the presence of gestational hypertension or chronic hypertension in pregnancy, accompanied by any one of the following: a 24-hour urinary protein excretion ≥0.3 g; a urinary albumin-to-creatinine ratio ≥0.3, a random urine protein ≥1+(for patients with chronic hypertension and pre-existing baseline proteinuria, in the absence of organ dysfunction, the diagnosis of superimposed preeclampsia requires a doubling of the proteinuria level (either 24-hour urinary protein or urinary microalbumin-to-creatinine ratio) from the baseline); no proteinuria but accompanied by any of the following organ or system involvement(cardiac, pulmonary, hepatic, renal, hematologic, digestive, or nervous system, or evidence of placental-fetal involvement).
Eclampsia is defined as the occurrence of new-onset, tonic-clonic seizures in a woman with preeclampsia, which cannot be attributed to other explainable causes.
Measured: from randomization to delivery
Incidence of maternal death
death during the study period resulting from any pregnancy-related or aggravated condition, excluding deaths from accidental or incidental causes, determined based on death records in hospital medical records or death certificates.
Measured: from randomization to delivery
Incidence of pregnancy loss
Pregnancy loss is defined as any of the following situations: spontaneous abortion, fetal death, stillbirth, medically Induced abortion or termination of pregnancy, neonatal death
Measured: from randomization to delivery
Incidence of Placental abruption
Placental abruption is defined as the partial or complete separation of the placenta from the uterine wall before the delivery of the fetus. It is characterized by sudden onset abdominal pain, vaginal bleeding, uterine tenderness, and/or fetal distress. The diagnosis is confirmed by the discharge diagnosis or operative records.
Measured: from randomization to delivery
Incidence of adverse events (AEs) and serious adverse events (SAEs)
all causes adverse events
Measured: from randomization to delivery
Incidence of all-cause maternal mortality
All-cause mortality, regardless of its association with pregnancy or childbirth.
Measured: from randomization to delivery
Incidence of hyperkalemia
Hyperkalemia is defined as a follow-up serum potassium level >5.5 mmol/L accompanied by pathological ECG changes, persistent serum potassium >5.5 mmol/L, or hyperkalemia diagnosed by a clinician during the study period.
Measured: from randomization to delivery
Incidence of sudden cardiac death
Sudden cardiac death is defined as unexpected natural death due to cardiac causes, occurring within one hour of symptom onset in a person with or without known pre-existing heart disease
Measured: from randomization to delivery
Incidence of hyponatremia
Hyponatremia is defined as a follow-up serum sodium level <135 mmol/L, or hyponatremia diagnosed by a clinician during the study period.
Measured: from randomization to delivery
Incidence of renal impairment
Renal impairment is defined as urinary protein quantification >2.0 g/24 h, or UACR ≥2000 mg/g in any follow-up or during the study period; or serum creatinine level >106 μmol/L.
Measured: from randomization to delivery
Incidence of hypotension
Hypotension is defined as at least two blood pressure readings <90/60 mm Hg during follow-up, or symptomatic hypotension diagnosed by a physician during treatment.
Measured: from randomization to delivery
Incremental Cost-Effectiveness Ratio (ICER)
Incremental Cost-Effectiveness Ratio (ICER) is defined as (Intervention Group Cost - Control Group Cost) / (Intervention Group Effectiveness - Control Group Effectiveness).
Measured: from randomization to delivery
Incidence of preterm birth
preterm birth is defined as the delivery of a live-born infant before 37 completed weeks of gestation, including both medically indicated and spontaneous preterm births, confirmed by hospital medical records, surgical notes, or discharge diagnoses.
Measured: At delivery
Gestational age at delivery
Gestational age at delivery
Measured: At delivery
The neonatal birth weight
Birth weight of the newborn
Measured: At delivery
Incidence of neonatal adverse outcomes
Neonatal adverse outcomes include neonatal intensive care unit (NICU) admission, small for gestational age (SGA), and severe neonatal complications.
Measured: delivery
Mean change in Insomnia Severity Index (ISI) score
Insomnia Severity Index (ISI) score is a patient-reported outcome assessing insomnia severity, with higher scores indicating more severe insomnia.
Measured: From baseline to 36-37 weeks of gestation
Mean change in spot urinary potassium
Spot urinary potassium concentration, used as a proxy indicator of dietary potassium intake.
Measured: From baseline to 30-32 weeks of gestation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jan 202625 Dec 2027

First posted19 Dec 2025
Study start6 Jan 2026
Primary completion25 Dec 2027 (estimated)
Study completion25 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hypertensive Disorders of PregnancyStudies of the same condition, open and under way.
More trials run by Peking UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 3,200 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07294807
Sponsor's protocol ID: XMHEJH-WU
Acronym: PREG-Salt
Status last verified: Nov 2025
First submitted: 7 Dec 2025
Last updated: 28 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Interested in taking part?

Yifang Yuan

0086-17310387323

yuanyf_pucri@bjmu.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 3
Preeclampsia Intervention Netherlands
Pre-Eclampsia Onset Less Than 37 Weeks, Pre-Eclampsia
Not yet recruiting
Community Support and Mobile Apps to Help Black Women Control High Blood Pressure After Pregnancy
Hypertensive Disorders of Pregnancy (HDP), Hypertension, Pregnancy Induced
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension
Not yet recruiting
HERE: Health Empowerment and Resources After Pregnancy
Cardiovascular Health
RecruitingPhase 4
Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL
Hypertensive Disorders of Pregnancy, Preeclampsia

All Hypertensive Disorders of Pregnancy trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness, Safety, and Cost-effectiveness of Salt Substitution in High-risk Pregnant Women for the Prevention of Hypertensive Disorders of Pregnancy
ClinicalTrials.gov ID: NCT07294807
Acronym / sponsor ID: PREG-Salt / XMHEJH-WU
Conditions: Hypertensive Disorders of Pregnancy
Keywords: Sodium reduction, Pregnancy disorders
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 3,200 participants (estimated)
Lead sponsor: Peking UniversityUniversity, hospital or other
Study start: 6 Jan 2026 (actual)
Primary completion: 25 Dec 2027 (estimated)
Study completion: 25 Dec 2027 (estimated)
First posted: 19 Dec 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Salt subsittute(intervention);
Usual salt (control) .

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

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.
to further evaluate whether salt substitute significantly reduces the incidence of hypertensive disorders of pregnancy, while assessing its safety and cost-effectiveness.

Inclusion Criteria:

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.

Exclusion Criteria:

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+.
A confirmed diagnosis of hyperkalemia.
History of hypotension or syncope.
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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Potassium-Enriched Salt substitutes	Experimental	Other: Potassium-enriched salt substituteParticipants 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 comparator	Other: Usual saltParticipants will continue to use usual salt (≥99% sodium chloride) in the preparation of home meals.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Singleton pregnancy with a viable fetus at ≤16 weeks of gestation.
Meets at least one of the following criteria (enrolled sequentially):
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. -

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Potassium-enriched salt substitutereplace usual salt with potassium-enriched salt containing 25% potassium chloride	Other	Potassium-Enriched Salt substitutes
Usual saltUsual salt (NaCl >99%)	Other	Usual salt

Primary outcome

Change in Systolic Blood Pressure
Time frame: from baseline to 36-37 weeks of gestation
Mean change in systolic blood pressure across antenatal visits (excluding the week before delivery) during the follow-up period.
Incidence of new-onset hypertensive disorders of pregnancy and related maternal adverse events
Time frame: from randomization to delivery
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.

21 secondary outcomes

Change in Diastolic Blood Pressure
Time frame: from baseline to 36-37 weeks of gestation
Incidence of new-onset hypertensive disorders of pregnancy
Time frame: from randomization to delivery
Incidence of clinically meaningful increase in blood pressure
Time frame: from randomization to delivery
Incidence of preeclampsia or eclampsia
Time frame: from randomization to delivery
Incidence of maternal death
Time frame: from randomization to delivery
Incidence of pregnancy loss
Time frame: from randomization to delivery
Incidence of Placental abruption
Time frame: from randomization to delivery
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: from randomization to delivery
Incidence of all-cause maternal mortality
Time frame: from randomization to delivery
Incidence of hyperkalemia
Time frame: from randomization to delivery
Incidence of sudden cardiac death
Time frame: from randomization to delivery
Incidence of hyponatremia
Time frame: from randomization to delivery
Incidence of renal impairment
Time frame: from randomization to delivery
Incidence of hypotension
Time frame: from randomization to delivery
Incremental Cost-Effectiveness Ratio (ICER)
Time frame: from randomization to delivery
Incidence of preterm birth
Time frame: At delivery
Gestational age at delivery
Time frame: At delivery
The neonatal birth weight
Time frame: At delivery
Incidence of neonatal adverse outcomes
Time frame: delivery
Mean change in Insomnia Severity Index (ISI) score
Time frame: From baseline to 36-37 weeks of gestation
Mean change in spot urinary potassium
Time frame: From baseline to 30-32 weeks of gestation

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
Individual participant dataSharing planned: Yes

Related trials for Hypertensive Disorders of Pregnancy

RecruitingPhase 3
Preeclampsia Intervention Netherlands
Pre-Eclampsia Onset Less Than 37 Weeks, Pre-Eclampsia
Not yet recruiting
Community Support and Mobile Apps to Help Black Women Control High Blood Pressure After Pregnancy
Hypertensive Disorders of Pregnancy (HDP), Hypertension, Pregnancy Induced
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension
Not yet recruiting
HERE: Health Empowerment and Resources After Pregnancy
Cardiovascular Health
RecruitingPhase 4
Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL
Hypertensive Disorders of Pregnancy, Preeclampsia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Yifang Yuan contact

0086-17310387323

yuanyf_pucri@bjmu.edu.cn

Jie Yuan contact

0086-15222768336

yuanjie_pucri@bjmu.edu.cn

Jie Qiao principal investigator

Peking University

Yangfeng Wu principal investigator

Peking University

110 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Potassium-enriched salt substitute and Usual salt in people with Hypertensive Disorders of Pregnancy, run by Peking University at 110 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 110 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yifang Yuan (0086-17310387323, yuanyf_pucri@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Systolic Blood Pressure (time frame: from baseline to 36-37 weeks of gestation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07294807.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.