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

December 19, 2025 updated by: Peking University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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. Specifically, the study aims include:

  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

Study Type

Interventional

Enrollment (Estimated)

3200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Wanzhou, China
        • Chongqing Wanzhou District Maternal and Child Health Care Hospital
        • Contact:
    • Chongqing Municipality
      • Bishan, Chongqing Municipality, China
        • Chongqing Bishan District Maternal and Child Health Care Hospital
        • Contact:
      • Fuling, Chongqing Municipality, China
        • Chongqing Fuling District Maternal and Child Health Care Hospital
        • Contact:
      • Gunan, Chongqing Municipality, China
        • Chongqing Qijiang District People's Hospital
        • Contact:
      • Hechuan, Chongqing Municipality, China
        • Chongqing Hechuan District Maternal and Child Health Care Hospital
        • Contact:
      • Jiangjin, Chongqing Municipality, China
        • Chongqing Jiangjin District Maternal and Child Health Care Hospital
        • Contact:
      • Qianjiang, Chongqing Municipality, China
        • Chongqing Qianjiang District Maternal and Child Health Care Hospital
        • Contact:
      • Shapingba, Chongqing Municipality, China
        • The First Affiliated Hospital of Army Medical University (Xinan Hospital)
        • Contact:
      • Shapingba, Chongqing Municipality, China
        • The Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
        • Contact:
      • Shapingba, Chongqing Municipality, China
        • University Town Hospital of Chongqing Medical University
        • Contact:
      • Wulong, Chongqing Municipality, China
        • Chongqing Wulong District Maternal and Child Health Care Hospital
        • Contact:
      • Wushan, Chongqing Municipality, China
        • Chongqing Wushan County People's Hospital
        • Contact:
      • Yongchuan, Chongqing Municipality, China
        • Chongqing Yongchuan District Maternal and Child Health Care Hospital
        • Contact:
      • Yubei, Chongqing Municipality, China
        • Chongqing Maternal and Child Health Care Hospital
        • Contact:
      • Yubei, Chongqing Municipality, China
        • Chongqing Yubei District Maternal and Child Health Care Hospital
        • Contact:
      • Yunyang, Chongqing Municipality, China
        • Chongqing Yunyang County People's Hospital
        • Contact:
      • Yuzhong, Chongqing Municipality, China
        • Army Specialty Medical Center (Daping Hospital)
        • Contact:
      • Yuzhong, Chongqing Municipality, China
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
      • Yuzhong, Chongqing Municipality, China
        • The Second Affiliated Hospital of Chongqing Medical University
        • Contact:
    • Hebei
      • Baoding, Hebei, China
        • Affiliated Hospital of Hebei University
        • Contact:
      • Baoding, Hebei, China
        • Baoding Maternal and Child Health Hospital
        • Contact:
      • Baoding, Hebei, China
        • Yixian Maternal and Child Health Hospital
        • Contact:
      • Cangzhou, Hebei, China
        • Cangzhou Central Hospital
        • Contact:
      • Cangzhou, Hebei, China
        • Cangzhou Maternal and Child Health Hospital
        • Contact:
      • Cangzhou, Hebei, China
        • Huanghua People's Hospital
        • Contact:
      • Hengshui, Hebei, China
        • Hengshui Fourth Hospital
        • Contact:
      • Hengshui, Hebei, China
        • Gucheng County Hospital
        • Contact:
      • Hengshui, Hebei, China
        • Hengshui Maternal and Child Health Care Hospital
        • Contact:
      • Langfang, Hebei, China
        • Langfang People's Hospital
        • Contact:
      • Langfang, Hebei, China
        • China Petroleum Central Hospital (Hebei)
        • Contact:
      • Langfang, Hebei, China
        • Hebei Yanda Hospital
        • Contact:
      • Qinhuangdao, Hebei, China
        • Qinhuangdao Changli County Maternal and Child Health Hospital
        • Contact:
      • Qinhuangdao, Hebei, China
        • Qinhuangdao Maternal and Child Health Hospital
        • Contact:
      • Qinhuangdao, Hebei, China
        • Qinhuangdao Qinglong County People's Hospital
        • Contact:
      • Shijiazhuang, Hebei, China
        • Shijiazhuang Maternity & Child Healthcare Hospital
        • Contact:
      • Shijiazhuang, Hebei, China
        • Xinle City Hospital
        • Contact:
      • Xingtai, Hebei, China
        • Xingtai People's Hospital
        • Contact:
      • Xingtai, Hebei, China
        • Linxi County People's Hospital
        • Contact:
      • Xingtai, Hebei, China
        • Weixian County People's Hospital
        • Contact:
    • Ningxia
      • Guyuan, Ningxia, China
        • Guyuan People's Hospital
        • Contact:
      • Guyuan, Ningxia, China
        • Guyuan Maternal and Child Health Care Hospital
        • Contact:
      • Lingwu, Ningxia, China
      • Pingluo Chengguanzhen, Ningxia, China
        • Pingluo County People's Hospital
        • Contact:
          • Jinmei Wang
          • Phone Number: 0086-18909526380
          • Email: pllcb@163.com
      • Shizuishan, Ningxia, China
        • Shizuishan First People's Hospital
        • Contact:
      • Wuzhong, Ningxia, China
        • Wuzhong People's Hospital
        • Contact:
      • Xixia, Ningxia, China
        • Ningxia Hui Autonomous Region Hospital of Traditional Chinese Medicine
        • Contact:
      • Yinchuan, Ningxia, China
        • Ningxia Hui Autonomous Region People's Hospital
        • Contact:
      • Yinchuan, Ningxia, China
        • Peking University First Hospital Ningxia Women and Children's Hospital
        • Contact:
      • Yinchuan, Ningxia, China
        • Yinchuan First People's Hospital
        • Contact:
      • Yinchuan, Ningxia, China
        • Yinchuan Maternal and Child Health Care Hospital
        • Contact:
      • Yuhai, Ningxia, China
        • Tongxin County People's Hospital
        • Contact:
      • Zhongwei, Ningxia, China
        • Zhongning County People's Hospital
        • Contact:
      • Zhongwei, Ningxia, China
    • Shandong
      • Binzhou, Shandong, China
        • Binzhou Medical university hospital
        • Contact:
      • Dezhou, Shandong, China
        • Qilu Hospital of Shandong University (Dezhou Hospital)
        • Contact:
      • Dongying, Shandong, China
        • Dongying Second People's Hospital
        • Contact:
      • Dong’e, Shandong, China
        • Dong'e County People's Hospital
        • Contact:
      • Feicheng, Shandong, China
        • Feicheng People's Hospital
        • Contact:
      • Heze, Shandong, China
        • Heze Municipal Hospital
        • Contact:
      • Jinan, Shandong, China
        • Qilu Hospital of Shandong University
        • Contact:
      • Jinan, Shandong, China
        • Shandong Provincial Hospital
        • Contact:
      • Jinan, Shandong, China
        • The Second Hospital of Shandong University
        • Contact:
      • Jinan, Shandong, China
        • Jinan Maternal and Child Health Care Hospital
        • Contact:
      • Jinan, Shandong, China
        • Shandong Provincial Maternal and Child Health Care Hospital
        • Contact:
      • Jinan, Shandong, China
        • The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital)
        • Contact:
      • Jinan, Shandong, China
        • The Second Jinan Maternal and Child Health Care Hospital
        • Contact:
      • Jining, Shandong, China
        • Jining First People's Hospital
        • Contact:
      • Jining, Shandong, China
        • The Affiliated Hospital of Jining Medical University
        • Contact:
      • Laizhou, Shandong, China
        • Laizhou Maternal and Child Health Hospital
        • Contact:
      • Lanling, Shandong, China
        • Lanling County People's Hospital
        • Contact:
      • Liaocheng, Shandong, China
        • Liaocheng People's Hospital
        • Contact:
      • Linyi, Shandong, China
        • Linyi people's hospital
        • Contact:
      • Qingdao, Shandong, China
        • Qingdao Chengyang District People's Hospital
        • Contact:
      • Qingdao, Shandong, China
        • Qingdao Women and Children's Hospital (Peking University People's Hospital Qingdao Branch)
        • Contact:
      • Rizhao, Shandong, China
        • Rizhao People's Hospital
        • Contact:
      • Taian, Shandong, China
        • Taian Central Hospital
        • Contact:
      • Weifang, Shandong, China
        • Weifang Maternal and Child Health Hospital
        • Contact:
      • Weihai, Shandong, China
        • Weihai Maternal and Child Health Hospital
        • Contact:
      • Yantai, Shandong, China
        • Yantai Yuhuangding Hospital
        • Contact:
      • Yantai, Shandong, China
        • Yantai Yeda Hospital
        • Contact:
      • Yatou, Shandong, China
        • Rongcheng Maternal and Child Health Hospital
        • Contact:
      • Zaozhuang, Shandong, China
        • Zaozhuang Maternal and Child Health Hospital
        • Contact:
      • Zibo, Shandong, China
        • Huantai County Maternal and Child Health Hospital
        • Contact:
      • Zibo, Shandong, China
        • Zibo Maternal and Child Health Hospital
        • Contact:
      • Zoucheng, Shandong, China
        • Zoucheng People's Hospital
        • Contact:
      • Zouping, Shandong, China
        • Zouping People's Hospital
        • Contact:
    • Xingjiang
      • Ürümqi, Xingjiang, China
        • Xinjiang Military Region General Hospital
        • Contact:
    • Xinjiang
      • Aksu, Xinjiang, China
        • The First People's Hospital of Aksu Prefecture
        • Contact:
      • Altay, Xinjiang, China
        • Altay Prefecture People's Hospital
        • Contact:
      • Artux, Xinjiang, China
        • Kizilsu Kirgiz Autonomous Prefecture People's Hospital
        • Contact:
      • Bole, Xinjiang, China
        • Bortala Mongolian Autonomous Prefecture People's Hospital
        • Contact:
      • Changji, Xinjiang, China
        • Changji Hui Autonomous Prefecture People's Hospital
        • Contact:
      • Changji, Xinjiang, China
        • The First Affiliated Hospital of Xinjiang Medical University (Changji Branch)
        • Contact:
      • Hami, Xinjiang, China
        • Hami Central Hospital
        • Contact:
      • Hotan, Xinjiang, China
        • Hotan Prefecture People's Hospital
        • Contact:
          • Maihebureti Maimaitinuer
          • Phone Number: 0086-13899476897
          • Email: 45139633@qq.com
      • Karamay, Xinjiang, China
        • Karamay Central Hospital
        • Contact:
      • Kashgar, Xinjiang, China
        • The First People's Hospital of Kashi
        • Contact:
      • Kashgar, Xinjiang, China
        • The Second People's Hospital of Kashi Prefecture
        • Contact:
      • Korla, Xinjiang, China
        • Bayingolin Mongolian Autonomous Prefecture People's Hospital
        • Contact:
      • Shihezi, Xinjiang, China
        • The First Affiliated Hospital of Shihezi University
        • Contact:
      • Turpan, Xinjiang, China
        • Turpan Gaochang District People's Hospital
        • Contact:
      • Turpan, Xinjiang, China
        • Turpan People's Hospital
        • Contact:
      • Yining, Xinjiang, China
        • Yili Prefecture Friendship Hospital
        • Contact:
      • Ürümqi, Xinjiang, China
        • The First Affiliated Hospital of Xinjiang Medical University
        • Contact:
      • Ürümqi, Xinjiang, China
        • People's Hospital of Xinjiang Uygur Autonomous Region
        • Contact:
      • Ürümqi, Xinjiang, China
        • Urumqi First People's Hospital (Railway Bureau Campus)
        • Contact:
      • Ürümqi, Xinjiang, China
        • Urumqi Maternal and Child Health Care Hospital (Urumqi You'ai Hospital)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Potassium-enriched salt substitute
replace usual salt with potassium-enriched salt containing 25% potassium chloride
Placebo Comparator: Usual salt
Participants will continue to use usual salt (≥99% sodium chloride) in the preparation of home meals.
Other: Usual salt
Usual salt (NaCl >99%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
from baseline to 36-37 weeks of gestation
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.
from randomization to delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gestational age at delivery
Time Frame: At delivery
Gestational age at delivery
At delivery
Change in Diastolic Blood Pressure
Time Frame: from baseline to 36-37 weeks of gestation
Mean change in diastolic blood pressure across antenatal visits (excluding the week before delivery) during the follow-up period.
from baseline to 36-37 weeks of gestation
Incremental Cost-Effectiveness Ratio (ICER)
Time Frame: from randomization to delivery
Incremental Cost-Effectiveness Ratio (ICER) is defined as (Intervention Group Cost - Control Group Cost) / (Intervention Group Effectiveness - Control Group Effectiveness).
from randomization to delivery
The neonatal birth weight
Time Frame: At delivery
Birth weight of the newborn
At delivery
Mean change in Insomnia Severity Index (ISI) score
Time Frame: From baseline to 36-37 weeks of gestation
Insomnia Severity Index (ISI) score is a patient-reported outcome assessing insomnia severity, with higher scores indicating more severe insomnia.
From baseline to 36-37 weeks of gestation
Mean change in spot urinary potassium
Time Frame: From baseline to 30-32 weeks of gestation
Spot urinary potassium concentration, used as a proxy indicator of dietary potassium intake.
From baseline to 30-32 weeks of gestation
Incidence of new-onset hypertensive disorders of pregnancy
Time Frame: from randomization to delivery
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.
from randomization to delivery
Incidence of clinically meaningful increase in blood pressure
Time Frame: from randomization to delivery
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.
from randomization to delivery
Incidence of preeclampsia or eclampsia
Time Frame: from randomization to delivery

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.
from randomization to delivery
Incidence of maternal death
Time Frame: from randomization to delivery
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.
from randomization to delivery
Incidence of pregnancy loss
Time Frame: from randomization to delivery
Pregnancy loss is defined as any of the following situations: spontaneous abortion, fetal death, stillbirth, medically Induced abortion or termination of pregnancy, neonatal death
from randomization to delivery
Incidence of Placental abruption
Time Frame: from randomization to delivery
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.
from randomization to delivery
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time Frame: from randomization to delivery
all causes adverse events
from randomization to delivery
Incidence of all-cause maternal mortality
Time Frame: from randomization to delivery
All-cause mortality, regardless of its association with pregnancy or childbirth.
from randomization to delivery
Incidence of hyperkalemia
Time Frame: from randomization to delivery
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.
from randomization to delivery
Incidence of sudden cardiac death
Time Frame: from randomization to delivery
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
from randomization to delivery
Incidence of hyponatremia
Time Frame: from randomization to delivery
Hyponatremia is defined as a follow-up serum sodium level <135 mmol/L, or hyponatremia diagnosed by a clinician during the study period.
from randomization to delivery
Incidence of renal impairment
Time Frame: from randomization to delivery
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.
from randomization to delivery
Incidence of hypotension
Time Frame: from randomization to delivery
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.
from randomization to delivery
Incidence of preterm birth
Time Frame: At delivery
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.
At delivery
Incidence of neonatal adverse outcomes
Time Frame: delivery
Neonatal adverse outcomes include neonatal intensive care unit (NICU) admission, small for gestational age (SGA), and severe neonatal complications.
delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Investigators

  • Principal Investigator: Yangfeng Wu, Peking University
  • Principal Investigator: Jie Qiao, Peking University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 25, 2025

Primary Completion (Estimated)

December 25, 2027

Study Completion (Estimated)

December 25, 2027

Study Registration Dates

First Submitted

December 7, 2025

First Submitted That Met QC Criteria

December 7, 2025

First Posted (Estimated)

December 19, 2025

Study Record Updates

Last Update Posted (Actual)

December 29, 2025

Last Update Submitted That Met QC Criteria

December 19, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • XMHEJH-WU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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