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

NCT07294807 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3200

Last updated 2025-12-29

No results posted yet for this study

Summary

The PREG-Salt study is to evaluate the effect, safety and cost-effectiveness of low-sodium salt in reducing blood pressure and preventing hypertensive disorders in pregnant women at high risk in China. The study will recruit about 3,200 participants from approximately 100 hospitals across multiple provinces in China. Eligible pregnant women (≤16 weeks of gestation) will be randomly assigned in a 1:1 ratio to the following 2 groups:

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

The intervention will last until delivery. The study employs an adaptive two-phase design. An interim analysis after the first phase (n=400) will inform whether the trial continues into the second phase and if any adjustments to the sample size are needed. The primary outcomes are:

Phase 1: The mean systolic blood pressure across antenatal visits (excluding the last week before delivery).

Phase 2: New-onset hypertensive disorders of pregnancy and related adverse events from randomization to delivery.

Conditions

  • Hypertensive Disorders of Pregnancy

Interventions

OTHER

Potassium-enriched salt substitute

replace usual salt with potassium-enriched salt containing 25% potassium chloride

OTHER

Usual salt

Usual salt (NaCl \>99%)

Sponsors & Collaborators

  • Peking University

    lead OTHER

Principal Investigators

  • Jie Qiao · Peking University

  • Yangfeng Wu · Peking University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-25
Primary Completion
2027-12-25
Completion
2027-12-25

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07294807 on ClinicalTrials.gov