Alginate-based Reflux Suppressant and Magnesium-aluminium Antacid Gel for Treatment of Heartburn in Pregnancy

Chulalongkorn University100 enrolled

Overview

This study evaluates the efficacy of alginate-based reflux suppressant and magnesium-aluminium antacid gel for treatment of heartburn in pregnancy. Half of the participants will receive alginate-based reflux suppressant, while the other half will receive magnesium-aluminium antacid gel.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

100

Conditions

Heartburn in Pregnancy

Interventions

Alginate-based reflux suppressantDRUG

magnesium-aluminium antacid gelDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Pregnant women gestational age less than 36 weeks with heartburn Exclusion Criteria: * Having medical disease that contraindicated to use study drug * Allergic to alginate-based reflux suppressant and magnesium-aluminium antacid gel

Locations (1)

Vorapong Phupong

Bangkok, Bangkok, Thailand

Outcomes

Primary Outcomes

Frequency of heartburn as measured by diary chart

Time frame: 2 weeks

Secondary Outcomes

Intensity of hearburn as measured by visual analog scale

Time frame: 2 weeks

satisfaction as measured by questionnaire

Time frame: 2 weeks

quality of life as measured by questionnaire SF-8

Time frame: 2 weeks

Number of participants with side effects

Time frame: 2 weeks

fetal outcomes as measured by birth weight and Apgar scores

Time frame: at birth

Data from ClinicalTrials.gov

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