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

Phase 4
Completed
Conditions
Heartburn in Pregnancy
Interventions
Drug: Alginate-based reflux suppressant
Drug: magnesium-aluminium antacid gel
Registration Number
NCT02470117
Lead Sponsor
Chulalongkorn University
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
100
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Alginate-based reflux suppressantAlginate-based reflux suppressantAlginate-based reflux suppressant 15 ml oral every 6 hours for 2 weeks
magnesium-aluminium antacid gelmagnesium-aluminium antacid gelmagnesium-aluminium antacid gel 15 ml oral every 6 hours for 2 weeks
Primary Outcome Measures
NameTimeMethod
Frequency of heartburn as measured by diary chart2 weeks
Secondary Outcome Measures
NameTimeMethod
Number of participants with side effects2 weeks
Intensity of hearburn as measured by visual analog scale2 weeks
quality of life as measured by questionnaire SF-82 weeks
satisfaction as measured by questionnaire2 weeks
fetal outcomes as measured by birth weight and Apgar scoresat birth

Trial Locations

Locations (1)

Vorapong Phupong

🇹🇭

Bangkok, Thailand

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