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

Comparison of the Efficacy of Alginate-based Reflux Suppressant and Magnesium-aluminium Antacid Gel for Treatment of Heartburn in Pregnancy : A Randomized Double-Blind Controlled Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02470117
Enrollment
100
Registered
2015-06-12
Start date
2015-06-30
Completion date
2016-07-31
Last updated
2016-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heartburn in Pregnancy

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.

Interventions

DRUGAlginate-based reflux suppressant
DRUGmagnesium-aluminium antacid gel

Sponsors

Chulalongkorn University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Frequency of heartburn as measured by diary chart2 weeks

Secondary

MeasureTime frame
Intensity of hearburn as measured by visual analog scale2 weeks
satisfaction as measured by questionnaire2 weeks
quality of life as measured by questionnaire SF-82 weeks
Number of participants with side effects2 weeks
fetal outcomes as measured by birth weight and Apgar scoresat birth

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026