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Completed

NCT Number: NCT02470117

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

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.

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Key information

Conditions

Heartburn in Pregnancy

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Vorapong Phupong

Bangkok, 10330, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alginate-based reflux suppressant

Drug

magnesium-aluminium antacid gel

Drug

Primary outcomes

  1. Frequency of heartburn as measured by diary chart

    Time frame: 2 weeks

Secondary outcomes

  1. Intensity of hearburn as measured by visual analog scale

    Time frame: 2 weeks

  2. satisfaction as measured by questionnaire

    Time frame: 2 weeks

  3. quality of life as measured by questionnaire SF-8

    Time frame: 2 weeks

  4. Number of participants with side effects

    Time frame: 2 weeks

  5. fetal outcomes as measured by birth weight and Apgar scores

    Time frame: at birth

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 12, 2015
Registry last updated
Jul 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.