Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alginate-based reflux suppressant | Active Comparator | Alginate-based reflux suppressant 15 ml oral every 6 hours for 2 weeks |
|
| magnesium-aluminium antacid gel | Sham Comparator | magnesium-aluminium antacid gel 15 ml oral every 6 hours for 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alginate-based reflux suppressant | Drug |
| ||
| magnesium-aluminium antacid gel |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of heartburn as measured by diary chart | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of hearburn as measured by visual analog scale | 2 weeks | |
| satisfaction as measured by questionnaire | 2 weeks | |
| quality of life as measured by questionnaire SF-8 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vorapong Phupong, M.D. | Chulalongkorn University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vorapong Phupong | Bangkok | Bangkok | 10330 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15814238 | Background | Hampson FC, Farndale A, Strugala V, Sykes J, Jolliffe IG, Dettmar PW. Alginate rafts and their characterisation. Int J Pharm. 2005 Apr 27;294(1-2):137-47. doi: 10.1016/j.ijpharm.2005.01.036. | |
| 23419381 | Background | Katz PO, Gerson LB, Vela MF. Guidelines for the diagnosis and management of gastroesophageal reflux disease. Am J Gastroenterol. 2013 Mar;108(3):308-28; quiz 329. doi: 10.1038/ajg.2012.444. Epub 2013 Feb 19. No abstract available. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| 2 weeks |
| Number of participants with side effects | 2 weeks |
| fetal outcomes as measured by birth weight and Apgar scores | at birth |
| 16831611 | Background | Mahadevan U, Kane S. American gastroenterological association institute technical review on the use of gastrointestinal medications in pregnancy. Gastroenterology. 2006 Jul;131(1):283-311. doi: 10.1053/j.gastro.2006.04.049. |
| 231639 | Background | Malmud LS, Charkes ND, Littlefield J, Reilley J, Stern H, Rosenberg R, Fisher RS. The mode of action alginic acid compound in the reduction of gastroesophageal reflux. J Nucl Med. 1979 Oct;20(10):1023-8. |
| 16225482 | Background | Richter JE. Review article: the management of heartburn in pregnancy. Aliment Pharmacol Ther. 2005 Nov 1;22(9):749-57. doi: 10.1111/j.1365-2036.2005.02654.x. |
| 24096290 | Result | Quartarone G. Gastroesophageal reflux in pregnancy: a systematic review on the benefit of raft forming agents. Minerva Ginecol. 2013 Oct;65(5):541-9. |
| 23209926 | Result | Strugala V, Bassin J, Swales VS, Lindow SW, Dettmar PW, Thomas EC. Assessment of the Safety and Efficacy of a Raft-Forming Alginate Reflux Suppressant (Liquid Gaviscon) for the Treatment of Heartburn during Pregnancy. ISRN Obstet Gynecol. 2012;2012:481870. doi: 10.5402/2012/481870. Epub 2012 Nov 4. |