Table of Contents
ISRN Obstetrics and Gynecology
Volume 2012 (2012), Article ID 481870, 6 pages
http://dx.doi.org/10.5402/2012/481870
Clinical Study

Assessment of the Safety and Efficacy of a Raft-Forming Alginate Reflux Suppressant (Liquid Gaviscon) for the Treatment of Heartburn during Pregnancy

1Technostics Limited, Daisy Building (2nd Floor), Castle Hill Hospital, Castle Road, Kingston Upon Hull HU16 5JQ, UK
2Medical Centre, Netcare Linksfield Hospital, Suite 205, 12th Avenue, Linksfield West, Johannesburg 2037, South Africa
3Elm Lane Surgery, Sheffield S5 7TW, UK
4Department of Obstetrics & Gynaecology, Hull Royal Infirmary, Anlaby Road, Kingston Upon Hull HU3 2JZ, UK
5Global Professional Relations, Reckitt Benckiser Group plc, 103-105 Bath Road, Slough SL1 3UH, UK

Received 26 September 2012; Accepted 3 October 2012

Academic Editors: S. Palomba and C. M. Peterson

Copyright © 2012 Vicki Strugala et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Gastro-oesophageal reflux (GER) and the symptoms of heartburn and regurgitation are common in pregnancy. These symptoms are transient and mostly resolve postpartum but have a negative impact on quality of life. Here, we present a prospective clinical evaluation of the safety and efficacy of an alginate raft-forming oral suspension that is licensed for use in pregnancy. The study was a multicentre, prospective, open-label, and baseline-controlled study of Liquid Gaviscon (LG) in the treatment of heartburn in pregnant women with current symptoms of heartburn and/or reflux requiring treatment (recruited 144). The efficacy of the study medication was rated by the investigator (primary endpoint) and patient. Treatment was deemed to be a success in 91% of patients as judged by the investigator (95% CI 85.0–95.3) and 90% (95% CI 84.1–94.8) when assessed by the patient themselves. Very few adverse events or serious adverse events were reported that were considered to be related to the study medication, and these were consistent with the normal population incidences. Serum sodium levels remained unchanged. This prospective open-label study in a large number of pregnant women has shown that LG is both safe and highly efficacious in the treatment of heartburn and GER symptoms in pregnancy.