Gastroesophageal reflux disease in pregnancy Digestive System Gastro-oesophageal reflux disease
Conditions
Interventions
1. Pregnant women attending antenatal clinic UMMC are screened for inclusion and exclusion criteria.
2. Eligible participants are then diagnosed with GERD using GERD questionnaire in d
Sponsors
University Malaya Medical Centre
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Pregnant women aged 18 - 40 years 2. Gestational age 14 weeks to less than 38 weeks 3. Able to provide signed and dated informed consent
Exclusion criteria
Exclusion criteria: 1. Pregnant women younger than 18 years or older than 40 years 2. Gestational age less than 14 weeks and more than 38 weeks 3. Presence of alarm symptoms (dysphagia, odynophagia, aspiration pneumonia, dysphonia, recurrent or persistent cough, gastrointestinal bleeding, frequent nausea/vomiting, persistent pain, iron deficiency anemia, and weight loss) 4. Presence of underlying gastrointestinal disease pre-pregnancy 5. Hypersensitivity to Gaviscon or omeprazole or both 6. Participants who are already on Gaviscon or omeprazole or both 7. Unable to provide signed and dated informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relief of GERD measured using GerdQ on day 7 and day 14. Sufficient relief is defined as score = 1 for question no 1, 2, 5 and 6. Complete relief is defined as a score of 0. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The severity of GERD symptoms and quality of life measured using Gerd-Health related Quality of Life (GERD-HRQL) upon recruitment on day 1 and after starting the treatment on day 7 and day 14 2. The time onset of the first 24-hour GERD symptom-free period after initial dosing as reported in patient symptom diary from day 1 to day 14 3. Use of any rescue treatment reported in the patient symptom diary over the course of 2 weeks | — |
Countries
Malaysia
Contacts
Public ContactTuscianthi Deva Tata
Outcome results
None listed