Constipation in pregnancy Digestive System Constipation
Conditions
Interventions
Participants will be randomized via block randomization into either a group taking macrogol or a control group taking lactulose. Macrogol 4000 is given as one sachet a day (10 g) and can be adjusted u
Sponsors
University Malaya Medical Centre
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Pregnancy in the third trimester from 28-32 weeks (32 weeks defined by up to 32 weeks + 6 days) 2. Fulfil ROME IV criteria for chronic constipation 3. Consented for inclusion in the study 4. Have telephone access and agree to telephone interview
Exclusion criteria
Exclusion criteria: 1. Pre-existing gastrointestinal disease or surgery 2. Pre-existing medical diseases that can alter gastrointestinal functions (hypothyroidism, diabetes mellitus) and those suffering from severe liver, renal or cardiac diseases 3. Hypersensitivity to lactulose or polyethylene glycol 4. Persistent nausea or vomiting in pregnancy 5. Unable to give consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Number of women responding in terms of Complete Spontaneous Bowel Movements (CSBMs), defined as three or more Complete Spontaneous Bowel Movements (CSBMs) per week for at least 3 out of 4 weeks of total treatment, measured at baseline and week 4 of treatment 2. Number of women responding in terms of improvement in symptoms measured by PAC-SYM 12 items, where a response is defined by a decrease in score of =1 from the baseline, measured at baseline and week 4 of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Tolerability in term of side effects over the course of treatment weeks: 1.1. Side effects including vomiting, abdominal bloating, flatulence and diarrhoea, reported in bowel diary over the course of 4 weeks treatment and measured at week 4 1.2. Diarrhoea defined by bowel movements more than three times a day with stool consistency measured using Bristol Score Chart score 6-7 reported in the bowel diary over the whole 4 weeks treatment and measured at week 4 2. Typical stool consistency measured using Bristol stool chart at baseline and at week 4 of treatment 3. The use of rescue treatment reported in the bowel diary over the course of 4 weeks treatment and measured at week 4 of treatment 4. Discontinuation of treatment due to adverse effects reported in the bowel diary over the course of 4 weeks treatment, measured at week 4 of treatment 5. First bowel movement after the first administration reported in the bowel diary and measured at week 4 of treatment 6. Patient improvement of specific constipation symptoms following the three subscales in PAC-SYM 12-items at baseline and week 4 of treatment 7. Patient improvement in quality of life including satisfaction as measured by PAC-QOL 28-items at baseline and week 4 of treatment | — |
Countries
Malaysia
Contacts
Public ContactAzyyati Hassan
Outcome results
None listed