Condition category
Digestive System
Date applied
13/08/2020
Date assigned
18/08/2020
Last edited
21/08/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Chronic constipation is common, affecting up to 60.7% of pregnant women. It has a remarkable impact on quality of life in various aspects including discomfort, poor general health, and physical, psychological and social functions. To date, evidence is scarce with regards to the treatment of this disorder in pregnancy. Polyethylene glycol has been shown to be in favour as the first line of treatment of chronic constipation in the general population. This study aims to evaluate the effectiveness and tolerability of this drug in women with chronic constipation during their pregnancy.

Who can participate?
Women in their third trimester of pregnancy with chronic constipation

What does the study involve?
The study involves comparing polyethylene glycol (macrogol) and lactulose. Participants will be randomly allocated to receive one of the two treatments for up to 4 weeks. Participants answer a few questionnaires before starting the treatment and at the end of the treatment. Over the course of treatment, participants complete a bowel diary.

What are the possible benefits and risks of participating?
Possible benefits come from the treatment that will be given free of charge and at the same time will treat their symptoms according to the standard treatment of constipation. The possible adverse events that can occur include abdominal bloating, vomiting, flatulence and diarrhoea. At the moment, there are no reported severe adverse events with these two treatments.

Where is the study run from?
University Malaya Medical Centre (Malaysia)

When is the study starting and how long is it expected to run for?
February 2020 to January 2021

Who is funding the study?
University Malaya Medical Centre (Malaysia)

Who is the main contact?
Azyyati binti Hassan
atieasan@gmail.com

Trial website

Contact information

Type

Public

Primary contact

Dr Azyyati Hassan

ORCID ID

Contact details

Kompleks Wanita dan Kanak-Kanak
University Malaya Medical Centre
Kuala Lumpur
50603
Malaysia
+60 (0)3 7949 4422
azyyatiha@ummc.edu.my

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

NMRR-20-1500-55812

Study information

Scientific title

Randomized controlled trial: low dose polyethylene glycol (macrogol 4000) versus lactulose in the treatment of constipation in pregnancy

Acronym

Study hypothesis

Low dose polyethylene glycol (PEG) is more effective in the treatment of chronic constipation in pregnancy compared to lactulose.

Ethics approval

Approved 11/8/2020, Medical Research Ethics Committee, University Malaya Medical Centre (Lembah Pantai, 59100 Kuala Lumpur, Malaysia; +6 (0)3 7949 3209/2251; ummc@ummc.edu.my), ref: 202071-8852

Study design

Single-center Interventional open-labelled randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Constipation in pregnancy

Intervention

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 up to two sachets a day. Lactulose is given as 15 ml a day (10 g) and can be adjusted up to 30 ml/day. Both are osmotic laxatives, taken in oral form. The duration of treatment is up to 4 weeks. Participants answer questionnaires before starting the treatment and at the end of the treatment. Over the course of treatment, participants will be given a bowel diary.

Intervention type

Drug

Phase

Not Applicable

Drug names

Macrogol 4000 (Forlax), Lactulose (duphalac)

Primary outcome measure

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 outcome measures

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

Overall trial start date

01/02/2020

Overall trial end date

31/01/2021

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

360

Participant 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

Recruitment start date

24/08/2020

Recruitment end date

30/11/2020

Locations

Countries of recruitment

Malaysia

Trial participating centre

University Malaya Medical Centre
Lembah Pantai
Kuala Lumpur
50603
Malaysia

Sponsor information

Organisation

University Malaya Medical Centre

Sponsor details

Department of Obstetrics and Gynaecology
Lembah Pantai
Kuala Lumpur
50603
Malaysia
+60 (0)3 7949 4422
ummc@ummc.edu.my

Sponsor type

Hospital/treatment centre

Website

http://ummc.edu.my

Funders

Funder type

Hospital/treatment centre

Funder name

University Malaya Medical Centre

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal. The protocol is not available online but can be provided upon request.

IPD sharing statement
The datasets generated and/or analysed during the current study will available upon request from the principal investigator (Azyyati Hassan; azyyatiha@ummc.edu.my) after the overall trial end date. Datasets are confidential and any data sharing will have to go through the Medical Research Ethics Committees at University Malaya Medical Centre.

Intention to publish date

31/01/2022

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

21/08/2020: Internal review. 19/08/2020: The recruitment start date was changed from 17/08/2020 to 24/08/2020. 18/08/2020: Trial's existence confirmed by Medical Research Ethics Committee, University Malaya Medical Centre.