ConstipationNCT01295138
Pilot Study of the Effect of Lactulose on Post Caesarean Section Constipation
A study testing Lactulose in people with Constipation and Abdominal Pain, run by NHS Fife at 1 site in United Kingdom.
Trial summary
Constipation following elective Caesarean sections (CS) is a common problem experienced by up to 50% of patients (1). The causes for this are multifactorial and include manipulation of the bowel during surgery, immobilisation and opiate based anaesthetic and analgesic techniques. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women only
- Conditions the study is for
- Constipation, Abdominal Pain, Nausea
- What is being tested?
- Lactulose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2011to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- All patients aged 16 years or older able to give informed consent undergoing their first or second elective CS
Who cannot join
- Unable to give informed consent
- A basic level of literacy sufficient to complete postoperative form.
- History of constipation
- Regular opiate use
- Previous bowel surgery or bowel adhesions
- Lactose intolerant
Show all 11Show fewer
- Diabetic
- Any patient unable to have spinal Anaesthesia
- Allergies/intolerant to bupivacaine, diamorphine, diclofenac, cocodamol, lactulose
- Patients receiving injury to bowel intraoperatively
- Patients receiving additional opiates perioperatively
Trial locations and contacts
1 site in 1 country.
Anthony Davis, MBCHB contact
United Kingdom1 site
Forth Park Hospital
Kirkcaldy, Fife, EH4 1QH
ANTHONY DAVIS, MB CHB
About this study
Constipation following elective Caesarean sections (CS) is a common problem experienced by up to 50% of patients (1). The causes for this are multifactorial and include manipulation of the bowel during surgery, immobilisation and opiate based anaesthetic and analgesic techniques. To try to alleviate the problem of postoperative constipation, some anaesthetists prescribe postoperative lactulose in addition to postoperative analgesia, although no data exists that shows whether this has any beneficial effect on postoperative constipation.
- Short term morbidity associated with Caesarean delivery. Hillan EM. Birth. 19 (4): 190-4).
- Conditions
- Constipation, Abdominal Pain, Nausea, Vomiting
- Being tested
- Lactulose
- Keywords
- Constipation, Caesarean section, Abdominal Pain, Nausea, Vomiting
- Medical subject headings
- Constipation, Abdominal Pain, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactuloseDrug
Also called Lactugal, Rectulose, Lactulose (non proprietry)
Lactulose liquid. 15mls twice daily
| Study group | Role | What they receive |
|---|---|---|
| Lactulose group | Experimental | Group receives 48 hours of lactulose post Caesarean section. Receives: Drug: Lactulose |
| Non-lactulose group | No intervention | Group receives no lactulose post Caesarean section. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in hours to passage of first stool post Caesarean Section.
Time (hours) to first bowel motion post elective LSCS betwwen Lactulose and non-Lactulose groups.
Measured: First 5 days post Caesarean section.
Secondary outcomes (2)
Frequency of abdominal pain between lactulose and non-lactulose groups.
Frequency of abdominal pain between lactulose and non-lactulose groups post Caesarean Section.
Measured: First 5 days post Caesarean section.
Frequency of nausea and vomiting between lactulose and non-lactulose groups
Frequency of nausea and vomiting between lactulose and non-lactulose groups post Caesarean Section.
Measured: First 5 days post-Caesarean
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Fife
- Sponsor type
- Other government
- Investigators
- Anthony Davis, MBCHB, Principal investigator, NHS Fife
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295138
- Sponsor's protocol ID
- FIFEANAES1
- Status last verified
- Dec 2010
- First submitted
- 30 Dec 2010
- Last updated
- 23 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Effect of Lactulose on Post Caesarean Section Constipation
- ClinicalTrials.gov ID
- NCT01295138
- Acronym / sponsor ID
- FIFEANAES1
- Conditions
- Constipation, Abdominal Pain, Nausea, Vomiting
- Keywords
- Constipation, Caesarean section, Abdominal Pain, Nausea, Vomiting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- NHS FifeOther government
- Study start
- Feb 2011
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 14 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Constipation following elective Caesarean sections (CS) is a common problem experienced by up to 50% of patients (1). The causes for this are multifactorial and include manipulation of the bowel during surgery, immobilisation and opiate based anaesthetic and analgesic techniques. To try to alleviate the problem of postoperative constipation, some anaesthetists prescribe postoperative lactulose in addition to postoperative analgesia, although no data exists that shows whether this has any beneficial effect on postoperative constipation.
- Short term morbidity associated with Caesarean delivery. Hillan EM. Birth. 19 (4): 190-4).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactulose group | Experimental | Drug: LactuloseGroup receives 48 hours of lactulose post Caesarean section. |
| Non-lactulose group | No intervention | –Group receives no lactulose post Caesarean section. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All patients aged 16 years or older able to give informed consent undergoing their first or second elective CS
Key exclusion criteria (11 listed)
- Unable to give informed consent
- A basic level of literacy sufficient to complete postoperative form.
- History of constipation
- Regular opiate use
- Previous bowel surgery or bowel adhesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LactuloseAlso: Lactugal, Rectulose, Lactulose (non proprietry)Lactulose liquid. 15mls twice daily | Drug | Lactulose group |
Primary outcome
Time in hours to passage of first stool post Caesarean Section.
Time frame: First 5 days post Caesarean section.
Time (hours) to first bowel motion post elective LSCS betwwen Lactulose and non-Lactulose groups.
2 secondary outcomes
Frequency of abdominal pain between lactulose and non-lactulose groups.
Time frame: First 5 days post Caesarean section.
Frequency of nausea and vomiting between lactulose and non-lactulose groups
Time frame: First 5 days post-Caesarean
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Davis, MBCHB contact
Anthony Davis, MBCHB principal investigator
NHS Fife
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactulose in people with Constipation and Abdominal Pain, run by NHS Fife at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anthony Davis, MBCHB (anthonydavis@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in hours to passage of first stool post Caesarean Section. (time frame: First 5 days post Caesarean section.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2011.