Pilot Study of the Effect of Lactulose on Post Caesarean Section Constipati... | Not Recruiting
Pilot Study of the Effect of Lactul... | Not Recruiting
Pilot Study of the Effect of Lactulose on Post Caesarean Section Constipation

Trial Source

Location not identified by Google services

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Medical Conditions
  • Constipation
  • Abdominal Pain
  • Nausea
  • Vomiting
Primary Contact Details
Not Recruiting
Recruitment Status
NCT01295138
Primary Trial ID Number

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This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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. 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.

1. Short term morbidity associated with Caesarean delivery. Hillan EM. Birth. 19 (4): 190-4).
Research Details
    Sorry, this information is not available
Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : Lactulose

Study Arm Groups : Lactulose group

Intervention Type
See Interventions above
Primary Outcome Measures
    Time in hours to passage of first stool post Caesarean Section.; First 5 days post Caesarean section.
Secondary Outcome Measures
    Frequency of abdominal pain between lactulose and non-lactulose groups.; First 5 days post Caesarean section.; Frequency of nausea and vomiting between lactulose and non-lactulose groups; First 5 days post-Caesarean
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Female
Age Range
16 Years - 50 Years
Who Can Participate
Patients
Number of Participants
30
Participant Inclusion Criteria
    Inclusion Criteria:

    - All patients aged 16 years or older able to give informed consent undergoing their first or second elective CS

    Exclusion Criteria:

    - 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

    - 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
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Forth Park Hospital
Fife
EH4 1QH
Trial Contact(s)
Primary Trial Contact
Anthony Davis, MBCHB
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Pilot Study of the Effect of Lactulose on Post Caesarean Section Constipation
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
FIFEANAES1
Sponsor(s)
NHS Fife
Key Dates

Recruitment Start Date

Feb 2011

Recruitment End Date

Feb 2012

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

30 Dec 2010

Last Updated

22 Feb 2011