Pilot Study of the Effect of Lactulose on Post Caesarean Section Constipation

February 22, 2011 updated by: NHS Fife

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
    • Fife
      • Kirkcaldy, Fife, United Kingdom, EH4 1QH
        • Forth Park Hospital
        • Contact:
          • ANTHONY DAVIS, MB CHB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 50 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lactulose group
Group receives 48 hours of lactulose post Caesarean section.
Drug: Lactulose
Lactulose liquid. 15mls twice daily
Other Names:
  • Lactugal, Rectulose, Lactulose (non proprietry)
NO_INTERVENTION: Non-lactulose group
Group receives no lactulose post Caesarean section.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
First 5 days post Caesarean section.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of abdominal pain between lactulose and non-lactulose groups.
Time Frame: First 5 days post Caesarean section.
Frequency of abdominal pain between lactulose and non-lactulose groups post Caesarean Section.
First 5 days post Caesarean section.
Frequency of nausea and vomiting between lactulose and non-lactulose groups
Time Frame: First 5 days post-Caesarean
Frequency of nausea and vomiting between lactulose and non-lactulose groups post Caesarean Section.
First 5 days post-Caesarean

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Fife

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (ANTICIPATED)

February 1, 2012

Study Completion (ANTICIPATED)

July 1, 2012

Study Registration Dates

First Submitted

December 30, 2010

First Submitted That Met QC Criteria

February 11, 2011

First Posted (ESTIMATE)

February 14, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 23, 2011

Last Update Submitted That Met QC Criteria

February 22, 2011

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIFEANAES1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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