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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by NHS Fife.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
NHS Fife
ClinicalTrials.gov Identifier:
NCT01295138
First received: December 30, 2010
Last updated: February 22, 2011
Last verified: December 2010
History of Changes
  Purpose

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).


Condition Intervention
Constipation
Abdominal Pain
Nausea
Vomiting
 Drug: Lactulose

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of the Effect of Lactulose on Post Caesarean Section Constipation

Resource links provided by NLM:

Drug Information available for: Lactulose
U.S. FDA Resources

Further study details as provided by NHS Fife:

Primary Outcome Measures:
  • Time in hours to passage of first stool post Caesarean Section. [ Time Frame: First 5 days post Caesarean section. ] [ Designated as safety issue: No ]
    Time (hours) to first bowel motion post elective LSCS betwwen Lactulose and non-Lactulose groups.


Secondary Outcome Measures:
  • Frequency of abdominal pain between lactulose and non-lactulose groups. [ Time Frame: First 5 days post Caesarean section. ] [ Designated as safety issue: No ]
    Frequency of abdominal pain between lactulose and non-lactulose groups post Caesarean Section.

  • Frequency of nausea and vomiting between lactulose and non-lactulose groups [ Time Frame: First 5 days post-Caesarean ] [ Designated as safety issue: No ]
    Frequency of nausea and vomiting between lactulose and non-lactulose groups post Caesarean Section.


Estimated Enrollment: 30
Study Start Date: February 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lactulose group
Group receives 48 hours of lactulose post Caesarean section.
 Drug: Lactulose
Lactulose liquid. 15mls twice daily
Other Name: Lactugal, Rectulose, Lactulose (non proprietry)
No Intervention: Non-lactulose group
Group receives no lactulose post Caesarean section.

  Eligibility

Ages Eligible for Study:   16 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01295138

Contacts
Contact: Anthony Davis, MBCHB anthonydavis@nhs.net

Locations
United Kingdom
Forth Park Hospital Not yet recruiting
Kirkcaldy, Fife, United Kingdom, EH4 1QH
Contact: ANTHONY DAVIS, MB CHB            
Sponsors and Collaborators
NHS Fife
Investigators
Principal Investigator: Anthony Davis, MBCHB NHS Fife
  More Information

No publications provided

Responsible Party: Dr Anthony Davis Consultant Anaesthetist, NHS Fife
ClinicalTrials.gov Identifier: NCT01295138     History of Changes
Other Study ID Numbers: FIFEANAES1
Study First Received: December 30, 2010
Last Updated: February 22, 2011
Health Authority: United Kingdom: Department of Health
United States: Federal Government

Keywords provided by NHS Fife:
Constipation
Caesarean section
Abdominal Pain
Nausea
Vomiting

Additional relevant MeSH terms:
Constipation
Abdominal Pain
Nausea
Vomiting
Pain
Signs and Symptoms
 Signs and Symptoms, Digestive
Lactulose
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013