We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01295138
Recruitment Status : Unknown
Verified December 2010 by NHS Fife.
Recruitment status was:  Not yet recruiting
First Posted : February 14, 2011
Last Update Posted : February 23, 2011
Sponsor:
Information provided by:

Study Description
Brief 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).


Condition or disease Intervention/treatment
Constipation Abdominal Pain Nausea Vomiting Drug: Lactulose

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of the Effect of Lactulose on Post Caesarean Section Constipation
Study Start Date : February 2011
Estimated Primary Completion Date : February 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr Anthony Davis Consultant Anaesthetist, NHS Fife
ClinicalTrials.gov Identifier: NCT01295138     History of Changes
Other Study ID Numbers: FIFEANAES1
First Posted: February 14, 2011    Key Record Dates
Last Update Posted: February 23, 2011
Last Verified: December 2010

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

Additional relevant MeSH terms:
Constipation
Nausea
Vomiting
Abdominal Pain
Signs and Symptoms, Digestive
Signs and Symptoms
Pain
Neurologic Manifestations
Nervous System Diseases
Lactulose
Gastrointestinal Agents