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

Primary Purpose

Constipation, Abdominal Pain, Nausea

Status

Unknown status

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Lactulose

About this trial

This is an interventional treatment trial for Constipation focused on measuring Constipation, Caesarean section, Abdominal Pain, Nausea, Vomiting

Eligibility Criteria

16 Years - 50 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Forth Park Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lactulose group

Non-lactulose group

Arm Description

Group receives 48 hours of lactulose post Caesarean section.

Group receives no lactulose post Caesarean section.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Frequency of abdominal pain between lactulose and non-lactulose groups.

Frequency of abdominal pain between lactulose and non-lactulose groups 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.

Full Information

NCT ID

NCT01295138

First Posted

December 30, 2010

Last Updated

February 22, 2011

Sponsor

NHS Fife

1. Study Identification

Unique Protocol Identification Number

NCT01295138

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2010

Overall Recruitment Status

Unknown status

Study Start Date

February 2011 (undefined)

Primary Completion Date

February 2012 (Anticipated)

Study Completion Date

July 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

NHS Fife

4. Oversight

Data Monitoring Committee

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Constipation, Abdominal Pain, Nausea, Vomiting

Keywords

Constipation, Caesarean section, Abdominal Pain, Nausea, Vomiting

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lactulose group

Arm Type

Experimental

Arm Description

Group receives 48 hours of lactulose post Caesarean section.

Arm Title

Non-lactulose group

Arm Type

No Intervention

Arm Description

Group receives no lactulose post Caesarean section.

Intervention Type

Drug

Intervention Name(s)

Lactulose

Other Intervention Name(s)

Lactugal, Rectulose, Lactulose (non proprietry)

Intervention Description

Lactulose liquid. 15mls twice daily

Primary Outcome Measure Information:

Title

Time in hours to passage of first stool post Caesarean Section.

Description

Time (hours) to first bowel motion post elective LSCS betwwen Lactulose and non-Lactulose groups.

Time Frame

First 5 days post Caesarean section.

Secondary Outcome Measure Information:

Title

Frequency of abdominal pain between lactulose and non-lactulose groups.

Description

Frequency of abdominal pain between lactulose and non-lactulose groups post Caesarean Section.

Time Frame

First 5 days post Caesarean section.

Title

Frequency of nausea and vomiting between lactulose and non-lactulose groups

Description

Frequency of nausea and vomiting between lactulose and non-lactulose groups post Caesarean Section.

Time Frame

First 5 days post-Caesarean

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anthony Davis, MBCHB

anthonydavis@nhs.net

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anthony Davis, MBCHB

Organizational Affiliation

NHS Fife

Official's Role

Principal Investigator

Facility Information:

Facility Name

Forth Park Hospital

City

Kirkcaldy

State/Province

Fife

ZIP/Postal Code

EH4 1QH

Country

United Kingdom

Facility Contact:

First Name & Middle Initial & Last Name & Degree

ANTHONY DAVIS, MB CHB

12. IPD Sharing Statement

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

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