Pilot Study of the Effect of Lactulose on Post Caesarean Section Constipation
Recruitment status was Not yet recruiting
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 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|
- 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.
- 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.
|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)|
Experimental: Lactulose group
Group receives 48 hours of lactulose post Caesarean section.
Lactulose liquid. 15mls twice daily
Other Name: Lactugal, Rectulose, Lactulose (non proprietry)
No Intervention: Non-lactulose group
Group receives no lactulose post Caesarean section.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01295138
|Contact: Anthony Davis, MBCHBfirstname.lastname@example.org|
|Forth Park Hospital||Not yet recruiting|
|Kirkcaldy, Fife, United Kingdom, EH4 1QH|
|Contact: ANTHONY DAVIS, MB CHB|
|Principal Investigator:||Anthony Davis, MBCHB||NHS Fife|