Pilot Study of the Effect of Lactulose on Post Caesarean Section Constipation
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|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
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||Phase|
|Constipation Abdominal Pain Nausea Vomiting||Drug: Lactulose||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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.
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
|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|