Pilot Study of the Effect of Lactulose on Post Caesarean Section Constipation | Not Recruiting
Pilot Study of the Effect of Lactulose on Post Caesarean Section Constipation

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Constipation
  • Abdominal Pain
  • Nausea
  • Vomiting
Primary Contact Details
Not Recruiting
Recruitment Status
Primary Trial ID Number
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).
Research Details
    Sorry, this information is not available
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Drug : Lactulose

Study Arm Groups : Lactulose group

Intervention Type
See Interventions above
Primary Outcome Measures
  • Time in hours to passage of first stool post Caesarean Section.; First 5 days post Caesarean section.
Secondary Outcome Measures
  • Frequency of abdominal pain between lactulose and non-lactulose groups.; First 5 days post Caesarean section.; Frequency of nausea and vomiting between lactulose and non-lactulose groups; First 5 days post-Caesarean
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Age Range
16 Years - 50 Years
Who Can Participate
Number of Participants
Participant Inclusion 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
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Forth Park Hospital
Trial Contact(s)
Primary Trial Contact
Anthony Davis, MBCHB
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
Scientific Title
Pilot Study of the Effect of Lactulose on Post Caesarean Section Constipation
EudraCT Number
Not available for this trial
    Sorry, this information is not available
Other Study ID Numbers
NHS Fife
Key Dates

Recruitment Start Date

Feb 2011

Recruitment End Date

Feb 2012

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

30 Dec 2011

Last Updated

22 Feb 2011