CClinicalTrials.gg
Status unknownNCT01295138Updated Feb 23, 2011

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

An interventional study of Lactulose in Constipation, Abdominal Pain and Nausea, sponsored by NHS Fife. Status unknown at 1 site in United Kingdom. Open to female participants aged 16 Years to 50 Years. Per ClinicalTrials.gov, last updated 2011-02-23.

Sponsored by NHS Fife · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2010), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
16 Years to 50 Years
Sex
Female
01

Study 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).
02

Conditions studied

  • Constipation
  • Abdominal Pain
  • Nausea
  • Vomiting

Keywords

  • Constipation
  • Caesarean section
  • Abdominal Pain
  • Nausea
  • Vomiting
03

In context

Nausea

822 studies on the registry are indexed under Nausea; 104 are open to participants now.

This study's planned enrollment of 30 is below the median of 115 across 703 interventional studies indexed under Nausea.

Browse Nausea studies →

Lead sponsor

NHS Fife is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • All patients aged 16 years or older able to give informed consent undergoing their first or second elective CS

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Lactulose group

    Group receives 48 hours of lactulose post Caesarean section.

    Drug: Lactulose

  • No intervention
    Non-lactulose group

    Group receives no lactulose post Caesarean section.

Interventions

  • DrugLactulose

    Lactulose liquid. 15mls twice daily

    Also known as: Lactugal, Rectulose, Lactulose (non proprietry)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: First 5 days post Caesarean section.

Secondary outcomes

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

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

    Time frame: First 5 days post Caesarean section.

  2. 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.

    Time frame: First 5 days post-Caesarean

07

Study locations

1 site
  • Forth Park Hospital
    Kirkcaldy, Fife EH4 1QH, United Kingdom
    • ANTHONY DAVIS, MB CHB · Contact
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01295138
Lead sponsor
NHS Fife
First posted
Feb 14, 2011
Start date
Feb 2011
Primary completion
Feb 2012 (estimated)
Completion
Jul 2012 (estimated)
Last update
Feb 23, 2011

Study contacts

Anthony Davis, MBCHB
Contact
anthonydavis@nhs.net
Anthony Davis, MBCHB
principal investigator · NHS Fife

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

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