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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01295138

Enrollment

Registered

2011-02-14

Start date

2011-02-28

Completion date

2012-07-31

Last updated

2011-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Pain, Constipation, Nausea, Vomiting

Keywords

Constipation, Caesarean section, Abdominal Pain, Nausea, Vomiting

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).

Interventions

DRUGLactulose

Lactulose liquid. 15mls twice daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

16 Years to 50 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Time in hours to passage of first stool post Caesarean Section.	First 5 days post Caesarean section.	Time (hours) to first bowel motion post elective LSCS betwwen Lactulose and non-Lactulose groups.

Secondary

Measure	Time frame	Description
Frequency of abdominal pain between lactulose and non-lactulose groups.	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	First 5 days post-Caesarean	Frequency of nausea and vomiting between lactulose and non-lactulose groups post Caesarean Section.

Countries

United Kingdom

Contacts

Primary ContactAnthony Davis, MBCHB

anthonydavis@nhs.net

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026