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

NCT ID: NCT01295138

Last Updated: 2011-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Constipation Abdominal Pain Nausea Vomiting

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lactulose group

Group receives 48 hours of lactulose post Caesarean section.

Group Type EXPERIMENTAL

Lactulose

Intervention Type DRUG

Lactulose liquid. 15mls twice daily

Non-lactulose group

Group receives no lactulose post Caesarean section.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lactulose

Lactulose liquid. 15mls twice daily

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lactugal, Rectulose, Lactulose (non proprietry)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

NHS Fife

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

NHS Fife

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anthony Davis, MBCHB

Role: PRINCIPAL_INVESTIGATOR

NHS Fife

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Forth Park Hospital

Kirkcaldy, Fife, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Anthony Davis, MBCHB

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

ANTHONY DAVIS, MB CHB

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FIFEANAES1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Oral Fluid Intake After Extubation
NCT05819645 COMPLETED NA
The Laparotomy Study
NCT02140593 COMPLETED PHASE4