Condition category
Pregnancy and Childbirth
Date applied
10/07/2017
Date assigned
14/08/2017
Last edited
26/10/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Postpartum infections are bacterial infections of the female reproductive system after childbirth. Post-partum infection is a significant global problem and with increasing antimicrobial resistance there is concern that without action, common procedures such as caesarean section will carry significant risks. Strategies are therefore needed to reduce this risk. The aim is to perform a small study to prepare for a larger study that will compare vaginal cleansing with chlorhexidine gluconate versus the standard practice of no vaginal cleansing immediately before caesarean section, to see whether it reduces post-partum endometritis and sepsis. There are a number of difficulties in performing a study with pregnant women undergoing caesarean section, particularly in an emergency procedure where there is a short interval between decision and delivery. Also, the follow-up of women after caesarean section is unlike other surgical procedures, as mothers are discharged from obstetric care quickly with no routine follow-up after the operation. They are motivated to recover and care for their baby. It is therefore necessary to perform this study to assess both the ability to recruit women and adequately follow them up.

Who can participate?
Women aged 16 and over who are over 24 weeks pregnant and having an elective or emergency caesarean section

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive the vaginal cleansing before their caesarean section. This involves an antiseptic solution swab of chlorhexidine gluconate applied to the vagina before the caesarean section. Those in the second group do not receive any vaginal cleansing. Participants are followed up with phone interviews 14 and 30 days later to assess if they developed any post-natal infections and their medical records are checked.

What are the possible benefits and risks of participating?
There are no direct benefits or risks of participating.

Where is the study run from?
1. Birmingham Women’s Hospital (UK)
2. Birmingham Heartlands Hospital (UK)
3. Shrewsbury and Telford Hospital (UK)

When is the study starting and how long is it expected to run for?
May 2017 to August 2018

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Mrs Lisa Leighton
l.j.leighton@bham.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Mrs Lisa Leighton

ORCID ID

Contact details

Birmingham Clinical Trials Unit (BCTU)
Institute of Applied Health Research
Public Health Building
University of Birmingham
Birmingham
B15 2TT
United Kingdom
+44 (0)121 415 9110
l.j.leighton@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

34861

Study information

Scientific title

Vaginal Preparation at caesarean section to Reduce Endometritis and Prevent Sepsis – a feasibility study of chlorhexidine gluconate

Acronym

PREPS

Study hypothesis

The aim of this study is to perform a feasibility study for a larger multi-centre randomised controlled trial (RCT) comparing vaginal cleansing with chlorhexidine gluconate versus standard practice of no vaginal cleansing immediately before cesarean to reduce post-partum endometritis and sepsis.

Ethics approval

London - City & East Research Ethics Committee, 12/06/2017, ref: 17/LO/0874

Study design

Randomised; Interventional; Design type: Prevention, Drug

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Specialty: Reproductive health and childbirth, Primary sub-specialty: General Obstetrics/ Midwifery; UKCRC code/ Disease: Reproductive Health and Childbirth/ Infections specific to the perinatal period

Intervention

Participants are randomly allocated to one of two groups:
1. Those in the first group receive the vaginal cleansing before their cesarean section (CS). This involves an antiseptic solution swab of 0.05% chlorhexidine gluconate applied to the vagina before the CS.
2. Those in the second group do not receive any vaginal cleansing.
Participants are followed up with postnatal phone interviews at days 14 and 30 to assess if they developed any post-natal infections and a check of their medical records will be performed.

Intervention type

Other

Phase

Drug names

Primary outcome measures

This is a feasibility randomised controlled trial so the outcomes relate to the ability to run this as a full randomised controlled trial. The decision to continue to a full trial will be decided by pre-defined stop-go criteria based on the following outcomes:
1. The proportion of eligible women recruited into the study
2. The proportion of women receiving the allocated intervention
3. The proportion of women who successfully complete the planned follow up process for both the 14 and 30 day telephone interview
4. Withdrawal from the study (defined as a participant requesting that no further data is to be collected from the participant)

The following predicted primary outcome for the full RCT will be collected to inform the sample size of the study and to test data collection methods for the full RCT:
1. Development of endometritis within 30 days after randomisation. Endometritis will be defined as per the definitions set out by the US Centre for Disease Control and Prevention (Centre for Disease Control and Prevention 2017). Obtained through a telephone interview with the woman at 14 and 30 days and a check of the medical records at 6 weeks post natal.

Secondary outcome measures

There are no secondary outcome measures.

Overall trial start date

18/05/2017

Overall trial end date

31/08/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women greater than or equal to 34 weeks pregnant having an elective or emergency CS, regardless of indication
2. Women aged 16 years and over
3. Women carrying singletons and all higher order multiples

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 250; UK Sample Size: 250

Participant exclusion criteria

1. Any women with a known allergy to chlorhexidine gluconate or any of its ingredients
2. Unable to give informed consent
3. Unable to receive a telephone interview at 6 weeks post natal
4. Preterm delivery less than 34 weeks
5. Receiving intrapartum antibiotics for GBS prophylaxis or suspected infection in labour

Recruitment start date

01/10/2017

Recruitment end date

01/02/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Birmingham Women’s Hospital - lead centre
Birmingham Women’s and Children’s NHS Foundation Trust Mindelsohn Way
Birmingham
B15 2TG
United Kingdom

Trial participating centre

Birmingham Heartlands Hospital
Heart of England NHS Foundation Trust Bordesley Green
Birmingham
B9 5SS
United Kingdom

Trial participating centre

Princess Royal Hospital
The Shrewsbury and Telford NHS Trust Mytton Oak Road
Shrewsbury
SY3 8XQ
United Kingdom

Sponsor information

Organisation

Birmingham Children's Hospital

Sponsor details

Birmingham Women's and Children's NHS Foundation Trust
Steelhouse Lane
Birmingham
B4 6NH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Results of this trial will be submitted for publication in a peer reviewed journal. The manuscript will be prepared by the chief investigator and authorship will be determined by the trial publication policy. Authors must acknowledge that the trial was performed with the support of BWCFT and NIHR RfPB.

IPD sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

31/08/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

26/10/2017: Internal review.