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 measure
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 (if study stopped)
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
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
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
Basic results (scientific)
Publication list
2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29881638
2019 qualiative study results in: https://www.ncbi.nlm.nih.gov/pubmed/31307417 (added 17/07/2019)