Vaginal preparation at caesarean section

ISRCTN	ISRCTN33435996
DOI	https://doi.org/10.1186/ISRCTN33435996
Protocol serial number	34861
Sponsor	Birmingham Children's Hospital
Funder	National Institute for Health Research

Submission date: 10/07/2017
Registration date: 14/08/2017
Last edited: 17/07/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Mrs Lisa Leighton
Public

Birmingham Clinical Trials Unit (BCTU)
Institute of Applied Health Research
Public Health Building
University of Birmingham
Birmingham
B15 2TT
United Kingdom

Phone	+44 (0)121 415 9110
Email	l.j.leighton@bham.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised; Interventional; Design type: Prevention, Drug
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Vaginal Preparation at caesarean section to Reduce Endometritis and Prevent Sepsis – a feasibility study of chlorhexidine gluconate
Study acronym	PREPS
Study objectives	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(s)	London - City & East Research Ethics Committee, 12/06/2017, ref: 17/LO/0874
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	There are no secondary outcome measures.
Completion date	31/08/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	16 Years
Sex	Female
Target sample size at registration	250
Key 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
Key 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
Date of first enrolment	01/10/2017
Date of final enrolment	01/02/2018

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

Birmingham Women’s Hospital - lead centre

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

Birmingham Heartlands Hospital

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

Princess Royal Hospital

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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The current data sharing plans for the current study are unknown and will be made available at a later date

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	qualiative study results	15/07/2019	17/07/2019	Yes	No
Protocol article	protocol	04/06/2018		Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

17/07/2019: Publication reference added.
11/06/2018: Publication reference added.
26/10/2017: Internal review.