Vaginal preparation at caesarean section

Conditions

Specialty: Reproductive health and childbirth, Primary sub-specialty: General Obstetrics/ Midwifery

Victoria Hodgetts Morton, Catherine A Hewitt, Amie Wilson, Nicola Farmer, Annalise Weckesser et al. (9 authors)

Acta Obstetricia Et Gynecologica Scandinavica2019-09-209 citations

10.1111/aogs.13737

Women’s perspectives on caesarean section recovery, infection and the PREPS trial: a qualitative pilot study

Annalise Weckesser, Nicola Farmer, Rinita Dam, Amie Wilson, Victoria Hodgetts Morton et al. (6 authors)

BMC Pregnancy and Childbirth2019-07-1534 citations

10.1186/s12884-019-2402-8

Interventions

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 solu

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
There are no secondary outcome measures.	—

Countries

United Kingdom

Contacts

Public ContactLisa Leighton

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

Outcome results

None listed