Effect of vaginal antiseptic prior to Caesarean Section on the rate of Post-Caesarean complications: A blinded randomised controlled trial

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620000971932

Acronym

Nil Known

Enrollment

375

Registered

2020-09-28

Start date

2020-10-01

Completion date

2022-03-15

Last updated

2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

General Objective To introduce uniform use of vaginal antiseptic wash immediately prior to Caesarean section and to determine the best antiseptic wash material in reducing post-operative infections or complications. Specific Aims 1. To determine the number of post-CS infections among women that will undergo pre-operative vaginal cleansing with either 1% povidone iodine or chlorohexidine or no toileting (control) during elective CS 2. To determine the number of post-CS infections among women that will undergo pre-operative vaginal cleansing with 1% povidone iodine or chlorohexidine or no toileting (control) during emergency CS 3. To compare the rate of infections among the three groups that receiving either 1% povidone iodine or chlorohexidine or no toileting for vaginal irrigation prior to any kind of CS 4. To identify the best antiseptic wash and methods for vaginal irrigation prior to CS for developing a uniform guideline through locally generated evidence 5. To determine the factors that may influence the outcomes such as post-CS infections or related complications

Interventions

Patients that will be undergoing for elective or emergency CS are randomised either to Arm1-1% povidone iodine Arm 2- chlorohexidine Arm 3 no vaginal irrigation group. Single vaginal Prepp will be done after anaesthesia is given, just prior to commencing Caesarean section, could be done by Midwife or obstetrician present

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

Any patients undergoing for either emergency or elective CS that provided voluntary informed consent will be included in the study.

Exclusion criteria

• Patients having signs of chorio, intrapartum pyrexia and other signs of infection will be excluded from the study. • Patients who develop intrapartum pyrexia as a result of syntocinon drip, prolonged labour or obstructed labour and provided voluntary informed consent will be included in the study initially. Their placental swabs will be taken for microscopic examination, culture and sensitivity (m/cs). They will be excluded from the study only if their swab results are positive for m/cs.

Outcome results