Vaginal cleansing in patients prior to emergency cesarean section and to see the effect on postoperative infections

Vaginal Cleansing Prior to Emergency Cesarean Section and Post-Operative Infectious Morbidity; Clinical Trial in a Low Resource Setting

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12622000336785

Enrollment

400

Registered

2022-02-23

Start date

2017-05-01

Completion date

2017-10-01

Last updated

2022-02-28

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

Conditions

None listed

Brief summary

Objective: To see the effectiveness of preoperative vaginal cleansing with povidone-iodine in terms of frequency of post-operative infectious morbidity such as postoperative endometritis, fever and wound infections in patients undergoing emergency cesarean section, by conducting a randomized trial of 400 term patients, age 15-45 years, for more than six hours in labour, with or without rupture of membranes.

Interventions

Vaginal cleansing was performed with two gauzes using povidone iodine 10%, rotating each gauze sponge 360- degrees in the vagina for 30 seconds three times in “vaginal cleaning group” only by the obstetrician, 5 mins prior to incision. The abdominal washing with povidone iodone 10% will be applied just prior to draping immediately after vaginal cleansing by the obstetrician. Adherence to the intervention is monitored by the staff nurse in operation notes register

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

15 Years to 45 Years

Healthy volunteers

Inclusion criteria

All patients who underwent emergency cesarean section at term i.e gestational age 37+0 to 41+6 weeks who were in labour for more than six hours, either booked or unbooked and with or without rupture of membranes.

Exclusion criteria

Women with preoperative fever >38°C, clinical features of chorioamnionitis, antepartum hemorrhage, severe anemia (hemoglobin less than 7g/dl), obstructed labor and those who failed to give consent were excluded.

Outcome results