Use of Antiseptic Solution for Vaginal Wash Before Cesarean Section

Not Applicable

Completed

• Conditions: Operation Wound; Infection; Endometritis
• Interventions: Drug: Saline solution; Drug: Clorhexidine

• Registration Number: NCT03442218
• Lead Sponsor: Saint Thomas Hospital, Panama

Brief Summary

To evaluate the rate of infections after cesarean sections in patients with premature rupture of membranes after vaginal wash either with an antiseptic solution (clorhexidine solution) vs. saline solution (placebo).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-01
• Primary Completion: 2017-08-31
• Study First Submitted: 2018-02-13
• Study First Submitted QC: 2018-02-21
• Study First Posted: 2018-02-22
• Study Completion: 2018-02-28
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-05
• Last Update Posted: 2019-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 203

Inclusion Criteria

• Women with gestation between 34 and 41 6/7 weeks.
• Premature rupture of membranes (> 6 hours).
• Use of prophylactic antibiotic 1 hour previous to cesarean section.

Exclusion Criteria

• Any source of infection diagnosed previous to surgery.
• Fever of unknown origin previous to surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline solution	Saline solution	Vaginal wash with saline solution
Clorhexidine	Clorhexidine	Vaginal wash with clorhexidine solution

Primary Outcome Measures

Name	Time	Method
Number of cases of endometritis after cesarean section	15 days	Endometritis

Secondary Outcome Measures

Name	Time	Method
Number of cases of fever (38°C or above) in the puerperium	15 days	Puerperal fever
Number of cases of cesarean site infection	15 days	Operative site infection

Trial Locations

Locations (1)

Saint Thomas Maternity Hospital; 🇵🇦 Panama, Panama