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NCT03442218 Clinical Trial

Use of Antiseptic Solution for Vaginal Wash Before Cesarean Section

Endometritis Clinical Trial

Official title:
Use fo Antiseptic Solution for Vaginal Wash Before Cesarean Section in Patients With Premature Rupture of Membranes. A Randomized, Double Blind, Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03442218
Other study ID # MHST2014-20
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2017
Est. completion date February 28, 2018

Study information
Verified date December 2019
Source Saint Thomas Hospital, Panama
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 203
Est. completion date February 28, 2018
Est. primary completion date August 31, 2017
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Clorhexidine
Vaginal wash with clorhexidine solution previous to cesarean section in patients with premature rupture of membranes.
• Saline solution
Vaginal wash with saline solution previous to cesarean section in patients with premature rupture of membranes.

Locations
Country Name City State
Panama Saint Thomas Maternity Hospital Panama

Sponsors (2)
Lead Sponsor Collaborator
Saint Thomas Hospital, Panama Sistema Nacional de Investigación (SNI) - Panamá

Country where clinical trial is conducted

Panama, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of cases of endometritis after cesarean section Endometritis 15 days
Secondary Number of cases of cesarean site infection Operative site infection 15 days
Secondary Number of cases of fever (38°C or above) in the puerperium Puerperal fever 15 days
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