Use of Antiseptic Solution for Vaginal Wash Before Cesarean Section

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03442218
• Date of registration: 13/02/2018
• Prospective Registration: No
• Primary sponsor: Saint Thomas Hospital, Panama
• Public title: Use of Antiseptic Solution for Vaginal Wash Before Cesarean Section
• Scientific title: Use fo Antiseptic Solution for Vaginal Wash Before Cesarean Section in Patients With Premature Rupture of Membranes. A Randomized, Double Blind, Controlled Trial.
• Date of first enrolment: June 1, 2017
• Target sample size: 203
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03442218
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Panama

Key inclusion & exclusion criteria

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.



Age minimum: N/A
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Operation Wound; Infection

Endometritis

Intervention(s)

Drug: Clorhexidine

Drug: Saline solution

Primary Outcome(s)

Number of cases of endometritis after cesarean section [Time Frame: 15 days]

Secondary Outcome(s)

Number of cases of cesarean site infection [Time Frame: 15 days]

Number of cases of fever (38°C or above) in the puerperium [Time Frame: 15 days]

Secondary ID(s)

MHST2014-20

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sistema Nacional de Investigación (SNI) - Panamá