Use of Antiseptic Solution for Vaginal Wash Before Cesarean Section

December 5, 2019 updated by: Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

203

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Panama
      • Panama, Panama
        • Saint Thomas Maternity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clorhexidine
Vaginal wash with clorhexidine solution
Drug: Clorhexidine
Vaginal wash with clorhexidine solution previous to cesarean section in patients with premature rupture of membranes.
Placebo Comparator: Saline solution
Vaginal wash with saline solution
Drug: Saline solution
Vaginal wash with saline solution previous to cesarean section in patients with premature rupture of membranes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of cases of endometritis after cesarean section
Time Frame: 15 days
Endometritis
15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of cases of cesarean site infection
Time Frame: 15 days
Operative site infection
15 days
Number of cases of fever (38°C or above) in the puerperium
Time Frame: 15 days
Puerperal fever
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Thomas Hospital, Panama

Collaborators

Sistema Nacional de Investigación (SNI) - Panamá

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

August 31, 2017

Study Completion (Actual)

February 28, 2018

Study Registration Dates

First Submitted

February 13, 2018

First Submitted That Met QC Criteria

February 21, 2018

First Posted (Actual)

February 22, 2018

Study Record Updates

Last Update Posted (Actual)

December 9, 2019

Last Update Submitted That Met QC Criteria

December 5, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MHST2014-20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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