Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 279 for:    Panama

Use of Antiseptic Solution for Vaginal Wash Before Cesarean Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03442218
Recruitment Status : Active, not recruiting
First Posted : February 22, 2018
Last Update Posted : February 22, 2018
Sponsor:
Collaborator:
Sistema Nacional de Investigación (SNI) - Panamá
Information provided by (Responsible Party):
Osvaldo A. Reyes T., 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).

Condition or disease Intervention/treatment Phase
Operation Wound; Infection Endometritis Drug: Clorhexidine Drug: Saline solution Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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.
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : August 31, 2017
Estimated Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

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.




Primary Outcome Measures :
  1. Number of cases of endometritis after cesarean section [ Time Frame: 15 days ]
    Endometritis


Secondary Outcome Measures :
  1. Number of cases of cesarean site infection [ Time Frame: 15 days ]
    Operative site infection

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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442218


Locations
Layout table for location information
Panama
Saint Thomas Maternity Hospital
Panama, Panama
Sponsors and Collaborators
Saint Thomas Hospital, Panama
Sistema Nacional de Investigación (SNI) - Panamá

Layout table for additonal information
Responsible Party: Osvaldo A. Reyes T., Head - Research Department, Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier: NCT03442218     History of Changes
Other Study ID Numbers: MHST2014-20
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama:
Cesarean
Operative site infection
Vaginal wash
Clorhexidine
Endometritis
Additional relevant MeSH terms:
Layout table for MeSH terms
Surgical Wound Infection
Endometritis
Infection
Pelvic Inflammatory Disease
Adnexal Diseases
Genital Diseases, Female
Uterine Diseases
Wound Infection
Postoperative Complications
Pathologic Processes
Anti-Infective Agents, Local
Pharmaceutical Solutions
Anti-Infective Agents