NCT03442218

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

December 9, 2019

Status Verified

December 1, 2019

Enrollment Period

3 months

First QC Date

February 13, 2018

Last Update Submit

December 5, 2019

Conditions

Operation Wound; InfectionEndometritis

Keywords

CesareanOperative site infectionVaginal washClorhexidineEndometritis

Outcome Measures

Primary Outcomes (1)

  • Number of cases of endometritis after cesarean section

    Endometritis

    15 days

Secondary Outcomes (2)

  • Number of cases of cesarean site infection

    15 days

  • Number of cases of fever (38°C or above) in the puerperium

    15 days

Study Arms (2)

Clorhexidine

EXPERIMENTAL

Vaginal wash with clorhexidine solution

Drug: Clorhexidine

Saline solution

PLACEBO COMPARATOR

Vaginal wash with saline solution

Drug: Saline solution

Interventions

ClorhexidineDRUG

Vaginal wash with clorhexidine solution previous to cesarean section in patients with premature rupture of membranes.

Clorhexidine
Saline solutionDRUG

Vaginal wash with saline solution previous to cesarean section in patients with premature rupture of membranes.

Saline solution

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Thomas Maternity Hospital

Panama City, Panama

Location

Related Publications (2)

  • Urena N, Reyes O. Preoperative vaginal cleansing with chlorhexidine vs placebo in patients with rupture of membranes: a prospective, randomized, double-blind, placebo-control study. Am J Obstet Gynecol MFM. 2022 Mar;4(2):100572. doi: 10.1016/j.ajogmf.2022.100572. Epub 2022 Jan 17.

    PMID: 35051671DERIVED

  • Haas DM, Morgan S, Contreras K, Kimball S. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. Cochrane Database Syst Rev. 2020 Apr 26;4(4):CD007892. doi: 10.1002/14651858.CD007892.pub7.

    PMID: 32335895DERIVED

MeSH Terms

Conditions

Surgical Wound InfectionEndometritis

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic Inflammatory DiseaseAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUterine DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head - Research Department

Study Record Dates

First Submitted

February 13, 2018

First Posted

February 22, 2018

Study Start

June 1, 2017

Primary Completion

August 31, 2017

Study Completion

February 28, 2018

Last Updated

December 9, 2019

Record last verified: 2019-12

Locations

PA(1)