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CompletedNCT03442218Updated Dec 9, 2019

Use of Antiseptic Solution for Vaginal Wash Before Cesarean Section

An interventional study of Clorhexidine and Saline solution in Operation Wound; Infection and Endometritis, sponsored by Saint Thomas Hospital, Panama. Completed at 1 site in Panama. Open to female participants. Per ClinicalTrials.gov, last updated 2019-12-09.

Sponsored by Saint Thomas Hospital, Panama · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
203
Allocation
Randomized
Sex
Female
01

Study 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).

02

Conditions studied

  • Operation Wound; Infection
  • Endometritis

Keywords

  • Cesarean
  • Operative site infection
  • Vaginal wash
  • Clorhexidine
  • Endometritis
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Any source of infection diagnosed previous to surgery.
  • Fever of unknown origin previous to surgery.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
203 participants (actual)

Study arms

  • Experimental
    Clorhexidine

    Vaginal wash with clorhexidine solution

    Drug: Clorhexidine

  • Placebo comparator
    Saline solution

    Vaginal wash with saline solution

    Drug: Saline solution

Interventions

  • DrugClorhexidine

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

  • DrugSaline solution

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

05

What researchers measure

Primary outcomes

  1. Number of cases of endometritis after cesarean section

    Endometritis

    Time frame: 15 days

Secondary outcomes

  1. Number of cases of cesarean site infection

    Operative site infection

    Time frame: 15 days

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

    Puerperal fever

    Time frame: 15 days

06

Study locations

1 site
  • Saint Thomas Maternity Hospital
    Panama, Panama
07

References and documents

Publications

  • 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. PubMed 35051671 ↗
  • 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. PubMed 32335895 ↗
08

Registry details

Key details

Study ID
NCT03442218
Lead sponsor
Saint Thomas Hospital, Panama
Collaborators
Sistema Nacional de Investigación (SNI) - Panamá
Responsible party
Osvaldo A. Reyes T. (Head - Research Department, Saint Thomas Hospital, Panama) — Principal investigator
First posted
Feb 22, 2018
Start date
Jun 1, 2017
Primary completion
Aug 31, 2017
Completion
Feb 28, 2018
Last update
Dec 9, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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