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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

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jun 2017, registered Feb 2018).
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

In context

Surgical Wound Infection

745 studies on the registry are indexed under Surgical Wound Infection; 151 are open to participants now.

This study's enrollment of 203 is close to the median of 200 across 581 interventional studies indexed under Surgical Wound Infection.

Browse Surgical Wound Infection studies →

Lead sponsor

Saint Thomas Hospital, Panama is the lead sponsor of 37 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.
05

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.

06

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

07

Study locations

1 site
  • Saint Thomas Maternity Hospital
    Panama, Panama
08

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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2017 to primary completion in Aug 2017, 2 months.

Of 201 non-industry interventional studies with no phase under Surgical Wound Infection, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's 2 months is below that.

Counting every sponsor, half of 208 studies reached it within 24 months; a quarter within 12 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 13, 2018
First posted
Feb 22, 2018
StartActual
Jun 1, 2017
Primary completionActual
Aug 31, 2017
CompletionActual
Feb 28, 2018
Last update
Dec 9, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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 ↗

Not currently enrolling

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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Discussion

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