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Use of Antiseptic Solution for Vaginal Wash Before Cesarean Section

NCT ID: NCT03442218

Last Updated: 2019-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2018-02-28

Brief Summary

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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).

Detailed Description

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Conditions

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Operation Wound; Infection Endometritis

Keywords

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Cesarean Operative site infection Vaginal wash Clorhexidine Endometritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Clorhexidine

Vaginal wash with clorhexidine solution

Group Type EXPERIMENTAL

Clorhexidine

Intervention Type DRUG

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

Saline solution

Vaginal wash with saline solution

Group Type PLACEBO_COMPARATOR

Saline solution

Intervention Type DRUG

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

Interventions

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Clorhexidine

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

Intervention Type DRUG

Saline solution

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

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sistema Nacional de Investigación (SNI) - Panamá

UNKNOWN

Sponsor Role collaborator

Saint Thomas Hospital, Panama

OTHER

Sponsor Role lead

Responsible Party

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Osvaldo A. Reyes T.

Head - Research Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Saint Thomas Maternity Hospital

Panama City, , Panama

Site Status

Countries

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Panama

References

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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.

Reference Type DERIVED
PMID: 35051671 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32335895 (View on PubMed)

Other Identifiers

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MHST2014-20

Identifier Type: -

Identifier Source: org_study_id