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Completed

NCT Number: NCT03442218

Use of Antiseptic Solution for Vaginal Wash Before Cesarean Section

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).

Completed

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Key information

Conditions

Operation Wound; Infection Adnexal Diseases Endometritis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Inflammatory Disease Postoperative Complications Surgical Wound Infection Urogenital Diseases Uterine Diseases Wound Infection

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Saint Thomas Maternity Hospital

Panama City, Panama

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clorhexidine

Drug

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

Saline Solution

Drug

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

Primary outcomes

  1. Number of cases of endometritis after cesarean section

    Time frame: 15 days

    Endometritis

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Saint Thomas Hospital, Panama

Other

Collaborators

  • Sistema Nacional de Investigación (SNI) - Panamá

Registry information

Official study title

Use fo Antiseptic Solution for Vaginal Wash Before Cesarean Section in Patients With Premature Rupture of Membranes. A Randomized, Double Blind, Controlled Trial.

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Feb 22, 2018
Registry last updated
Dec 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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