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NCT Number: NCT06072352

Intrapartum Vulval and Perineal Cleansing Using Chlorhexidine Versus Normal Saline

Maternal infection during pregnancy is one of the leading causes of maternal mortality, accounting for 10.7% of maternal deaths worldwide (~37,000 annually). Majority of maternal infection occurs during intrapartum (36%) and postpartum (47%) period, of which the genital tract is the source of infection in 89% of intrapartum and 54% of postpartum sepsis.

Introduction of skin flora into the genital tract during vaginal examination in women with rupture of membranes or active labour may cause intrapartum and puerperal sepsis. We hypothesize intrapartum vulval and perineal cleansing before vaginal examination could reduce the chance of peripartum infection caused by introducing the skin flora to intrauterine environment.

We plan to carry out a randomized controlled trial of intrapartum vulval and perineal cleansing using chlorhexidine, compared sterile water, prior to vaginal examination during labour and its effect on maternal and neonatal sepsis.

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Key information

Conditions

Maternal Infection During Pregnancy

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All women age ≥ 18 years old
  • Live singleton pregnancy
  • Planned vaginal delivery
  • Term in labour (after 37+0 weeks of gestation)
  • Availability of GBS result at 35-37 weeks

Exclusion criteria

  • Preterm delivery (between 24+0 to 36+6 weeks of gestation)
  • Multiple pregnancy
  • Presence of fever before onset of labour
  • History of antibiotics use 7 days before onset of labour
  • History of adverse reaction to chlorhexidine
  • Planned Caesarean delivery
  • Planned delivery in other units
  • Women with autoimmune disease, immunodeficiency, human immunodeficiency virus or on long term steroids
  • Stillbirth
  • Known genital herpes
  • Genital wart during pregnancy

Treatment and study plan

Perineal cleansing using chlorhexidine acetate solution

Other

Perineal cleansing using chlorhexidine acetate solution

Normal Saline

Other

Perineal cleansing using normal saline

Primary outcomes

  1. A composite of endometritis, wound infection, or other infection

    Time frame: delivery to within six weeks of delivery

    endometritis, wound infection, or other infection

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

A Multicenter Randomized Controlled Trial Comparing Routine Intrapartum Vulval and Perineal Cleansing Using Chlorhexidine Versus Normal Saline to Decrease Maternal and Neonatal Infection

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 10, 2023
Registry last updated
Oct 10, 2023

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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