Intrapartum Vulval and Perineal Cleansing Using Chlorhexidine Versus Normal Saline

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

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06072352

Enrollment

3500

Registered

2023-10-10

Start date

2023-10-01

Completion date

2026-12-31

Last updated

2023-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal Infection During Pregnancy

Brief summary

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.

Interventions

OTHERNormal saline

Perineal cleansing using normal saline

OTHERPerineal cleansing using chlorhexidine acetate solution

Perineal cleansing using chlorhexidine acetate solution

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
A composite of endometritis, wound infection, or other infection	delivery to within six weeks of delivery	endometritis, wound infection, or other infection

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026