Skip Prep of Vaginal Delivery to Prevent Puerperal / Perinatal Infection in Vaginal Delivery

Establishment of Clinical Practice Guideline to Prevent Puerperal / Perinatal Infection in Vaginal Delivery for Pregnant Women and Newborns

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05122169

Enrollment

4140

Registered

2021-11-16

Start date

2021-12-31

Completion date

2026-05-31

Last updated

2021-11-26

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

Conditions

Surgical Site Infection, Vaginal Delivery

Keywords

Chlorhexidine-alcohol, Povidone-iodine, Perineal infection, Surgical site infection

Brief summary

This is a multi-center, randomized, controlled trial study to find whether use of chlorhexidine-alcohol or povidone-iodine for pre-vaginal delivery skin prep is superior to reduce postpartum infection in pregnant women with vaginal delivery. The primary outcome is the episiotomy site infection.

Interventions

DRUGPovidone-Iodine

Skin preparation with povidone-iodine pre-vaginal delivery skin preparation.

DRUGChlorhexidine

Skin preparation with chlorhexidine-alcohol pre-vaginal delivery skin preparation.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

19 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Women with singleton pregnancy * Women who will undergo vaginal delivery after 37+0/7 weeks of gestation

Exclusion criteria

* Women who are allergy to chlorhexidine, alcohol, iodine, or shellfish * Women with any infection at perineum (before vaginal delivery)

Design outcomes

Primary

Measure	Time frame	Description
Number of participant with episiotomy site infection	21 days	Superficial or deep infection of episiotomy site

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026