Vaginal DeliveryNCT05122169
Skip Prep of Vaginal Delivery to Prevent Puerperal / Perinatal Infection in Vaginal Delivery
A study testing Povidone-Iodine and Chlorhexidine in people with Vaginal Delivery and Surgical Site Infection, run by Seoul National University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Delivery, Surgical Site Infection
- What is being tested?
- Povidone-Iodine and Chlorhexidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,140 participants
- Where
- No sites listed yet
- Study dates
- Dec 2021to 31 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women with singleton pregnancy
- Women who will undergo vaginal delivery after 37+0/7 weeks of gestation
Who cannot join
- Women who are allergy to chlorhexidine, alcohol, iodine, or shellfish
- Women with any infection at perineum (before vaginal delivery)
About this study
Official title: Establishment of Clinical Practice Guideline to Prevent Puerperal / Perinatal Infection in Vaginal Delivery for Pregnant Women and Newborns
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.
- Conditions
- Vaginal Delivery, Surgical Site Infection
- Being tested
- Povidone-Iodine, Chlorhexidine
- Keywords
- Chlorhexidine-alcohol, Povidone-iodine, Perineal infection, Surgical site infection
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone-IodineDrug
Also called Povidone-iodine 10%
Skin preparation with povidone-iodine pre-vaginal delivery skin preparation.
ChlorhexidineDrug
Also called Hexitanol 2% Soln., Chlorhexidine Gluconate Solution
Skin preparation with chlorhexidine-alcohol pre-vaginal delivery skin preparation.
| Study group | Role | What they receive |
|---|---|---|
| chlorhexidine | Experimental | Pre-vaginal delivery skip prep using chlorhexidine-alcohol Receives: Drug: Chlorhexidine |
| Povidone-iodine | Active comparator | Pre-vaginal delivery skip prep using Povidone-iodine Receives: Drug: Povidone-Iodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participant with episiotomy site infection
Superficial or deep infection of episiotomy site
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study startDec 2021 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaginal DeliveryStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4,140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joong Shin Park, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122169
- Sponsor's protocol ID
- Vaginal Delivery Skin Prep
- Status last verified
- Nov 2021
- First submitted
- 8 Nov 2021
- Last updated
- 26 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jung YM, Lee SM, Kim SY, Chung JH, Won HS, Lee KA, Park MH, Cho GJ, Oh MJ, Choi ES, Ahn KH, Hong SC, Sung JH, Roh CR, Kim SM, Kim BJ, Kim HJ, Oh KJ, Hong S, Park IY, Park JS. The Skin Antiseptic agents at Vaginal dElivery (SAVE) trial: study protocol for a randomized controlled trial. Trials. 2023 Feb 21;24(1):130. doi: 10.1186/s13063-023-07101-w.
PubMed 36810189
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Clinical Practice Guideline to Prevent Puerperal / Perinatal Infection in Vaginal Delivery for Pregnant Women and Newborns
- ClinicalTrials.gov ID
- NCT05122169
- Acronym / sponsor ID
- Vaginal Delivery Skin Prep
- Conditions
- Vaginal Delivery, Surgical Site Infection
- Keywords
- Chlorhexidine-alcohol, Povidone-iodine, Perineal infection, Surgical site infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,140 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chlorhexidine | Experimental | Drug: ChlorhexidinePre-vaginal delivery skip prep using chlorhexidine-alcohol |
| Povidone-iodine | Active comparator | Drug: Povidone-IodinePre-vaginal delivery skip prep using Povidone-iodine |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women with singleton pregnancy
- Women who will undergo vaginal delivery after 37+0/7 weeks of gestation
Key exclusion criteria (2 listed)
- Women who are allergy to chlorhexidine, alcohol, iodine, or shellfish
- Women with any infection at perineum (before vaginal delivery)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Povidone-IodineAlso: Povidone-iodine 10%Skin preparation with povidone-iodine pre-vaginal delivery skin preparation. | Drug | Povidone-iodine |
| ChlorhexidineAlso: Hexitanol 2% Soln., Chlorhexidine Gluconate SolutionSkin preparation with chlorhexidine-alcohol pre-vaginal delivery skin preparation. | Drug | chlorhexidine |
Primary outcome
Number of participant with episiotomy site infection
Time frame: 21 days
Superficial or deep infection of episiotomy site
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
- Derived from this study: PubMed 36810189Jung YM, Lee SM, Kim SY, Chung JH, Won HS, Lee KA, Park MH, Cho GJ, Oh MJ, Choi ES, Ahn KH, Hong SC, Sung JH, Roh CR, Kim SM, Kim BJ, Kim HJ, Oh KJ, Hong S, Park IY, Park JS. The Skin Antiseptic agents at Vaginal dElivery (SAVE) trial: study protocol for a randomized controlled trial. Trials. 2023 Feb 21;24(1):130. doi: 10.1186/s13063-023-07101-w.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Povidone-Iodine and Chlorhexidine in people with Vaginal Delivery and Surgical Site Infection, run by Seoul National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participant with episiotomy site infection (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05122169, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2021.