Perineal InfectionNCT06880445
Different Perineal Preparations Before Vaginal Birth to Maternal/Neonatal Infections and Cost Effectiveness
A study testing Povidone-Iodine (PVP-I) and Water in people with Perineal Infection and Maternal Infections Affecting Fetus or Newborn, run by Tzu-Ying Huang at 1 site in Taiwan.
Trial summary
The vaginal microbiome plays a crucial role in women's health, primarily composed of beneficial bacteria such as Lactobacillus, which help maintain an acidic environment in the vagina, preventing the growth of pathogens. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perineal Infection, Maternal Infections Affecting Fetus or Newborn, Cost Effectiveness
- What is being tested?
- Povidone-Iodine (PVP-I) and Water
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Nov 2024to 1 Jul 2025
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Maternity:
- Born after 37 weeks of pregnancy;
- Pregnant women with low-risk pregnancy;
- Be able to communicate in Mandarin and Taiwanese, and be able to read Chinese;
- A single fetus with a cephalic position;
- Aged 18 years or above (inclusive) with clear consciousness and no cognitive impairment;
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- Do not use antibiotics during pregnancy;
- There are no fetal diagnostic abnormalities during pregnancy check-up.
- Newborn:
- Newborns over 37 weeks
- Apgar Score is greater than 7 points in the first minute of life
- Having given birth to a newborn and undergoing perineal cleaning/disinfection methods specified in the study during the second stage of labor
Who cannot join
- The mother's water broke for more than 18 hours during labor;
- Mother had a fever;
- Used vacuum suction during delivery;
- Shoulder dystocia;
- Fetal distress;
- A perineal wound of 3 degrees or above
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Far Eastern Memorial Hospital
New Taipei City, Banqiao District, 220
About this study
Official title: Different Perineal Cleaning and Disinfection Preparations Before Vaginal Birth to Maternal/Neonatal Infections and Cost Effectiveness: A Randomized Control Trial
The vaginal microbiome plays a crucial role in women's health, primarily composed of beneficial bacteria such as Lactobacillus, which help maintain an acidic environment in the vagina, preventing the growth of pathogens. Research indicates that the vaginal environment during pregnancy is more conducive to the growth of Lactobacillus. Traditionally, perineal disinfection is performed during vaginal delivery; however, studies have shown that excessive use of disinfectants like povidone-iodine may reduce the presence of Lactobacillus in the vagina. Furthermore, not using perineal disinfection does not increase the risk of postpartum infections for mothers and infants, and may even benefit the development of the newborn's microbiome. Considering the medical costs and nursing labor involved, this study aims to compare the effects of different perineal preparation methods on postpartum infection rates and medical costs, with the goal of improving maternal and infant care quality during delivery and reducing healthcare costs.
5、 Method This study employs an experimental research design. After obtaining informed consent from participants, they will be randomly assigned to either the control group or the experimental group using a random number table. The control group will undergo perineal preparation using clean water, while the experimental group will use povidone-iodine for disinfection. The study will document patient demographics, prenatal vital signs, maternal and infant postpartum temperatures, blood test results, and oral bacterial culture outcomes to monitor postpartum infection rates. The REEDA scale will be used to assess perineal wound healing.
6、Expected results： The anticipated results indicate that using clean water for perineal preparation will not increase the risk of postpartum infections for mothers and infants, while also saving medical costs. Additionally, water disinfection may allow newborns to acquire beneficial bacteria such as Lactobacillus from the mother's vagina during delivery, promoting healthy gut microbiome development.
- Being tested
- Povidone-Iodine (PVP-I), Water
- Keywords
- Perineal cleaning and disinfection, Maternal/Neonatal Infections, Cost Effectiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone-Iodine (PVP-I)Procedure or surgery
The experimental group will use povidone-iodine for disinfection.
WaterProcedure or surgery
The control group will undergo perineal preparation using clean water
| Study group | Role | What they receive |
|---|---|---|
| Perineal Disinfection | Experimental | Not described Receives: Procedure: Povidone-Iodine (PVP-I) |
| Perineal Cleaning | Placebo comparator | Not described Receives: Procedure: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Different Perineal cleaning and disinfection Preparations Before Vaginal Birth to Maternal/Neonatal Infections and Cost Effectiveness: A Randomized Control Trial
Cases that agree to participate in the study will collect data on a self made login form.
During the study period, perineal preparation and 24hours postpartum perineal wound healing was assessed using the REEDA scale at the time of discharge and on the day of discharge, and neonatal oral bacterial culture was performed by the researcher.
Measured: 2Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start30 Nov 2024
- Primary completion25 Jun 2025
- Study completion1 Jul 2025
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 Perineal InfectionStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This stu dy used the Random Allocation Software developed by Mahmood Saghaei to randomly assign the research subjects into the control group and the experimental group. The control group used clean water to prepare the perineum for the second stage of labor, while the experimental group used betadine disinfection for perineal preparation for the second stage of labor.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tzu-Ying Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tzu-Ying Huang, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880445
- Sponsor's protocol ID
- 113236-F
- Status last verified
- Aug 2025
- First submitted
- 5 Dec 2024
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang TY, Chen LL, Peng FS, Chu FY, Gau ML. Effects of two different perineal preparations before vaginal birth on maternal and neonatal infections and hospital resources: A randomized controlled trial. Eur J Midwifery. 2026 Sep 3;10. doi: 10.18332/ejm/226734. eCollection 2026.
PubMed 42694794
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Perineal Cleaning and Disinfection Preparations Before Vaginal Birth to Maternal/Neonatal Infections and Cost Effectiveness: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06880445
- Acronym / sponsor ID
- 113236-F
- Keywords
- Perineal cleaning and disinfection, Maternal/Neonatal Infections, Cost Effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Tzu-Ying HuangUniversity, hospital or other
- Study start
- 30 Nov 2024 (actual)
- Primary completion
- 25 Jun 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 17 Mar 2025 (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.
The vaginal microbiome plays a crucial role in women's health, primarily composed of beneficial bacteria such as Lactobacillus, which help maintain an acidic environment in the vagina, preventing the growth of pathogens. Research indicates that the vaginal environment during pregnancy is more conducive to the growth of Lactobacillus. Traditionally, perineal disinfection is performed during vaginal delivery; however, studies have shown that excessive use of disinfectants like povidone-iodine may reduce the presence of Lactobacillus in the vagina. Furthermore, not using perineal disinfection does not increase the risk of postpartum infections for mothers and infants, and may even benefit the development of the newborn's microbiome. Considering the medical costs and nursing labor involved, this study aims to compare the effects of different perineal preparation methods on postpartum infection rates and medical costs, with the goal of improving maternal and infant care quality during delivery and reducing healthcare costs.
5、 Method This study employs an experimental research design. After obtaining informed consent from participants, they will be randomly assigned to either the control group or the experimental group using a random number table. The control group will undergo perineal preparation using clean water, while the experimental group will use povidone-iodine for disinfection. The study will document patient demographics, prenatal vital signs, maternal and infant postpartum temperatures, blood test results, and oral bacterial culture outcomes to monitor postpartum infection rates. The REEDA scale will be used to assess perineal wound healing.
6、Expected results： The anticipated results indicate that using clean water for perineal preparation will not increase the risk of postpartum infections for mothers and infants, while also saving medical costs. Additionally, water disinfection may allow newborns to acquire beneficial bacteria such as Lactobacillus from the mother's vagina during delivery, promoting healthy gut microbiome development.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This stu dy used the Random Allocation Software developed by Mahmood Saghaei to randomly assign the research subjects into the control group and the experimental group. The control group used clean water to prepare the perineum for the second stage of labor, while the experimental group used betadine disinfection for perineal preparation for the second stage of labor.
| Arm | Type | Receives |
|---|---|---|
| Perineal Disinfection | Experimental | Procedure: Povidone-Iodine (PVP-I) |
| Perineal Cleaning | Placebo comparator | Procedure: Water |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Born after 37 weeks of pregnancy;
- Pregnant women with low-risk pregnancy;
- Be able to communicate in Mandarin and Taiwanese, and be able to read Chinese;
- A single fetus with a cephalic position;
- Aged 18 years or above (inclusive) with clear consciousness and no cognitive impairment;
Key exclusion criteria (6 listed)
- The mother's water broke for more than 18 hours during labor;
- Mother had a fever;
- Used vacuum suction during delivery;
- Shoulder dystocia;
- Fetal distress;
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-Iodine (PVP-I)The experimental group will use povidone-iodine for disinfection. | Procedure or surgery | Perineal Disinfection |
| WaterThe control group will undergo perineal preparation using clean water | Procedure or surgery | Perineal Cleaning |
Primary outcome
Different Perineal cleaning and disinfection Preparations Before Vaginal Birth to Maternal/Neonatal Infections and Cost Effectiveness: A Randomized Control Trial
Time frame: 2Years
Cases that agree to participate in the study will collect data on a self made login form. During the study period, perineal preparation and 24hours postpartum perineal wound healing was assessed using the REEDA scale at the time of discharge and on the day of discharge, and neonatal oral bacterial culture was performed by the researcher.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Derived from this study: PubMed 42694794Huang TY, Chen LL, Peng FS, Chu FY, Gau ML. Effects of two different perineal preparations before vaginal birth on maternal and neonatal infections and hospital resources: A randomized controlled trial. Eur J Midwifery. 2026 Sep 3;10. doi: 10.18332/ejm/226734. eCollection 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Povidone-Iodine (PVP-I) and Water in people with Perineal Infection and Maternal Infections Affecting Fetus or Newborn, run by Tzu-Ying Huang at 1 site in Taiwan.
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 12 inclusion and 6 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: finished, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Different Perineal cleaning and disinfection Preparations Before Vaginal Birth to Maternal/Neonatal Infections and Cost Effectiveness: A Randomized Control Trial (time frame: 2Years). 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 NCT06880445, 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 15 Aug 2025.