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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perineal Disinfection | Experimental |
| |
| Perineal Cleaning | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Povidone-Iodine (PVP-I) | Procedure | The experimental group will use povidone-iodine for disinfection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2Years |
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Inclusion Criteria:
Maternity:
Newborn:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Far Eastern Memorial Hospital | New Taipei City | Banqiao District | 220 | Taiwan |
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| ID | Term |
|---|---|
| D011206 | Povidone-Iodine |
| D014867 | Water |
| ID | Term |
|---|---|
| D007466 | Iodophors |
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D011145 | Polyvinyls |
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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.
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| Water | Procedure | The control group will undergo perineal preparation using clean water |
|
| D014753 |
| Vinyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011205 | Povidone |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |