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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorhexidine acetate solution | Experimental |
| |
| Normal saline | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perineal cleansing using chlorhexidine acetate solution | Other | Perineal cleansing using chlorhexidine acetate solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| A composite of endometritis, wound infection, or other infection | endometritis, wound infection, or other infection | delivery to within six weeks of delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Normal saline | Other | Perineal cleansing using normal saline |
|