Puerperal Infection Clinical Trial
Official title:
Effect of Vaginal Douching With Betadine Versus Non Douching Before CS for Prevention of Post Operative Infections
NCT number | NCT03397615 |
Other study ID # | 16 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 3, 2019 |
Est. completion date | December 2019 |
The present study was a prospective randomized controlled trial in which subjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery or received no vaginal preparation
Status | Recruiting |
Enrollment | 1200 |
Est. completion date | December 2019 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Any patient undergoing CS Exclusion Criteria: - • Betadine allegy. - Rupture membranes. - Accidental Hemorrhage. - H/O suggestive chorioamnionitis ; uterine tenderness, offensive vaginal discharge, fever medical disorders as diabetes, hypertension , cardiac or renal diseqases |
Country | Name | City | State |
---|---|---|---|
Egypt | Kasr Alainy medical school | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postpartum endometritis | a clinical diagnosis, usually involving fever, uterine fundal tenderness, or prurulent lochia requiring antibiotic therapy. | 6 weeks after Cesarean section | |
Secondary | Postoperative wound infection | erythema, tenderness, prurulent drainage from the incision site, with or without fever, requiring antibiotic therapy | 6 weeks after Cesarean section | |
Secondary | Postoperative fever | temperature higher than 38 degrees C | 3 weeks after Cesarean section |
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