Infection; Cesarean Section Clinical Trial
Official title:
Preoperative Vaginal Cleansing With Povidone Iodine and the Risk of Post Cesarean Endometritis
Preoperative vaginal cleansing with povidone iodine and the risk of post cesarean endometritis.
Status | Recruiting |
Enrollment | 306 |
Est. completion date | October 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: 1. Patients 18-40 years of age who will undergo cesarean deliveries. 2. Able to communicate well with the investigator & to comply with the requirements of the entire study. 3. Verbal consent obtained from subject and husband / witness before undergoing the study entry (with the understanding that consent may be withdrawn by the patient at any time without prejudice). Exclusion Criteria: 1. Patients with allergy to iodine containing solutions. 2. Patients with ante-partum hemorrhage. 3. Patients with ruptured membranes. 4. Patients with any known disease that increases the risk of infection e.g. immunocompromized, those receiving steroids ...etc. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Egypt | Ain Shams maternity hospital | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams Maternity Hospital |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Subjects with post cesarean endometritis | Number of Subjects with post cesarean endometritis as diagnosed by fever 38.4°C and greater in first 48 hours after cesarean section with any of the following (uterine tenderness, foul smelling lochia or positive C-reactive protein) | 48 hours | Yes |
Secondary | Number of Subjects with allergic reaction to povidone iodine | Number of Subjects with allergic reaction to povidone iodine | 48 hours | Yes |
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