Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00386477
Status:
TERMINATED
Last Update Posted:
2010-02-08
First Post:
2006-10-09
Brief Title:
Vaginal Cleansing at Cesarean Delivery to Reduce Infection A Randomized Controlled Trial
Sponsor:
Indiana University School of Medicine
Organization:
Indiana University
Study Overview
Official Title:
Vaginal Cleansing at Cesarean Delivery to Reduce Infection A Randomized Controlled Trial
Status:
TERMINATED
Status Verified Date:
2010-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty recruiting
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of the project is to find out whether cleansing the vagina before a cesarean delivery decreases the risk of complications and infections after having the baby If this is the case cleansing the vagina before cesarean delivery can help improve outcomes for many women and make their early postpartum recovery much more pleasant giving a healthier start for the family
Detailed Description:
Infectious morbidity frequently complicates cesarean delivery Endometritis can complicate the postoperative course of a cesarean delivery 6-27 of the time This complication up to 10 times more frequent than after vaginal delivery can lead to serious complications Additionally cesarean deliveries are frequently complicated by maternal fever and wound complications including seroma hematoma infection and separation These morbidities can lead to significant delay in a return to normal function Our study will randomize 1000 women who are about to undergo a cesarean delivery into one of two groups The control group will receive the standard surgical preparation of the abdomen alone the current standard pre-cesarean preparation The other group will also receive a povidone iodine washingscrub of the vagina before the cesarean delivery Maternal and surgical variables will be recorded At one months postpartum maternal outpatient data will be reviewed and the incidence of postpartum uterine infection wound separations and other wound and infectious complications will be determined and compared between the two treatment groups
Comparison Women receiving standard surgical abdominal cleansing versus women receiving standard abdominal and preoperative vaginal cleansing before cesarean delivery
Comparison Women receiving standard surgical abdominal cleansing versus women receiving standard abdominal and preoperative vaginal cleansing before cesarean delivery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 0509-55 | OTHER | IUPUI-Clarian IRB number | None |