Ignite Creation Date:
2024-05-06 @ 2:16 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02009098
Status:
WITHDRAWN
Last Update Posted:
2015-04-21
First Post:
2013-05-05
Brief Title:
RCT of Postoperative Infections Following Caesarean Section Infections Following Caesarean Section
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
Antibiotic Prophylaxis and Intervention for Postpartum Infections Following Caesarean Section
Status:
WITHDRAWN
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APIPICS
Brief Summary:
Background Women undergoing Caesarean Section CS have an increased risk of postpartum infections compared to women undergoing vaginal delivery In Denmark the incidence of post-CS infections is 7-10 The most common infections are endometritis Urinary tract infections UTI and wound infections WI
Prophylactic antibiotics are effective in preventing postoperative infections and national guidelines recommend that antibiotics should be administered as a single dose immediately before surgical incision CS is an exception to this pre-incision administration approach National guidelines recommend administration of antibiotics after umbilical cord clamping to avoid exposure of the child to antibiotics before birth Recent studies of antibiotic prophylaxis for CS suggest that prophylactic antibiotics administered before incision compared to after umbilical cord clamping may reduce post-CS infections by up to 50 Two Cochrane reviews from 2012 criticize these types of studies for lack of data for outcomes on the baby and on late infection in the mother
This study is a double-blinded randomized controlled trial with a concurrent Health Economic Assessment The study will examine the effect of change in timing of prophylactic antibiotics on the rate of post-CS infections endometritis UTI and WI The study will be performed at the obstetric departments at Odense University Hospital OUH Hvidovre Hospital HH and Hospital South West Jutland HSWJ in collaboration with the Department of Clinical Microbiology OUH to ensure that the most appropriate antibiotic regime is used Furthermore collaboration with a neonatologist will ensure appropriate assessment of neonatal outcome
The investigators plan to enroll the first patient at OUH February 2013 HH and HSWJ will follow with a couple of months delay The inclusion period is scheduled to last until the investigators have 2844 participants who have answered the questionnaire The investigators expect to complete the inclusion period in October 2014 last patient last visit LPLV Microbiological analyzes and data processing is expected to be completed one year after the LPLV The study population is all women delivering a child by CS during the project period at Department of Gynaecology and Obstetrics of OUH HH and HSWJ
Objective Investigate whether and by how much antibiotics administered 15-60 minutes before incision versus after umbilical cord clamping reduces the rate of postpartum infections in a Danish population of women undergoing CS
Hypothesis Antibiotics administered pre-incision will result in fewer postoperative infections than antibiotics administered after the umbilical cord is cut
Hypothesis Antibiotics administered before incision are cost-effective compared to administration after umbilical cord clamping measured by post-CS infection and as cost per Quality Adjusted Life Year QALY
Prophylactic antibiotics are effective in preventing postoperative infections and national guidelines recommend that antibiotics should be administered as a single dose immediately before surgical incision CS is an exception to this pre-incision administration approach National guidelines recommend administration of antibiotics after umbilical cord clamping to avoid exposure of the child to antibiotics before birth Recent studies of antibiotic prophylaxis for CS suggest that prophylactic antibiotics administered before incision compared to after umbilical cord clamping may reduce post-CS infections by up to 50 Two Cochrane reviews from 2012 criticize these types of studies for lack of data for outcomes on the baby and on late infection in the mother
This study is a double-blinded randomized controlled trial with a concurrent Health Economic Assessment The study will examine the effect of change in timing of prophylactic antibiotics on the rate of post-CS infections endometritis UTI and WI The study will be performed at the obstetric departments at Odense University Hospital OUH Hvidovre Hospital HH and Hospital South West Jutland HSWJ in collaboration with the Department of Clinical Microbiology OUH to ensure that the most appropriate antibiotic regime is used Furthermore collaboration with a neonatologist will ensure appropriate assessment of neonatal outcome
The investigators plan to enroll the first patient at OUH February 2013 HH and HSWJ will follow with a couple of months delay The inclusion period is scheduled to last until the investigators have 2844 participants who have answered the questionnaire The investigators expect to complete the inclusion period in October 2014 last patient last visit LPLV Microbiological analyzes and data processing is expected to be completed one year after the LPLV The study population is all women delivering a child by CS during the project period at Department of Gynaecology and Obstetrics of OUH HH and HSWJ
Objective Investigate whether and by how much antibiotics administered 15-60 minutes before incision versus after umbilical cord clamping reduces the rate of postpartum infections in a Danish population of women undergoing CS
Hypothesis Antibiotics administered pre-incision will result in fewer postoperative infections than antibiotics administered after the umbilical cord is cut
Hypothesis Antibiotics administered before incision are cost-effective compared to administration after umbilical cord clamping measured by post-CS infection and as cost per Quality Adjusted Life Year QALY
Detailed Description:
None
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 |
|---|---|---|---|
| 2012-002068-29 | EUDRACT_NUMBER | None | None |