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RCT of Postoperative Infections Following Caesarean Section Infections Following Caesarean Section (APIPICS)

Primary Purpose

Postoperative Infection

Status
Withdrawn
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Cefuroxime
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Infection focused on measuring Randomized Controlled Trial, Caesarean Section, preoperative, intraoperative, prophylactic antibiotics, antibiotics, timing, surgical site infections, endometritis, wound infections, urinary tract infections, infectious morbidity, neonatal antibiotics exposure, Antibiotic Prophylaxis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

All women delivering a child by CS at term, at Odense University Hospital, Hvidovre Hospital or Hospital of South West Jutland, Denmark, will be included in the study. Informed consent will be obtained during pregnancy.

Inclusion Criteria:

  • Age ≥ 18 year
  • Women, who can read and understand Danish
  • A gestational age ≥ completed 28 weeks of gestation
  • Rupture of membranes and active labour (uterine contractions) is allowed.

Exclusion Criteria:

  • Hypersensitivity to cefuroxime or to any other cephalosporin antibiotics
  • Previous immediate and/or severe hypersensitivity reaction to penicillin or any other beta-lactam antibiotic.
  • Systemic exposure to any antibiotic agent within 1 week before delivery

    _ Antibiotic indicated due to PROM, fever or other indications at the time of caesarean section.

  • Women being immunologically incompetent (e.g. HIV positive)

Sites / Locations

  • Hospital of South West Jutland
  • Hvidovre Hospital
  • Odense University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

præoperativ antibiotic

postoperativ antibiotic

Arm Description

iv Cefuroxime 1,5g administered 15-60 minutes before incision

iv Cefuroxime 1,5g administered after umbilical cord clamping

Outcomes

Primary Outcome Measures

Women: The incidence of post-CS infection (endometritis, urinary tract infections, and wound infections)
To be able to collect information about symptoms of infection after discharge a self-administered questionnaire will be sent to all participants within 30 days post-CS. Furthermore data on postoperative infections, recorded by diagnoses codes or surgical procedures, will be obtained from the Danish National Patient Registry.
Infant: admission to special care unit

Secondary Outcome Measures

Women: length of the primary and any secondary hospitalization
Women: readmissions to hospital/contact to the general practitioner on suspicion of infection after Caesarean Section
Women: antibiotic treatment on suspicion of infection after Caesarean Section
Infant: use of antifungal treatment against oral thrush
Infant: necrotizing enterocolitis
Infant: antibiotic treatment during hospital stay
Infant: the need for intensive care treatment and length of stay in hospital
Infant: Neonatal sepsis
Neonatal sepsis, Neonatal sepsis workup
Women: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Adverse reactions/events registered during hospitalization (complications, examinations, treatments, antibiotic use)

Full Information

First Posted
May 5, 2013
Last Updated
April 20, 2015
Sponsor
Odense University Hospital
Collaborators
Region of Southern Denmark, University of Southern Denmark, Hvidovre University Hospital, Hospital of South West Jutland
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1. Study Identification

Unique Protocol Identification Number
NCT02009098
Brief Title
RCT of Postoperative Infections Following Caesarean Section Infections Following Caesarean Section
Acronym
APIPICS
Official Title
Antibiotic Prophylaxis and Intervention for Postpartum Infections Following Caesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Withdrawn
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
Collaborators
Region of Southern Denmark, University of Southern Denmark, Hvidovre University Hospital, Hospital of South West Jutland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Infection
Keywords
Randomized Controlled Trial, Caesarean Section, preoperative, intraoperative, prophylactic antibiotics, antibiotics, timing, surgical site infections, endometritis, wound infections, urinary tract infections, infectious morbidity, neonatal antibiotics exposure, Antibiotic Prophylaxis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
præoperativ antibiotic
Arm Type
Active Comparator
Arm Description
iv Cefuroxime 1,5g administered 15-60 minutes before incision
Arm Title
postoperativ antibiotic
Arm Type
Active Comparator
Arm Description
iv Cefuroxime 1,5g administered after umbilical cord clamping
Intervention Type
Drug
Intervention Name(s)
Cefuroxime
Other Intervention Name(s)
Cefuroxime "Fresenius Kabi"
Intervention Description
iv Cefuroxime 1,5g administered 15-60 minutes before incision versus iv Cefuroxime 1,5g administered after umbilical cord clamping
Primary Outcome Measure Information:
Title
Women: The incidence of post-CS infection (endometritis, urinary tract infections, and wound infections)
Description
To be able to collect information about symptoms of infection after discharge a self-administered questionnaire will be sent to all participants within 30 days post-CS. Furthermore data on postoperative infections, recorded by diagnoses codes or surgical procedures, will be obtained from the Danish National Patient Registry.
Time Frame
within the first 30 days after surgery
Title
Infant: admission to special care unit
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 4 days
Secondary Outcome Measure Information:
Title
Women: length of the primary and any secondary hospitalization
Time Frame
within the first 30 days after Caesarean Section
Title
Women: readmissions to hospital/contact to the general practitioner on suspicion of infection after Caesarean Section
Time Frame
within the first 30 days after Caesarean Section
Title
Women: antibiotic treatment on suspicion of infection after Caesarean Section
Time Frame
within the first 30 days after Caesarean Section
Title
Infant: use of antifungal treatment against oral thrush
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 4 days
Title
Infant: necrotizing enterocolitis
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 4 days
Title
Infant: antibiotic treatment during hospital stay
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 4 days
Title
Infant: the need for intensive care treatment and length of stay in hospital
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 4 days
Title
Infant: Neonatal sepsis
Description
Neonatal sepsis, Neonatal sepsis workup
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 4 days
Title
Women: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
Adverse reactions/events registered during hospitalization (complications, examinations, treatments, antibiotic use)
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 4 days
Other Pre-specified Outcome Measures:
Title
Characteristics of the study population, which may affect the primary outcome "postoperative infections"
Description
Date of admission, Date of birth, Birthplace, Date of discharges. Ethnicity, Maternal age, height and prepregnancy weight, Parity, Multiple gestations, Gravidity, Prior caesareans, Prior abdominal surgery, Drug/alcohol abuse, Diabetes mellitus, Preeclampsia, Smoking status, self-reported, Urine track infection (before birth). Presence of labor, Length of labor, Preterm labor, Rupture of membranes, Length of rupture of membranes, Number of vaginal examinations, Use of internal monitoring, Meconium, Use of antenatal steroids, cervical dilators, vacuum, amnioinfusion, extraamniotic saline infusion. Type of section, Anaesthesia type, Uterine incision type, Uterine closure layers, Uterine incision extensions, Need for transfusion, Intraoperative blood loss, Time of day, Operative time, Deviation from the standard surgical procedure. Birth weight (gram), Gestational age (week
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 4 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
All women delivering a child by CS at term, at Odense University Hospital, Hvidovre Hospital or Hospital of South West Jutland, Denmark, will be included in the study. Informed consent will be obtained during pregnancy. Inclusion Criteria: Age ≥ 18 year Women, who can read and understand Danish A gestational age ≥ completed 28 weeks of gestation Rupture of membranes and active labour (uterine contractions) is allowed. Exclusion Criteria: Hypersensitivity to cefuroxime or to any other cephalosporin antibiotics Previous immediate and/or severe hypersensitivity reaction to penicillin or any other beta-lactam antibiotic. Systemic exposure to any antibiotic agent within 1 week before delivery _ Antibiotic indicated due to PROM, fever or other indications at the time of caesarean section. Women being immunologically incompetent (e.g. HIV positive)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Stener Joergensen, MD, PhD
Organizational Affiliation
Odense University Hospital, department of Gynaecology and Obstetrics, University of Southern Denmark, Faculty of Health Sciences, institute of Clinical Research, research unit, department of Gynaecology and Obstetrics
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital of South West Jutland
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Name
Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

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RCT of Postoperative Infections Following Caesarean Section Infections Following Caesarean Section

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