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Trial record 19 of 20 for:    "Endometritis" | "Anti-Bacterial Agents"

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

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ClinicalTrials.gov Identifier: NCT02009098
Recruitment Status : Withdrawn
First Posted : December 11, 2013
Last Update Posted : April 21, 2015
Sponsor:
Collaborators:
Region of Southern Denmark
University of Southern Denmark
Hvidovre University Hospital
Hospital of South West Jutland
Information provided by (Responsible Party):
Nana Hyldig, Odense University Hospital

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).


Condition or disease Intervention/treatment Phase
Postoperative Infection Drug: Cefuroxime Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Antibiotic Prophylaxis and Intervention for Postpartum Infections Following Caesarean Section
Study Start Date : October 2014
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : June 2016

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Arm Intervention/treatment
Active Comparator: præoperativ antibiotic
iv Cefuroxime 1,5g administered 15-60 minutes before incision
Drug: Cefuroxime
iv Cefuroxime 1,5g administered 15-60 minutes before incision versus iv Cefuroxime 1,5g administered after umbilical cord clamping
Other Name: Cefuroxime "Fresenius Kabi"

Active Comparator: postoperativ antibiotic
iv Cefuroxime 1,5g administered after umbilical cord clamping
Drug: Cefuroxime
iv Cefuroxime 1,5g administered 15-60 minutes before incision versus iv Cefuroxime 1,5g administered after umbilical cord clamping
Other Name: Cefuroxime "Fresenius Kabi"




Primary Outcome Measures :
  1. Women: The incidence of post-CS infection (endometritis, urinary tract infections, and wound infections) [ Time Frame: within the first 30 days after surgery ]
    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.

  2. 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 Measures :
  1. Women: length of the primary and any secondary hospitalization [ Time Frame: within the first 30 days after Caesarean Section ]
  2. 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 ]
  3. Women: antibiotic treatment on suspicion of infection after Caesarean Section [ Time Frame: within the first 30 days after Caesarean Section ]
  4. 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 ]
  5. Infant: necrotizing enterocolitis [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 days ]
  6. Infant: antibiotic treatment during hospital stay [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 days ]
  7. 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 ]
  8. Infant: Neonatal sepsis [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 days ]
    Neonatal sepsis, Neonatal sepsis workup

  9. Women: Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 days ]
    Adverse reactions/events registered during hospitalization (complications, examinations, treatments, antibiotic use)


Other Outcome Measures:
  1. Characteristics of the study population, which may affect the primary outcome "postoperative infections" [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 days ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02009098


Locations
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Denmark
Hospital of South West Jutland
Esbjerg, Denmark, 6700
Hvidovre Hospital
Hvidovre, Denmark, 2650
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Region of Southern Denmark
University of Southern Denmark
Hvidovre University Hospital
Hospital of South West Jutland
Investigators
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Study Chair: Jan Stener Joergensen, MD, PhD 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

Additional Information:
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Responsible Party: Nana Hyldig, principal investigator, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02009098     History of Changes
Other Study ID Numbers: 2012-002068-29
2012-002068-29 ( EudraCT Number )
First Posted: December 11, 2013    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: October 2014
Keywords provided by Nana Hyldig, Odense University Hospital:
prophylactic antibiotics
antibiotics
endometritis
neonatal antibiotics exposure
Antibiotic Prophylaxis
Randomized Controlled Trial
Caesarean Section
preoperative
intraoperative
timing
surgical site infections
wound infections
urinary tract infections
infectious morbidity
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Anti-Bacterial Agents
Cefuroxime
Cefuroxime axetil
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents