Postoperative InfectionPhase 4APIPICSNCT02009098
RCT of Postoperative Infections Following Caesarean Section Infections Following Caesarean Section
A Phase 4 study testing Cefuroxime in people with Postoperative Infection, run by Odense University Hospital at 3 sites in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Infection
- What is being tested?
- Cefuroxime
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesDenmark
- Study dates
- Oct 2014to Jun 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Hospital of South West Jutland
Esbjerg, 6700
Hvidovre Hospital
Hvidovre, 2650
Odense University Hospital
Odense, 5000
About this study
Official title: Antibiotic Prophylaxis and Intervention for Postpartum Infections Following Caesarean Section
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.
Read more
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).
- Conditions
- Postoperative Infection
- Being tested
- Cefuroxime
- 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
- Medical subject headings
- Surgical Wound Infection, Endometritis, Wound Infection, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefuroximeDrug
Also called Cefuroxime "Fresenius Kabi"
iv Cefuroxime 1,5g administered 15-60 minutes before incision versus iv Cefuroxime 1,5g administered after umbilical cord clamping
| Study group | Role | What they receive |
|---|---|---|
| præoperativ antibiotic | Active comparator | iv Cefuroxime 1,5g administered 15-60 minutes before incision Receives: Drug: Cefuroxime |
| postoperativ antibiotic | Active comparator | iv Cefuroxime 1,5g administered after umbilical cord clamping Receives: Drug: Cefuroxime |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within the first 30 days after surgery
Infant: admission to special care unit
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 days
Secondary outcomes (9)
Women: length of the primary and any secondary hospitalization
Measured: within the first 30 days after Caesarean Section
Women: readmissions to hospital/contact to the general practitioner on suspicion of infection after Caesarean Section
Measured: within the first 30 days after Caesarean Section
Women: antibiotic treatment on suspicion of infection after Caesarean Section
Measured: within the first 30 days after Caesarean Section
Infant: use of antifungal treatment against oral thrush
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 days
Infant: necrotizing enterocolitis
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 days
Infant: antibiotic treatment during hospital stay
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 days
Infant: the need for intensive care treatment and length of stay in hospital
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 days
Infant: Neonatal sepsis
Neonatal sepsis, Neonatal sepsis workup
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 days
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)
Measured: participants will be followed for the duration of hospital stay, an expected average of 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startOct 2014
- Primary completionOct 2015 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative InfectionStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Region of Southern Denmark, University of Southern Denmark, Hvidovre University Hospital, Esbjerg Hospital - University Hospital of Southern Denmark
- Responsible party
- Principal investigator, Nana Hyldig, Odense University Hospital
- Investigators
- Jan Stener Joergensen, MD, PhD, Study chair, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02009098
- Sponsor's protocol ID
- 2012-002068-29
- Other IDs
- 2012-002068-29
- Acronym
- APIPICS
- Status last verified
- Oct 2014
- First submitted
- 5 May 2013
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Prophylaxis and Intervention for Postpartum Infections Following Caesarean Section
- ClinicalTrials.gov ID
- NCT02009098
- Acronym / sponsor ID
- APIPICS / 2012-002068-29
- Conditions
- Postoperative Infection
- Keywords
- Randomized Controlled Trial, Caesarean Section, preoperative, intraoperative, prophylactic antibiotics, antibiotics, timing, surgical site infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Region of Southern Denmark, University of Southern Denmark, Hvidovre University Hospital, Esbjerg Hospital - University Hospital of Southern Denmark
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| præoperativ antibiotic | Active comparator | Drug: Cefuroximeiv Cefuroxime 1,5g administered 15-60 minutes before incision |
| postoperativ antibiotic | Active comparator | Drug: Cefuroximeiv Cefuroxime 1,5g administered after umbilical cord clamping |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CefuroximeAlso: Cefuroxime "Fresenius Kabi"iv Cefuroxime 1,5g administered 15-60 minutes before incision versus iv Cefuroxime 1,5g administered after umbilical cord clamping | Drug | postoperativ antibiotic, præoperativ antibiotic |
Primary outcome
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.
Infant: admission to special care unit
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 days
9 secondary outcomes
Women: length of the primary and any secondary hospitalization
Time frame: within the first 30 days after Caesarean Section
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
Women: antibiotic treatment on suspicion of infection after Caesarean Section
Time frame: within the first 30 days after Caesarean Section
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
Infant: necrotizing enterocolitis
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 days
Infant: antibiotic treatment during hospital stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 days
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
Infant: Neonatal sepsis
Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 days
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Stener Joergensen, MD, PhD study chair
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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cefuroxime in people with Postoperative Infection, run by Odense University Hospital at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Women: The incidence of post-CS infection (endometritis, urinary tract infections, and wound infections) (time frame: within the first 30 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2015.