Surgical Wound InfectionPhase 4NCT02072798
Antibiotics and Gut Microbiota Among Newborn Infants
A Phase 4 study testing Cefuroxime in people with Surgical Wound Infection and Infection; Cesarean Section, run by Odense University Hospital at 1 site 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
- Surgical Wound Infection, Infection; Cesarean Section, Complications; Cesarean Section
- 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
- 42 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2014to Aug 2014
- 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.
- BMI < 30
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, group B Streptococcus or other indications at the time of caesarean section.
- Women being immunologically incompetent (e.g. HIV positive)
- Very sick newborn infants transferred to a neonatal intensive care unit and treated with antibiotics will be excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antibiotic Prophylaxis 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
At birth, all mammals must rapidly adapt to intake of complex milk nutrients via the gut and simultaneously tolerate the invasion of billions of microbes. This requires rapid maturation of the digestive and immune functions to avoid gut disorders and infections. Full-term, breast-fed infants normally adapt well, but factors such as caesarean birth, high hygiene levels, antibiotics treatment and formula feeding may inhibit immune development both short and long term. Birth by caesarean section in high-hygiene hospital environments, and widespread use of antibiotics, are factors that reduce gut microbiota density and diversity in the newborn for some time after birth. On the other hand, high-hygiene environments and antibiotics are essential tools to combat infections, especially for the weakest newborn infants.
This pilot study will be a feasibility study to the original study, which examines the effect of change in timing of prophylactic antibiotics on the rate of post-CS infections (endometritis, UTI and WI). The pilot study focus on antibiotic and changes in the gut microbiota of newborn infants. The feasibility study will only include pregnant women in Odense with a body mass index below 30, and planned cesarean section.
- Being tested
- Cefuroxime
- Keywords
- Randomized Controlled Trial, Caesarean Section, Surgical Site Infections, Wound Infections, Infectious Morbidity
- Medical subject headings
- Surgical Wound Infection, Infections, Wound Infection
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 |
|---|---|---|
| preoperative antibiotic | Active comparator | iv Cefuroxime 1,5g administered 15-60 minutes before incision Receives: Drug: Cefuroxime |
| postoperative 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.
Maternal: incidence of post-CS infection (endometritis, urinary tract infections and wound infection) in each study group
Measured: Within the first 30 days after surgery
Infant: fecal microbiota at the tenth day of life
Measured: on the tenth day of life
Secondary outcomes (5)
Maternal: Length of hospitalization
Measured: Within the first 30 days after Caesarean Section
Maternal: readmissions to hospital on suspicion of postpartum infection following cesarean section
Measured: Within the first 30 days after Caesarean Section
Antibiotic treatment
Measured: within the first 30 days after Caesarean Section
Infant: concentration of cefuroxime in blood samples
Measured: during the first 24 hours of life
Infant: immunological analyses in blood samples on day 3
Measured: On the third day of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Wound 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
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Aase and Ejnar Danielsens Foundation, Region of Southern Denmark, University of Southern Denmark
- Responsible party
- Principal investigator, Nana Hyldig, Odense University Hospital
- Investigators
- Nana Hyldig, PhD student, Study chair, Odense University Hospital, department of Plastic Surgery, 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
- NCT02072798
- Sponsor's protocol ID
- s-20130117
- Other IDs
- 2012-002068-29
- Status last verified
- Feb 2014
- First submitted
- 25 Feb 2014
- Last updated
- 12 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kamal SS, Hyldig N, Krych L, Greisen G, Krogfelt KA, Zachariassen G, Nielsen DS. Impact of Early Exposure to Cefuroxime on the Composition of the Gut Microbiota in Infants Following Cesarean Delivery. J Pediatr. 2019 Jul;210:99-105.e2. doi: 10.1016/j.jpeds.2019.03.001. Epub 2019 Apr 30.
PubMed 31053348
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Prophylaxis for Postpartum Infections Following Caesarean Section
- ClinicalTrials.gov ID
- NCT02072798
- Acronym / sponsor ID
- s-20130117
- Keywords
- Randomized Controlled Trial, Caesarean Section, Surgical Site Infections, Wound Infections, Infectious Morbidity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen, Aase and Ejnar Danielsens Foundation, Region of Southern Denmark, University of Southern Denmark
- Study start
- Feb 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 27 Feb 2014 (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.
At birth, all mammals must rapidly adapt to intake of complex milk nutrients via the gut and simultaneously tolerate the invasion of billions of microbes. This requires rapid maturation of the digestive and immune functions to avoid gut disorders and infections. Full-term, breast-fed infants normally adapt well, but factors such as caesarean birth, high hygiene levels, antibiotics treatment and formula feeding may inhibit immune development both short and long term. Birth by caesarean section in high-hygiene hospital environments, and widespread use of antibiotics, are factors that reduce gut microbiota density and diversity in the newborn for some time after birth. On the other hand, high-hygiene environments and antibiotics are essential tools to combat infections, especially for the weakest newborn infants.
This pilot study will be a feasibility study to the original study, which examines the effect of change in timing of prophylactic antibiotics on the rate of post-CS infections (endometritis, UTI and WI). The pilot study focus on antibiotic and changes in the gut microbiota of newborn infants. The feasibility study will only include pregnant women in Odense with a body mass index below 30, and planned cesarean section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preoperative antibiotic | Active comparator | Drug: Cefuroximeiv Cefuroxime 1,5g administered 15-60 minutes before incision |
| postoperative 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 (5 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.
- BMI < 30
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, group B Streptococcus or other indications at the time of caesarean section.
- Women being immunologically incompetent (e.g. HIV positive)
- Very sick newborn infants transferred to a neonatal intensive care unit and treated with antibiotics will be excluded from the study
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 | postoperative antibiotic, preoperative antibiotic |
Primary outcome
Maternal: incidence of post-CS infection (endometritis, urinary tract infections and wound infection) in each study group
Time frame: Within the first 30 days after surgery
Infant: fecal microbiota at the tenth day of life
Time frame: on the tenth day of life
5 secondary outcomes
Maternal: Length of hospitalization
Time frame: Within the first 30 days after Caesarean Section
Maternal: readmissions to hospital on suspicion of postpartum infection following cesarean section
Time frame: Within the first 30 days after Caesarean Section
Antibiotic treatment
Time frame: within the first 30 days after Caesarean Section
Infant: concentration of cefuroxime in blood samples
Time frame: during the first 24 hours of life
Infant: immunological analyses in blood samples on day 3
Time frame: On the third day of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2014.
- Derived from this study: PubMed 31053348Kamal SS, Hyldig N, Krych L, Greisen G, Krogfelt KA, Zachariassen G, Nielsen DS. Impact of Early Exposure to Cefuroxime on the Composition of the Gut Microbiota in Infants Following Cesarean Delivery. J Pediatr. 2019 Jul;210:99-105.e2. doi: 10.1016/j.jpeds.2019.03.001. Epub 2019 Apr 30.
- "The NEOMUNE centre" is a research platform aiming to improve clinical care of newborn infants, particular those born with developmental problemsLink provided by the sponsor.
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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.
Nana Hyldig, PhD student study chair
Odense University Hospital, department of Plastic Surgery, University of Southern Denmark, Faculty of Health Sciences, institute of Clinical Research, research unit, department of Gynaecology and Obstetrics
1 site 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 Surgical Wound Infection and Infection; Cesarean Section, run by Odense University Hospital at 1 site 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 5 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: finished, as of the sponsor's last update on 12 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maternal: incidence of post-CS infection (endometritis, urinary tract infections and wound infection) in each study group (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?
On the ClinicalTrials.gov record for NCT02072798, which also lists 1 linked publication.
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 12 Aug 2014.