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Antibiotics and Gut Microbiota Among Newborn Infants

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ClinicalTrials.gov Identifier: NCT02072798
Recruitment Status : Completed
First Posted : February 27, 2014
Last Update Posted : August 12, 2014
Sponsor:
Collaborators:
University of Copenhagen
Aase and Ejnar Danielsens Foundation
Region of Southern Denmark
University of Southern Denmark
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.

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.


Condition or disease Intervention/treatment Phase
Surgical Wound Infection Infection; Cesarean Section Complications; Cesarean Section Drug: Cefuroxime Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antibiotic Prophylaxis for Postpartum Infections Following Caesarean Section
Study Start Date : February 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: preoperative 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: postoperative 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. 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 ]
  2. Infant: fecal microbiota at the tenth day of life [ Time Frame: on the tenth day of life ]

Secondary Outcome Measures :
  1. Maternal: Length of hospitalization [ Time Frame: Within the first 30 days after Caesarean Section ]
  2. Maternal: readmissions to hospital on suspicion of postpartum infection following cesarean section [ Time Frame: Within the first 30 days after Caesarean Section ]
  3. Antibiotic treatment [ Time Frame: within the first 30 days after Caesarean Section ]
  4. Infant: concentration of cefuroxime in blood samples [ Time Frame: during the first 24 hours of life ]
  5. Infant: immunological analyses in blood samples on day 3 [ Time Frame: On the third day of life ]


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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

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.
  • BMI < 30

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, 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

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): NCT02072798


Locations
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Denmark
Odense University Hospital
Odense, Fyn, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
University of Copenhagen
Aase and Ejnar Danielsens Foundation
Region of Southern Denmark
University of Southern Denmark
Investigators
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Study Chair: Nana Hyldig, PhD student 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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nana Hyldig, PhD Student, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02072798     History of Changes
Other Study ID Numbers: s-20130117
2012-002068-29 ( EudraCT Number )
First Posted: February 27, 2014    Key Record Dates
Last Update Posted: August 12, 2014
Last Verified: February 2014
Keywords provided by Nana Hyldig, Odense University Hospital:
Randomized Controlled Trial
Caesarean Section
Surgical Site Infections
Wound Infections
Infectious Morbidity
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Wound Infection
Surgical Wound Infection
Surgical Wound
Wounds and Injuries
Postoperative Complications
Pathologic Processes
Anti-Bacterial Agents
Cefuroxime
Cefuroxime axetil
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents