Antibiotics and Gut Microbiota Among Newborn Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Surgical Wound Infection Infection; Cesarean Section Complications; Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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preoperative antibiotic

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

Group Type ACTIVE_COMPARATOR

Cefuroxime

Intervention Type DRUG

iv Cefuroxime 1,5g administered 15-60 minutes before incision versus iv Cefuroxime 1,5g administered after umbilical cord clamping

postoperative antibiotic

iv Cefuroxime 1,5g administered after umbilical cord clamping

Group Type ACTIVE_COMPARATOR

Cefuroxime

Intervention Type DRUG

iv Cefuroxime 1,5g administered 15-60 minutes before incision versus iv Cefuroxime 1,5g administered after umbilical cord clamping

Interventions

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Cefuroxime

iv Cefuroxime 1,5g administered 15-60 minutes before incision versus iv Cefuroxime 1,5g administered after umbilical cord clamping

Intervention Type DRUG

Other Intervention Names

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Cefuroxime "Fresenius Kabi"

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Nana Hyldig

PhD Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nana Hyldig, PhD student

Role: 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