Ignite Creation Date:
2024-05-06 @ 2:35 AM
Last Modification Date:
2024-10-26 @ 11:20 AM
Study NCT ID:
NCT02072798
Status:
COMPLETED
Last Update Posted:
2014-08-12
First Post:
2014-02-25
Brief Title:
Antibiotics and Gut Microbiota Among Newborn Infants
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
Antibiotic Prophylaxis for Postpartum Infections Following Caesarean Section
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2012-002068-29 | EUDRACT_NUMBER | None | None |