Microbial ColonizationCSBabyBiomeNCT06030713
Timing of Maternal Antibiotic Prophylaxis During a Cesarean Section and the Early Infant Gut Microbiome
A study testing Cefazolin in people with Microbial Colonization and Antibiotic Side Effect, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
In this study, investigators seek to determine whether the timing of antibiotics given to mothers during an elective C-section affects the composition of their infant's gut microbiome. To do this, a randomized controlled trial (RCT) was carried out with women undergoing elective C-sections. Read more about this study
- Who is it for?
- Ages Up to 1 yearHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization, Antibiotic Side Effect, Cesarean Section Complications
- What is being tested?
- Cefazolin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2019to 1 Mar 2023
- Phase
- Interventional
- 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 Up to 1 year
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Females undergoing elective CS at the UMCG
- Gestational age in weeks equal to or above 38 weeks
Who cannot join
- Cephalosporin allergy
- Exposure to antibiotic agent 2 weeks before CS
- Temperature >37.5 C before CS
- Pre-labour rupture of membranes
- Emergency CS
- No -20 freezer at home
- No command of the Dutch language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Timing of Umbilical Cord Clamping During an Elective Caesarean Delivery and Its Association With Neonatal Gut Microbiome.
In this study, investigators seek to determine whether the timing of antibiotics given to mothers during an elective C-section affects the composition of their infant's gut microbiome. To do this, a randomized controlled trial (RCT) was carried out with women undergoing elective C-sections. These women were either given antibiotics before the skin incision (AB+) or after the umbilical cord was clamped (AB-).
Read the detailed description
Rationale: During a caesarean delivery, umbilical cord clamping can occur before or after administering a perioperative prophylactic antibiotic to the mother. If the cord is clamped before the antibiotic administration, this antibiotic cannot reach the infant. Conversely, if the cord is clamped after the antibiotic administration, these maternal antibiotics cross the placenta and enter the infant's circulation. In this study, investigators hypothesize that such antibiotics modify the composition and functionality of the neonatal gut microbiome. A changed neonatal microbiome associates with the onset of asthma, allergies, type 1 diabetes, and obesity later in life. Such a small intervention could influence the future health of the infant significantly.
Objective: The primary aim of this study is to contrast the composition and functionality of the neonatal gut microbiome from mothers given antibiotic prophylaxis before skin incision with the microbiome of neonates from mothers given the antibiotic after umbilical cord clamping during an elective caesarean delivery.
Study design: Randomized controlled trial
Study population: Pregnant women at >38 weeks of gestation undergoing elective caesarean section at the UMCG will be randomized into two groups. The gut microbiome of the neonates from both groups will be analyzed.
Intervention: The timing of umbilical cord clamping differs between the two groups. One gram of Cefazolin (once, intravenous) will be administered to one group before skin incision, while 1g cefazolin will be given to another group after umbilical cord clamping during an elective caesarean section.
Main study parameters/endpoints: The primary endpoint of this study is the variance in the composition and functionality of the neonatal gut microbiome over a year, contrasting neonates from mothers given antibiotic prophylaxis before skin incision with neonates from mothers given the antibiotic after umbilical cord clamping.
- Being tested
- Cefazolin
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefazolinDrug
Also called DB01327, J01DB04
Cord clamping before or after antibiotic (cefazolin) prophylaxis
| Study group | Role | What they receive |
|---|---|---|
| Cord clamped after antibiotic prophylaxis | Active comparator | Umbilical cord clamped after 1g of cephazolin Receives: Drug: Cefazolin |
| Cord clamped before antibiotic prophylaxis | Experimental | Umbilical cord clamped before 1g of cephazolin Receives: Drug: Cefazolin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant microbial species level differences between two groups
Centered log ratio transformed relative abundance differences of bacterial species (relative abundance of > 0.05% and present in at least 2 infants) between two interventional groups
Measured: First 6 weeks of life
Infant Alpha Diversity differences between two groups
Alpha Diversity difference measured by the Shannon Diversity Index of infant microbiome at species level between two interventional groups
Measured: First 6 weeks of life
Infant Beta Diversity differences between two groups
Beta Diversity difference in Aitchison distances between the two intervention groups
Measured: First 6 weeks of life
Infant Antibiotic Resistance total gene load differences between two groups
Infant Antibiotic Resistance total gene load differenced measured in RPKM between the two interventional groups
Measured: First 6 weeks of life
Secondary outcomes (1)
Number of participants with post c-section maternal wound infection
Number of participants with early and late post C-section wound infection in mothers
Measured: First 6 weeks of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start1 Mar 2019
- Primary completion1 Oct 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Timing of umbilical cord clamping is different in the two arms. One gram of Cefazolin (once, intravenous) will be given to one group of women before skin incision compared to 1g cefazolin given to another group of women after umbilical cord clamping during an elective caesarean section.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Trishla Sinha, MD, Principal investigator, University Medical Center GroningenAlexandra Zhernakova, MD/PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030713
- Sponsor's protocol ID
- CS_Baby_Biome_2017/240
- Other IDs
- NL61493.042.17, METc 2017.240
- Acronym
- CSBabyBiome
- Status last verified
- Sep 2023
- First submitted
- 25 Aug 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The sequencing data of the microbiome will be available for other researchers via EGA
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Umbilical Cord Clamping During an Elective Caesarean Delivery and Its Association With Neonatal Gut Microbiome.
- ClinicalTrials.gov ID
- NCT06030713
- Acronym / sponsor ID
- CSBabyBiome / CS_Baby_Biome_2017/240
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 11 Sep 2023 (actual)
- 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.
In this study, investigators seek to determine whether the timing of antibiotics given to mothers during an elective C-section affects the composition of their infant's gut microbiome. To do this, a randomized controlled trial (RCT) was carried out with women undergoing elective C-sections. These women were either given antibiotics before the skin incision (AB+) or after the umbilical cord was clamped (AB-).
Detailed description
Rationale: During a caesarean delivery, umbilical cord clamping can occur before or after administering a perioperative prophylactic antibiotic to the mother. If the cord is clamped before the antibiotic administration, this antibiotic cannot reach the infant. Conversely, if the cord is clamped after the antibiotic administration, these maternal antibiotics cross the placenta and enter the infant's circulation. In this study, investigators hypothesize that such antibiotics modify the composition and functionality of the neonatal gut microbiome. A changed neonatal microbiome associates with the onset of asthma, allergies, type 1 diabetes, and obesity later in life. Such a small intervention could influence the future health of the infant significantly.
Objective: The primary aim of this study is to contrast the composition and functionality of the neonatal gut microbiome from mothers given antibiotic prophylaxis before skin incision with the microbiome of neonates from mothers given the antibiotic after umbilical cord clamping during an elective caesarean delivery.
Study design: Randomized controlled trial
Study population: Pregnant women at >38 weeks of gestation undergoing elective caesarean section at the UMCG will be randomized into two groups. The gut microbiome of the neonates from both groups will be analyzed.
Intervention: The timing of umbilical cord clamping differs between the two groups. One gram of Cefazolin (once, intravenous) will be administered to one group before skin incision, while 1g cefazolin will be given to another group after umbilical cord clamping during an elective caesarean section.
Main study parameters/endpoints: The primary endpoint of this study is the variance in the composition and functionality of the neonatal gut microbiome over a year, contrasting neonates from mothers given antibiotic prophylaxis before skin incision with neonates from mothers given the antibiotic after umbilical cord clamping.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Timing of umbilical cord clamping is different in the two arms. One gram of Cefazolin (once, intravenous) will be given to one group of women before skin incision compared to 1g cefazolin given to another group of women after umbilical cord clamping during an elective caesarean section.
| Arm | Type | Receives |
|---|---|---|
| Cord clamped after antibiotic prophylaxis | Active comparator | Drug: CefazolinUmbilical cord clamped after 1g of cephazolin |
| Cord clamped before antibiotic prophylaxis | Experimental | Drug: CefazolinUmbilical cord clamped before 1g of cephazolin |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Females undergoing elective CS at the UMCG
- Gestational age in weeks equal to or above 38 weeks
Key exclusion criteria (7 listed)
- Cephalosporin allergy
- Exposure to antibiotic agent 2 weeks before CS
- Temperature >37.5 C before CS
- Pre-labour rupture of membranes
- Emergency CS
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 |
|---|---|---|
| CefazolinAlso: DB01327, J01DB04Cord clamping before or after antibiotic (cefazolin) prophylaxis | Drug | Cord clamped after antibiotic prophylaxis, Cord clamped before antibiotic prophylaxis |
Primary outcome
Infant microbial species level differences between two groups
Time frame: First 6 weeks of life
Centered log ratio transformed relative abundance differences of bacterial species (relative abundance of > 0.05% and present in at least 2 infants) between two interventional groups
Infant Alpha Diversity differences between two groups
Time frame: First 6 weeks of life
Alpha Diversity difference measured by the Shannon Diversity Index of infant microbiome at species level between two interventional groups
Infant Beta Diversity differences between two groups
Time frame: First 6 weeks of life
Beta Diversity difference in Aitchison distances between the two intervention groups
Infant Antibiotic Resistance total gene load differences between two groups
Time frame: First 6 weeks of life
Infant Antibiotic Resistance total gene load differenced measured in RPKM between the two interventional groups
1 secondary outcome
Number of participants with post c-section maternal wound infection
Time frame: First 6 weeks 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 13 Sep 2023.
- Individual participant dataSharing planned: Yes. The sequencing data of the microbiome will be available for other researchers via EGA
Related trials for Microbial Colonization
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
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.
Trishla Sinha, MD principal investigator
University Medical Center Groningen
Alexandra Zhernakova, MD/PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cefazolin in people with Microbial Colonization and Antibiotic Side Effect, run by University Medical Center Groningen at 1 site in Netherlands.
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 2 inclusion and 7 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 13 Sep 2023. 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 Netherlands. 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.
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?
Infant microbial species level differences between two groups (time frame: First 6 weeks of life). The study lists 4 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 13 Sep 2023.