Cesarean SectionPhase 4NCT00133029
The Timing of Prophylactic Antibiotics in Cesarean Section and the Risk of Post-operative Febrile Morbidity
A Phase 4 study testing Timing of prophylactic antibiotic administration in people with Cesarean Section, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the timing of prophylactic antibiotic administration for cesarean section (immediate preoperative versus intraoperative administration) impacts the rate of postoperative febrile morbidity. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Timing of prophylactic antibiotic administration
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Jul 2006
- 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 Any age
- Women only
- Child, Adult, Older adult
Who may be able to join
- Gestational age > 36 weeks
- Ability to understand requirements of the study
- Elective/non-emergent cesarean section selected as route of delivery by treating physicians
Who cannot join
- Known fetal anomaly
- Exposure to antibiotics within 7 days of admission, including intrapartum group B streptococcal (GBS) prophylaxis
- Emergent cesarean delivery (i.e. for fetal distress, maternal distress, obstetric hemorrhage)
- Overt maternal intrapartum infection requiring antibiotics
- Prolonged rupture of membranes (>18 hours)
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
The purpose of this study is to determine whether the timing of prophylactic antibiotic administration for cesarean section (immediate preoperative versus intraoperative administration) impacts the rate of postoperative febrile morbidity. The specific aim of the project is to test the hypothesis that preoperative antibiotic administration will decrease the rate of composite postoperative febrile morbidity.
- Conditions
- Cesarean Section
- Being tested
- Timing of prophylactic antibiotic administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timing of prophylactic antibiotic administrationDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2005 (estimated)
- Study startJul 2004
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Investigators
- George A. Macones, MD, MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00133029
- Sponsor's protocol ID
- 705719
- Status last verified
- Aug 2016
- First submitted
- 19 Aug 2005
- Last updated
- 15 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Timing of Prophylactic Antibiotics in Cesarean Section and the Risk of Post-operative Febrile Morbidity
- ClinicalTrials.gov ID
- NCT00133029
- Acronym / sponsor ID
- 705719
- Conditions
- Cesarean Section
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jul 2004
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 22 Aug 2005 (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.
The purpose of this study is to determine whether the timing of prophylactic antibiotic administration for cesarean section (immediate preoperative versus intraoperative administration) impacts the rate of postoperative febrile morbidity. The specific aim of the project is to test the hypothesis that preoperative antibiotic administration will decrease the rate of composite postoperative febrile morbidity.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Gestational age > 36 weeks
- Ability to understand requirements of the study
- Elective/non-emergent cesarean section selected as route of delivery by treating physicians
Key exclusion criteria (5 listed)
- Known fetal anomaly
- Exposure to antibiotics within 7 days of admission, including intrapartum group B streptococcal (GBS) prophylaxis
- Emergent cesarean delivery (i.e. for fetal distress, maternal distress, obstetric hemorrhage)
- Overt maternal intrapartum infection requiring antibiotics
- Prolonged rupture of membranes (>18 hours)
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 |
|---|---|---|
| Timing of prophylactic antibiotic administration | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2016.
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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.
George A. Macones, MD, MSCE principal investigator
University of Pennsylvania
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 Timing of prophylactic antibiotic administration in people with Cesarean Section, run by University of Pennsylvania at 1 site in United States.
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 3 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: stopped early, as of the sponsor's last update on 15 Aug 2016. 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 United States. 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 was stopped early. Results are not available in the source record.
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.
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 15 Aug 2016.