Antibiotics , Elective Cesarean, ChinaNCT02126228
no Antibiotics for Elective Cesarean With Low Risk of Infection
An observational study of Antibiotics , Elective Cesarean, China, run by Fanzhen Hong at 1 site in China.
Trial summary
The purpose of this study is to discuss whether the parturients who underwent elective cesarean of such kind do not need prophylactic use of antibiotics and evaluate the risks and economic benefits involved. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Antibiotics , Elective Cesarean, China
- How many people
- 212 participants
- Where
- 1 siteChina
- Study dates
- Nov 2012to Dec 2013
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: antibiotics group:202 none antibiotics group:212
Who may be able to join
- Elective cesarean
- With normal temperature;
- No signs of infection;
- Normal degree of cleanliness in vaginal; .Normal amniotic fluid.
Who cannot join
- Failure of vaginal delivery and emergency cesarean;
- Premature rupture of membranes;
- Antibiotics having been applied to 3 days before cesarean;
- Having inflammation before cesarean: such as vaginitis, pelvic inflammatory disease, chorioamnionitis;
- Having infections in respiratory or urinary system before cesarean;
- Placenta previa or placental abruption;
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- With medical and surgical complications;
- BMI ≥ 30kg/m2;
- Total blood loss more than 1000ml within 2 hours after cesarean
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial on Antibiotics Application For Low Infection-risked Elective Cesarean
The purpose of this study is to discuss whether the parturients who underwent elective cesarean of such kind do not need prophylactic use of antibiotics and evaluate the risks and economic benefits involved.
- Conditions
- Antibiotics , Elective Cesarean, China
- Keywords
- antibiotics, cesarean
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature
Measured: 3days
Secondary outcomes (1)
Postpartum hemorrhage volume estimates and Routine blood test.
Measured: 3days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startNov 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antibiotics , Elective Cesarean, ChinaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 212 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Fanzhen Hong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fanzhen Hong, Shandong University
- Investigators
- YONGPING XU, MD.PhD, Study director, Obstetrics of 2nd Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126228
- Sponsor's protocol ID
- 2ndhsdu-ob
- Status last verified
- Apr 2014
- First submitted
- 23 Apr 2014
- Last updated
- 29 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Committee opinion no. 465: antimicrobial prophylaxis for cesarean delivery: timing of administration. Obstet Gynecol. 2010 Sep;116(3):791-792. doi: 10.1097/AOG.0b013e3181f68086.
PubMed 20733474
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on Antibiotics Application For Low Infection-risked Elective Cesarean
- ClinicalTrials.gov ID
- NCT02126228
- Acronym / sponsor ID
- 2ndhsdu-ob
- Conditions
- Antibiotics , Elective Cesarean, China
- Keywords
- antibiotics, cesarean
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Fanzhen HongUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Apr 2014 (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 discuss whether the parturients who underwent elective cesarean of such kind do not need prophylactic use of antibiotics and evaluate the risks and economic benefits involved.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- antibiotics group:202 none antibiotics group:212
Key inclusion criteria (4 listed)
- Elective cesarean
- With normal temperature;
- No signs of infection;
- Normal degree of cleanliness in vaginal; .Normal amniotic fluid.
Key exclusion criteria (9 listed)
- Failure of vaginal delivery and emergency cesarean;
- Premature rupture of membranes;
- Antibiotics having been applied to 3 days before cesarean;
- Having inflammation before cesarean: such as vaginitis, pelvic inflammatory disease, chorioamnionitis;
- Having infections in respiratory or urinary system before cesarean;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Temperature
Time frame: 3days
1 secondary outcome
Postpartum hemorrhage volume estimates and Routine blood test.
Time frame: 3days
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 29 Apr 2014.
- Background: PubMed 20733474Committee opinion no. 465: antimicrobial prophylaxis for cesarean delivery: timing of administration. Obstet Gynecol. 2010 Sep;116(3):791-792. doi: 10.1097/AOG.0b013e3181f68086.
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.
YONGPING XU, MD.PhD study director
Obstetrics of 2nd Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antibiotics , Elective Cesarean, China, run by Fanzhen Hong at 1 site in China.
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 4 inclusion and 9 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 29 Apr 2014. 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 China. 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?
Temperature (time frame: 3days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02126228, which also lists 1 linked publication.
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 29 Apr 2014.