Obstetric ComplicationPhase 4NCT03478163
Antibiotics During Intrauterine Balloon Tamponade Placement
A Phase 4 study testing CeFAZolin 1000 MG and Clindamycin 900 MG in 6 ML Injection in people with Obstetric Complication and Postpartum Hemorrhage, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The goal of this study is to identify whether antibiotics given at the time of placement of an intrauterine balloon tamponade (IBT) will result in reduction of the risk of endometritis. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obstetric Complication, Postpartum Hemorrhage, Postpartum Endometritis
- What is being tested?
- CeFAZolin 1000 MG and Clindamycin 900 MG in 6 ML Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2018to 3 May 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Able to give consent
- Gestational age > 24 weeks
- Postpartum
- Placement of an IBT within the last 2 hours with plans for it to remain in situ for at least 2 hours
- Primary obstetrician amenable to proceeding with either method of management during the study period.
Who cannot join
- Age < 18 years old
- IBT removed within 2 hours of placement
- Chorioamnionitis
- Insufficient documentation of demographics, delivery outcomes, or peripartum events including postpartum hemorrhage, infectious outcomes
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
The goal of this study is to identify whether antibiotics given at the time of placement of an intrauterine balloon tamponade (IBT) will result in reduction of the risk of endometritis. The investigators hypothesize that antibiotics given at the time of intrauterine balloon tamponade will reduce the likelihood of postpartum endometritis.
Read the detailed description
The investigators will perform a randomized, controlled trial of women who have had a postpartum hemorrhage and received an intrauterine balloon tamponade.
Patients who are candidates for study enrollment will be identified on Labor \& Delivery or in the Maternal-Fetal Care Unit. Patients who give consent will be randomized by random number generator to receive either antibiotics (Group A) or no antibiotics (Group B).
If the patient is randomized to Group A, she will receive a 24-hour course of antibiotics. The primary antibiotic of choice will be cefazolin 1 gm iv q8 hours. If the patient has contraindications to the use of cefazolin including cefazolin allergy, hypersensitivity, or severe beta lactam allergy, then clindamycin 900 mg iv q8 hours will be used instead.
If the patient is randomized to Group B, she will not receive antibiotics as part of the study, though if at any time her provider chooses to administer antibiotics either prophylactically or for treatment she will not prohibited in any way from this or any other treatment as appropriate.
- Being tested
- CeFAZolin 1000 MG, Clindamycin 900 MG in 6 ML Injection
- Keywords
- Bakri, Intrauterine balloon tamponade, Antibiotics
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeFAZolin 1000 MGDrug
Cefazolin 1000 mg every 8 hours for 3 doses
Clindamycin 900 MG in 6 ML InjectionDrug
Clindamycin 900 mg every 8 hours for 3 doses
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The patient will not receive antibiotics as part of the study, though if at any time her provider chooses to administer antibiotics either prophylactically or for treatment she will not prohibited in any way from this or any other treatment as appropriate. |
| Antibiotics | Experimental | The patient will receive a 24-hour course of antibiotics. The primary antibiotic of choice will be cefazolin 1 gm iv q8 hours. If the patient has contraindications to the use of cefazolin including cefazolin allergy, hypersensitivity, or severe beta lactam allergy, then clindamycin 900 mg iv q8 hours will be used instead. Receives: Drug: CeFAZolin 1000 MG; Drug: Clindamycin 900 MG in 6 ML Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum Endometritis
Number of participants with postpartum endometritis as defined by clinical documentation
Measured: 6 weeks
Secondary outcomes (10)
Number of Participants With a Fever
Number of participants with a fever > 38 degrees celsius
Measured: 6 weeks
Receiving Postpartum Antibiotics
Receiving postpartum antibiotics
Measured: 6 weeks
Hysterectomy
Hysterectomy
Measured: 6 weeks
EBL
Estimated blood loss prior to removal and with IBT in
Measured: 2 weeks
Postpartum Hemoglobin
Postpartum hemoglobin value
Measured: 2 weeks
Blood Transfusion
Blood transfusions
Measured: 2 weeks
Maternal ICU Admission
Maternal ICU Admission
Measured: 6 weeks
Maternal Death
Maternal death
Measured: 6 weeks
Resource Utilization Measures
Duration of admission to maternal-fetal care unit and total hospital admission length of stay
Measured: 6 weeks
Hospital Readmission
Hospital readmission
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start8 Mar 2018
- Primary completion3 May 2021
- Study completion3 May 2021
Why it stopped: Problems with recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obstetric ComplicationStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label, randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimberly Gregory, Cedars-Sinai Medical Center
- Investigators
- Kimberly Gregory, MD MPH, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478163
- Sponsor's protocol ID
- Pro00051005
- Status last verified
- Sep 2021
- First submitted
- 12 Mar 2018
- Last updated
- 7 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotics During Intrauterine Balloon Tamponade Placement
- ClinicalTrials.gov ID
- NCT03478163
- Acronym / sponsor ID
- Pro00051005
- Keywords
- Bakri, Intrauterine balloon tamponade, Antibiotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Problems with recruitment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 8 Mar 2018 (actual)
- Primary completion
- 3 May 2021 (actual)
- Study completion
- 3 May 2021 (actual)
- First posted
- 27 Mar 2018 (actual)
- Results
- Posted 7 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to identify whether antibiotics given at the time of placement of an intrauterine balloon tamponade (IBT) will result in reduction of the risk of endometritis. The investigators hypothesize that antibiotics given at the time of intrauterine balloon tamponade will reduce the likelihood of postpartum endometritis.
Detailed description
The investigators will perform a randomized, controlled trial of women who have had a postpartum hemorrhage and received an intrauterine balloon tamponade.
Patients who are candidates for study enrollment will be identified on Labor \& Delivery or in the Maternal-Fetal Care Unit. Patients who give consent will be randomized by random number generator to receive either antibiotics (Group A) or no antibiotics (Group B).
If the patient is randomized to Group A, she will receive a 24-hour course of antibiotics. The primary antibiotic of choice will be cefazolin 1 gm iv q8 hours. If the patient has contraindications to the use of cefazolin including cefazolin allergy, hypersensitivity, or severe beta lactam allergy, then clindamycin 900 mg iv q8 hours will be used instead.
If the patient is randomized to Group B, she will not receive antibiotics as part of the study, though if at any time her provider chooses to administer antibiotics either prophylactically or for treatment she will not prohibited in any way from this or any other treatment as appropriate.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The patient will not receive antibiotics as part of the study, though if at any time her provider chooses to administer antibiotics either prophylactically or for treatment she will not prohibited in any way from this or any other treatment as appropriate. |
| Antibiotics | Experimental | Drug: CeFAZolin 1000 MG, Drug: Clindamycin 900 MG in 6 ML InjectionThe patient will receive a 24-hour course of antibiotics. The primary antibiotic of choice will be cefazolin 1 gm iv q8 hours. If the patient has contraindications to the use of cefazolin including cefazolin allergy, hypersensitivity, or severe beta lactam allergy, then clindamycin 900 mg iv q8 hours will be used instead. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female
- Able to give consent
- Gestational age > 24 weeks
- Postpartum
- Placement of an IBT within the last 2 hours with plans for it to remain in situ for at least 2 hours
Key exclusion criteria (4 listed)
- Age < 18 years old
- IBT removed within 2 hours of placement
- Chorioamnionitis
- Insufficient documentation of demographics, delivery outcomes, or peripartum events including postpartum hemorrhage, infectious outcomes
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 |
|---|---|---|
| CeFAZolin 1000 MGCefazolin 1000 mg every 8 hours for 3 doses | Drug | Antibiotics |
| Clindamycin 900 MG in 6 ML InjectionClindamycin 900 mg every 8 hours for 3 doses | Drug | Antibiotics |
Primary outcome
Postpartum Endometritis
Time frame: 6 weeks
Number of participants with postpartum endometritis as defined by clinical documentation
10 secondary outcomes
Number of Participants With a Fever
Time frame: 6 weeks
Receiving Postpartum Antibiotics
Time frame: 6 weeks
Hysterectomy
Time frame: 6 weeks
EBL
Time frame: 2 weeks
Postpartum Hemoglobin
Time frame: 2 weeks
Blood Transfusion
Time frame: 2 weeks
Maternal ICU Admission
Time frame: 6 weeks
Maternal Death
Time frame: 6 weeks
Resource Utilization Measures
Time frame: 6 weeks
Hospital Readmission
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Kimberly Gregory, MD MPH principal investigator
Cedars-Sinai Medical Center
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 CeFAZolin 1000 MG and Clindamycin 900 MG in 6 ML Injection in people with Obstetric Complication and Postpartum Hemorrhage, run by Cedars-Sinai Medical Center 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 6 inclusion and 4 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 7 Oct 2021. 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?
Yes. Results are posted in the registry (first posted 7 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Postpartum Endometritis (time frame: 6 weeks). 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 7 Oct 2021.