Not provided
Not provided
Not provided
Not provided
Not provided
Problems with recruitment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CeFAZolin 1000 MG | Drug | Cefazolin 1000 mg every 8 hours for 3 doses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Postpartum Endometritis | Number of participants with postpartum endometritis as defined by clinical documentation | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Fever | Number of participants with a fever > 38 degrees celsius | 6 weeks |
| Receiving Postpartum Antibiotics | Receiving postpartum antibiotics |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patient must be postpartum
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kimberly Gregory, MD MPH | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Control | 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. |
| FG001 | Antibiotics | 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. CeFAZolin 1000 MG: Cefazolin 1000 mg every 8 hours for 3 doses Clindamycin 900 MG in 6 ML Injection: Clindamycin 900 mg every 8 hours for 3 doses |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control | 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. |
| BG001 | Antibiotics |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postpartum Endometritis | Number of participants with postpartum endometritis as defined by clinical documentation | Posted | Count of Participants | Participants | 6 weeks |
|
6 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Wong, MD MHDS | Cedars Sinai | 310-423-0895 | wongmsx@cshs.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 15, 2018 | Aug 16, 2021 | Prot_SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002437 | Cefazolin |
| D002981 | Clindamycin |
| D007267 | Injections |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
Not provided
Not provided
Open label, randomized controlled trial
Not provided
Not provided
Not provided
Not provided
| Clindamycin 900 MG in 6 ML Injection |
| Drug |
Clindamycin 900 mg every 8 hours for 3 doses |
|
| 6 weeks |
| Hysterectomy | Hysterectomy | 6 weeks |
| EBL | Estimated blood loss prior to removal and with IBT in | 2 weeks |
| Postpartum Hemoglobin | Postpartum hemoglobin value | 2 weeks |
| Blood Transfusion | Blood transfusions | 2 weeks |
| Maternal ICU Admission | Maternal ICU Admission | 6 weeks |
| Maternal Death | Maternal death | 6 weeks |
| Resource Utilization Measures | Duration of admission to maternal-fetal care unit and total hospital admission length of stay | 6 weeks |
| Hospital Readmission | Hospital readmission | 6 weeks |
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. CeFAZolin 1000 MG: Cefazolin 1000 mg every 8 hours for 3 doses Clindamycin 900 MG in 6 ML Injection: Clindamycin 900 mg every 8 hours for 3 doses |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Gravidity | Mean | Full Range | pregnancies |
|
| Parity | Mean | Full Range | pregnancies |
|
| Preexisting Hypertension | Count of Participants | Participants |
|
| Gestational Hypertension or Preeclampsia | Count of Participants | Participants |
|
| Asthma | Count of Participants | Participants |
|
| Previous C-section | Count of Participants | Participants |
|
| Insurance | Count of Participants | Participants |
|
| BMI | BMI Information for 1/5 control participants unavailable | Mean | Full Range | kg/m^2 |
|
| Multiple Gestation | Multiple gestation information unavailable for 1/5 control participants | Count of Participants | Participants |
|
| Gestational Age at Delivery | Gestational age information unavailable for 1/5 control participants | Mean | Full Range | weeks |
|
| Birthweight | Birthweight information unavailable for 2/5 control participants and 1/6 antibiotics participants | Mean | Full Range | grams |
|
| Induction | Induction information unavailable for 1/6 antibiotics participants | Count of Participants | Participants |
|
| Labor Augmented by Pitocin | Labor Augmented by Pitocin information unavailable for 1/5 control participants | Count of Participants | Participants |
|
| GBS Status | GBS status unavailable for 1/5 control participants | Count of Participants | Participants |
|
| Mode of Delivery | Count of Participants | Participants |
|
| IBT Volume | Mean | Full Range | cc |
|
| Balloon Deflation: Rapid or Strep | Count of Participants | Participants |
|
| Number of Serial Deflations | Count of Participants | Participants |
|
|
|
| Secondary | Number of Participants With a Fever | Number of participants with a fever > 38 degrees celsius | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| Secondary | Receiving Postpartum Antibiotics | Receiving postpartum antibiotics | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| Secondary | Hysterectomy | Hysterectomy | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| Secondary | EBL | Estimated blood loss prior to removal and with IBT in | Posted | Mean | Full Range | cc | 2 weeks |
|
|
|
| Secondary | Postpartum Hemoglobin | Postpartum hemoglobin value | Posted | Mean | Full Range | g/dL | 2 weeks |
|
|
|
| Secondary | Blood Transfusion | Blood transfusions | Blood transfusion information unavailable for 1/6 antibiotics participants | Posted | Count of Participants | Participants | 2 weeks |
|
|
|
| Secondary | Maternal ICU Admission | Maternal ICU Admission | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| Secondary | Maternal Death | Maternal death | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| Secondary | Resource Utilization Measures | Duration of admission to maternal-fetal care unit and total hospital admission length of stay | Duration of admission to maternal-fetal care unit and total hospital admission information unavailable for 1/5 control participants | Posted | Mean | Full Range | hours | 6 weeks |
|
|
|
| Secondary | Hospital Readmission | Hospital readmission | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Antibiotics | 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. CeFAZolin 1000 MG: Cefazolin 1000 mg every 8 hours for 3 doses Clindamycin 900 MG in 6 ML Injection: Clindamycin 900 mg every 8 hours for 3 doses | 0 | 6 | 0 | 6 | 0 | 6 |
Not provided
Not provided
Not provided
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Private |
|
| 2 RBC Transfusions |
|
| 3 RBC Transfusions |
|