A Phase 4 interventional study of CeFAZolin 1000 MG and Clindamycin 900 MG in 6 ML Injection in Obstetric Complication, Postpartum Hemorrhage and Postpartum Endometritis, sponsored by Cedars-Sinai Medical Center. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-07.
Sponsored by Cedars-Sinai Medical Center · Phase 4, Interventional, and Prevention
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.
Exclusion Criteria:
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.
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.
Drug: CeFAZolin 1000 MG · Drug: Clindamycin 900 MG in 6 ML Injection
Cefazolin 1000 mg every 8 hours for 3 doses
Clindamycin 900 mg every 8 hours for 3 doses
Postpartum Endometritis
Number of participants with postpartum endometritis as defined by clinical documentation
Time frame: 6 weeks
Number of Participants With a Fever
Number of participants with a fever \> 38 degrees celsius
Time frame: 6 weeks
Receiving Postpartum Antibiotics
Receiving postpartum antibiotics
Time frame: 6 weeks
Hysterectomy
Hysterectomy
Time frame: 6 weeks
EBL
Estimated blood loss prior to removal and with IBT in
Time frame: 2 weeks
Postpartum Hemoglobin
Postpartum hemoglobin value
Time frame: 2 weeks
Blood Transfusion
Blood transfusions
Time frame: 2 weeks
Maternal ICU Admission
Maternal ICU Admission
Time frame: 6 weeks
Maternal Death
Maternal death
Time frame: 6 weeks
Resource Utilization Measures
Duration of admission to maternal-fetal care unit and total hospital admission length of stay
Time frame: 6 weeks
Hospital Readmission
Hospital readmission
Time frame: 6 weeks
| Milestone | Control | Antibiotics |
|---|---|---|
| Started | 5 | 6 |
| Completed | 5 | 6 |
| Not completed | 0 | 0 |
Number of participants with postpartum endometritis as defined by clinical documentation
| Participants | Control | Antibiotics |
|---|---|---|
| Postpartum Endometritis | 0 | 3 |
Number of participants with a fever \> 38 degrees celsius
| Participants | Control | Antibiotics |
|---|---|---|
| Number of Participants With a Fever | 0 | 3 |
Receiving postpartum antibiotics
| Participants | Control | Antibiotics |
|---|---|---|
| Receiving Postpartum Antibiotics | 0 | 3 |
Hysterectomy
| Participants | Control | Antibiotics |
|---|---|---|
| Hysterectomy | 0 | 0 |
Estimated blood loss prior to removal and with IBT in
| cc | Control | Antibiotics |
|---|---|---|
| Estimated Blood Loss Pre-IBT | 1626 (1400 to 1800) | 1385.83 (965 to 1800) |
| Estimated Blood Loss with IBT in | 165.6 (115 to 295) | 197 (80 to 430) |
Postpartum hemoglobin value
| g/dL | Control | Antibiotics |
|---|---|---|
| Postpartum Hemoglobin | 9.52 (9 to 10.3) | 9.23 (8 to 10.7) |
Blood transfusions
| Participants | Control | Antibiotics |
|---|---|---|
| 0 RBC Transfusions | 3 | 0 |
| 1 RBC Transfusions | 0 | 2 |
| 2 RBC Transfusions | 2 | 2 |
| 3 RBC Transfusions | 0 | 1 |
Maternal ICU Admission
| Participants | Control | Antibiotics |
|---|---|---|
| Maternal ICU Admission | 0 | 0 |
Maternal death
| Participants | Control | Antibiotics |
|---|---|---|
| Maternal Death | 0 | 0 |
Duration of admission to maternal-fetal care unit and total hospital admission length of stay
| hours | Control | Antibiotics |
|---|---|---|
| MFCU Length of Stay | 29.75 (19 to 53) | 30.67 (20 to 40) |
| Total Hospital Length of Stay | 83.75 (71 to 104) | 88.83 (64 to 122) |
Hospital readmission
| Participants | Control | Antibiotics |
|---|---|---|
| Hospital Readmission | 0 | 0 |
Collected over 6 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Antibiotics | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Age, Continuous(years) | Control | Antibiotics | Total |
|---|---|---|---|
| Mean | 36 (30 to 41) | 33.83 (27 to 39) | 34.82 (27 to 41) |
| Sex: Female, Male(Participants) | Control | Antibiotics | Total |
|---|---|---|---|
| Female | 5 | 6 | 11 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Control | Antibiotics | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 4 | 5 | 9 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Control | Antibiotics | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 3 | 3 |
| White | 4 | 3 | 7 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Gravidity(pregnancies) | Control | Antibiotics | Total |
|---|---|---|---|
| Mean | 3 (2 to 4) | 1.67 (0 to 3) | 2.27 (0 to 4) |
| Parity(pregnancies) | Control | Antibiotics | Total |
|---|---|---|---|
| Mean | 1 (0 to 2) | 0.33 (0 to 1) | 0.64 (0 to 2) |
| Preexisting Hypertension(Participants) | Control | Antibiotics | Total |
|---|---|---|---|
| Count of participants | 0 | 1 | 1 |
| Gestational Hypertension or Preeclampsia(Participants) | Control | Antibiotics | Total |
|---|---|---|---|
| Count of participants | 0 | 0 | 0 |
14 further baseline measures are reported on the registry.
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Cedars-Sinai Medical Center