A Phase 4 interventional study of Postpartum Antibiotics and No postpartum antibiotics in The Primary Outcome of This Study Will be the Rate of Endometritis, sponsored by Washington University School of Medicine. Terminated at 2 sites in United States. Open to female participants aged 14 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-19.
Sponsored by Washington University School of Medicine · Phase 4, Interventional, and Treatment
To determine if prophylactic postpartum antibiotics are required post-cesarean delivery for pregnancies with treated chorioamnionitis.
Bacterial infection of the amniotic cavity, termed "chorioamnionitis", is a major cause of perinatal mortality and maternal morbidity. Early administration of broad-spectrum antibiotic therapy in the laboring patient with chorioamnionitis has both neonatal and maternal benefits. Less known is the ideal postpartum antibiotic regimen - or if postpartum antibiotics are even required at all - needed to decrease febrile morbidity. Current practice has seen a wide range of practice styles ranging from no treatment to antibiotic prophylaxis for up to 48 hours after delivery.
If antibiotics are prescribed, there is good evidence to support one additional dose of antibiotics as compared to 24 hour dosing to decrease the rate of endometritis. Less clear is whether antibiotics are required at all for the properly treated patient with chorioamnionitis who requires a cesarean delivery. One study comparing continued antibiotics versus no-treatment failed to show a difference in the rate of postpartum endometritis. The conclusion from this study was that continuation of preoperative clindamycin and gentamicin in the postoperative period did not reduce the risk of endometritis compared to a single preoperative dose however this study was terminated early due to failure to recruit their stated sample size.
Puerperal endometritis rates vary by mode of delivery but it is known that the rate is lower in vaginal deliveries as compared to cesarean delivery. The patient with chorioamnionitis that requires a cesarean delivery makes an excellent study target. Given the lack of studied protocols, there currently are many acceptable methods for treating the patient with chorioamnionitis. Our proposed study plans to evaluate the two most common methods of treatment to determine the most effective regimen. If post-delivery antibiotics do not show a benefit to these highest risk subjects, it is likely inferred that patients that undergo a vaginal delivery will not require antibiotics as well.
Specific Aims There is conflicting data regarding the necessity of post-delivery antibiotics for patients with chorioamnionitis who undergo cesarean delivery. The primary objective of this study is to determine if postpartum antibiotics are necessary for antepartum treated cases of chorioamnionitis in patients undergoing a cesarean section.
50 studies on the registry are indexed under Endometritis; 11 are open to participants now.
This study's enrollment of 80 is below the median of 300 across 38 interventional studies indexed under Endometritis.
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Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive one additional dose of postpartum antibiotics (Clinda, Gentamicin)
Drug: Postpartum Antibiotics
No further postpartum antibiotics
Drug: No postpartum antibiotics
Patients randomized into this arm will receive one additional dose of gentamicin (1.5 mg/kg) and clindamycin (900mg) in the postpartum setting.
Patients randomized into this arm will not receive any postpartum antibiotics after delivery. They will be managed identically to the other arm in terms of chorioamnionitis (fever pre-delivery). The groups will be managed identically if endometritis (post-partum fever) develops.
Number of Paricipants With Endometritis
Endometritis is defined as uterine infection and is diagnosed by maternal temp \> 38.0C on two occasions over a 4 hour period or any temp \> 39.0C after delivery \> 12 hours after delivery. Endometritis will be managed per currently accepted endometritis protocol - (Amp 2 gQ6, Gentamicin 5 mg/kg q24, Clindamycin 900 mg q8).
Time frame: 7 days post-partum
Number of Participants With Infection-related Complications
Infection related complications will include common complications attributed to infections there are not the primary outcome (endometritis). This will include infections of the wound and pelvic abscesses.
Time frame: 7 days post-partum
Duration of Hospital Stay After Cesarean Delivery
This is the duration of hospital stay (in days) after their cesarean delivery.
Time frame: Up to 7 Days
| Milestone | Postpartum Antibiotics | No Postpartum Antibiotics |
|---|---|---|
| Started | 41 | 39 |
| Completed | 41 | 39 |
| Not completed | 0 | 0 |
Endometritis is defined as uterine infection and is diagnosed by maternal temp \> 38.0C on two occasions over a 4 hour period or any temp \> 39.0C after delivery \> 12 hours after delivery. Endometritis will be managed per currently accepted endometritis protocol - (Amp 2 gQ6, Gentamicin 5 mg/kg q24, Clindamycin 900 mg q8).
| Participants | Postpartum Antibiotics | No Postpartum Antibiotics |
|---|---|---|
| Number of Paricipants With Endometritis | 4 | 3 |
Infection related complications will include common complications attributed to infections there are not the primary outcome (endometritis). This will include infections of the wound and pelvic abscesses.
| Participants | Postpartum Antibiotics | No Postpartum Antibiotics |
|---|---|---|
| Number of Participants With Infection-related Complications | 7 | 2 |
This is the duration of hospital stay (in days) after their cesarean delivery.
| days | Postpartum Antibiotics | No Postpartum Antibiotics |
|---|---|---|
| Duration of Hospital Stay After Cesarean Delivery | 4 (4 to 4) | 4 (3 to 4) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Postpartum Antibiotics | — | 0/41 (0%) | 0/41 (0%) |
| No Postpartum Antibiotics | — | 0/39 (0%) | 0/39 (0%) |
| Age, Categorical(Participants) | Postpartum Antibiotics | No Postpartum Antibiotics | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 41 | 39 | 80 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Postpartum Antibiotics | No Postpartum Antibiotics | Total |
|---|---|---|---|
| Mean | 24.7 ± 6 | 25.3 ± 6.6 | 25 ± 6 |
| Sex: Female, Male(Participants) | Postpartum Antibiotics | No Postpartum Antibiotics | Total |
|---|---|---|---|
| Female | 41 | 39 | 80 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Postpartum Antibiotics | No Postpartum Antibiotics | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 23 | 26 | 49 |
| White | 13 | 8 | 21 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 5 | 9 |
| Region of Enrollment(Participants) | Postpartum Antibiotics | No Postpartum Antibiotics | Total |
|---|---|---|---|
| United States | 41 | 39 | 80 |
This study is terminated, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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