Treatment Utility of Postpartum Antibiotics in Chorioamnionitis (TUPAC)
Primary Purpose
The Primary Outcome of This Study Will be the Rate of Endometritis
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Postpartum Antibiotics
No postpartum antibiotics
Sponsored by
About this trial
This is an interventional treatment trial for The Primary Outcome of This Study Will be the Rate of Endometritis
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of chorioamnionitis
- Undergoing cesarean section for delivery
Exclusion Criteria:
- Multiple gestations,
- Allergy to beta-lactam antibiotics
- Patients with estimated creatinine clearance (ClCr) less than 70 mL/min
- Maternal fever explained by etiology other than chorioamnionitis
- Inability to comply with the study protocol.
Sites / Locations
- Barnes-Jewish Hospital
- St. Louis University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Postpartum Antibiotics
No postpartum antibiotics
Arm Description
Patients will receive one additional dose of postpartum antibiotics (Clinda, Gentamicin)
No further postpartum antibiotics
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Duration of Hospital Stay After Cesarean Delivery
This is the duration of hospital stay (in days) after their cesarean delivery.
Full Information
NCT ID
NCT01585129
First Posted
April 23, 2012
Last Updated
May 21, 2018
Sponsor
Washington University School of Medicine
Collaborators
St. Louis University
1. Study Identification
Unique Protocol Identification Number
NCT01585129
Brief Title
Treatment Utility of Postpartum Antibiotics in Chorioamnionitis
Acronym
TUPAC
Official Title
Treatment Utility of Postpartum Antibiotics in Chorioamnionitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
Futility in patient enrollment
Study Start Date
September 2010 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
St. Louis University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To determine if prophylactic postpartum antibiotics are required post-cesarean delivery for pregnancies with treated chorioamnionitis.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
The Primary Outcome of This Study Will be the Rate of Endometritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Postpartum Antibiotics
Arm Type
Experimental
Arm Description
Patients will receive one additional dose of postpartum antibiotics (Clinda, Gentamicin)
Arm Title
No postpartum antibiotics
Arm Type
Placebo Comparator
Arm Description
No further postpartum antibiotics
Intervention Type
Drug
Intervention Name(s)
Postpartum Antibiotics
Intervention Description
Patients randomized into this arm will receive one additional dose of gentamicin (1.5 mg/kg) and clindamycin (900mg) in the postpartum setting.
Intervention Type
Drug
Intervention Name(s)
No postpartum antibiotics
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Paricipants With Endometritis
Description
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
Secondary Outcome Measure Information:
Title
Number of Participants With Infection-related Complications
Description
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
Title
Duration of Hospital Stay After Cesarean Delivery
Description
This is the duration of hospital stay (in days) after their cesarean delivery.
Time Frame
Up to 7 Days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of chorioamnionitis
Undergoing cesarean section for delivery
Exclusion Criteria:
Multiple gestations,
Allergy to beta-lactam antibiotics
Patients with estimated creatinine clearance (ClCr) less than 70 mL/min
Maternal fever explained by etiology other than chorioamnionitis
Inability to comply with the study protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony L Shanks, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
St. Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
3186087
Citation
Gibbs RS, Dinsmoor MJ, Newton ER, Ramamurthy RS. A randomized trial of intrapartum versus immediate postpartum treatment of women with intra-amniotic infection. Obstet Gynecol. 1988 Dec;72(6):823-8. doi: 10.1097/00006250-198812000-00001.
Results Reference
background
PubMed Identifier
3684121
Citation
Sperling RS, Ramamurthy RS, Gibbs RS. A comparison of intrapartum versus immediate postpartum treatment of intra-amniotic infection. Obstet Gynecol. 1987 Dec;70(6):861-5.
Results Reference
background
PubMed Identifier
3421256
Citation
Gilstrap LC 3rd, Leveno KJ, Cox SM, Burris JS, Mashburn M, Rosenfeld CR. Intrapartum treatment of acute chorioamnionitis: impact on neonatal sepsis. Am J Obstet Gynecol. 1988 Sep;159(3):579-83. doi: 10.1016/s0002-9378(88)80012-7.
Results Reference
background
PubMed Identifier
14672470
Citation
Edwards RK, Duff P. Single additional dose postpartum therapy for women with chorioamnionitis. Obstet Gynecol. 2003 Nov;102(5 Pt 1):957-61. doi: 10.1016/s0029-7844(03)00863-9.
Results Reference
background
PubMed Identifier
9369828
Citation
Chapman SJ, Owen J. Randomized trial of single-dose versus multiple-dose cefotetan for the postpartum treatment of intrapartum chorioamnionitis. Am J Obstet Gynecol. 1997 Oct;177(4):831-4. doi: 10.1016/s0002-9378(97)70277-1.
Results Reference
background
PubMed Identifier
9822512
Citation
Turnquest MA, How HY, Cook CR, O'Rourke TP, Cureton AC, Spinnato JA, Brown HL. Chorioamnionitis: is continuation of antibiotic therapy necessary after cesarean section? Am J Obstet Gynecol. 1998 Nov;179(5):1261-6. doi: 10.1016/s0002-9378(98)70143-7.
Results Reference
background
PubMed Identifier
3511414
Citation
Duff P. Pathophysiology and management of postcesarean endomyometritis. Obstet Gynecol. 1986 Feb;67(2):269-76. doi: 10.1097/00006250-198602000-00021.
Results Reference
background
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Treatment Utility of Postpartum Antibiotics in Chorioamnionitis
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