Treatment Utility of Postpartum Antibiotics in Chorioamnionitis (TUPAC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Washington University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
St. Louis University
Information provided by (Responsible Party):
Anthony Shanks, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01585129
First received: April 23, 2012
Last updated: April 24, 2012
Last verified: April 2012
  Purpose

To determine if prophylactic postpartum antibiotics are required post-cesarean delivery for pregnancies with treated chorioamnionitis.


Condition Intervention Phase
The Primary Outcome of This Study Will be the Rate of Endometritis in the Study Population.
Drug: Postpartum Antibiotics
Drug: No postpartum antibiotics
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Treatment Utility of Postpartum Antibiotics in Chorioamnionitis

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Endometritis [ Time Frame: 7 days post-partum ] [ Designated as safety issue: No ]
    Endometritis is defined as 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:
  • Infection-related complications [ Time Frame: 7 days post-partum ] [ Designated as safety issue: No ]
    To include wound infections, pelvic abscesses, etc.

  • Duration of hospital stay [ Time Frame: 7 days post-partum ] [ Designated as safety issue: No ]

Estimated Enrollment: 238
Study Start Date: September 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Postpartum Antibiotics
Patients will receive one additional dose of postpartum antibiotics (Clinda, Gentamicin)
Drug: 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.
Placebo Comparator: No postpartum antibiotics
No further postpartum antibiotics
Drug: No postpartum antibiotics
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.

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.

  Eligibility

Ages Eligible for Study:   14 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01585129

Locations
United States, Missouri
Barnes-Jewish Hospital Recruiting
St. Louis, Missouri, United States, 63110
Contact: Anthony Shanks, MD    314-362-7315    shanksa@wudosis.wustl.edu   
Principal Investigator: Anthony Shanks, MD         
St. Louis University Not yet recruiting
St. Louis, Missouri, United States, 63110
Contact: Anthony Shanks, MD    314-362-7315    shanksa@wudosis.wustl.edu   
Principal Investigator: Anthony Shanks, MD         
Sponsors and Collaborators
Washington University School of Medicine
St. Louis University
  More Information

Publications:
Responsible Party: Anthony Shanks, MD, Assistant Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01585129     History of Changes
Other Study ID Numbers: 09-0704
Study First Received: April 23, 2012
Last Updated: April 24, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Chorioamnionitis
Endometritis
Fetal Diseases
Pregnancy Complications
Fetal Membranes, Premature Rupture
Obstetric Labor Complications
Placenta Diseases
Pelvic Inflammatory Disease
Adnexal Diseases
Genital Diseases, Female
Uterine Diseases
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on April 17, 2014