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Treatment Utility of Postpartum Antibiotics in Chorioamnionitis (TUPAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01585129
Recruitment Status : Terminated (Futility in patient enrollment)
First Posted : April 25, 2012
Results First Posted : May 22, 2018
Last Update Posted : June 19, 2018
St. Louis University
Information provided by (Responsible Party):
Washington University School of Medicine

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

Condition or disease Intervention/treatment Phase
The Primary Outcome of This Study Will be the Rate of Endometritis Drug: Postpartum Antibiotics Drug: No postpartum antibiotics Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Treatment Utility of Postpartum Antibiotics in Chorioamnionitis
Study Start Date : September 2010
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Number of Paricipants With Endometritis [ Time Frame: 7 days post-partum ]
    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 :
  1. Number of Participants With Infection-related Complications [ Time Frame: 7 days post-partum ]
    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.

  2. Duration of Hospital Stay After Cesarean Delivery [ Time Frame: Up to 7 Days ]
    This is the duration of hospital stay (in days) after their cesarean delivery.

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01585129

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United States, Missouri
Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
St. Louis University
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
St. Louis University
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Principal Investigator: Anthony L Shanks, MD Washington University School of Medicine

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Responsible Party: Washington University School of Medicine Identifier: NCT01585129    
Other Study ID Numbers: 09-0704
First Posted: April 25, 2012    Key Record Dates
Results First Posted: May 22, 2018
Last Update Posted: June 19, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Pelvic Inflammatory Disease
Adnexal Diseases
Genital Diseases, Female
Uterine Diseases
Fetal Diseases
Pregnancy Complications
Fetal Membranes, Premature Rupture
Obstetric Labor Complications
Placenta Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents