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Trial record 2 of 20 for:    "Endometritis" | "Anti-Bacterial Agents"

Treatment Utility of Postpartum Antibiotics in Chorioamnionitis (TUPAC)

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
St. Louis University
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition The Primary Outcome of This Study Will be the Rate of Endometritis
Interventions Drug: Postpartum Antibiotics
Drug: No postpartum antibiotics
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Postpartum Antibiotics No Postpartum Antibiotics
Hide Arm/Group Description

Patients will receive one additional dose of postpartum antibiotics (Clinda, Gentamicin)

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.

No further postpartum antibiotics

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.

Period Title: Overall Study
Started 41 39
Completed 41 39
Not Completed 0 0
Arm/Group Title Postpartum Antibiotics No Postpartum Antibiotics Total
Hide Arm/Group Description

Patients will receive one additional dose of postpartum antibiotics (Clinda, Gentamicin)

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.

No further postpartum antibiotics

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.

Total of all reporting groups
Overall Number of Baseline Participants 41 39 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 39 participants 80 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
41
 100.0%
39
 100.0%
80
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 39 participants 80 participants
24.7  (6) 25.3  (6.6) 25  (6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 39 participants 80 participants
Female
41
 100.0%
39
 100.0%
80
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 39 participants 80 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   2.4%
0
   0.0%
1
   1.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
23
  56.1%
26
  66.7%
49
  61.3%
White
13
  31.7%
8
  20.5%
21
  26.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
   9.8%
5
  12.8%
9
  11.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 41 participants 39 participants 80 participants
41
 100.0%
39
 100.0%
80
 100.0%
1.Primary Outcome
Title Number of Paricipants With Endometritis
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Postpartum Antibiotics No Postpartum Antibiotics
Hide Arm/Group Description:

Patients will receive one additional dose of postpartum antibiotics (Clinda, Gentamicin)

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.

No further postpartum antibiotics

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.

Overall Number of Participants Analyzed 41 39
Measure Type: Count of Participants
Unit of Measure: Participants
4
   9.8%
3
   7.7%
2.Secondary Outcome
Title Number of Participants With Infection-related Complications
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Postpartum Antibiotics No Postpartum Antibiotics
Hide Arm/Group Description:

Patients will receive one additional dose of postpartum antibiotics (Clinda, Gentamicin)

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.

No further postpartum antibiotics

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.

Overall Number of Participants Analyzed 41 39
Measure Type: Count of Participants
Unit of Measure: Participants
7
  17.1%
2
   5.1%
3.Secondary Outcome
Title Duration of Hospital Stay After Cesarean Delivery
Hide Description This is the duration of hospital stay (in days) after their cesarean delivery.
Time Frame Up to 7 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Postpartum Antibiotics No Postpartum Antibiotics
Hide Arm/Group Description:

Patients will receive one additional dose of postpartum antibiotics (Clinda, Gentamicin)

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.

No further postpartum antibiotics

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.

Overall Number of Participants Analyzed 41 39
Mean (95% Confidence Interval)
Unit of Measure: days
4
(4 to 4)
4
(3 to 4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Postpartum Antibiotics No Postpartum Antibiotics
Hide Arm/Group Description

Patients will receive one additional dose of postpartum antibiotics (Clinda, Gentamicin)

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.

No further postpartum antibiotics

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.

All-Cause Mortality
Postpartum Antibiotics No Postpartum Antibiotics
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Postpartum Antibiotics No Postpartum Antibiotics
Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)   0/39 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Postpartum Antibiotics No Postpartum Antibiotics
Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)   0/39 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Anthony Shanks
Organization: WashingtonU
Phone: 3179448182
EMail: ashanks@iupui.edu
Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01585129     History of Changes
Other Study ID Numbers: 09-0704
First Submitted: April 23, 2012
First Posted: April 25, 2012
Results First Submitted: January 25, 2018
Results First Posted: May 22, 2018
Last Update Posted: June 19, 2018