The Primary Outcome of This Study Will be the Rate of Endometritis Clinical Trial
— TUPACOfficial title:
Treatment Utility of Postpartum Antibiotics in Chorioamnionitis
NCT number | NCT01585129 |
Other study ID # | 09-0704 |
Secondary ID | |
Status | Terminated |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | September 2010 |
Est. completion date | July 2014 |
Verified date | May 2018 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To determine if prophylactic postpartum antibiotics are required post-cesarean delivery for pregnancies with treated chorioamnionitis.
Status | Terminated |
Enrollment | 80 |
Est. completion date | July 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 14 Years to 50 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Barnes-Jewish Hospital | Saint Louis | Missouri |
United States | St. Louis University | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine | St. Louis University |
United States,
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. — View Citation
Duff P. Pathophysiology and management of postcesarean endomyometritis. Obstet Gynecol. 1986 Feb;67(2):269-76. Review. — View Citation
Edwards RK, Duff P. Single additional dose postpartum therapy for women with chorioamnionitis. Obstet Gynecol. 2003 Nov;102(5 Pt 1):957-61. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | 7 days post-partum | |
Secondary | 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. | 7 days post-partum | |
Secondary | Duration of Hospital Stay After Cesarean Delivery | This is the duration of hospital stay (in days) after their cesarean delivery. | Up to 7 Days |