Treatment Utility of Postpartum Antibiotics in Chorioamnionitis (TUPAC)

• ClinicalTrials.gov Identifier: NCT01585129
• Recruitment Status: Terminated
• First Posted: April 25, 2012
• Results First Posted: May 22, 2018
• Last Update Posted: June 19, 2018
• Sponsor: Washington University School of Medicine
• Collaborator: St. Louis University
• Information provided by (Responsible Party): Washington University School of Medicine

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 50 Years (Child, Adult)
• Sexes 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

Locations

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

Investigators

• Principal Investigator: Anthony L Shanks, MD; Washington University School of Medicine

More Information

Publications:

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.

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.

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.

Edwards RK, Duff P. Single additional dose postpartum therapy for women with chorioamnionitis. Obstet Gynecol. 2003 Nov;102(5 Pt 1):957-61.

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.

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.

Duff P. Pathophysiology and management of postcesarean endomyometritis. Obstet Gynecol. 1986 Feb;67(2):269-76. Review.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT01585129
• Other Study ID Numbers: 09-0704
• First Posted: April 25, 2012
• Results First Posted: May 22, 2018
• Last Update Posted: June 19, 2018
• Last Verified: May 2018

Additional relevant MeSH terms:

Endometritis; Chorioamnionitis; Pelvic Inflammatory Disease; Adnexal Diseases; 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