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This is a double blinded randomized control trial involving administration of 2 grams prophylactic azithromycin in third trimester patients undergoing induction of labor at our institution to demonstrate reduction in maternal and neonatal infection.
Induction rates have more than tripled in the last quarter century, and even more in the past five years in light of evidence that the 39th week is the optimal gestational age for birth. Inductions are one of the most commonly performed medical procedures, and may span several days. One of the complications associated with induction include maternal infection, which includes chorioamnionitis, endometritis, pyelonephritis, neonatal infection, perineal and cesarean wound infections. There are many well-known risk factors for these infections that include longer duration of rupture of membrane, prolonged labor, nulliparity, internal monitoring, multiple vaginal examinations and several others. Well-established guidelines are available for treating infection once diagnosed, however the role of antibiotic prophylaxis to prevent infection in patients undergoing induction of labor is less clear. In this study, the investigators propose that administration of 2 grams oral azithromycin prior to the start of induction of labor will decrease rates of intrapartum and postpartum infections. Azithromycin is the ideal antibiotic to study in this trial since it is long acting, inexpensive, well tolerated, and has proven benefits in prior studies for prevention of obstetrical infection in cesarean deliveries and spontaneous labor. This is a double blinded randomized control trial involving administration of 2 grams prophylactic azithromycin in third trimester patients undergoing induction of labor at our institution to demonstrate reduction in maternal and neonatal infection. Decreasing rates of infection will improve both maternal and neonatal outcomes as well as decrease hospital length of stay and associated costs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azithromycin Arm | Active Comparator | Administration of 2 grams oral azithromycin (4 tablets of 500 mg) prior to the start of induction , once. |
|
| Placebo Arm | Placebo Comparator | Administration of 4 magnesium oxide tablets prior to the start of induction , once. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin Pill | Drug | Azithromycin 2 grams to be administered prior to start of induction for those randomized to intervention group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Composite Infection | single oral dose of Azithromycin given prior to the start of induction of labor will decrease rates of composite infection | Delivery and 6 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Infection | single oral dose of azithromycin will also decrease rates of chorioamnionitis, endometritis, wound infection (both perineal and cesarean), neonatal infection and readmission rates, pyelonephritis, endomyometritis | Delivery and 6 weeks postpartum |
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Inclusion Criteria:
• Third trimester of pregnancy defined as 28 0/7 weeks or more
Exclusion Criteria:
• Does not read or write in English or Spanish
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristina Nalbandyan, DO | Contact | 8187306222 | knalbandian@westernu.edu | |
| Kristina Roloff, DO | Contact | 9514427424 | kristyroloff@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arrowhead Regional Medical Center | Recruiting | Colton | California | 92324 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Natality public-use data 2016-2018, on CDC WONDER Online Database. Division of Vital Statistics, 2020. | ||
| 30089070 | Result | Grobman WA, Rice MM, Reddy UM, Tita ATN, Silver RM, Mallett G, Hill K, Thom EA, El-Sayed YY, Perez-Delboy A, Rouse DJ, Saade GR, Boggess KA, Chauhan SP, Iams JD, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Labor Induction versus Expectant Management in Low-Risk Nulliparous Women. N Engl J Med. 2018 Aug 9;379(6):513-523. doi: 10.1056/NEJMoa1800566. | |
| 30817905 |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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The investigators propose a double blinded randomized control trial of patients scheduled to undergo induction of labor at our institution. Enrolled patients will be randomized to receive a single dose of 2 grams Azithromycin or placebo. Induction will proceed per hospital protocols and the primary and secondary outcomes will be obtained from chart review after delivery and will end 6 weeks postpartum
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Pharmacy will have data set with participants idea and placebo vs study drug. All others will be blinded.
| Placebo | Drug | 4 magnesium oxide tablets prior to the start of induction for those randomized to placebo |
|
| Result |
| Grobman WA, Caughey AB. Elective induction of labor at 39 weeks compared with expectant management: a meta-analysis of cohort studies. Am J Obstet Gynecol. 2019 Oct;221(4):304-310. doi: 10.1016/j.ajog.2019.02.046. Epub 2019 Feb 25. |
| 31821329 | Result | Woodd SL, Montoya A, Barreix M, Pi L, Calvert C, Rehman AM, Chou D, Campbell OMR. Incidence of maternal peripartum infection: A systematic review and meta-analysis. PLoS Med. 2019 Dec 10;16(12):e1002984. doi: 10.1371/journal.pmed.1002984. eCollection 2019 Dec. |
| 20569811 | Result | Tita AT, Andrews WW. Diagnosis and management of clinical chorioamnionitis. Clin Perinatol. 2010 Jun;37(2):339-54. doi: 10.1016/j.clp.2010.02.003. |
| 35728781 | Result | Pierce SL, Peck JD, Zornes C, Standerfer E, Edwards RK. Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term: a pilot randomized controlled trial. Am J Obstet Gynecol MFM. 2022 Sep;4(5):100681. doi: 10.1016/j.ajogmf.2022.100681. Epub 2022 Jun 18. |
| 27682034 | Result | Tita AT, Szychowski JM, Boggess K, Saade G, Longo S, Clark E, Esplin S, Cleary K, Wapner R, Letson K, Owens M, Abramovici A, Ambalavanan N, Cutter G, Andrews W; C/SOAP Trial Consortium. Adjunctive Azithromycin Prophylaxis for Cesarean Delivery. N Engl J Med. 2016 Sep 29;375(13):1231-41. doi: 10.1056/NEJMoa1602044. |
| Organic Chemicals |