Infections
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Azithromycin 2 grams to be administered prior to start of induction for those randomized to intervention group
DRUGPlacebo
4 magnesium oxide tablets prior to the start of induction for those randomized to placebo
Sponsors
Arrowhead Regional Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Pharmacy will have data set with participants idea and placebo vs study drug. All others will be blinded.
Intervention model description
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
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* • Third trimester of pregnancy defined as 28 0/7 weeks or more * Singleton pregnancy * Age 18-45 * Induction of labor initiated for medical or obstetrical reason or electively over 39 weeks of gestation * No contraindication to vaginal delivery * Reassuring fetal heart rate tracing * Able and willing to provide informed consent
Exclusion criteria
* • Does not read or write in English or Spanish * Unable or unwilling to give informed consent * Use of antibiotic or antiviral agent within the last 7 days * Evidence of active infection at the time of initiation of induction (patients with rectovaginal group B streptococcus positive results will be allowed to participate as it is a colonizing organism, unless they show evidence of active infection) * Incarcerated Women * Active substance abuse * Age \< 18
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Composite Infection | Delivery and 6 weeks postpartum | single oral dose of Azithromycin given prior to the start of induction of labor will decrease rates of composite infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Infection | Delivery and 6 weeks postpartum | 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 |
Countries
United States
Contacts
Primary ContactKristina Nalbandyan, DO
Backup ContactKristina Roloff, DO
Outcome results
None listed