InfectionsPhase 1NCT06543290
Azithromycin Before Induction
A Phase 1 study testing Azithromycin Pill in people with Infections, run by Arrowhead Regional Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infections
- What is being tested?
- Azithromycin Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2023to 7 Aug 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- • 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Arrowhead Regional Medical Center
Colton, California, 92324
Kristina Nalbandyan, DO, 8187306222, knalbandian@westernu.edu
Kristina Roloff, DO, 9514427424, kristyroloff@gmail.com
About this study
Official title: Azithromycin to Prevent Chorioamnionitis in Women Undergoing Induction of Labor, a Randomized Control Trial
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.
Read the 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.
- Conditions
- Infections
- Being tested
- Azithromycin Pill, Placebo
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin PillDrug
Azithromycin 2 grams to be administered prior to start of induction for those randomized to intervention group
PlaceboDrug
4 magnesium oxide tablets prior to the start of induction for those randomized to placebo
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin Arm | Active comparator | Administration of 2 grams oral azithromycin (4 tablets of 500 mg) prior to the start of induction , once. Receives: Drug: Azithromycin Pill |
| Placebo Arm | Placebo comparator | Administration of 4 magnesium oxide tablets prior to the start of induction , once. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Composite Infection
single oral dose of Azithromycin given prior to the start of induction of labor will decrease rates of composite infection
Measured: Delivery and 6 weeks postpartum
Secondary outcomes (1)
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
Measured: Delivery and 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start7 Aug 2023
- Primary completion7 Aug 2026 (estimated)
- Study completion7 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arrowhead Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543290
- Sponsor's protocol ID
- 23-33
- Status last verified
- Sep 2025
- First submitted
- 5 Aug 2024
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Natality public-use data 2016-2018, on CDC WONDER Online Database. Division of Vital Statistics, 2020.
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.
PubMed 30089070Grobman 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.
PubMed 30817905Woodd 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.
PubMed 31821329Tita 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.
PubMed 20569811Pierce 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.
PubMed 35728781Tita 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.
PubMed 27682034
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Azithromycin to Prevent Chorioamnionitis in Women Undergoing Induction of Labor, a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06543290
- Acronym / sponsor ID
- 23-33
- Conditions
- Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Arrowhead Regional Medical CenterUniversity, hospital or other
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 7 Aug 2026 (estimated)
- Study completion
- 7 Aug 2026 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Azithromycin Arm | Active comparator | Drug: Azithromycin PillAdministration of 2 grams oral azithromycin (4 tablets of 500 mg) prior to the start of induction , once. |
| Placebo Arm | Placebo comparator | Drug: PlaceboAdministration of 4 magnesium oxide tablets prior to the start of induction , once. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- • Third trimester of pregnancy defined as 28 0/7 weeks or more
Key exclusion criteria (7 listed)
- • Does not read or write in English or Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azithromycin PillAzithromycin 2 grams to be administered prior to start of induction for those randomized to intervention group | Drug | Azithromycin Arm |
| Placebo4 magnesium oxide tablets prior to the start of induction for those randomized to placebo | Drug | Placebo Arm |
Primary outcome
Change in Composite Infection
Time frame: 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
1 secondary outcome
Change in Infection
Time frame: Delivery and 6 weeks postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Results publicationNatality public-use data 2016-2018, on CDC WONDER Online Database. Division of Vital Statistics, 2020.
- Results publication: PubMed 30089070Grobman 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.
- Results publication: PubMed 30817905Grobman 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.
- Results publication: PubMed 31821329Woodd 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.
- Results publication: PubMed 20569811Tita 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.
- Results publication: PubMed 35728781Pierce 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.
- Results publication: PubMed 27682034Tita 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.
- Individual participant dataSharing planned: Undecided
Related trials for Infections
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
RecruitingPhase 2/3
Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide
Chronic Hepatitis D
RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
Enrolling by invitationObservational study
Evaluation and Long-Term Follow-up of Patients With Inflammatory Disorders
Inflammation
RecruitingPhase 3
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Sepsis, PROM, Preterm (Pregnancy)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Azithromycin Pill in people with Infections, run by Arrowhead Regional Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristina Nalbandyan, DO (8187306222, knalbandian@westernu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Composite Infection (time frame: Delivery and 6 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06543290, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.