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Obstetrical ComplicationsPhase 3PRECEDENCT06605118

Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial

A Phase 3 study testing Azithromycin Injection in people with Obstetrical Complications and Labor and Delivery Complication, run by The George Washington University Biostatistics Center at 14 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a phase-III multi-center double-blind randomized controlled trial of 8,000 individuals undergoing a scheduled or prelabor cesarean delivery who are randomized to either adjunctive azithromycin prophylaxis or to placebo. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
What is being tested?
Azithromycin Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
8,000 participants
Where
14 sitesUnited States
Study dates
6 Nov 2024to 30 Nov 2027
Phase
Phase 3
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 Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • ≥ 23 weeks' gestation (ACOG dating criteria)
  • Scheduled or prelabor cesarean delivery
  • Singleton or twin gestation

Who cannot join

  • Allergy or contraindication to azithromycin or macrolide antibiotics, including those with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin
  • Chorioamnionitis
  • Bacterial infection (e.g., pyelonephritis) requiring ongoing antibiotic treatment after delivery
  • Premature rupture of membranes (PROM) or labor (i.e., contractions with ongoing cervical change)
  • Fetal demise or known major congenital anomaly
  • Azithromycin treatment within 7 days
Show all 12Show fewer
  • Planned use of antimicrobial prophylaxis after delivery for any reason
  • Known structural heart disease or active cardiomyopathy (current ejection fraction<40%)
  • Known arrhythmia with QT prolongation or taking scheduled medications known to prolong the QT interval such that it would preclude the use of azithromycin
  • Refusal or unable to obtain consent (e.g., language barrier)
  • Participating in another intervention study that influences the primary outcome in this study
  • Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, do not have to be excluded.

Trial locations and contacts

14 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Rebecca G Clifton, PhD contact

301-881-9260

rclifton@bsc.gwu.edu

Steven Weiner, MS contact

weiner@bsc.gwu.edu

14 sites in 1 country

United States14 sites, 14 recruiting

  • University of Alabama - Birmingham

    Birmingham, Alabama, 35233

    Nancy Saxon, RN, 205-934-1616, nbsaxon@uabmc.edu

    Alan TN Tita, MD

    Recruiting

  • University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599

    Kelly Clark, RN, 919-350-6117, kelly_clark@med.unc.edu

    John M Thorp, MD

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Elizabeth Rangel, RN, elizabeth.rangel@northwestern.edu

    Lynn Yee, MD

    Recruiting

  • Case Western Reserve University

    Cleveland, Ohio, 44109

    Abigail Pierse, BS, 216-778-8443, apierse@metrohealth.org

    Kelly Gibson, MD

    Recruiting

  • Ohio State University

    Columbus, Ohio, 43210

    Anna Bartholomew, RN, BSN, 614-685-3229, anna.bartholomew@osumc.edu

    Maged Costantine, MD

    Recruiting

  • Duke University

    Durham, North Carolina, 27710

    Jennifer Ferrara, RNC MSN, 919-681-6176, jennifer.ferrara@duke.edu

    Brenna L Hughes, MD MS

    Recruiting

  • Baylor College of Medicine

    Houston, Texas, 77030

    Christina Reed, RN, NP, 832-826-7377, christina.reed@bcm.edu

    Jia Chen, RN, CCRP, 713-798-3798, jia.chen@bcm.edu

    Recruiting

  • University of Texas - Houston

    Houston, Texas, 77030

    Felecia Ortiz, RN, 713-500-6467, felecia.ortiz@uth.tmc.edu

    Hector Mendez-Figueroa, MD

    Recruiting

  • Columbia University

    New York, New York, 10032

    Megan Loffredo, MD, CCRC, 203-722-1058, ml4639@cumc.columbia.edu

    Noelia Zork, MD

    Recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Amee Feager, RN, BSN, 636-699-3433, amee.feager@pennmedicine.upenn.edu

    Lorraine Dugoff, MD

    Recruiting

  • Magee Women's Hospital

    Pittsburgh, Pennsylvania, 15213

    Jeanette Boyce, RN, 412-527-8118, tessje@upmc.edu

    Hyagriv Simhan, MD, MS

    Recruiting

  • Brown Univeristy

    Providence, Rhode Island, 02905

    Angelica DeMartino, RN, BSN, 401-274-1122 ext. 48521, amdemartino@wihri.org

    Dwight J Rouse, MD

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84132

    Amber Sowles, RN, 801-585-5499, amber.sowles@hsc.utah.edu

    Torri Metz, MD

    Recruiting

  • Regents of the University of California San Francisco

    San Francisco, California, 94143

    Natalie Oman, MPH, 206-718-4703, natalie.oman@ucsf.edu

    Mary Norton, MD

    Recruiting

Other trials in United States

About this study

Official title: Azithromycin Prophylaxis for Prelabor Cesarean Delivery Trial

This is a phase-III multi-center double-blind randomized controlled trial of 8,000 individuals undergoing a scheduled or prelabor cesarean delivery who are randomized to either adjunctive azithromycin prophylaxis or to placebo. Both groups also will receive standard of care preoperative antibiotics (excluding azithromycin). The primary endpoint is a maternal infection composite defined as any one of the following up to 6 weeks postpartum: endometritis, wound infection, abscess, septic thrombosis, sepsis, pneumonia, pyelonephritis and breast infection.

Read the detailed description

This is a phase-III multi-center double-blind randomized controlled trial of 8,000 individuals undergoing a scheduled or prelabor cesarean delivery who are randomized to either azithromycin prophylaxis or to placebo. All participants will receive standard of care preoperative antibiotics. The primary objective is to evaluate in patients undergoing scheduled/prelabor cesarean if pre-incision adjunctive azithromycin prophylaxis reduces the risk of post-cesarean infections compared with placebo. Secondary objectives include 1) to assess the perinatal and maternal safety of pre-incision adjunctive azithromycin, 2) to evaluate whether adjunctive azithromycin prophylaxis reduces maternal and neonatal resource use outcomes compared with placebo, and 3) to evaluate whether adjunctive azithromycin influences maternal and neonatal infection with resistant organisms compared with placebo.

Individuals will be randomized prior to the start of the cesarean to either 500mg of intravenous azithromycin or to placebo (normal saline). Maternal blood and cord blood will be collected on a subset of the population. Research staff will abstract maternal and neonatal outcomes following delivery and discharge from the hospital. A single maternal follow-up study visit at 6 weeks (4-8 weeks) postpartum will be scheduled to ascertain maternal and neonatal outcomes.

Being tested
Azithromycin Injection, Placebo, Standard of Care Preoperative antibiotics
Keywords
cesarean delivery, infection, maternal morbidity, antibiotics, prevention
Medical subject headings
Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Azithromycin InjectionDrug

    500mg azithromycin in 250 mL of normal saline

  • PlaceboDrug

    250 mL of normal saline

  • Standard of Care Preoperative antibioticsDrug

    standard of care preoperative antibiotics (excluding azithromycin) prior to incision

Study groups in NCT06605118
Study groupRoleWhat they receive
Azithromycin prophylaxis and standard of care preoperative antibioticsExperimental500mg of intravenous azithromycin administered up to 1 hour prior to cesarean incision (or as soon as feasible after incision) and infused over one hour per FDA infusion recommendations for azithromycin. Additionally patients will received standard of care preoperative antibiotics (excluding azithromycin) prior to incision.
Receives: Drug: Azithromycin Injection; Drug: Standard of Care Preoperative antibiotics
Placebo and standard of care preoperative antibioticsPlacebo comparatorNormal saline administered up to 1 hour prior to cesarean incision (or as soon as feasible after incision) and infused over one hour in addition to standard of care preoperative antibiotics (excluding azithromycin) prior to incision.
Receives: Drug: Placebo; Drug: Standard of Care Preoperative antibiotics

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maternal infection composite

    a maternal infection composite defined as any one of the following: endometritis, wound infection, abdominal or pelvic abscess, septic pelvic thrombosis, sepsis, pneumonia, pyelonephritis and breast infection

    Measured: Delivery up to 6 weeks postpartum (a period of up to 6 weeks)

Secondary outcomes (11)

  1. Non-infections wound complications

    any of the following wound complications without diagnosis of a wound infection: seroma, wound breakdown, erythema and/or hematoma

    Measured: Delivery up to 6 weeks postpartum (a period of up to 6 weeks)

  2. Perinatal composite outcome

    Any of the following:

    • Neonatal death occurring within 28 days of birth or prior to initial discharge from hospital
    • Respiratory distress syndrome
    • Necrotizing enterocolitis grade 2 or higher
    • Periventricular leucomalacia
    • Intraventricular hemorrhage grades 3 or 4
    • Bronchopulmonary dysplasia grade 3 or higher
    • Suspected sepsis
    • Confirmed sepsis
    • Cardiac resuscitation
    • Severe neonatal drug reaction defined as anaphylaxis or any other reported severe event suspected to be due to azithromycin
    • Hypertrophic pyloric stenosis defined as physician diagnosis supported by surgical intervention (pyloromyotomy) or pathology evaluation through 6 weeks from birth.

    Measured: hospital discharge, 6 weeks of birth, or death (whichever occurs first)

  3. Number of neonates with Allergic Reaction

    Neonatal allergic reaction (e.g., skin rash) through discharge or 7 days from birth, whichever is earliest, suspected to be due to study medication.

    Measured: birth through hospital discharge, or 7 days from birth, whichever is earliest

  4. Number of Neonates with Gastrointestinal Symptoms

    vomiting, diarrhea, feeding difficulty through discharge or 7 days from birth, whichever is earliest

    Measured: birth through hospital discharge, or 7 days from birth, whichever is earliest

  5. Number of Maternal Deaths

    Death

    Measured: From randomization through 6 weeks postpartum (a period of up to 6 weeks)

  6. Maternal Resource Composite

    • Hospital readmission
    • Emergency room (ER) visit
    • Unscheduled clinic visits

    Measured: From hospital discharge following delivery through 6 weeks postpartum (a period of up to 6 weeks)

  7. Neonatal Resource Composite

    • Hospital readmission
    • Emergency Room (ER) visit

    Measured: From hospital discharge following delivery through 6 weeks postpartum (a period of up to 6 weeks)

  8. Maternal Hospital Length of Stay

    Length of hospital stay in days

    Measured: Hospital admission to hospital discharge (up to 42 days)

  9. Rate of Neonatal ICU Admission

    Number of neonates admitted to NICU

    Measured: Delivery to hospital discharge (up to 120 days)

  10. Number of Participants with Maternal Resistant Infection

    bacteria and resistance patterns from clinical cultures

    Measured: Randomization through 6 weeks postpartum (a period of up to 6 weeks)

  11. Number of Neonates with Neonatal Resistant Infection

    bacteria and resistance patterns from clinical cultures

    Measured: From birth up to 6 weeks of age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2024
  2. Study start6 Nov 2024
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion30 Nov 2027 (estimated)

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized shortly before delivery to receive either azithromycin administered intravenously or a placebo control of normal saline administered intravenously
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
8,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06605118
Sponsor's protocol ID
HD036801-PRECEDE
Other IDs
U01HD114634, U24HD036801
Acronym
PRECEDE
Status last verified
Apr 2026
First submitted
13 Sep 2024
Last updated
9 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Data will be shared via NICHD DASH in accordance with NIH policy.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Azithromycin Injection in people with Obstetrical Complications and Labor and Delivery Complication, run by The George Washington University Biostatistics Center at 14 sites 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 3 inclusion and 12 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 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Rebecca G Clifton, PhD (301-881-9260, rclifton@bsc.gwu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maternal infection composite (time frame: Delivery up to 6 weeks postpartum (a period of up to 6 weeks)). 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 NCT06605118.

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 9 Apr 2026.

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