Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term 2.0

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
University of Oklahoma
Study ID
NCT06488781
Phase
PHASE2
Status
Recruiting
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Conditions

  • Labor Complication
  • Obesity in Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
15 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Azithromycin — DRUG
    Azithromycin 500 milligrams intravenously once and cefazolin 2 grams intravenously every 8 hours for up to three doses
  • Placebo — DRUG
    Placebo given in place of other two active drugs

Study Details

Obesity increases the risk of pregnancy complications, including puerperal infections and cesarean delivery, and risk rises with increasing body mass index (BMI). Since obese women are more likely to have comorbidities that would necessitate delivery prior to their due date (i.e. prior to 40 weeks gestation), and class III obesity specifically is an indication for delivery by 39 weeks, these patients have a high rate of labor induction. In nulliparous women from the general population (obese and non-obese), labor induction at 39 weeks (compared to expectant management) is associated with less maternal morbidity and a lower cesarean rate. Researchers previously conducted a pilot randomized placebo-controlled trial in obese, nulliparous women undergoing labor induction at term and found that the cesarean delivery rate was lower in women who received a prophylactic antibiotic regimen during labor compared with those who received the placebo. Researchers proposed multi-center trial aims to test this hypothesis in a large sample with adequate power to determine whether prophylactic antibiotics during labor are associated with a decrease in the rate of cesarean delivery in term, nulliparous, obese women. If the findings from the pilot trial are confirmed, this would represent a novel intervention to decrease the cesarean delivery rate in a subset of women at highest risk for cesarean-related complications.

Key Dates

Start date
Apr 29, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
787 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Prophylactic antibiotics
    Azithromycin 500 milligrams intravenously once and cefazolin 2 grams intravenously every 8 hours for up to three doses
  • Placebo Comparator: Placebo
    Placebos, similar in appearance, in place of azithromycin and cefazolin

Primary Outcome Measure

Rate of cesarean delivery [ Time Frame: 30 days postpartum ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104
Christy Zornes, MHR
[email protected]
405-271-8001
Kyra Woods, BA
[email protected]
405-271-8001
Stephanie Pierce, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Oklahoma Health Sciences Center· Oklahoma City, OK

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