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

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Minor Study description revised
    • Collaborators: 4 to 5
    v6
  2. Notable Start date: Jul 26, 2024 to Apr 29, 2025v5
  3. Minor Collaborators expanded, about 14 wordsv4
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 2024 to Jul 26, 2024
    • Site details revised
    v3
  5. Notable Start date: Jul 1, 2024 to Aug 2024v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT06488781
Lead Sponsor University of Oklahoma
Collaborators: University of Alabama at Birmingham, University of Florida, Duke University, Case Western Reserve University, University of Utah
Conditions
(from sponsor)
Obesity in Pregnancy, Labor Complication
Related terms Obstetric Labor Complications, Pregnancy in Obesity
Enrollment 787 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov