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NCT06488781 · ClinicalTrials.gov registry record · Phase 2
Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term 2.0
A Phase 2 study of Labor Complication and Obesity in Pregnancy, sponsored by University of Oklahoma.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 787
- Enrollment target
- 1
- Study location
NCT06488781: Recruiting Phase 2 study of Labor Complication and Obesity in Pregnancy, sponsored by University of Oklahoma.
NCT06488781 is a Phase 2 study of Labor Complication and Obesity in Pregnancy that is actively recruiting participants, run by University of Oklahoma. The registered enrollment target is 787 participants, above the 160-participant average among 5 other Labor Complication trials with a reported enrollment target (392% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06488781, a Phase 2 study of Labor Complication and Obesity in Pregnancy, is actively recruiting participants, sponsored by University of Oklahoma.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 787 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Determine whether a prophylactic antibiotic regimen during labor induction will decrease the rate of cesarean delivery in obese, nulliparous women undergoing induction of labor
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Azithromycin
Study Locations (1)
Oklahoma
- University of Oklahoma Health Sciences Center - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 787 participants |
| Start Date | 2025-04-29 |
| Est. Completion | 2028-12 |
| Phase | Phase 2 |
What NCT06488781 shows while recruiting
NCT06488781 is an interventional study that assigns participants to a tested intervention. The registered 787 participants enrollment target is mid-sized for trials with a published cap, above the 160-participant average among 5 other Labor Complication trials with a reported enrollment target (392% higher).
The record links to 2 conditions, with Labor Complication appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06488781 reports a single indexed study location in Oklahoma.
Frequently Asked Questions
What is clinical trial NCT06488781 about?
NCT06488781 is a clinical study titled "Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term 2.0". 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 g...
What is the current status of trial NCT06488781?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 787 participants. The study started on 2025-04-29. Estimated completion is 2028-12.
What conditions does trial NCT06488781 study?
This clinical trial studies the following conditions: Labor Complication, Obesity in Pregnancy.
What interventions are being tested in trial NCT06488781?
The interventions under investigation include: Placebo (DRUG), Azithromycin (DRUG).
Who is sponsoring clinical trial NCT06488781?
This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06488781 being conducted?
This trial has 1 study location across Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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