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NCT03801252 · ClinicalTrials.gov registry record · Early Phase 1
Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term
A Early Phase 1 study, sponsored by University of Oklahoma.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 186
- Enrollment target
NCT03801252: Completed Early Phase 1 study, sponsored by University of Oklahoma.
NCT03801252 is a Early Phase 1 study that has completed, run by University of Oklahoma. The registered enrollment target is 186 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (251% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03801252, a Early Phase 1 study, has completed, sponsored by University of Oklahoma.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 186 participants
- Enrollment target
Study Summary
Obesity increases the risk of pregnancy complications, including among others puerperal infections and cesarean delivery, and risk rises with increasing body mass index (BMI). Class III obesity is an indication for delivery by 39 weeks, and 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 morbidity and a lower cesarean rate. Antibiotic prophylaxis, standard before cesarean delivery, is associated with less post-cesarean infection if azithromycin is added to the standard cefazolin. In this placebo-controlled pilot trial, investigators will estimate the parameters necessary to calculate the sample size for a planned multicenter clinical trial of prophylactic antibiotics administered at the start of labor inductions of morbidly obese nulliparous women at term.
Primary Outcome
Rate at which women give birth via cesarean section
Interventions
- DRUG Placebo
- DRUG Azithromycin
- DRUG Cefazolin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 186 participants |
| Start Date | 2018-12-12 |
| Est. Completion | 2021-06-01 |
| Phase | Early Phase 1 |
What the finished NCT03801252 record still lists
NCT03801252 is an interventional study that assigns participants to a tested intervention. The registered 186 participants enrollment target is mid-sized for trials with a published cap, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (251% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03801252 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03801252 about?
NCT03801252 is a clinical study titled "Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term". Obesity increases the risk of pregnancy complications, including among others puerperal infections and cesarean delivery, and risk rises with increasing body mass index (BMI). Class III obesity is an indication for delivery by 39 weeks, and these patients have a high rate of labor induction. In null...
What is the current status of trial NCT03801252?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 186 participants. The study started on 2018-12-12. Estimated completion is 2021-06-01.
What interventions are being tested in trial NCT03801252?
The interventions under investigation include: Placebo (DRUG), Azithromycin (DRUG), Cefazolin (DRUG).
Who is sponsoring clinical trial NCT03801252?
This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03801252's enrollment target sits among peer trials
186 75th of 2000 higher than 1,926 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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