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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 is a Early Phase 1 study that has completed, run by University of Oklahoma. The registered enrollment target is 186 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03801252
The ClinicalTrials.gov registry entry for NCT03801252 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 186 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Oklahoma, which has 358 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03801252 reports 0 study locations.
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.
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