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

NCT03801252 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2024-04-19

Study results available
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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.

Conditions

  • Obesity
  • Induction of Labor Affected Fetus / Newborn

Interventions

DRUG

Cefazolin

intravenous drugs used as prophylactic antibiotics

DRUG

Placebo

Intravenous saline

DRUG

Azithromycin

prophylactic antibiotic

Sponsors & Collaborators

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Stephanie Pierce, MD · University of Oklahoma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-12
Primary Completion
2021-06-01
Completion
2021-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03801252 on ClinicalTrials.gov