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

Sponsor
University of Oklahoma (Other)
Overall Status
Completed
CT.gov ID
NCT03801252
Collaborator
(none)
183
Enrollment
1
Location
2
Arms
29.6
Actual Duration (Months)
6.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Detailed Description

Investigators will enroll consenting women delivering at The Children's Hospital at OU Medical Center who meet enrollment criteria. Flyers will be distributed to providers to give to women who may be eligible for the study at prenatal visits, so that they may review the information prior to presenting for their induction of labor. Labor induction may be a scheduled procedure. However, many inductions occur in an unscheduled fashion due to medical or obstetric indications. Therefore, it is difficult to predict which women will ultimately require labor induction and at what gestational age they will require it, so it is not feasible to approach and consent all women during a clinic visit prior to labor induction. Distribution of flyers will allow patients to have information about the study prior to presenting for labor induction. Furthermore, unlike women in spontaneous labor, women being consented just prior to a labor induction are not vulnerable in the same way as one might consider a patient in labor, since they will not have the distraction and discomfort of uterine contractions that are presenting in laboring patients.

Study Design

Study Type:
Interventional
Actual Enrollment :
183 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled clinical trialRandomized controlled clinical trial
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
One arm includes double placebo drugs that will be blinded from the investigator and participant
Primary Purpose:
Treatment
Official Title:
Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term (APPOINT): A Pilot Randomized Controlled Trial
Actual Study Start Date :
Dec 12, 2018
Actual Primary Completion Date :
Jun 1, 2021
Actual Study Completion Date :
Jun 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cefazolin + Azithromycin

Women will be randomized 1:1 to receive cefazolin 2 grams intravenously at the start of the labor induction and every 8 hours thereafter for a maximum of three doses and azithromycin 500 mg intravenously once at the start of the labor induction

Drug: Cefazolin
intravenous drugs used as prophylactic antibiotics

Drug: Azithromycin
prophylactic antibiotic
Placebo Comparator: Placebo + Placebo

Women will be randomized 1:1 to receive placebo intravenously at the start of the labor induction and every 8 hours thereafter for a maximum of three doses and placebo intravenously once at the start of the labor induction

Drug: Placebo
Intravenous saline
Other Names:
  • Saline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cesarean delivery rate [30 days after delivery]

      Rate at which women give birth via cesarean section

    2. puerperal infection rate [30 days after delivery]

      chorioamnionitis, endometritis and/or cesarean wound infection

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • BMI ≥30

    • No prior deliveries at or beyond 20 weeks gestation

    • Undergoing induction of labor

    • Gestational age 37 weeks or more

    • Age 15-45

    Exclusion Criteria:

    • Fetal death prior to labor induction

    • Known fetal anomaly

    • Multiple gestation

    • Ruptured membranes for more than 12 hours

    • Chorioamnionitis or other infection requiring antibiotics at the start of the labor induction

    • Previous myometrial surgery

    • Allergy to either drug used in the protocol (cefazolin or azithromycin)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104

    Sponsors and Collaborators

    • University of Oklahoma

    Investigators

    • Principal Investigator: Stephanie Pierce, MD, University of Oklahoma

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Oklahoma
    ClinicalTrials.gov Identifier:
    NCT03801252
    Other Study ID Numbers:
    • APPOINT
    First Posted:
    Jan 11, 2019
    Last Update Posted:
    Sep 29, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Obesity
    Azithromycin
    Cefazolin

    Study Results

    No Results Posted as of Sep 29, 2021