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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03801252
Recruitment Status : Completed
First Posted : January 11, 2019
Last Update Posted : September 29, 2021
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

Study Description
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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
Obesity Induction of Labor Affected Fetus / Newborn Drug: Cefazolin Drug: Placebo Drug: Azithromycin 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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized 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 : December 12, 2018
Actual Primary Completion Date : June 1, 2021
Actual Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arms and Interventions
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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 Name: Saline


Outcome Measures
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Primary Outcome Measures :
  1. Cesarean delivery rate [ Time Frame: 30 days after delivery ]
    Rate at which women give birth via cesarean section

  2. puerperal infection rate [ Time Frame: 30 days after delivery ]
    chorioamnionitis, endometritis and/or cesarean wound infection


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women of child-bearing age
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03801252


Locations
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United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
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Principal Investigator: Stephanie Pierce, MD University of Oklahoma
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT03801252    
Other Study ID Numbers: APPOINT
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021

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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:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
 Azithromycin
Cefazolin
Anti-Bacterial Agents
Anti-Infective Agents