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

Early Phase 1

Completed

• Conditions: Obesity; Induction of Labor Affected Fetus / Newborn
• Interventions: Drug: Cefazolin; Drug: Placebo; Drug: Azithromycin

• Registration Number: NCT03801252
• Lead Sponsor: University of Oklahoma

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.

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 Timeline

• Study Start: 2018-12-12
• Study First Submitted: 2019-01-09
• Study First Submitted QC: 2019-01-10
• Study First Posted: 2019-01-11
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01
• Results First Submitted: 2023-01-09
• Status Verified: 2023-11
• Results First Submitted QC: 2023-11-03
• Last Update Submitted: 2023-11-03
• Results First Posted: 2024-04-19
• Last Update Posted: 2024-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 186

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cefazolin + Azithromycin	Cefazolin	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
Placebo + 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
Cefazolin + Azithromycin	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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Cesarean Delivery	30 days after delivery	Rate at which women give birth via cesarean section
Number of Participants With Puerperal Infections	30 days after delivery	Chorioamnionitis, endometritis and/or cesarean wound infection

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Postpartum Hemorrhage	30 days after delivery	Experience of postpartum hemorrhage
Number of Participants Who Underwent A Blood Transfusion	30 days after delivery	Need of a blood transfusion
Neonatal Outcomes	30 days after delivery	Neonatal complications
Number of Participants With ICU Admission	30 days after delivery	Intensive care unit admission
Number of Participants With Maternal Hospital Readmission	30 days after delivery	Maternal hospital readmission within 30 days after delivery
Primary Indications for Cesarean Delivery	30 days after delivery	Nonreassuring fetal status, failed induction, active-phase arrest, second-stage arrest, or other

Trial Locations

Locations (1)

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States