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

• ClinicalTrials.gov Identifier: NCT03801252
• Recruitment Status: Completed
• First Posted: January 11, 2019
• Last Update Posted: September 29, 2021
• Sponsor: University of Oklahoma
• Information provided by (Responsible Party): University of Oklahoma

Tracking Information

• First Submitted Date: January 9, 2019
• First Posted Date: January 11, 2019
• Last Update Posted Date: September 29, 2021
• Actual Study Start Date: December 12, 2018
• Actual Primary Completion Date: June 1, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 10, 2019)

• Cesarean delivery rate [ Time Frame: 30 days after delivery ]
  Rate at which women give birth via cesarean section
• puerperal infection rate [ Time Frame: 30 days after delivery ]
  chorioamnionitis, endometritis and/or cesarean wound infection

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term
• Official Title: Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term (APPOINT): A Pilot Randomized Controlled Trial
• 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 Type: Interventional
• Study Phase: Early Phase 1

Study Design

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

Condition

• Obesity
• Induction of Labor Affected Fetus / Newborn

Intervention

• Drug: Cefazolin
  intravenous drugs used as prophylactic antibiotics
• Drug: Placebo
  Intravenous saline
  Other Name: Saline
• Drug: Azithromycin
  prophylactic antibiotic

Study Arms

• 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
  Interventions:

  • Drug: Cefazolin
  • Drug: Azithromycin
• 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
  Intervention: Drug: Placebo

• Publications *: Pierce SL, Peck JD, Zornes C, Standerfer E, Edwards RK. Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term: a pilot randomized controlled trial. Am J Obstet Gynecol MFM. 2022 Sep;4(5):100681. doi: 10.1016/j.ajogmf.2022.100681. Epub 2022 Jun 18.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 27, 2021): 183
• Original Estimated Enrollment (submitted: January 10, 2019): 100
• Actual Study Completion Date: June 1, 2021
• Actual Primary Completion Date: June 1, 2021 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Women of child-bearing age

• Ages: 15 Years to 45 Years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03801252
• Other Study ID Numbers: APPOINT
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of Oklahoma
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Oklahoma
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Oklahoma
• Verification Date: September 2021