Skip to main content
OpenTrials
Completed

NCT Number: NCT03801252

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

15 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cefazolin

Drug

intravenous drugs used as prophylactic antibiotics

Placebo

Drug

Intravenous saline

Other names: Saline

Azithromycin

Drug

prophylactic antibiotic

Primary outcomes

  1. Number of Participants With Cesarean Delivery

    Time frame: 30 days after delivery

    Rate at which women give birth via cesarean section

  2. Number of Participants With Puerperal Infections

    Time frame: 30 days after delivery

    Chorioamnionitis, endometritis and/or cesarean wound infection

Secondary outcomes

  1. Number of Participants With Postpartum Hemorrhage

    Time frame: 30 days after delivery

    Experience of postpartum hemorrhage

  2. Number of Participants Who Underwent A Blood Transfusion

    Time frame: 30 days after delivery

    Need of a blood transfusion

  3. Number of Participants With ICU Admission

    Time frame: 30 days after delivery

    Intensive care unit admission

  4. Number of Participants With Maternal Hospital Readmission

    Time frame: 30 days after delivery

    Maternal hospital readmission within 30 days after delivery

  5. Primary Indications for Cesarean Delivery

    Time frame: 30 days after delivery

    Nonreassuring fetal status, failed induction, active-phase arrest, second-stage arrest, or other

  6. Neonatal Outcomes

    Time frame: 30 days after delivery

    Neonatal complications

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term (APPOINT): A Pilot Randomized Controlled Trial

Acronym: APPOINT

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jan 11, 2019
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.