Clinical trial NCT03801252: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Obesity
Induction of Labor Affected Fetus / Newborn
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 186
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled clinical trial
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Number of Participants With Cesarean Delivery
timeFrame: 30 days after delivery
measure: Number of Participants With Puerperal Infections
timeFrame: 30 days after delivery
Secondary outcomes:
measure: Number of Participants With Postpartum Hemorrhage
timeFrame: 30 days after delivery
measure: Number of Participants Who Underwent A Blood Transfusion
timeFrame: 30 days after delivery
measure: Number of Participants With ICU Admission
timeFrame: 30 days after delivery
measure: Number of Participants With Maternal Hospital Readmission
timeFrame: 30 days after delivery
measure: Primary Indications for Cesarean Delivery
timeFrame: 30 days after delivery
measure: Neonatal Outcomes
timeFrame: 30 days after delivery
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Stephanie Pierce, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.