Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 2/13/2019 |
| Start Date: | March 15, 2019 |
| End Date: | July 1, 2021 |
| Contact: | Christina Zornes, MHR |
| Email: | christy-zornes@ouhsc.edu |
| Phone: | 4052718001 |
Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term (APPOINT): A Pilot Randomized Controlled Trial
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.
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.
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.
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.
Inclusion Criteria:
- BMI ≥40
- No prior deliveries at or beyond 20 weeks gestation
- Undergoing induction of labor
- Gestational age 37 weeks or more
- Age 18-45
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)
We found this trial at
1
site
940 NE 13th St
Oklahoma City, Oklahoma 73190
Oklahoma City, Oklahoma 73190
(405) 271-6458
Principal Investigator: Stephanie Pierce, MD
Phone: 405-271-8001
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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