University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
NCT Number: NCT03801252
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.
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Notify Me15 year–45 year
Female
Interventional
Early Phase 1
Oklahoma City, Oklahoma, 73104, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
intravenous drugs used as prophylactic antibiotics
Intravenous saline
Other names: Saline
prophylactic antibiotic
Time frame: 30 days after delivery
Rate at which women give birth via cesarean section
Time frame: 30 days after delivery
Chorioamnionitis, endometritis and/or cesarean wound infection
Time frame: 30 days after delivery
Experience of postpartum hemorrhage
Time frame: 30 days after delivery
Need of a blood transfusion
Time frame: 30 days after delivery
Intensive care unit admission
Time frame: 30 days after delivery
Maternal hospital readmission within 30 days after delivery
Time frame: 30 days after delivery
Nonreassuring fetal status, failed induction, active-phase arrest, second-stage arrest, or other
Time frame: 30 days after delivery
Neonatal complications
University of Oklahoma
Other
Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term (APPOINT): A Pilot Randomized Controlled Trial
Acronym: APPOINT
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.
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