Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term 2.0
NCT Number: NCT06488781
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Obesity in Pregnancy|Labor Complication
Interventions: DRUG: Azithromycin|DRUG: Placebo
Sponsor: University of Oklahoma
Sex: FEMALE
Age: CHILD, ADULT
Enrollment: 787
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-08
Completion Date: 2028-12
Locations: University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, 73104, United States

Summary:
Obesity increases the risk of pregnancy complications, including puerperal infections and cesarean delivery, and risk rises with increasing body mass index (BMI). Since obese women are more likely to have comorbidities that would necessitate delivery prior to their due date (i.e. prior to 40 weeks gestation), and class III obesity specifically is an indication for delivery by 39 weeks, 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 maternal morbidity and a lower cesarean rate. Researchers previously conducted a pilot randomized placebo-controlled trial in obese, nulliparous women undergoing labor induction at term and found that the cesarean delivery rate was lower in women who received a prophylactic antibiotic regimen during labor compared with those who received the placebo. Researchers proposed multi-center trial aims to test this hypothesis in a large sample with adequate power to determine whether prophylactic antibiotics during labor are associated with a decrease in the rate of cesarean delivery in term, nulliparous, obese women. If the findings from the pilot trial are confirmed, this would represent a novel intervention to decrease the cesarean delivery rate in a subset of women at highest risk for cesarean-related complications.

Primary Outcome Measures: Rate of cesarean delivery, Determine whether a prophylactic antibiotic regimen during labor induction will decrease the rate of cesarean delivery in obese, nulliparous women undergoing induction of labor, 30 days postpartum
Secondary Outcome Measures: Rate of chorioamnionitis development, Defined clinically by fever and maternal and fetal signs such as tachycardia and uterine tenderness, 30 days postpartum|Rate of endometritis, Maternal development of endometritis, 30 days postpartum|Rate of cesarean wound infection, Rate of maternal would infection from cesarean section, 30 days postpartum|Rate of postpartum hemorrhage, Rate of maternal postpartum hemorrhage, 30 days postpartum|Rate of blood transfusion, Rate of maternal blood transfusions, 30 days postpartum|Rate of intensive care unit admission, Maternal admission into intensive care unit, 30 days postpartum|Rate of hospital readmission, Maternal hospital readmission after delivery, 30 days postpartum|Rate of indications for cesarean delivery, Rate of indications for a cesarean delivery, 30 days postpartum|Maternal hospital stay, Length of maternal hospital stay, 30 days postpartum|Neonate hospital stay, Length of neonatal hospital stay, 30 days postpartum|Rate of NICU admission, Neonatal intensive care unit (NICU) admission, 30 days postpartum|APGAR score, 5-minute APGAR score \<4 (neonate), 30 days postpartum|Rate of respiratory distress syndrome, Development of infant respiratory distress syndrome, 30 days postpartum|Rate of sepsis, Infant sepsis (either suspected or confirmed), 30 days postpartum|Rate of necrotizing enterocolitis, Infant necrotizing enterocolitis, 30 days postpartum|Periventricular leukomalacia, Development of periventricular leukomalacia in infant as seen by ultrasound, 30 days postpartum|Rate of intraventricular hemorrhage, Intraventricular hemorrhage grade III or higher, 30 days postpartum|Neonatal death, Death of neonate, 30 days postpartum