Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term 2.0
- Conditions
- Obesity in PregnancyLabor Complication
- Interventions
- Drug: Placebo
- Registration Number
- NCT06488781
- Lead Sponsor
- University of Oklahoma
- Brief 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.
- Detailed Description
This is a multi-center randomized placebo-controlled trial in which nulliparous women with obesity who are undergoing induction of labor at term and not receiving IAP for GBS will be recruited (n=787). The participants will be randomized 1:1 to receive either prophylactic antibiotics during their labor induction (azithromycin 500 milligrams intravenously once and cefazolin 2 grams intravenously every 8 hours for up to three doses) or like-appearing placebos. The participants and their obstetrical providers will be blinded to the study intervention. The study will be conducted with an identical protocol at five study sites. Trained research nurses/assistants at each study site will consent and enroll participants, collect biospecimens, and collect demographic information and data on pregnancy and neonatal outcomes, and will convey this data to the primary site for analysis.
Researchers hypothesize that the group that receives the study drug regimen of prophylactic antibiotics during induction of labor will have a lower rate of cesarean delivery than the group that receives the placebo. They also hypothesize that the group that receives the study drug regimen will have a lower rate of puerperal infection than the placebo group.
Nulliparous women with obesity who are undergoing induction of labor at term will be eligible for participation in the study. Across all sites, 787 total subjects will be recruited.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 787
- BMI ≥30
- No prior deliveries at or beyond 20 weeks gestation
- Undergoing induction of labor
- Gestational age 37 weeks or more
- Age 15-45
- Not receiving IAP for GBS prophylaxis
- 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 azithromycin or beta-lactam antibiotics
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebos, similar in appearance, in place of azithromycin and cefazolin Prophylactic antibiotics Azithromycin Azithromycin 500 milligrams intravenously once and cefazolin 2 grams intravenously every 8 hours for up to three doses
- Primary Outcome Measures
Name Time Method Rate of cesarean delivery 30 days postpartum Determine whether a prophylactic antibiotic regimen during labor induction will decrease the rate of cesarean delivery in obese, nulliparous women undergoing induction of labor
- Secondary Outcome Measures
Name Time Method Maternal hospital stay 30 days postpartum Length of maternal hospital stay
Neonate hospital stay 30 days postpartum Length of neonatal hospital stay
Rate of postpartum hemorrhage 30 days postpartum Rate of maternal postpartum hemorrhage
Rate of blood transfusion 30 days postpartum Rate of maternal blood transfusions
Rate of intensive care unit admission 30 days postpartum Maternal admission into intensive care unit
Rate of hospital readmission 30 days postpartum Maternal hospital readmission after delivery
Rate of indications for cesarean delivery 30 days postpartum Rate of indications for a cesarean delivery
Rate of chorioamnionitis development 30 days postpartum Defined clinically by fever and maternal and fetal signs such as tachycardia and uterine tenderness
Rate of cesarean wound infection 30 days postpartum Rate of maternal would infection from cesarean section
Rate of endometritis 30 days postpartum Maternal development of endometritis
Rate of necrotizing enterocolitis 30 days postpartum Infant necrotizing enterocolitis
Periventricular leukomalacia 30 days postpartum Development of periventricular leukomalacia in infant as seen by ultrasound
Rate of intraventricular hemorrhage 30 days postpartum Intraventricular hemorrhage grade III or higher
Neonatal death 30 days postpartum Death of neonate
Rate of NICU admission 30 days postpartum Neonatal intensive care unit (NICU) admission
APGAR score 30 days postpartum 5-minute APGAR score \<4 (neonate)
Rate of respiratory distress syndrome 30 days postpartum Development of infant respiratory distress syndrome
Rate of sepsis 30 days postpartum Infant sepsis (either suspected or confirmed)
Trial Locations
- Locations (1)
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States