NCT Number: NCT06488781
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.
Interested in participating?
Request Info15 year–45 year
Female
Interventional
Phase 2
Oklahoma City, Oklahoma, 73104, United States
Location status: Recruiting
Christy Zornes, MHR
CONTACT
405-271-8001 ext. 48137
Kyra Woods, BA
CONTACT
405-271-8001 ext. 45750
Stephanie Pierce, MD
PRINCIPAL_INVESTIGATOR
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 six 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Azithromycin 500 milligrams intravenously once and cefazolin 2 grams intravenously every 8 hours for up to three doses
Other names: Cefazolin
Placebo given in place of other two active drugs
Time frame: 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
Time frame: 30 days postpartum
Defined clinically by fever and maternal and fetal signs such as tachycardia and uterine tenderness
Time frame: 30 days postpartum
Maternal development of endometritis
Time frame: 30 days postpartum
Rate of maternal would infection from cesarean section
Time frame: 30 days postpartum
Rate of maternal postpartum hemorrhage
Time frame: 30 days postpartum
Rate of maternal blood transfusions
Time frame: 30 days postpartum
Maternal admission into intensive care unit
Time frame: 30 days postpartum
Maternal hospital readmission after delivery
Time frame: 30 days postpartum
Rate of indications for a cesarean delivery
Time frame: 30 days postpartum
Length of maternal hospital stay
Time frame: 30 days postpartum
Length of neonatal hospital stay
Time frame: 30 days postpartum
Neonatal intensive care unit (NICU) admission
Time frame: 30 days postpartum
5-minute APGAR score <4 (neonate)
Time frame: 30 days postpartum
Development of infant respiratory distress syndrome
Time frame: 30 days postpartum
Infant sepsis (either suspected or confirmed)
Time frame: 30 days postpartum
Infant necrotizing enterocolitis
Time frame: 30 days postpartum
Development of periventricular leukomalacia in infant as seen by ultrasound
Time frame: 30 days postpartum
Intraventricular hemorrhage grade III or higher
Time frame: 30 days postpartum
Death of neonate
Contact information is provided by the study sponsor or research team.
University of Oklahoma
Other
Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term 2.0 (APPOINT 2.0): A Multi-center Randomized Controlled Trial
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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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