Clinical trial

Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term 2.0

Recruiting now · Phase 2 · 1 countries · Registry ID NCT06488781

Recruiting nowPhase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age15 Years to 45 Years
SexFemale
Healthy volunteersNot accepted
ConditionObesity in Pregnancy, Labor Complication

Full registry criteria

Inclusion Criteria: * 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 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 azithromycin or beta-lactam antibiotics

Treatments and study arms

Azithromycin

Drug

Azithromycin 500 milligrams intravenously once and cefazolin 2 grams intravenously every 8 hours for up to three doses

Placebo

Drug

Placebo given in place of other two active drugs

Primary outcomes

Rate of cesarean delivery30 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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Oklahoma Health Sciences Center🇺🇸 Oklahoma City, Oklahoma, United States
Christy Zornes, MHRContact
Kyra Woods, BAContact
Stephanie Pierce, MDPrincipal Investigator