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

Phase

Condition

Obesity

Diabetes Prevention

Treatment

Placebo

Azithromycin

Clinical Study ID

NCT06488781

APPOINT 2.0

Ages 15-45
Female

Study 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.

Eligibility Criteria

Inclusion

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

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 laborinduction
Previous myometrial surgery
Allergy to azithromycin or beta-lactam antibiotics

Study Design

Placebo

July 26, 2024

December 31, 2028

Study 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.

Connect with a study center

University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Active - Recruiting

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