Early Phase 1
N=186
Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term
Obesity · Induction of Labor Affected Fetus / Newborn
Bottom Line
View on ClinicalTrials.gov: NCT03801252 ↗Enrolled (actual)
186
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Number of Participants With Cesarean Delivery — 27; 37 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Cefazolin (Drug); Placebo (Drug); Azithromycin (Drug)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- Female
- Sponsor
- University of Oklahoma
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Cesarean Delivery |
27; 37 | — |
| PRIMARY Number of Participants With Puerperal Infections |
8; 9 | — |
| SECONDARY Number of Participants With Postpartum Hemorrhage |
16; 16 | — |
| SECONDARY Number of Participants Who Underwent A Blood Transfusion |
4; 4 | — |
| SECONDARY Number of Participants With ICU Admission |
1; 0 | — |
| SECONDARY Number of Participants With Maternal Hospital Readmission |
1; 2 | — |
| SECONDARY Primary Indications for Cesarean Delivery |
12; 14; 11; 11; 2; 6 | — |
| SECONDARY Neonatal Outcomes |
11; 10; 8; 7; 1; 3 | — |
Summary
Obesity increases the risk of pregnancy complications, including among others puerperal infections and cesarean delivery, and risk rises with increasing body mass index (BMI). Class III obesity is an indication for delivery by 39 weeks, and 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 morbidity and a lower cesarean rate. Antibiotic prophylaxis, standard before cesarean delivery, is associated with less post-cesarean infection if azithromycin is added to the standard cefazolin. In this placebo-controlled pilot trial, investigators will estimate the parameters necessary to calculate the sample size for a planned multicenter clinical trial of prophylactic antibiotics administered at the start of labor inductions of morbidly obese nulliparous women at term.
Eligibility 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
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 either drug used in the protocol (cefazolin or azithromycin)
Data sourced from ClinicalTrials.gov (NCT03801252). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.