An Early Phase 1 interventional study of Cefazolin and Placebo in Obesity and Induction of Labor Affected Fetus / Newborn, sponsored by University of Oklahoma. Completed at 1 site in United States. Open to female participants aged 15 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-19.
Sponsored by University of Oklahoma · Early Phase 1, Interventional, and Treatment
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.
Investigators will enroll consenting women delivering at The Children's Hospital at OU Medical Center who meet enrollment criteria. Flyers will be distributed to providers to give to women who may be eligible for the study at prenatal visits, so that they may review the information prior to presenting for their induction of labor. Labor induction may be a scheduled procedure. However, many inductions occur in an unscheduled fashion due to medical or obstetric indications. Therefore, it is difficult to predict which women will ultimately require labor induction and at what gestational age they will require it, so it is not feasible to approach and consent all women during a clinic visit prior to labor induction. Distribution of flyers will allow patients to have information about the study prior to presenting for labor induction. Furthermore, unlike women in spontaneous labor, women being consented just prior to a labor induction are not vulnerable in the same way as one might consider a patient in labor, since they will not have the distraction and discomfort of uterine contractions that are presenting in laboring patients.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 186 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →University of Oklahoma is the lead sponsor of 424 studies on the registry; 99 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Women will be randomized 1:1 to receive cefazolin 2 grams intravenously at the start of the labor induction and every 8 hours thereafter for a maximum of three doses and azithromycin 500 mg intravenously once at the start of the labor induction
Drug: Cefazolin · Drug: Azithromycin
Women will be randomized 1:1 to receive placebo intravenously at the start of the labor induction and every 8 hours thereafter for a maximum of three doses and placebo intravenously once at the start of the labor induction
Drug: Placebo
intravenous drugs used as prophylactic antibiotics
Intravenous saline
Also known as: Saline
prophylactic antibiotic
Number of Participants With Cesarean Delivery
Rate at which women give birth via cesarean section
Time frame: 30 days after delivery
Number of Participants With Puerperal Infections
Chorioamnionitis, endometritis and/or cesarean wound infection
Time frame: 30 days after delivery
Number of Participants With Postpartum Hemorrhage
Experience of postpartum hemorrhage
Time frame: 30 days after delivery
Number of Participants Who Underwent A Blood Transfusion
Need of a blood transfusion
Time frame: 30 days after delivery
Number of Participants With ICU Admission
Intensive care unit admission
Time frame: 30 days after delivery
Number of Participants With Maternal Hospital Readmission
Maternal hospital readmission within 30 days after delivery
Time frame: 30 days after delivery
Primary Indications for Cesarean Delivery
Nonreassuring fetal status, failed induction, active-phase arrest, second-stage arrest, or other
Time frame: 30 days after delivery
Neonatal Outcomes
Neonatal complications
Time frame: 30 days after delivery
Researchers enrolled women delivering at The Children's Hospital at OU Medical Center who met enrollment criteria and consented to study participation. Patients were given information about the study during a third trimester prenatal care visit. However, they were enrolled in the hospital before their labor induction is started.
| Milestone | Cefazolin + Azithromycin | Placebo + Placebo |
|---|---|---|
| Started | 93 | 93 |
| Completed | 92 | 91 |
| Not completed | 1 | 2 |
| Withdrew: Protocol violation | 1 | 2 |
Rate at which women give birth via cesarean section
| Participants | Cefazolin + Azithromycin | Placebo + Placebo |
|---|---|---|
| Number of Participants With Cesarean Delivery | 27 | 37 |
Chorioamnionitis, endometritis and/or cesarean wound infection
| Participants | Cefazolin + Azithromycin | Placebo + Placebo |
|---|---|---|
| Number of Participants With Puerperal Infections | 8 | 9 |
Experience of postpartum hemorrhage
| Participants | Cefazolin + Azithromycin | Placebo + Placebo |
|---|---|---|
| Number of Participants With Postpartum Hemorrhage | 16 | 16 |
Need of a blood transfusion
| Participants | Cefazolin + Azithromycin | Placebo + Placebo |
|---|---|---|
| Number of Participants Who Underwent A Blood Transfusion | 4 | 4 |
Intensive care unit admission
| Participants | Cefazolin + Azithromycin | Placebo + Placebo |
|---|---|---|
| Number of Participants With ICU Admission | 1 | 0 |
Maternal hospital readmission within 30 days after delivery
| Participants | Cefazolin + Azithromycin | Placebo + Placebo |
|---|---|---|
| Number of Participants With Maternal Hospital Readmission | 1 | 2 |
Nonreassuring fetal status, failed induction, active-phase arrest, second-stage arrest, or other
| Participants | Cefazolin + Azithromycin | Placebo + Placebo |
|---|---|---|
| Nonreassuring fetal status | 12 | 14 |
| Failed induction | 11 | 11 |
| Active-phase arrest | 2 | 6 |
| Second-stage arrest | 1 | 4 |
| Other | 1 | 2 |
Neonatal complications
| Participants | Cefazolin + Azithromycin | Placebo + Placebo |
|---|---|---|
| NICU admission | 11 | 10 |
| Respiratory distress syndrome | 8 | 7 |
| Intubation required within first 72 hours | 1 | 3 |
| Hyperbilirubinemia requiring phototherapy | 41 | 37 |
| Suspected or confirmed sepsis | 11 | 8 |
| Culture with organisms identified | 0 | 0 |
| Necrotizing enterocolitis | 0 | 0 |
| Periventricular leukomalacia | 0 | 0 |
| Intraventricular hemorrhage grade III or higher | 0 | 0 |
| Neonatal death | 0 | 0 |
| Neonatal complications composite | 50 | 42 |
Collected over 30 days after delivery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cefazolin + Azithromycin | 0/93 (0%) | 0/93 (0%) | 4/93 (4.3%) |
| Placebo + Placebo | 0/93 (0%) | 0/93 (0%) | 0/93 (0%) |
| Event | Cefazolin + Azithromycin | Placebo + Placebo |
|---|---|---|
| NICU admissionPregnancy, puerperium and perinatal conditions | 2/93 | 0/93 |
| VomittingGastrointestinal disorders | 1/93 | 0/93 |
| Postpartum preeclampsia/readmissionPregnancy, puerperium and perinatal conditions | 1/93 | 0/93 |
| Age, Customized(years) | Cefazolin + Azithromycin | Placebo + Placebo | Total |
|---|---|---|---|
| Age (y) | 26.9 ± 5.6 | 25.3 ± 5.2 | 26.1 ± 5.4 |
| Sex/Gender, Customized(Participants) | Cefazolin + Azithromycin | Placebo + Placebo | Total |
|---|---|---|---|
| Female participants | 93 | 93 | 186 |
| Race/Ethnicity, Customized(Participants) | Cefazolin + Azithromycin | Placebo + Placebo | Total |
|---|---|---|---|
| Race and ethnicity — White | 57 | 46 | 103 |
| Race and ethnicity — Black | 7 | 9 | 16 |
| Race and ethnicity — Hispanic | 16 | 18 | 34 |
| Race and ethnicity — Asian | 4 | 2 | 6 |
| Race and ethnicity — Native American | 7 | 11 | 18 |
| Race and ethnicity — Other | 2 | 5 | 7 |
| Race and ethnicity — Not reported | 0 | 2 | 2 |
| Region of Enrollment(participants) | Cefazolin + Azithromycin | Placebo + Placebo | Total |
|---|---|---|---|
| United States | 93 | 93 | 186 |
| BMI ≥30(Participants) | Cefazolin + Azithromycin | Placebo + Placebo | Total |
|---|---|---|---|
| Class I (BMI, 30-34 kg/m^2) | 19 | 19 | 38 |
| Class II (BMI, 35-39 kg/m^2) | 23 | 24 | 47 |
| Class III (BMI, ≥40 kg/m^2) | 51 | 50 | 101 |
| Gestational age 37 weeks or more(days) | Cefazolin + Azithromycin | Placebo + Placebo | Total |
|---|---|---|---|
| Mean | 271.4 ± 8.4 | 271.7 ± 6.2 | 271.6 ± 7.3 |
| Chronic hypertension(Participants) | Cefazolin + Azithromycin | Placebo + Placebo | Total |
|---|---|---|---|
| Count of participants | 9 | 8 | 17 |
| Gestational hypertension(Participants) | Cefazolin + Azithromycin | Placebo + Placebo | Total |
|---|---|---|---|
| Count of participants | 32 | 18 | 50 |
3 further baseline measures are reported on the registry.
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University of Oklahoma