Trial Outcomes & Findings for Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term (NCT NCT03801252)
NCT ID: NCT03801252
Last Updated: 2024-04-19
Results Overview
Rate at which women give birth via cesarean section
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
186 participants
Primary outcome timeframe
30 days after delivery
Results posted on
2024-04-19
Participant Flow
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.
Participant milestones
| Measure |
Cefazolin + Azithromycin
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
Cefazolin: intravenous drugs used as prophylactic antibiotics
Azithromycin: prophylactic antibiotic
|
Placebo + Placebo
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
Placebo: Intravenous saline
|
|---|---|---|
|
Overall Study
STARTED
|
93
|
93
|
|
Overall Study
COMPLETED
|
92
|
91
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Cefazolin + Azithromycin
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
Cefazolin: intravenous drugs used as prophylactic antibiotics
Azithromycin: prophylactic antibiotic
|
Placebo + Placebo
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
Placebo: Intravenous saline
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
2
|
Baseline Characteristics
Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term
Baseline characteristics by cohort
| Measure |
Cefazolin + Azithromycin
n=93 Participants
Women were 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
Cefazolin: intravenous drugs used as prophylactic antibiotics
Azithromycin: prophylactic antibiotic
|
Placebo + Placebo
n=93 Participants
Women were 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
Placebo: Intravenous saline
|
Total
n=186 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age (y)
|
26.9 years
STANDARD_DEVIATION 5.6 • n=99 Participants
|
25.3 years
STANDARD_DEVIATION 5.2 • n=107 Participants
|
26.1 years
STANDARD_DEVIATION 5.4 • n=206 Participants
|
|
Sex/Gender, Customized
Female participants
|
93 Participants
n=99 Participants
|
93 Participants
n=107 Participants
|
186 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity · White
|
57 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
103 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity · Black
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity · Hispanic
|
16 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity · Asian
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity · Native American
|
7 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity · Other
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity · Not reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
93 participants
n=99 Participants
|
93 participants
n=107 Participants
|
186 participants
n=206 Participants
|
|
BMI ≥30
Class I (BMI, 30-34 kg/m^2)
|
19 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
BMI ≥30
Class II (BMI, 35-39 kg/m^2)
|
23 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
BMI ≥30
Class III (BMI, ≥40 kg/m^2)
|
51 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
101 Participants
n=206 Participants
|
|
Gestational age 37 weeks or more
|
271.4 days
STANDARD_DEVIATION 8.4 • n=99 Participants
|
271.7 days
STANDARD_DEVIATION 6.2 • n=107 Participants
|
271.6 days
STANDARD_DEVIATION 7.3 • n=206 Participants
|
|
Chronic hypertension
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Gestational hypertension
|
32 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Preeclampsia
|
19 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Diabetes mellitus
Gestational
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Diabetes mellitus
Pregestational
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Fetal growth restriction
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 30 days after deliveryRate at which women give birth via cesarean section
Outcome measures
| Measure |
Cefazolin + Azithromycin
n=93 Participants
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
Cefazolin: intravenous drugs used as prophylactic antibiotics
Azithromycin: prophylactic antibiotic
|
Placebo + Placebo
n=93 Participants
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
Placebo: Intravenous saline
|
|---|---|---|
|
Number of Participants With Cesarean Delivery
|
27 Participants
|
37 Participants
|
PRIMARY outcome
Timeframe: 30 days after deliveryChorioamnionitis, endometritis and/or cesarean wound infection
Outcome measures
| Measure |
Cefazolin + Azithromycin
n=93 Participants
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
Cefazolin: intravenous drugs used as prophylactic antibiotics
Azithromycin: prophylactic antibiotic
|
Placebo + Placebo
n=93 Participants
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
Placebo: Intravenous saline
|
|---|---|---|
|
Number of Participants With Puerperal Infections
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 30 days after deliveryExperience of postpartum hemorrhage
Outcome measures
| Measure |
Cefazolin + Azithromycin
n=93 Participants
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
Cefazolin: intravenous drugs used as prophylactic antibiotics
Azithromycin: prophylactic antibiotic
|
Placebo + Placebo
n=93 Participants
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
Placebo: Intravenous saline
|
|---|---|---|
|
Number of Participants With Postpartum Hemorrhage
|
16 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 30 days after deliveryNeed of a blood transfusion
Outcome measures
| Measure |
Cefazolin + Azithromycin
n=93 Participants
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
Cefazolin: intravenous drugs used as prophylactic antibiotics
Azithromycin: prophylactic antibiotic
|
Placebo + Placebo
n=93 Participants
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
Placebo: Intravenous saline
|
|---|---|---|
|
Number of Participants Who Underwent A Blood Transfusion
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 30 days after deliveryIntensive care unit admission
Outcome measures
| Measure |
Cefazolin + Azithromycin
n=93 Participants
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
Cefazolin: intravenous drugs used as prophylactic antibiotics
Azithromycin: prophylactic antibiotic
|
Placebo + Placebo
n=93 Participants
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
Placebo: Intravenous saline
|
|---|---|---|
|
Number of Participants With ICU Admission
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 days after deliveryMaternal hospital readmission within 30 days after delivery
Outcome measures
| Measure |
Cefazolin + Azithromycin
n=93 Participants
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
Cefazolin: intravenous drugs used as prophylactic antibiotics
Azithromycin: prophylactic antibiotic
|
Placebo + Placebo
n=93 Participants
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
Placebo: Intravenous saline
|
|---|---|---|
|
Number of Participants With Maternal Hospital Readmission
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 30 days after deliveryNonreassuring fetal status, failed induction, active-phase arrest, second-stage arrest, or other
Outcome measures
| Measure |
Cefazolin + Azithromycin
n=27 Participants
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
Cefazolin: intravenous drugs used as prophylactic antibiotics
Azithromycin: prophylactic antibiotic
|
Placebo + Placebo
n=37 Participants
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
Placebo: Intravenous saline
|
|---|---|---|
|
Primary Indications for Cesarean Delivery
Nonreassuring fetal status
|
12 Participants
|
14 Participants
|
|
Primary Indications for Cesarean Delivery
Failed induction
|
11 Participants
|
11 Participants
|
|
Primary Indications for Cesarean Delivery
Active-phase arrest
|
2 Participants
|
6 Participants
|
|
Primary Indications for Cesarean Delivery
Second-stage arrest
|
1 Participants
|
4 Participants
|
|
Primary Indications for Cesarean Delivery
Other
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 30 days after deliveryNeonatal complications
Outcome measures
| Measure |
Cefazolin + Azithromycin
n=93 Participants
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
Cefazolin: intravenous drugs used as prophylactic antibiotics
Azithromycin: prophylactic antibiotic
|
Placebo + Placebo
n=93 Participants
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
Placebo: Intravenous saline
|
|---|---|---|
|
Neonatal Outcomes
Intubation required within first 72 hours
|
1 Participants
|
3 Participants
|
|
Neonatal Outcomes
NICU admission
|
11 Participants
|
10 Participants
|
|
Neonatal Outcomes
Respiratory distress syndrome
|
8 Participants
|
7 Participants
|
|
Neonatal Outcomes
Hyperbilirubinemia requiring phototherapy
|
41 Participants
|
37 Participants
|
|
Neonatal Outcomes
Suspected or confirmed sepsis
|
11 Participants
|
8 Participants
|
|
Neonatal Outcomes
Culture with organisms identified
|
0 Participants
|
0 Participants
|
|
Neonatal Outcomes
Necrotizing enterocolitis
|
0 Participants
|
0 Participants
|
|
Neonatal Outcomes
Periventricular leukomalacia
|
0 Participants
|
0 Participants
|
|
Neonatal Outcomes
Intraventricular hemorrhage grade III or higher
|
0 Participants
|
0 Participants
|
|
Neonatal Outcomes
Neonatal death
|
0 Participants
|
0 Participants
|
|
Neonatal Outcomes
Neonatal complications composite
|
50 Participants
|
42 Participants
|
Adverse Events
Cefazolin + Azithromycin
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo + Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cefazolin + Azithromycin
n=93 participants at risk
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
Cefazolin: intravenous drugs used as prophylactic antibiotics
Azithromycin: prophylactic antibiotic
|
Placebo + Placebo
n=93 participants at risk
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
Placebo: Intravenous saline
|
|---|---|---|
|
Gastrointestinal disorders
Vomitting
|
1.1%
1/93 • Number of events 1 • 30 days after delivery
|
0.00%
0/93 • 30 days after delivery
|
|
Pregnancy, puerperium and perinatal conditions
NICU admission
|
2.2%
2/93 • Number of events 2 • 30 days after delivery
|
0.00%
0/93 • 30 days after delivery
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum preeclampsia/readmission
|
1.1%
1/93 • Number of events 1 • 30 days after delivery
|
0.00%
0/93 • 30 days after delivery
|
Additional Information
Dr. Stephanie Pierce
University of Oklahoma Health Sciences Center
Phone: (405) 271-8787
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place