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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cefazolin + Azithromycin | Experimental | 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 |
|
| Placebo + Placebo | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cefazolin | Drug | intravenous drugs used as prophylactic antibiotics |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Cesarean Delivery | Rate at which women give birth via cesarean section | 30 days after delivery |
| Number of Participants With Puerperal Infections | Chorioamnionitis, endometritis and/or cesarean wound infection | 30 days after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Postpartum Hemorrhage | Experience of postpartum hemorrhage | 30 days after delivery |
| Number of Participants Who Underwent A Blood Transfusion | Need of a blood transfusion |
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Inclusion Criteria:
Exclusion Criteria:
Women of child-bearing age
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie Pierce, MD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35728781 | Derived | Pierce SL, Peck JD, Zornes C, Standerfer E, Edwards RK. Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term: a pilot randomized controlled trial. Am J Obstet Gynecol MFM. 2022 Sep;4(5):100681. doi: 10.1016/j.ajogmf.2022.100681. Epub 2022 Jun 18. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cefazolin + Azithromycin | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Cesarean Delivery | Rate at which women give birth via cesarean section | Posted | Count of Participants | Participants | 30 days after delivery |
|
30 days after delivery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomitting | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stephanie Pierce | University of Oklahoma Health Sciences Center | (405) 271-8787 | stephanie-pierce@ouhsc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 2, 2020 | Nov 28, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 14, 2020 | Nov 28, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D002437 | Cefazolin |
| D012965 | Sodium Chloride |
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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Randomized controlled clinical trial
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One arm includes double placebo drugs that will be blinded from the investigator and participant
| Placebo |
| Drug |
Intravenous saline |
|
|
| Azithromycin | Drug | prophylactic antibiotic |
|
| 30 days after delivery |
| Number of Participants With ICU Admission | Intensive care unit admission | 30 days after delivery |
| Number of Participants With Maternal Hospital Readmission | Maternal hospital readmission within 30 days after delivery | 30 days after delivery |
| Primary Indications for Cesarean Delivery | Nonreassuring fetal status, failed induction, active-phase arrest, second-stage arrest, or other | 30 days after delivery |
| Neonatal Outcomes | Neonatal complications | 30 days after delivery |
| BG001 |
| Placebo + Placebo |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI ≥30 | Count of Participants | Participants |
|
| Gestational age 37 weeks or more | Mean | Standard Deviation | days |
|
| Chronic hypertension | Count of Participants | Participants |
|
| Gestational hypertension | Count of Participants | Participants |
|
| Preeclampsia | Count of Participants | Participants |
|
| Diabetes mellitus | Count of Participants | Participants |
|
| Fetal growth restriction | Count of Participants | Participants |
|
|
|
| Primary | Number of Participants With Puerperal Infections | Chorioamnionitis, endometritis and/or cesarean wound infection | Posted | Count of Participants | Participants | 30 days after delivery |
|
|
|
| Secondary | Number of Participants With Postpartum Hemorrhage | Experience of postpartum hemorrhage | Posted | Count of Participants | Participants | 30 days after delivery |
|
|
|
| Secondary | Number of Participants Who Underwent A Blood Transfusion | Need of a blood transfusion | Posted | Count of Participants | Participants | 30 days after delivery |
|
|
|
| Secondary | Number of Participants With ICU Admission | Intensive care unit admission | Posted | Count of Participants | Participants | 30 days after delivery |
|
|
|
| Secondary | Number of Participants With Maternal Hospital Readmission | Maternal hospital readmission within 30 days after delivery | Posted | Count of Participants | Participants | 30 days after delivery |
|
|
|
| Secondary | Primary Indications for Cesarean Delivery | Nonreassuring fetal status, failed induction, active-phase arrest, second-stage arrest, or other | Posted | Count of Participants | Participants | 30 days after delivery |
|
|
|
| Secondary | Neonatal Outcomes | Neonatal complications | Posted | Count of Participants | Participants | 30 days after delivery |
|
|
|
| 0 |
| 93 |
| 0 |
| 93 |
| 4 |
| 93 |
| EG001 | 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 | 0 | 93 | 0 | 93 | 0 | 93 |
| NICU admission | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Postpartum preeclampsia/readmission | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| Active-phase arrest |
|
| Second-stage arrest |
|
| Other |
|
| Intubation required within first 72 hours |
|
| Hyperbilirubinemia requiring phototherapy |
|
| Suspected or confirmed sepsis |
|
| Culture with organisms identified |
|
| Necrotizing enterocolitis |
|
| Periventricular leukomalacia |
|
| Intraventricular hemorrhage grade III or higher |
|
| Neonatal death |
|
| Neonatal complications composite |
|