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Pregnant patients with obesity are more likely to undergo induction of labor and have a higher risk of failed induction compared to patients with normal weight. The association between maternal obesity and labor dysfunction leading to cesarean delivery is poorly understood. Oxytocin is the mostly common medication used in induction of labor, yet optimal dosing of this medication is unknown. Studies have suggested that patients with obesity may be less responsive to oxytocin. This trial will compare a high and low dose oxytocin dosing regimen for the induction of labor in women with obesity.
This study is a pragmatic single center randomized, double blinded controlled trial. Nulliparous women with a pre-pregnancy body mass index (BMI) ≥30 kg/m2 undergoing induction of labor at ≥37 weeks' gestation will be eligible for enrollment. Women will be randomly allocated to receive oxytocin using either a high-dose or low-dose regimen. Patients, providers, and research staff will be blinded to the dosing regimen. All other aspects of obstetric management will be at the discretion of the patient's clinical care team.
Postpartum maternal, neonatal, and delivery outcomes will be collected. Postpartum data through hospital discharge will be collected from the medical record. Information about complications following hospital discharge through 6 weeks after delivery will be collected during a research follow-up telephone call performed 6-8 weeks following delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-dose oxytocin regimen | Experimental | Starting dose 6 mU/min and increased by 6 mU/min every 30 minutes until adequate contractions achieved, at the discretion of the obstetric providers. |
|
| Low-dose oxytocin regimen | Experimental | Starting dose 2 mU/min and increased by 2 mU/min every 30 minutes until adequate contractions achieved, at the discretion of the obstetric providers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-dose oxytocin | Drug | Starting dose 6 mU/min and increased by 6 mU/min every 30 minutes until adequate contractions achieved, at the discretion of the obstetric providers. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Delivered by Cesarean | Until delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Time From Start of Induction to Delivery | Time from start of induction with medication or Foley catheter until delivery | From start of induction to delivery |
| Duration of the First Stage of Labor |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine | Columbus | Ohio | 43210 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | High-dose Oxytocin Regimen | Starting dose 6 mU/min and increased by 6 mU/min every 30 minutes until adequate contractions achieved, at the discretion of the obstetric providers. High-dose oxytocin: Starting dose 6 mU/min and increased by 6 mU/min every 30 minutes until adequate contractions achieved, at the discretion of the obstetric providers. |
| FG001 | Low-dose Oxytocin Regimen | Starting dose 2 mU/min and increased by 2 mU/min every 30 minutes until adequate contractions achieved, at the discretion of the obstetric providers. Low-dose oxytocin: Starting dose 2 mU/min and increased by 2 mU/min every 30 minutes until adequate contractions achieved, at the discretion of the obstetric providers. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High-dose | Group randomized to high-dose oxytocin regimen |
| BG001 | Low-dose | Group randomized to low-dose oxytocin regimen |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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 Delivered by Cesarean | Posted | Count of Participants | Participants | Until delivery |
|
|
6 weeks following delivery
An adverse event (AE) will be defined as any untoward or unfavorable medical occurrence in a study participant, whether or not considered related to the subject's participation in the research.
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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 | High-dose | Group randomized to high-dose oxytocin regimen | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospital readmission | Investigations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather Frey, MD, MSCI | The Ohio State University | 614-688-6798 | Heather.Frey@osumc.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 21, 2022 | Dec 24, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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Participants, research staff, and clinical care providers will be blinded to the dosing regimen.
| Low-dose oxytocin | Drug | Starting dose 2 mU/min and increased by 2 mU/min every 30 minutes until adequate contractions achieved, at the discretion of the obstetric providers. |
|
Time from start of labor to complete dilation
| From start of induction to delivery |
| Occurrence of Tachysystole | Defined as more than 5 contractions in 10 minutes averaged over 30 minutes | From start of induction to delivery |
| Incidence of Uterine Rupture | Defined as a complete disruption of all uterine layers including serosa | From start of induction to delivery |
| Incidence of Clinical Chorioamnionitis | Defined based on clinical diagnosis as documented by the clinical care team | From start of induction thorough delivery |
| Incidence of Postpartum Maternal Infectious Morbidity | Defined as a composite outcome of endomyometritis, puerperal sepsis, or surgical site infection as documented in the the clinical record | Within 6 weeks following delivery |
| Incidence of Maternal Death | Within 6 weeks of delivery |
| Incidence of Immediate Postpartum Hemorrhage | Defined as >1000 mL of blood loss within 24 hours of delivery | Within 24 hours of delivery |
| Incidence of Maternal Blood Transfusion | Defined as need for blood transfusion | From randomization through hospital discharge up to 6 weeks portpartum |
| Incidence of Maternal ICU Admission | From randomization through 6 weeks postpartum |
| Incidence of Composite Neonatal Morbidity Outcomes | Apgar score <5 at 5 min, arterial cord pH <7.0 or base deficit >12 mmol/dL, perinatal death | Within 6 weeks of delivery |
| Incidence of NICU Admission | Within 6 weeks of delivery |
| Maternal Length of Stay | Duration of hospitalization for delivery | Within 6 weeks of delivery |
| Neonatal Length of Stay | Duration of birth hospitalization | Within 6 weeks of delivery |
| Perception of the Labor, Birth, and Postpartum Experience | Patient perception as measured using the validated Childbirth Perception Scale. This is a 12-item instrument developed to assess a patient's perception of the labor and delivery experience. Each item is formatted on a four-point scale ranging from 0 to 3. The overall range in total score is 1-36 with higher scores indicating a less positive perception. | Assessed within 12-96 hours after delivery |
| Labor Agentry Score | Patient perception of labor agentry as measured using validated Labor Agentry Scale. This 29-item tool was developed to assess a patient's expectancies and experiences with control in labor. Each item is scored 1 to 7. Overall total score can range from 29-201 with higher scores indicated greater perceived control during childbirth. | Assessed within 12-96 hours after delivery |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Delivery BMI, Continuous | Median | Inter-Quartile Range | kg/m^2 |
|
| Delivery BMI ≥40 | Count of Participants | Participants |
|
| Gestational age, continuous | Median | Inter-Quartile Range | weeks |
|
| Admission Bishop score <5 | Count of Participants | Participants |
|
| Maximum oxytocin dose | Median | Full Range | mu/min |
|
|
| Secondary | Duration of Time From Start of Induction to Delivery | Time from start of induction with medication or Foley catheter until delivery | Posted | Median | Inter-Quartile Range | hours | From start of induction to delivery |
|
|
|
| Secondary | Duration of the First Stage of Labor | Time from start of labor to complete dilation | Posted | Median | Inter-Quartile Range | hours | From start of induction to delivery |
|
|
|
| Secondary | Occurrence of Tachysystole | Defined as more than 5 contractions in 10 minutes averaged over 30 minutes | Posted | Count of Participants | Participants | From start of induction to delivery |
|
|
|
| Secondary | Incidence of Uterine Rupture | Defined as a complete disruption of all uterine layers including serosa | Posted | Count of Participants | Participants | From start of induction to delivery |
|
|
|
| Secondary | Incidence of Clinical Chorioamnionitis | Defined based on clinical diagnosis as documented by the clinical care team | Posted | Count of Participants | Participants | From start of induction thorough delivery |
|
|
|
| Secondary | Incidence of Postpartum Maternal Infectious Morbidity | Defined as a composite outcome of endomyometritis, puerperal sepsis, or surgical site infection as documented in the the clinical record | Posted | Count of Participants | Participants | Within 6 weeks following delivery |
|
|
|
| Secondary | Incidence of Maternal Death | Posted | Count of Participants | Participants | Within 6 weeks of delivery |
|
|
|
| Secondary | Incidence of Immediate Postpartum Hemorrhage | Defined as >1000 mL of blood loss within 24 hours of delivery | Posted | Count of Participants | Participants | Within 24 hours of delivery |
|
|
|
| Secondary | Incidence of Maternal Blood Transfusion | Defined as need for blood transfusion | Posted | Count of Participants | Participants | From randomization through hospital discharge up to 6 weeks portpartum |
|
|
|
| Secondary | Incidence of Maternal ICU Admission | Posted | Count of Participants | Participants | From randomization through 6 weeks postpartum |
|
|
|
| Secondary | Incidence of Composite Neonatal Morbidity Outcomes | Apgar score <5 at 5 min, arterial cord pH <7.0 or base deficit >12 mmol/dL, perinatal death | Posted | Count of Participants | Participants | Within 6 weeks of delivery |
|
|
|
| Secondary | Incidence of NICU Admission | Posted | Count of Participants | Participants | Within 6 weeks of delivery |
|
|
|
| Secondary | Maternal Length of Stay | Duration of hospitalization for delivery | Posted | Median | Full Range | days | Within 6 weeks of delivery |
|
|
|
| Secondary | Neonatal Length of Stay | Duration of birth hospitalization | Posted | Median | Full Range | days | Within 6 weeks of delivery |
|
|
|
| Secondary | Perception of the Labor, Birth, and Postpartum Experience | Patient perception as measured using the validated Childbirth Perception Scale. This is a 12-item instrument developed to assess a patient's perception of the labor and delivery experience. Each item is formatted on a four-point scale ranging from 0 to 3. The overall range in total score is 1-36 with higher scores indicating a less positive perception. | Posted | Median | Inter-Quartile Range | score on a scale | Assessed within 12-96 hours after delivery |
|
|
|
| Secondary | Labor Agentry Score | Patient perception of labor agentry as measured using validated Labor Agentry Scale. This 29-item tool was developed to assess a patient's expectancies and experiences with control in labor. Each item is scored 1 to 7. Overall total score can range from 29-201 with higher scores indicated greater perceived control during childbirth. | Posted | Median | Inter-Quartile Range | score on a scale | Assessed within 12-96 hours after delivery |
|
|
|
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Low-dose | Group randomized to low-dose oxytocin regimen | 0 | 10 | 0 | 10 | 3 | 10 |
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| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |