Pregnant Patients With Obesity
Conditions
Keywords
Oxytocin, Pregnant patients with obesity, Induction of labor
Brief summary
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.
Detailed description
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.
Interventions
DRUGHigh-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.
DRUGLow-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.
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Participants, research staff, and clinical care providers will be blinded to the dosing regimen.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Nulliparity 2. Maternal age \>18 years 3. Gestational age ≥37w0d 4. Induction of labor, defined as initiation of labor with medication or intracervical Foley catheter in a patient without observed spontaneous cervical change and \<6 contractions per hour (average of one contraction every 10 minutes) at the time of initial presentation. Women with prelabor rupture of membranes (PROM) can be included if the other criteria are also met with regards to cervical dilation and contractions. 5. Singleton gestation 6. Cephalic presentation 7. Indication for oxytocin use in the first stage of labor 8. No contraindication to labor or vaginal delivery 9. Pre-pregnancy BMI ≥30 kg/m2 based on patient report and confirmed by pre-pregnancy or first trimester weight as recorded in the medical record 10. Cervical dilation ≤4 cm at time of initiation of induction
Exclusion criteria
1. Fetal demise 2. Major fetal congenital malformation or known chromosomal abnormality 3. Prior uterine surgery (e.g., cesarean, myomectomy) 4. Non-reassuring fetal wellbeing as indication for induction 5. Intraamniotic infection suspected or diagnosed prior to randomization 6. Non-English 7. Multifetal gestation 8. Gestational age \<37 weeks 9. Spontaneous labor 10. Cervical dilation \> 4 cm at initiation of induction 11. Initiation of oxytocin in the second stage of labor 12. Use of oxytocin prior to randomization or planned use of oxytocin with foley catheter for cervical ripening 13. Fetal malpresentation 14. Estimated fetal weight \>4500 g in a patient with diabetes, or estimated fetal weight \>5000 g in a non-diabetic patient 15. Abnormal placentation (e.g. previa, suspected placenta accreta spectrum) 16. Physician/provider or patient refusal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Delivered by Cesarean | Until delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of the First Stage of Labor | From start of induction to delivery | Time from start of labor to complete dilation |
| Occurrence of Tachysystole | From start of induction to delivery | Defined as more than 5 contractions in 10 minutes averaged over 30 minutes |
| Incidence of Uterine Rupture | From start of induction to delivery | Defined as a complete disruption of all uterine layers including serosa |
| Incidence of Clinical Chorioamnionitis | From start of induction thorough delivery | Defined based on clinical diagnosis as documented by the clinical care team |
| Incidence of Postpartum Maternal Infectious Morbidity | Within 6 weeks following delivery | Defined as a composite outcome of endomyometritis, puerperal sepsis, or surgical site infection as documented in the the clinical record |
| Incidence of Maternal Death | Within 6 weeks of delivery | — |
| Incidence of Immediate Postpartum Hemorrhage | Within 24 hours of delivery | Defined as \>1000 mL of blood loss within 24 hours of delivery |
| Duration of Time From Start of Induction to Delivery | From start of induction to delivery | Time from start of induction with medication or Foley catheter until delivery |
| Incidence of Maternal ICU Admission | From randomization through 6 weeks postpartum | — |
| Incidence of Composite Neonatal Morbidity Outcomes | Within 6 weeks of delivery | Apgar score \<5 at 5 min, arterial cord pH \<7.0 or base deficit \>12 mmol/dL, perinatal death |
| Incidence of NICU Admission | Within 6 weeks of delivery | — |
| Maternal Length of Stay | Within 6 weeks of delivery | Duration of hospitalization for delivery |
| Neonatal Length of Stay | Within 6 weeks of delivery | Duration of birth hospitalization |
| Perception of the Labor, Birth, and Postpartum Experience | Assessed within 12-96 hours after delivery | 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. |
| Labor Agentry Score | Assessed within 12-96 hours after delivery | 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. |
| Incidence of Maternal Blood Transfusion | From randomization through hospital discharge up to 6 weeks portpartum | Defined as need for blood transfusion |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| High-dose Group randomized to high-dose oxytocin regimen | 10 |
| Low-dose Group randomized to low-dose oxytocin regimen | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | High-dose | Total | Low-dose |
|---|---|---|---|
| Admission Bishop score <5 | 8 Participants | 15 Participants | 7 Participants |
| Age, Continuous Maternal age | 25.5 years STANDARD_DEVIATION 4.53 | 26.2 years STANDARD_DEVIATION 5.26 | 26.9 years STANDARD_DEVIATION 6.06 |
| Delivery BMI ≥40 | 6 Participants | 12 Participants | 6 Participants |
| Delivery BMI, Continuous | 41.8 kg/m^2 | 41.6 kg/m^2 | 41.4 kg/m^2 |
| Gestational age, continuous | 38.0 weeks | 38.7 weeks | 39.1 weeks |
| Maximum oxytocin dose | 16.5 mu/min | 13 mu/min | 10 mu/min |
| Race/Ethnicity, Customized Race/ethnicity Hispanic | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/ethnicity Non-Hispanic Black | 3 Participants | 4 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/ethnicity Non-Hispanic White | 7 Participants | 14 Participants | 7 Participants |
| Region of Enrollment United States | 10 participants | 20 participants | 10 participants |
| Sex: Female, Male Female | 10 Participants | 20 Participants | 10 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 3 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Number of Participants Delivered by Cesarean
Time frame: Until delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High-dose | Number of Participants Delivered by Cesarean | 3 Participants |
| Low-dose | Number of Participants Delivered by Cesarean | 3 Participants |
Secondary
Duration of the First Stage of Labor
Time from start of labor to complete dilation
Time frame: From start of induction to delivery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| High-dose | Duration of the First Stage of Labor | 17.3 hours |
| Low-dose | Duration of the First Stage of Labor | 21.4 hours |
Secondary
Duration of Time From Start of Induction to Delivery
Time from start of induction with medication or Foley catheter until delivery
Time frame: From start of induction to delivery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| High-dose | Duration of Time From Start of Induction to Delivery | 22.6 hours |
| Low-dose | Duration of Time From Start of Induction to Delivery | 24.7 hours |
Secondary
Incidence of Clinical Chorioamnionitis
Defined based on clinical diagnosis as documented by the clinical care team
Time frame: From start of induction thorough delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High-dose | Incidence of Clinical Chorioamnionitis | 3 Participants |
| Low-dose | Incidence of Clinical Chorioamnionitis | 1 Participants |
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
Time frame: Within 6 weeks of delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High-dose | Incidence of Composite Neonatal Morbidity Outcomes | 1 Participants |
| Low-dose | Incidence of Composite Neonatal Morbidity Outcomes | 1 Participants |
Secondary
Incidence of Immediate Postpartum Hemorrhage
Defined as \>1000 mL of blood loss within 24 hours of delivery
Time frame: Within 24 hours of delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High-dose | Incidence of Immediate Postpartum Hemorrhage | 0 Participants |
| Low-dose | Incidence of Immediate Postpartum Hemorrhage | 1 Participants |
Secondary
Incidence of Maternal Blood Transfusion
Defined as need for blood transfusion
Time frame: From randomization through hospital discharge up to 6 weeks portpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High-dose | Incidence of Maternal Blood Transfusion | 0 Participants |
| Low-dose | Incidence of Maternal Blood Transfusion | 1 Participants |
Secondary
Incidence of Maternal Death
Time frame: Within 6 weeks of delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High-dose | Incidence of Maternal Death | 0 Participants |
| Low-dose | Incidence of Maternal Death | 0 Participants |
Secondary
Incidence of Maternal ICU Admission
Time frame: From randomization through 6 weeks postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High-dose | Incidence of Maternal ICU Admission | 0 Participants |
| Low-dose | Incidence of Maternal ICU Admission | 0 Participants |
Secondary
Incidence of NICU Admission
Time frame: Within 6 weeks of delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High-dose | Incidence of NICU Admission | 1 Participants |
| Low-dose | Incidence of NICU Admission | 2 Participants |
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
Time frame: Within 6 weeks following delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High-dose | Incidence of Postpartum Maternal Infectious Morbidity | 0 Participants |
| Low-dose | Incidence of Postpartum Maternal Infectious Morbidity | 0 Participants |
Secondary
Incidence of Uterine Rupture
Defined as a complete disruption of all uterine layers including serosa
Time frame: From start of induction to delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High-dose | Incidence of Uterine Rupture | 0 Participants |
| Low-dose | Incidence of Uterine Rupture | 0 Participants |
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.
Time frame: Assessed within 12-96 hours after delivery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| High-dose | Labor Agentry Score | 139.5 score on a scale |
| Low-dose | Labor Agentry Score | 185 score on a scale |
Secondary
Maternal Length of Stay
Duration of hospitalization for delivery
Time frame: Within 6 weeks of delivery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| High-dose | Maternal Length of Stay | 3 days |
| Low-dose | Maternal Length of Stay | 3 days |
Secondary
Neonatal Length of Stay
Duration of birth hospitalization
Time frame: Within 6 weeks of delivery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| High-dose | Neonatal Length of Stay | 2 days |
| Low-dose | Neonatal Length of Stay | 2 days |
Secondary
Occurrence of Tachysystole
Defined as more than 5 contractions in 10 minutes averaged over 30 minutes
Time frame: From start of induction to delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High-dose | Occurrence of Tachysystole | 5 Participants |
| Low-dose | Occurrence of Tachysystole | 3 Participants |
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.
Time frame: Assessed within 12-96 hours after delivery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| High-dose | Perception of the Labor, Birth, and Postpartum Experience | 14 score on a scale |
| Low-dose | Perception of the Labor, Birth, and Postpartum Experience | 9 score on a scale |