Cesarean Delivery, Labor Induction, Obesity
Conditions
Brief summary
Obese pregnant women (BMI ≥ 30 kg/m2) are more likely than their normal-weight counterparts to require induction of labor because of increased rates of obstetric complications including pregnancy related hypertensive disorders, diabetes, and prolonged gestations. Several studies have shown that obese women experience increased labor duration and oxytocin needs when compared to normal-weight women. This in turn results in increased rates for unplanned cesarean delivery (CD) as a result of failed induction of labor (IOL), arrest disorders and non-reassuring fetal heart rate tracing, that is dose-dependent with increasing class of obesity. The investigators hypothesize that obese pregnant women and unfavorable cervix (Bishop score ≤ 6), IOL ≥ 24 weeks gestation using the Foley balloon plus vaginal misoprostol will result in reduced cesarean delivery rates when compared to vaginal misoprostol alone.
Detailed description
Nulliparous pregnant women at ≥ 32 weeks' gestation admitted to labor and delivery for IOL and who meet the inclusion and exclusion criteria will be approached by the research staff. Group 1 will be composed of women allocated to the Foley balloon plus misoprostol. These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team. Group 2 will be composed of women allocated to vaginal misoprostol-only. These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score \> 6), misoprostol administration will be discontinued. Similarly, further management will be left at the discretion of the labor team. In both groups, if IV oxytocin is indicated, it will be withheld until 4 hours after the last dose of misoprostol to prevent uterine hyperstimulation. Other aspects of labor management will be similar for both groups, including continuous electronic fetal monitoring with external Doppler device or fetal scalp electrode. Uterine contraction assessment will be performed with either an external tocodynamometer or an intrauterine pressure catheter.
Interventions
DRUGVaginal Misoprostol
DEVICEFoley Balloon + Vaginal Misoprostol
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Nulliparous women aged 18 or above * BMI ≥ 30 at the time of labor induction * Singleton gestation * Cephalic presentation (includes successful external cephalic version) * Intact fetal membranes * Unfavorable cervix (Bishop score of ≤ 6) * Gestational age ≥ 32 weeks
Exclusion criteria
* Patient not candidate for IOL with misoprostol as deemed by the treating physician * Multiple gestation * Major fetal anomalies * Fetal demise
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With a Need for Cesarean Delivery | Induction to delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Induction-to-delivery Interval in Hours | Induction to delivery | — |
| Number of Participants With a Need for Oxytocin Augmentation | Induction to delivery | — |
| Number of Participants Exhibiting Tachysystole Resulting in Fetal Heart Rate Abnormalities | Induction to delivery | Uterine tachysystole is a condition of excessively frequent uterine contractions during pregnancy. Tachysystole is indicated ≥ 5 contractions in a 10 minute period averaged over a 30-minute window. |
| Number of Participants With Clinical Chorioamnionitis | Induction to delivery | Clinical chorioamnionitis is indicated by maternal fever ≥ 100.4 Fahrenheit, uterine fundal tenderness, maternal or fetal tachycardia (\>100/min and \>160/min, respectively), and purulent or foul amniotic fluid. |
| Number of Participants With a Need for Operative Vaginal Delivery | Induction to delivery | — |
| Composite Maternal Morbidity as Indicated by the Number of Participants With Measures of Maternal Morbidity | Induction to discharge (approximately 5 days) | Measures of maternal morbidity assessed: * Maternal ICU admission * Postpartum endometritis * Surgical-site infections prior to discharge * Venous thromboembolism * Need for transfusion * Maternal death |
| Indication for Cesarean Delivery | Induction to delivery | Categories of Indications for Cesarean Delivery: 1. = Cephalopelvic disproportion 2. = Failed induction/Failure to progress 3. = Cord prolapse 4. = Non-reassuring fetal tracing 5. = Malpresentation 6. = Placental abruption 7. = Other |
| Number of Newborns With Transient Tachypnea (TTN) | From delivery to neonatal discharge (approximately 2 to 7 days) | — |
| Number of Newborns With Respiratory Distress Syndrome (RDS) | From delivery to neonatal discharge (approximately 2 to 7 days) | — |
| Number of Newborns With Meconium Aspiration Syndrome | From delivery to neonatal discharge (approximately 2 to 7 days) | — |
| Number of Newborns With Culture-proven Sepsis | From delivery to neonatal discharge (approximately 2 to 7 days) | — |
| Number of Newborns With Seizures | From delivery to neonatal discharge (approximately 2 to 7 days) | — |
| Composite Neonatal Morbidity as Indicated by the Number of Newborns With Measures of Neonatal Morbidity | From delivery to neonatal discharge (approximately 2 to 7 days) | Measures of neonatal morbidity assessed: * Apgar score ≤ 7 at 5 mins * Umbilical cord potential of hydrogen (pH) \< 7.1 * Neonatal injury: brachial plexus injury, fracture * Perinatal death |
| Number of Newborns Admitted to the Neonatal Intensive Care Unit (NICU) | From delivery to neonatal discharge (approximately 2 to 7 days) | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Combined Approach: Foley Balloon + Vaginal Misoprostol These women will receive vaginal misoprostol per standard protocol at 25 micrograms every 4 hours. In addition, a 26 Fr-Foley balloon catheter will be inserted by routine clinical standards. The Foley will be inserted through the internal cervical os, filled with 60 mL of normal saline, and then pulled snugly against the internal os. The catheter of the Foley will be taped to the patient's inner thigh under gentle traction. If the Foley is unable to be placed, the patient will be reexamined in 1 hour and placement will be reattempted if Bishop's score is still 6 or less by the healthcare provider. When the Foley balloon had fallen out or had to be removed because 12 hours have passed since insertion as per protocol, further management of labor will be left at the discretion of the labor team.
Foley Balloon + Vaginal Misoprostol | 113 |
| Single Approach: Vaginal Misoprostol Only These women will receive 25 micrograms of misoprostol per vagina every 4 hours. Once the cervix becomes favorable (Bishop score \> 6), misoprostol administration will be discontinued. Further management will be left at the discretion of the labor team.
Vaginal Misoprostol | 123 |
| Total | 236 |
Baseline characteristics
| Characteristic | Combined Approach: Foley Balloon + Vaginal Misoprostol | Single Approach: Vaginal Misoprostol Only | Total |
|---|---|---|---|
| Age, Continuous | 25.3 years STANDARD_DEVIATION 5.8 | 23.4 years STANDARD_DEVIATION 6.1 | 24.3 years STANDARD_DEVIATION 6 |
| Bishop score | 3 units on a scale | 3 units on a scale | 3 units on a scale |
| Body Mass index | 38.9 kg/m^2 STANDARD_DEVIATION 10.3 | 37.7 kg/m^2 STANDARD_DEVIATION 9.6 | 38.3 kg/m^2 STANDARD_DEVIATION 10 |
| Gestational Age | 38.7 weeks STANDARD_DEVIATION 5.2 | 38.6 weeks STANDARD_DEVIATION 5.4 | 38.6 weeks STANDARD_DEVIATION 5.4 |
| Number of participants who are married | 64 Participants | 67 Participants | 131 Participants |
| Number of participants who had prenatal care | 110 Participants | 121 Participants | 231 Participants |
| Number of participants with diabetes in pregnancy | 20 Participants | 24 Participants | 44 Participants |
| Number of participants with government subsidized insurance | 60 Participants | 73 Participants | 133 Participants |
| Number of participants with hypertensive disease | 60 Participants | 62 Participants | 122 Participants |
| Race/Ethnicity, Customized African Amercian | 25 Participants | 26 Participants | 51 Participants |
| Race/Ethnicity, Customized Caucasian | 14 Participants | 15 Participants | 29 Participants |
| Race/Ethnicity, Customized Hispanic | 68 Participants | 74 Participants | 142 Participants |
| Race/Ethnicity, Customized Other | 6 Participants | 8 Participants | 14 Participants |
| Region of Enrollment United States | 113 Participants | 123 Participants | 236 Participants |
| Sex: Female, Male Female | 113 Participants | 123 Participants | 236 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 / 113 | 0 / 123 |
| other Total, other adverse events | 0 / 113 | 0 / 123 |
| serious Total, serious adverse events | 0 / 113 | 0 / 123 |
Outcome results
Primary
Number of Participants With a Need for Cesarean Delivery
Time frame: Induction to delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Combined Approach: Foley Balloon + Vaginal Misoprostol | Number of Participants With a Need for Cesarean Delivery | 51 Participants |
| Single Approach: Vaginal Misoprostol Only | Number of Participants With a Need for Cesarean Delivery | 53 Participants |
Secondary
Composite Maternal Morbidity as Indicated by the Number of Participants With Measures of Maternal Morbidity
Measures of maternal morbidity assessed: * Maternal ICU admission * Postpartum endometritis * Surgical-site infections prior to discharge * Venous thromboembolism * Need for transfusion * Maternal death
Time frame: Induction to discharge (approximately 5 days)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Combined Approach: Foley Balloon + Vaginal Misoprostol | Composite Maternal Morbidity as Indicated by the Number of Participants With Measures of Maternal Morbidity | Maternal ICU Admission | 0 Participants |
| Combined Approach: Foley Balloon + Vaginal Misoprostol | Composite Maternal Morbidity as Indicated by the Number of Participants With Measures of Maternal Morbidity | Postpartum endometritis | 3 Participants |
| Combined Approach: Foley Balloon + Vaginal Misoprostol | Composite Maternal Morbidity as Indicated by the Number of Participants With Measures of Maternal Morbidity | Surgical site infection | 5 Participants |
| Single Approach: Vaginal Misoprostol Only | Composite Maternal Morbidity as Indicated by the Number of Participants With Measures of Maternal Morbidity | Maternal ICU Admission | 3 Participants |
| Single Approach: Vaginal Misoprostol Only | Composite Maternal Morbidity as Indicated by the Number of Participants With Measures of Maternal Morbidity | Postpartum endometritis | 0 Participants |
| Single Approach: Vaginal Misoprostol Only | Composite Maternal Morbidity as Indicated by the Number of Participants With Measures of Maternal Morbidity | Surgical site infection | 1 Participants |
Secondary
Composite Neonatal Morbidity as Indicated by the Number of Newborns With Measures of Neonatal Morbidity
Measures of neonatal morbidity assessed: * Apgar score ≤ 7 at 5 mins * Umbilical cord potential of hydrogen (pH) \< 7.1 * Neonatal injury: brachial plexus injury, fracture * Perinatal death
Time frame: From delivery to neonatal discharge (approximately 2 to 7 days)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Combined Approach: Foley Balloon + Vaginal Misoprostol | Composite Neonatal Morbidity as Indicated by the Number of Newborns With Measures of Neonatal Morbidity | any neonatal injury | 3 Participants |
| Combined Approach: Foley Balloon + Vaginal Misoprostol | Composite Neonatal Morbidity as Indicated by the Number of Newborns With Measures of Neonatal Morbidity | Apgar score < 7 at 5 minutes | 4 Participants |
| Combined Approach: Foley Balloon + Vaginal Misoprostol | Composite Neonatal Morbidity as Indicated by the Number of Newborns With Measures of Neonatal Morbidity | cord pH < 7.1 | 5 Participants |
| Single Approach: Vaginal Misoprostol Only | Composite Neonatal Morbidity as Indicated by the Number of Newborns With Measures of Neonatal Morbidity | Apgar score < 7 at 5 minutes | 3 Participants |
| Single Approach: Vaginal Misoprostol Only | Composite Neonatal Morbidity as Indicated by the Number of Newborns With Measures of Neonatal Morbidity | cord pH < 7.1 | 5 Participants |
| Single Approach: Vaginal Misoprostol Only | Composite Neonatal Morbidity as Indicated by the Number of Newborns With Measures of Neonatal Morbidity | any neonatal injury | 3 Participants |
Secondary
Indication for Cesarean Delivery
Categories of Indications for Cesarean Delivery: 1. = Cephalopelvic disproportion 2. = Failed induction/Failure to progress 3. = Cord prolapse 4. = Non-reassuring fetal tracing 5. = Malpresentation 6. = Placental abruption 7. = Other
Time frame: Induction to delivery
Population: Only 51 in the Combined arm and 53 in the single arm delivered by cesarean.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Combined Approach: Foley Balloon + Vaginal Misoprostol | Indication for Cesarean Delivery | Arrest disorders | 31 Participants |
| Combined Approach: Foley Balloon + Vaginal Misoprostol | Indication for Cesarean Delivery | Nonreassuring fetal heart rate | 13 Participants |
| Combined Approach: Foley Balloon + Vaginal Misoprostol | Indication for Cesarean Delivery | Other | 7 Participants |
| Single Approach: Vaginal Misoprostol Only | Indication for Cesarean Delivery | Arrest disorders | 28 Participants |
| Single Approach: Vaginal Misoprostol Only | Indication for Cesarean Delivery | Nonreassuring fetal heart rate | 18 Participants |
| Single Approach: Vaginal Misoprostol Only | Indication for Cesarean Delivery | Other | 7 Participants |
Secondary
Induction-to-delivery Interval in Hours
Time frame: Induction to delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Combined Approach: Foley Balloon + Vaginal Misoprostol | Induction-to-delivery Interval in Hours | 24.8 hours | Standard Deviation 13.8 |
| Single Approach: Vaginal Misoprostol Only | Induction-to-delivery Interval in Hours | 24.5 hours | Standard Deviation 14 |
Secondary
Number of Newborns Admitted to the Neonatal Intensive Care Unit (NICU)
Time frame: From delivery to neonatal discharge (approximately 2 to 7 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Combined Approach: Foley Balloon + Vaginal Misoprostol | Number of Newborns Admitted to the Neonatal Intensive Care Unit (NICU) | 24 Participants |
| Single Approach: Vaginal Misoprostol Only | Number of Newborns Admitted to the Neonatal Intensive Care Unit (NICU) | 20 Participants |
Secondary
Number of Newborns With Culture-proven Sepsis
Time frame: From delivery to neonatal discharge (approximately 2 to 7 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Combined Approach: Foley Balloon + Vaginal Misoprostol | Number of Newborns With Culture-proven Sepsis | 0 Participants |
| Single Approach: Vaginal Misoprostol Only | Number of Newborns With Culture-proven Sepsis | 1 Participants |
Secondary
Number of Newborns With Meconium Aspiration Syndrome
Time frame: From delivery to neonatal discharge (approximately 2 to 7 days)
Population: Data was not collected for this outcome measure.
Secondary
Number of Newborns With Respiratory Distress Syndrome (RDS)
Time frame: From delivery to neonatal discharge (approximately 2 to 7 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Combined Approach: Foley Balloon + Vaginal Misoprostol | Number of Newborns With Respiratory Distress Syndrome (RDS) | 5 Participants |
| Single Approach: Vaginal Misoprostol Only | Number of Newborns With Respiratory Distress Syndrome (RDS) | 4 Participants |
Secondary
Number of Newborns With Seizures
Time frame: From delivery to neonatal discharge (approximately 2 to 7 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Combined Approach: Foley Balloon + Vaginal Misoprostol | Number of Newborns With Seizures | 0 Participants |
| Single Approach: Vaginal Misoprostol Only | Number of Newborns With Seizures | 0 Participants |
Secondary
Number of Newborns With Transient Tachypnea (TTN)
Time frame: From delivery to neonatal discharge (approximately 2 to 7 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Combined Approach: Foley Balloon + Vaginal Misoprostol | Number of Newborns With Transient Tachypnea (TTN) | 5 Participants |
| Single Approach: Vaginal Misoprostol Only | Number of Newborns With Transient Tachypnea (TTN) | 5 Participants |
Secondary
Number of Participants Exhibiting Tachysystole Resulting in Fetal Heart Rate Abnormalities
Uterine tachysystole is a condition of excessively frequent uterine contractions during pregnancy. Tachysystole is indicated ≥ 5 contractions in a 10 minute period averaged over a 30-minute window.
Time frame: Induction to delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Combined Approach: Foley Balloon + Vaginal Misoprostol | Number of Participants Exhibiting Tachysystole Resulting in Fetal Heart Rate Abnormalities | 10 Participants |
| Single Approach: Vaginal Misoprostol Only | Number of Participants Exhibiting Tachysystole Resulting in Fetal Heart Rate Abnormalities | 20 Participants |
Secondary
Number of Participants With a Need for Operative Vaginal Delivery
Time frame: Induction to delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Combined Approach: Foley Balloon + Vaginal Misoprostol | Number of Participants With a Need for Operative Vaginal Delivery | 5 Participants |
| Single Approach: Vaginal Misoprostol Only | Number of Participants With a Need for Operative Vaginal Delivery | 6 Participants |
Secondary
Number of Participants With a Need for Oxytocin Augmentation
Time frame: Induction to delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Combined Approach: Foley Balloon + Vaginal Misoprostol | Number of Participants With a Need for Oxytocin Augmentation | 89 Participants |
| Single Approach: Vaginal Misoprostol Only | Number of Participants With a Need for Oxytocin Augmentation | 103 Participants |
Secondary
Number of Participants With Clinical Chorioamnionitis
Clinical chorioamnionitis is indicated by maternal fever ≥ 100.4 Fahrenheit, uterine fundal tenderness, maternal or fetal tachycardia (\>100/min and \>160/min, respectively), and purulent or foul amniotic fluid.
Time frame: Induction to delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Combined Approach: Foley Balloon + Vaginal Misoprostol | Number of Participants With Clinical Chorioamnionitis | 1 Participants |
| Single Approach: Vaginal Misoprostol Only | Number of Participants With Clinical Chorioamnionitis | 1 Participants |