Cervical Ripening for Obese Women: A Randomized, Comparative Effectiveness Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Efficacy of Transcervical Foley Balloon Plus Vaginal Misoprostol Versus Vaginal Misoprostol Alone For Cervical Ripening In Nulliparous Obese Women: A Randomized, Comparative Effectiveness Trial

Conditions
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Obesity, Labor Induction, Cesarean Delivery

Intervention / Treatment
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* Drug: Vaginal Misoprostol
* Device: Foley Balloon + Vaginal Misoprostol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined approach: Foley Balloon + Vaginal Misoprostol<br>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. | Device: Foley Balloon + Vaginal Misoprostol<br> <br> |
| Active Comparator: Single approach: Vaginal Misoprostol only<br>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. | Drug: Vaginal Misoprostol<br> <br> * Other names: Cytotec;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Need for Cesarean Delivery |  | Induction to delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Indication for Cesarean Delivery | Categories of Indications for Cesarean Delivery: = Cephalopelvic disproportion = Failed induction/Failure to progress = Cord prolapse = Non-reassuring fetal tracing = Malpresentation = Placental abruption = Other | Induction to delivery | 
| 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 | 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. | Induction to delivery | 
| 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. | Induction to delivery | 
| 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 | Measures of maternal morbidity assessed: Maternal ICU admission Postpartum endometritis Surgical-site infections prior to discharge Venous thromboembolism Need for transfusion Maternal death | Induction to discharge (approximately 5 days) | 
| Number of Newborns Admitted to the Neonatal Intensive Care Unit (NICU) |  | From delivery to neonatal discharge (approximately 2 to 7 days) | 
| 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 | 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 | From delivery to neonatal discharge (approximately 2 to 7 days) |