Labor Induction and Maternal BMI, Comparison of Different Pre-induction Cervical Ripening Methods

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether mechanical cervical ripening (using the Cook double balloon catheter) is superior or inferior to pharmacological agents (PGE1) in overweight and obese women undergoing labor induction.

Official Title
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Labor Induction and Maternal BMI: Comparison of Different Pre-induction Cervical Ripening Methods: The Cook Double Balloon Catheter vs PGE1 Tablets in Lean, Overweight, and Obese Women. A Prospective Randomized Study.

Conditions
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Obesity, Labor Complications

Intervention / Treatment
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* Device: Cook double balloon catheter
* Drug: PGE1 tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years of age or older. Diagnosed to be pregnant (al least 37 weeks of gestation) with a medical indication for labor induction, including: postdate pregnancy, preeclampsia, gestational or chronic hypertension, Gestational Diabetes Mellitus at term, Oligohydramnios, Polyhydramnios, fetal growth restriction, maternal background disease necessitating delivery, Isoimmunisation, maternal Thrombophilia, intrahepatic cholestasis of pregnancy. Having a Bishop score of 4 points or less. Diagnosed as having singleton pregnancy at term (37 weeks at least) in a vertex presentation, with intact membranes, and absence of significant regular uterine contraction. Willingness to comply with the protocol for the duration of the study. Has agreed and signed an informed consent after given oral and written explanation. Exclusion Criteria: Anay contraindication for a vaginal delivery (i.e. placenta previa, non vertex presentation, estimated fetal weight of less than 4500 gr). Ruptured membranes. Previous cesarian section or presence of any uterine scar. Documented labor with four or more spontanous uterine contractions per hour. Suspected fetal distress necessitating immediate intervention. Proven malignancy of the cervix. Active vaginal bleeding. Active inflammatory or purulent condition of the lower genital tract. Active asthma.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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: Cook double balloon catheter<br>Insertion of the Cook double balloon catheter to the cervix until both balloons are properly located in the cervical canal. After properly located it is inflated with 20 ml of saline. Then both balloons are additionally inflated to a total of 80 ml each balloon. Twelve hours later the balloons are deflated and the device is removed. | Device: Cook double balloon catheter<br> <br> |
| Active Comparator: PGE1 tablet insertion<br>Insertion of 25 mg PGE1 (Prostaglandin E1) tablet is inserted in the posterior fornix. The patient woll the be instructed to stay in bed for the next 60 minutes. After six hours a repeated dose will be administered. Total of 4 PGE1 doses within 24 hours. | Drug: PGE1 tablet<br> <br> * Other names: Prostaglandin E1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cesarian section rate |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of excessive uterine activity Incidence of excessive uterine activity | At least 6 uterine contractions per 10- minutes period, or hyperstimulation, if combined with fetal heart rate abnormalities, or hypertonus defined as single contraction of 2-minute duration. | 24 hours | 
| Active labor onset |  | 24 hours | 
| Proportion of vaginal delivery |  | 24 hours | 
| Treatment failure | Proportion of subjects with unfavorable/unchanged Bishop score 12-24 hours after ripening | 12-24 hours | 
| The ripening-to-delivery time interval |  | 24 hours | 
| Need for oxytocin induction and/or augmentation of labor |  | 24 hours | 
| Mode of delivery | NVD vs. instrumental | 24 hours | 
| Intra-partum or postpartum fever |  | 48 hours | 
| Incidence of meconium staining |  | 24 hours | 
| The proportion of neonates with 5-minute Apgar scores of less than 7 |  | 48 hours | 
| The number of neonates who were admitted to the neonatal intensive care unit |  | 48 hours | 
| morbidity and mortality | Number of cases of serious maternal and/or neonatal morbidity or death (including uterine rupture, maternal admission to the intensive care unit, maternal septicemia, placental abruption, hemorrhage at required blood transfusion, hysterectomy, neonatal seizures, birth asphyxia, meconium aspiration syndrome, or neonatal sepsis). | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Labor complications, Induction of labor, Mechanical cervical ripening