Cervical Ripening Balloon for 12 Hours vs. 1 Hour.

Study Overview
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Brief Summary
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The aim of this study is a comparison of induction of labor with a cervical ripening balloon left in place for one hour compared to twelve hours. The primary outcome is time to delivery. Women admitted for induction of labor will be recruited and randomized to either a cervical ripening balloon for one hour or twelve hours. the management of delivery after the extraction of the balloon will be left to the discretion of the attending physician.

Detailed Description
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The common IOL techniques used for pregnant women with unfavorable cervix might be specified to either mechanical induction via cervical ripening balloon (CRB) or pharmacological induction. The insertion of a CRB is believed to mechanically ripen the uterine cervix with a better safety profile than prostaglandins. The duration of the balloon placement varied considerably, and it was commonly placed for 12-24 hours. Nevertheless, recent randomized controlled studies have demonstrated favorable results following only 6 hours of CRB placement with or without additional administration of oxytocin. We believe that mechanical ripening of the cervix can be achieved even less than six hours. Our study aims to evaluate the time to delivery and pregnancy outcomes after placement of CRB of only 1 hour compared to either 6 or 12 hours. Study Protocol: Women planned for induction of labor will be approached by a trained resident and will sign informed consent. All participants will be randomized to either one hour or twelve hours CRB placement using a computer program randomization scheme, block size of 20, by the department research coordinator who will keep the sequential in sealed envelopes. Demographic parameters will be retrieved from the computerized database of Rambam Medical Center (RMC). Eligible women will undergo the usual procedure of CRB insertion using a double lumen Cook cervical ripening balloon (CCRB). The CRB will be removed approximately after an hour in the intervention group and after twelve hours in the control group. Thereafter, the women will proceed amniotomy or Pitocin use at the discretion of the labor and delivery physician

Official Title
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Comparison of Labor Induction With Cervical Ripening Balloon, One Versus Tweleve Hours Placement: a Randomized Controlled Trial

Conditions
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Induction of Labor

Intervention / Treatment
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* Device: cervical ripening balloon for one hour
* Device: cervical ripening balloon for twelve hours


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Nulliparous or multiparous gravidas Gestational age ≥ 370/7 to 416/7 gestational weeks Age 18-45 Signed informed consent Exclusion Criteria: Contraindications for vaginal delivery Multifetal gestation Rupture of membranes Bishop score > 6 The cervix is dilated to more than 2 cm Previous caesarean delivery

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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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
Interventional Model Description: This will be an open-label,1:1, randomized controlled trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cervical ripening balloon for 1 hour<br>Eligible women will undergo the usual procedure of CRB insertion using a double lumen Cook cervical ripening balloon (CCRB). The CRB will be removed approximately after an hour in the intervention group and thereafter, the women will proceed amniotomy or Pitocin use at the discretion of the labor and delivery physician | Device: cervical ripening balloon for one hour<br>* The cervical ripening balloon will be left in place for one hour and after balloon removal the induction of labor will proceed at the discretion of the attending physician at labor and delivery room<br>|
| Active Comparator: cervical ripening balloon for 12 hours<br>Eligible women will undergo the usual procedure of CRB insertion using a double lumen Cook cervical ripening balloon (CCRB). The CRB will be removed approximately after 12 hours in the control group and thereafter, the women will proceed amniotomy or Pitocin use at the discretion of the labor and delivery physician | Device: cervical ripening balloon for twelve hours<br>* The cervical ripening balloon will be left in place for for twelve hours and after balloon removal the induction of labor will proceed at the discretion of the attending physician at labor and delivery room<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insertion to delivery time interval | The time interval between balloon insertion to delivery | From date of balloon insertion until the date of delivery, assessed up to 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to compare the mode of delivery | Mode of delivery | From date of balloon insertion until the date of delivery, assessed up to 4 days | 
| to compare the time to active and second stage of labor | Time to active and second stage of labor | From date of balloon insertion until the date of delivery, assessed up to 4 days | 
| to compare the rate of chorioamnionitis | Rate of chorioamnionitis | From date of balloon insertion until the date of discharge, assessed up to 8 days | 
| to compare the rate of post-partum hemorrhage | Rate of post-partum hemorrhage and need for blood transfusion | From date of balloon insertion until the date of discharge, assessed up to 8 days | 
| to compare the need for blood transfusion | the need for blood transfusion | From date of balloon insertion until the date of discharge, assessed up to 8 days | 
| to compare the rate of anal sphincter injuries | Rate of obstetric anal sphincter injuries | From date of balloon insertion until the date of discharge, assessed up to 8 days | 
| To compare the length of maternal hospital stay | Length of maternal hospital stay | From date of balloon insertion until the date of discharge, assessed up to 8 days | 
| To compare the overall satisfaction rate | Overall satisfaction using the Birth satisfaction scale questionnaire with higher score means a better outcome. minimal score 30, maximal score 150. | From date of balloon insertion until the date of discharge, assessed up to 8 days | 
| To compare the Apgar score between the groups | Apgar score - higher score means better outcome. Minimal score is 0, maximal Apgar score is 10. | at the date of delivery | 
| To compare the rate of neonatal acidemia between the groups | Neonatal acidemia | From date of delivery until the date of neonate discharge, assessed up to 14 days | 
| To compare the rate of admission to neonatal intensive care unit between the groups | Admission to neonatal intensive care unit | From date of delivery until the date of neonate discharge, assessed up to 14 days | 
| To compare the rate of Respiratory complications between the groups | Respiratory complications | From date of delivery until the date of neonate discharge, assessed up to 14 days | 
| To compare the rate of neonatal sepsis between the groups | Neonatal sepsis | From date of delivery until the date of neonate discharge, assessed up to 14 days | 
| To compare the rate of birthweightbetween the groups | Birthweight in grams | at the date of delivery |