Ripening Interventions: Prostaglandins vs EASI Catheter

Study Overview
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Brief Summary
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The primary aim of this randomized clinical trial is to compare the effect of misoprostol vs extra amniotic saline infusion via a catheter (EASI) for cervical ripening on the proportion of patients delivered by cesarean section for fetal intolerance of labor versus vaginal delivery. The primary hypothesis is that patients undergoing cervical ripening with EASI catheter are less likely to undergo cesarean section for fetal intolerance of labor when compared to women who receive misoprostol.

Detailed Description
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Induction of labor is a common obstetrical practice. In fact, the rate of induction has risen to 184/1000 live births. It is well known that a favorable Bishop score, defined as Bishop score 5-8, improves the safety and success rate for induction of labor and vaginal delivery. Several methods for cervical ripening, both mechanical and pharmacological, have been developed to improve Bishop score in women eligible for induction of labor with an unfavorable cervix. These methods include: misoprostol, dinoprostone, intracervical catheter with and without extra-amniotic saline infusion, and laminaria. Several studies have investigated the optimum cervical ripening agent, and review of current literature supports that misoprostol given in a dose of 25 micrograms every 4 hours intravaginally as the most efficacious and inexpensive regimen while maintaining safe maternal and fetal outcomes. Several studies have shown that misoprostol has a significantly shorter time to delivery compared with other methods of ripening. In fact, in a 2003 Cochrane Database Systematic Review, misoprostol was shown to have increased cervical ripening effectiveness and reduced failure to achieve vaginal delivery in 12-24 hours. Further, while uterine hyper-stimulation and tachysystole were more common in the misoprostol groups, no adverse neonatal outcomes were described. However, misoprostol has been shown to have a higher incidence of cesarean section for fetal intolerance to labor compared to other cervical ripening methods including EASI. Several studies support the ideal route of administration and dosage of misoprostol to be 25 micrograms every 4 hours intravaginally. This regimen leads to effective cervical ripening while reducing the dose-dependent effect of misoprostol on uterine tachysystole and hyperstimulation. Another aspect to consider in cervical ripening method is cost. Misoprostol is much less expensive than other methods including dinoprostone. In fact, one article reports that the average cost per patient for misoprostol treatment was $85 compared to $606 for dinoprostone insert. Extra-amniotic saline infusion (EASI) has been introduced as a mechanical, non-pharmacological cervical ripening method. It involves placement of a Foley catheter through the cervix and is supplemented with continuous extra-amniotic infusion of saline. This is thought to improve prostaglandin release, resulting in shortened duration of labor. Several studies have been performed to determine the safety and efficacy of the EASI method. Since misoprostol is efficacious, safe, and inexpensive, it is a superior method for cervical ripening and will act as a control for an experimental group undergoing cervical ripening with the EASI catheter. Our hypothesis is that cervical ripening with the EASI method will result in fewer cesarean sections for fetal intolerance to labor as compared to misoprostol. Furthermore, patients undergoing cervical ripening with EASI will experience a shorter time to delivery, have less expense, have fewer adverse effects, and will be more satisfied with EASI catheter than with misoprostol.

Official Title
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The RIPE Study: Ripening Interventions: Prostaglandins vs EASI Catheter

Conditions
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Cesarean Section

Intervention / Treatment
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* Drug: Misoprostol
* Device: Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton pregnancy Cephalic presentation 36 completed weeks of gestation Intact membranes Unfavorable cervix (defined as Bishop score < 5) Indication for induction of labor Fetal Station less than or equal to -3 Exclusion Criteria: Clinically significant vaginal bleeding Evidence of spontaneous labor (3 contractions in 10 minutes) Contraindication to induction of labor or to use of prostaglandins Fetal station higher than -3

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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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 |
| --- | --- |
| Active Comparator: Misoprostol<br>Patients randomized to this arm will receive 25 micrograms of misoprostol every four hours. | Drug: Misoprostol<br>* Misoprostol,25 micrograms every 4 hours.<br>* Other names: Cytotec;|
| Experimental: EASI Catheter<br>Patients randomized to this arm will receive extra amniotic saline infusion (EASI) administered via catheter | Device: Catheter<br>* A catheter with extra amniotic saline infusion (EASI) is placed in the uterus and applies pressure to the cervix to cause it to ripen<br>* Other names: EASI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Women Undergoing Cesarean Section for Fetal Intolerance of Labor | The number of women undergoing cesarean section will be compared between the misoprostol arm and EASI arm. The primary hypothesis is that the odds of receiving a cesarean section is lower among patients assigned to EASI when compared to patients who receive misoprostol. | At time of delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Extra amniotic saline infusion, Misoprostol, Labor induction