Foley Catheter Versus Vaginal Misoprostol for Cervical Ripening and Induction of Labor

Study Overview
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Brief Summary
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PURPOSE: The purpose of this study is to determine the effectiveness of balloon dilatation (Foley) with vaginal misoprostol for cervical ripening and induction of labor. METHOD: a randomized clinical assay has been performed with 160 women with indication of induction of labor, randomly divided in two groups, 80 for Foley catheter and 80 for misoprostol.

Detailed Description
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The cesarean delivery rate has risen dramatically in almost all world. Brazil shows the highest rate in the world so we need urgently efforts to reduce this fact. Several studies have shown that maternal morbidity and mortality rates are higher in cesarean deliveries. On the other hand an abdominal delivery cost much more than a vaginal delivery. A clinical trial to assess the performance of two simple and sheep methods can provide evidence based on local experience. Our results alow us to recommend both methods for clinical practice with a good possibility to reduce cesarean rates and without adverse events.

Official Title
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TRANSCERVICAL FOLEY CATHETER (FOLEY) Versus INTRAVAGINAL MISOPROSTOL FOR CERVICAL RIPENING AND INDUCTION OF LABOR: A RANDOMIZED CLINICAL TRIAL.

Conditions
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Pregnancy, Prolonged, Pre Eclampsia, Oligohydramnios

Intervention / Treatment
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* Drug: Misoprostol
* Device: Foley


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age from 37 weeks, feto unic, alive and cephalic, Bishop index equal or lesser than four. Exclusion Criteria: uterine scar, premature rupture of the membranes, fetal weight bigger than 4000 g, previous placenta, conditions that imposed the immediate ending of the gestation.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 40 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>Use 25 micrograms vaginal every 6 hours (max dosis 200 micrograms in 48 hours) | Drug: Misoprostol<br>* Vaginal application of 25 micrograms every 6 hours until cervical ripening reach Bishop 6 or more<br>* Other names: Prostokos 25 micrograms;|
| Active Comparator: Foley<br>Foley catheter number 14 or 16 was installed intracervical for no more than 48 hours. | Device: Foley<br>* After Foley introduction, every 6 hours vaginal exam was performed. The cases on Bishop score increase or occurred spontaneous exit of catheter or spontaneous labour had been initiated are considered success.The failure was adopted if after48 hours occurred no cervical modifications.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cervical ripening | Foley Group: catheter stay no more that 48 hours. Every 6 hours vaginal exam was performed. The cases on Bishop score increase or occurred spontaneous exit of catheter or spontaneous labour had been initiated are considered success.The failure was adopted if after48 hours occurred no cervical modifications. Misoprostol group: was introduced 25 microgram every 6 hour (max 200microg)if cervical conditions were unchanged. In the case of cervical evolution or start of labour the method was considered success.The failure was adopted if after 48 there was no cervical modifications. | 48 hous after start the method | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cesarean | After 48 hours if there was no cervical ripening or espontaneous labor the case was classified as failure of method and a cesarean was performed | The action of methods were assessed for 48 hours after start. | 
| Need of oxytocin | In cases on the cervical ripening had occurred but the spontaneous labor not start. | 48 hours after start method | 
| need of neonatal intensive care | The condition of babies at birth and needs of intensive care as mechanic ventilation or others interventions. | 7 first days after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Balloon dilatation,, misoprostol,, cervical ripening,, obstetric labor,, labor induced.