Comparison of Vaginal Misoprostol Plus Supracervical Balloon Versus Vaginal Misoprostol Alone for Induction of Labor

Study Overview
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Brief Summary
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Demonstrate that with concomitant and synchronous use of supracervical balloon and vaginal misoprostol for induction of labour, vaginal delivery is achieved in less time compared with vaginal misoprostol alone.

Official Title
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Prospective Randomized Clinical Trial Comparing the Effect of Vaginal Misoprostol Synchronously With Supracervical Balloon Versus Vaginal Misoprostol Alone for Induction of Labor

Conditions
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Induction of Labor, Cervical Ripening, Pregnancy

Intervention / Treatment
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* Drug: Misoprostol
* Device: Foley catheter


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Singleton pregnancy Cephalic presentation Reassuring fetal heart rate pattern Intact membranes Bishop score less than 6 Exclusion criteria Severe preeclampsia Prematurity ( < 37 weeks gestation dated by first trimester ultrasound) Previous cesarean section or previous uterine surgery Intrauterine growth restriction Premature rupture of membranes Maternal colonization with Streptococcus Agalactiae at any time during pregnancy Multifetal pregnancy Breech presentation Stillbirth Any contraindication for vaginal delivery

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: Vaginal misoprostol alone<br>Women in this group will receive 25mcg of vaginal misoprostol every 4 hours up to a maximum of 5 doses. Misoprostol will be stopped in case of a favorable cervix or if the patient is in active labor. In case of no progression after 5 doses of misoprostol, intravenous oxytocin will be perfused 4 hours after the last dose of misoprostol according to local protocols | Drug: Misoprostol<br>* Administration of 25 mcg of vaginal misoprostol every 4 hours up to 5 doses<br>* Other names: Misofar;|
| Experimental: Vaginal misoprostol + Foley catheter<br>Women in this group will receive 25mcg of vaginal misoprostol every 4 hours up to a maximum of 5 doses. At the same time a 16French Foley catheter will be inserted through the internal os with visualization of the cervix by sterile speculum examination. The catheter balloon will be inflated with 30 ml of sterile normal saline solution and then the catheter will be taped with gentle traction to the inner thigh of the patient until spontaneous expulsion. If this does not occur, the catheter will be deflated and removed after 12 hours. Misoprostol will be stopped in case of a favorable cervix or if the patient is in active labor. In case of no progression after 5 doses of misoprostol, intravenous oxytocin will be perfused 4 hours after the last dose of misoprostol. | Drug: Misoprostol<br>* Administration of 25 mcg of vaginal misoprostol every 4 hours up to 5 doses<br>* Other names: Misofar;Device: Foley catheter<br>* Insertion of a Foley catheter (16French) through the internal os for a maximum of 12 hours<br>* Other names: Supracervical balloon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induction to delivery time |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bishop score at 12 hours from the onset of induction |  | 1 year | 
| Bishop score at 24 hours from the onset of induction |  | 1 year | 
| Number of doses of misoprostol required |  | 1 year | 
| Percentage of pregnant women requiring oxytocin |  | 1 year | 
| Maximum dosage of oxytocin given (mU / min) |  | 1 year | 
| Percentage of pregnant women requiring epidural analgesia |  | 1 year | 
| Percentage of pregnant women with tachysystole and / or hypertonus with absence of fetal heart rate decelerations |  | 1 year | 
| Percentage of pregnant women with tachysystole and / or hypertonus with fetal heart rate decelerations |  | 1 year | 
| Percentage of pregnant women with intrapartum fever |  | 1 year | 
| Percentage of pregnant women with maternal side effects |  | 1 year | 
| Percentage of pregnant women with vaginal delivery within 12 hours from the onset of induction |  | 1 year | 
| Percentage of pregnant women with vaginal delivery within 24 hours from the onset of induction |  | through study completion | 
| Total rate of cesarean section |  | 1 year | 
| Percentage of cesarean sections for failed induction |  | 1 year | 
| Percentage of cesarean sections for nonreassuring fetal status |  | 1 year | 
| Neonatal intensive care unit admission |  | 1 year | 
| Apgar score at 5 minutes |  | 1 year | 
| Umbilical artery ph |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical ripening, misoprostol, supracervical balloon, Foley catheter