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

Phase 4

• Conditions: Pregnancy; Induction of Labor; Cervical Ripening
• Interventions: Drug: Misoprostol; Device: Foley catheter

• Registration Number: NCT02762942
• Lead Sponsor: Consorci Sanitari de Terrassa

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-26
• Status Verified: 2016-05
• Study Start: 2016-05
• Study First Submitted QC: 2016-05-04
• Study First Posted: 2016-05-05
• Last Update Submitted: 2016-05-11
• Last Update Posted: 2016-05-12
• Primary Completion: 2017-05
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaginal misoprostol + Foley catheter	Foley catheter	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.
Vaginal misoprostol alone	Misoprostol	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
Vaginal misoprostol + Foley catheter	Misoprostol	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.

Primary Outcome Measures

Name	Time	Method
Induction to delivery time	1 year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Consorci Sanitari de Terrassa; 🇪🇸 Terrassa, Barcelona, Spain