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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02762942
• Other study ID #: 2015-002061-29
• Secondary ID: 2015-002061-29
• Status: Recruiting
• Phase: Phase 4
• First received: April 26, 2016
• Last updated: May 11, 2016
• Start date: May 2016
• Est. completion date: September 2017

Study information

• Verified date: May 2016
• Source: Consorci Sanitari de Terrassa
• Contact: Àngels Vives Argilagós, MD
• Phone: +34 937310007
• Email: MAVives[@]cst.cat
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Ripening
• Induction of Labor
• Pregnancy

Intervention

Drug:
• Misoprostol
Administration of 25 mcg of vaginal misoprostol every 4 hours up to 5 doses

Device:
• Foley catheter
Insertion of a Foley catheter (16French) through the internal os for a maximum of 12 hours

Locations

Country	Name	City	State
Spain	Consorci Sanitari de Terrassa	Terrassa	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Sanitari de Terrassa

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Induction to delivery time		1 year	No
Secondary	Bishop score at 12 hours from the onset of induction		1 year	No
Secondary	Bishop score at 24 hours from the onset of induction		1 year	No
Secondary	Number of doses of misoprostol required		1 year	No
Secondary	Percentage of pregnant women requiring oxytocin		1 year	No
Secondary	Maximum dosage of oxytocin given (mU / min)		1 year	No
Secondary	Percentage of pregnant women requiring epidural analgesia		1 year	No
Secondary	Percentage of pregnant women with tachysystole and / or hypertonus with absence of fetal heart rate decelerations		1 year	Yes
Secondary	Percentage of pregnant women with tachysystole and / or hypertonus with fetal heart rate decelerations		1 year	Yes
Secondary	Percentage of pregnant women with intrapartum fever		1 year	Yes
Secondary	Percentage of pregnant women with maternal side effects		1 year	Yes
Secondary	Percentage of pregnant women with vaginal delivery within 12 hours from the onset of induction		1 year	No
Secondary	Percentage of pregnant women with vaginal delivery within 24 hours from the onset of induction		through study completion	No
Secondary	Total rate of cesarean section		1 year	No
Secondary	Percentage of cesarean sections for failed induction		1 year	No
Secondary	Percentage of cesarean sections for nonreassuring fetal status		1 year	Yes
Secondary	Neonatal intensive care unit admission		1 year	Yes
Secondary	Apgar score at 5 minutes		1 year	Yes
Secondary	Umbilical artery ph		1 year	Yes