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

Consorci Sanitari de Terrassa80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Induction of Labor Cervical Ripening Pregnancy

Interventions

MisoprostolDRUG

Administration of 25 mcg of vaginal misoprostol every 4 hours up to 5 doses

Foley catheterDEVICE

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Consorci Sanitari de Terrassa

Terrassa, Barcelona, Spain

RECRUITING

Outcomes

Primary Outcomes

Induction to delivery time

Time frame: 1 year

Secondary Outcomes

Bishop score at 12 hours from the onset of induction

Time frame: 1 year

Bishop score at 24 hours from the onset of induction

Time frame: 1 year

Number of doses of misoprostol required

Time frame: 1 year

Percentage of pregnant women requiring oxytocin

Time frame: 1 year

Maximum dosage of oxytocin given (mU / min)

Time frame: 1 year

Percentage of pregnant women requiring epidural analgesia

Time frame: 1 year

Percentage of pregnant women with tachysystole and / or hypertonus with absence of fetal heart rate decelerations

Time frame: 1 year

Percentage of pregnant women with tachysystole and / or hypertonus with fetal heart rate decelerations

Time frame: 1 year

Percentage of pregnant women with intrapartum fever

Time frame: 1 year

Percentage of pregnant women with maternal side effects

Time frame: 1 year

Percentage of pregnant women with vaginal delivery within 12 hours from the onset of induction

Central Contacts

Àngels Vives Argilagós, MD

CONTACT

+34 937310007 MAVives@cst.cat

Marino Romero Ramírez, MD

CONTACT

+34 937310007 marino.rora@gmail.com

Data from ClinicalTrials.gov

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