Clinical trial NCT02762942: Comparison of Vaginal Misoprostol Plus Supracervical Balloon Versus Vaginal Misoprostol Alone for Induction of Labor
Official title: Prospective Randomized Clinical Trial Comparing the Effect of Vaginal Misoprostol Synchronously With Supracervical Balloon Versus Vaginal Misoprostol Alone for Induction of Labor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Induction of Labor
Cervical Ripening
Pregnancy
Keywords: cervical ripening
misoprostol
supracervical balloon
Foley catheter
Lead sponsor: Consorci Sanitari de Terrassa
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Induction to delivery time
timeFrame: 1 year
Secondary outcomes:
measure: Bishop score at 12 hours from the onset of induction
timeFrame: 1 year
measure: Bishop score at 24 hours from the onset of induction
timeFrame: 1 year
measure: Number of doses of misoprostol required
timeFrame: 1 year
measure: Percentage of pregnant women requiring oxytocin
timeFrame: 1 year
measure: Maximum dosage of oxytocin given (mU / min)
timeFrame: 1 year
measure: Percentage of pregnant women requiring epidural analgesia
timeFrame: 1 year
measure: Percentage of pregnant women with tachysystole and / or hypertonus with absence of fetal heart rate decelerations
timeFrame: 1 year
measure: Percentage of pregnant women with tachysystole and / or hypertonus with fetal heart rate decelerations
timeFrame: 1 year
measure: Percentage of pregnant women with intrapartum fever
timeFrame: 1 year
measure: Percentage of pregnant women with maternal side effects
timeFrame: 1 year
measure: Percentage of pregnant women with vaginal delivery within 12 hours from the onset of induction
timeFrame: 1 year
measure: Percentage of pregnant women with vaginal delivery within 24 hours from the onset of induction
timeFrame: through study completion
measure: Total rate of cesarean section
timeFrame: 1 year
measure: Percentage of cesarean sections for failed induction
timeFrame: 1 year
measure: Percentage of cesarean sections for nonreassuring fetal status
timeFrame: 1 year
measure: Neonatal intensive care unit admission
timeFrame: 1 year
measure: Apgar score at 5 minutes
timeFrame: 1 year
measure: Umbilical artery ph
timeFrame: 1 year
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
state: Barcelona
Study officials:
affiliation: Consorci Sanitari de Terrassa
name: Àngels Vives Argilagós, MD
role: PRINCIPAL_INVESTIGATOR
References: