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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02762942
Enrollment
80
Registered
2016-05-05
Start date
2016-05-31
Completion date
2017-09-30
Last updated
2016-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Ripening, Induction of Labor, Pregnancy

Keywords

cervical ripening, misoprostol, supracervical balloon, Foley catheter

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.

Interventions

DRUGMisoprostol

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

DEVICEFoley catheter

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

Sponsors

Consorci Sanitari de Terrassa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Induction to delivery time1 year

Secondary

MeasureTime frame
Bishop score at 12 hours from the onset of induction1 year
Bishop score at 24 hours from the onset of induction1 year
Number of doses of misoprostol required1 year
Percentage of pregnant women requiring oxytocin1 year
Maximum dosage of oxytocin given (mU / min)1 year
Percentage of pregnant women requiring epidural analgesia1 year
Percentage of pregnant women with tachysystole and / or hypertonus with absence of fetal heart rate decelerations1 year
Percentage of pregnant women with tachysystole and / or hypertonus with fetal heart rate decelerations1 year
Percentage of pregnant women with intrapartum fever1 year
Percentage of pregnant women with maternal side effects1 year
Percentage of pregnant women with vaginal delivery within 12 hours from the onset of induction1 year
Percentage of pregnant women with vaginal delivery within 24 hours from the onset of inductionthrough study completion
Total rate of cesarean section1 year
Percentage of cesarean sections for failed induction1 year
Percentage of cesarean sections for nonreassuring fetal status1 year
Neonatal intensive care unit admission1 year
Apgar score at 5 minutes1 year
Umbilical artery ph1 year

Countries

Spain

Contacts

Primary ContactÀngels Vives Argilagós, MD
MAVives@cst.cat+34 937310007
Backup ContactMarino Romero Ramírez, MD
marino.rora@gmail.com+34 937310007

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026