N/A N=200 Randomized Supportive Care

A Randomized Comparison of Transcervical Foley Bulb With Vaginal Misoprostol to Vaginal Misoprostol Alone for Induction of Labor

Pregnancy

Bottom Line

View on ClinicalTrials.gov: NCT02566005 ↗

Enrolled (actual)

200

Serious AEs

0.0%

Results posted

Mar 2018

Primary outcome: Primary: The Time Interval From Induction to Delivery: All Participants — 20.97; 16.27 hours

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: misoprostol (Device); Foley bulb (Device)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: St. Luke's-Roosevelt Hospital Center
Primary completion: Jul 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY The Time Interval From Induction to Delivery: All Participants	20.97; 16.27	—
PRIMARY Time (Hours) From Induction to Delivery: Nulliparous	22.7; 18.15	—
PRIMARY Time (Hours) From Induction to Delivery: Multiparous	15.99; 11.89	—
PRIMARY Time From Induction to Delivery: VD	18.87; 15.55	—
PRIMARY Time From Induction to Delivery: CD	24.38; 17.95	—
PRIMARY Per Treatment Protocol: Time (Hours) From Induction to Delivery	20.5109; 16.6814	—
SECONDARY The Time From Induction Until to Active Phase Labor	17.43; 12.81	—
SECONDARY The Time From Active Phase to Delivery	3.11; 3.76	—
SECONDARY Incidence of Chorioamnionitis	8; 4	—
SECONDARY Incidence of Uterine Tachysystole	12; 6	—
SECONDARY Incidence of Patient Discomfort	—	—
SECONDARY Estimated Blood Loss	493.3; 490.5	—

Summary

A randomized, prospective trial will be offered to women admitted to the Roosevelt Hospital labor floor for labor induction. The hypothesis is that the simultaneous use of a foley bulb together with vaginal misoprostol will result in shorter induction to delivery time compared with vaginal misoprostol alone

Eligibility Criteria

Inclusion Criteria

Term 37 weeks or more, singleton in cephalic presentation
Age 18 years and older
Patient admitted for induction of labor

Exclusion Criteria

Malpresentation
Preterm labor less than 37 weeks of gestation
Patients with fetal anomalies
Premature rupture of membranes
If the cervix is closed and unable to place the foley bulb
Multiple gestation
Non-reassuring fetal heart tracing
Contraindication to misoprostol
Contraindication to vaginal delivery (i.e. placenta previa, vasa previa, active vaginal bleeding, marginal previa, macrosomia, etc). History of prior uterine surgery such as cesarean section or myomectomy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02566005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.