Included mode of birth, pain scores and duration of labor were also evaluated
Sample size required: 2500
To detect a 31% reduction in the composite neonatal outcome (10.0% to 6.9%)
80% power 80% and type 1 error of 0.05
695 participants included | Study stopped at time of interim analysis by Data and Safety Monitoring Committee due to (1) slow rate of recruitment (2) loss of patients from time of consent to randomization and (3) very low rates of adverse outcomes
Balloon group: 347 women
PG group: 348 women
There were no significant differences for the following
Composite neonatal measure
Relative risk (RR) 0.77 (95% CI 0.51 to 1.02; P=0.070)
Cord arterial pH <7.10 (P=0.072)
Nursery admissions (P=0.379)
Neonatal antibiotic use (P=0.103)
Cesarean delivery (P=0.240)
Nulliparous women in the balloon group had lower rates of the primary outcome (P=0.032)
Parous women in the balloon group were less likely to have an unassisted vaginal birth (P=0.045)
Parous women with a favorable cervix and in the balloon group had higher rates of cesarean than those in the PG group (21.2% vs 2.4%; P =0.009)
No differences were detected for other secondary outcomes such as
PPH | Analgesic use | Maternal antibiotic use | Cord prolapse | Meconium stained fluid
Uterine hyperstimulation: Only occurred in the PG group (3.0% versus 0%; P =0.029)
Only 6% of women in the balloon arm returned to hospital because of labor onset
Outpatient balloon catheter for IOL may be superior to inpatient PG for nulliparous women resulting in decreased composite adverse neonatal outcomes
For parous women, similar benefits were not seen and there may be increased risk for cesarean with a favorable cervix
OBG Project CME requires a modern web browser (Internet Explorer 10+, Mozilla Firefox, Apple Safari, Google Chrome, Microsoft Edge). Certain educational activities may require additional software to view multimedia, presentation, or printable versions of their content. These activities will be marked as such and will provide links to the required software. That software may be: Adobe Flash, Apple QuickTime, Adobe Acrobat, Microsoft PowerPoint, Windows Media Player, or Real Networks Real One Player.
Disclosure of Unlabeled Use
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
Jointly provided by
NOT ENOUGH CME HOURS
It appears you don't have enough CME Hours to take this Post-Test. Feel free to buy additional CME hours or upgrade your current CME subscription plan