Foley Bulb Insertion by Blind Placement Compared With Direct Visualization: A Randomized Controlled Trial

Area of Science:

• Obstetrics and Gynecology
• Reproductive Medicine
• Clinical Trials

Background:

• Cervical ripening is crucial for labor induction in women with unfavorable cervix.
• Traditional methods for balloon catheter placement include digital and speculum techniques.
• Assessing the comparative safety and efficacy of these placement methods is essential for optimizing obstetric care.

Purpose of the Study:

• To determine if digital placement of a balloon catheter is noninferior to the speculum method regarding maternal infection rates.
• To compare secondary outcomes, including cesarean delivery rates and patient satisfaction.
• To evaluate the overall safety and feasibility of digital balloon catheter placement for preinduction cervical ripening.

Main Methods:

• An open-label, noninferiority randomized trial involving 372 pregnant women undergoing labor induction.
• Participants were assigned to either digital or sterile speculum placement of a balloon catheter.
• The primary outcome was a composite of maternal infection (fever, chorioamnionitis, endometritis).

Main Results:

• No significant difference in the composite maternal infection rate between digital (15.7%) and speculum (12.8%) placement groups (absolute difference 2.8%, 95% CI -4.3 to 9.9%).
• Digital placement was noninferior to the speculum method for preventing maternal infection.
• The speculum group required a second balloon catheter more frequently; patient satisfaction and adverse events were similar between groups.

Conclusions:

• Digital placement of balloon catheters for cervical ripening is a safe and effective alternative to the speculum method.
• This approach does not increase the risk of maternal infection and may reduce the need for repeat procedures.
• The digital method offers a reasonable option for preinduction cervical ripening, enhancing obstetric care choices.