Foley Bulb Insertion Method: Blind vs. Direct
Condition: Pregnancy Related
Study type: Interventional

Summary: 
      The investigators will compare, in a randomized clinical trial, two methods of placement
      (placement with a gloved hand vs. placement with a sterile speculum) of a Foley bulb
      transcervical dilator. The primary outcome is rate of infection.
    

Detailed description: 
      The target population for this study is women who present for scheduled induction of labor.
      If there is a decision by the obstetric team to place a transcervical Foley dilator for
      cervical ripen-ning, the obstetric team will notify the research team so that the patient may
      be screened for the study. If the patient consents to participation, written informed consent
      will be obtained by person-to-person contact. The PI, study coordinator, or a collaborator
      will be responsible for the in-formed consent. After informed consent is obtained, the
      patient will be randomized to the study group (digital placement) or the control group
      (placement with a sterile speculum).

      The control group will undergo induction of labor by placement via sterile speculum of a
      22-French transcervical Foley catheter. The cervix is visualized with a sterile vaginal
      speculum and cleaned with iodine or chlorhexidine. A Foley catheter is introduced into the
      cervix and the bal-loon is filled with 60 ml of sterile 0.9% NaCl. The Foley catheter will be
      left in place for at least 12 hours, and no longer than 24 hours. After placement standard
      intrapartum management of the patient will ensue.

      The study group will undergo induction of labor by digital blind placement of a 22-French
      trans-cervical Foley catheter. A Foley catheter is introduced into the cervix using digits
      and hands wearing sterile gloves and the balloon is filled with 60 ml of sterile 0.9% NaCl.
      The Foley catheter will be left in place for at least 12 hours, and no longer than 24 hours.
      After placement standard intrapartum management of the patient will ensue.

      If cervix remains unfavorable after extraction of the dilators (< 3cm and at most 60%
      effaced), a second Foley catheter will be used in this case for a maximum of 12 hrs. No
      crossover will be allowed. In other words, a second Foley bulb will be placed in the same
      manner as the first assignment arm.

      In any attempts, if the Foley bulb is not able to be placed in either insertion technique , a
      prostaglandin agent for cervical ripening may be used and insertion of the mechanical dilator
      can be re-attempted at a later time, as is the standard of care at our institution. No cross
      over will be allowed.

      This will be an unblinded randomized clinical trial.

      No significant adverse effects are expected with the use of transcervical Foley catheters for
      mechanical dilation. The most significant risks are vaginal bleeding due to cervical trauma
      and incidental rupture of membranes, as well as pain or discomfort with placement. The
      patient will undergo inpatient induction of labor, so any adverse reaction would be promptly
      detected and addressed.
    

Intervention name(s): Method of placement of Foley bulb transcervical dilator
Intervention type(s): Procedure
Intervention description(s): This trial will assess two methods used to place a Foley bulb transcervical dilator.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention