Cervical Ripening With Foley Bulb Versus Dilapan-S at Home

Summary

DILAPAN-S® was FDA-approved for pre-induction cervical ripening in 2015. Since that time, there have been limited studies comparing its efficacy, safety, and patient satisfaction to other mechanical cervical ripening techniques. The purpose of this trial is to perform a noninferiority randomized clinical trial comparing DILAPAN-S® to the Foley catheter for outpatient cervical ripening in term elective labor inductions, examining time spent on the labor and delivery unit, patient safety, and patient satisfaction feedback.

Conditions

• Induced; Birth
• Induction of Labor Affected Fetus / Newborn

Interventions

DEVICE

Foley bulb placement

A 16 F Foley catheter with a 30-mL balloon and stylet is inserted into the endocervical canal under direct visualization by sterile speculum exam or by digital palpation. The Foley catheter is advanced to or past the internal os, and the balloon is filled with 30-40 mL of sterile water. The catheter is then placed on genital traction by taping the end of the catheter to the medial portion of the thigh.

DEVICE

DILAPAN-S® placement

A bivalve speculum will be used to visualize and prepare the cervix with an antiseptic solution. The DILAPAN-S® (4 x 65 mm) will be inserted in the cervical canal until it traverses the internal os. As many dilators as needed to achieve the desired effect should be inserted. Specific number of pieces always depends on decision and clinical judgement of physician and indications. A gauze pad moistened with sterile water or saline may be inserted into the vagina to help keep the DILAPAN-S® in place, if needed

Sponsors & Collaborators

• Medicem International CR s.r.o.

  collaborator INDUSTRY

• Medicem Technology s.r.o.

  collaborator OTHER

• Christiana Care Health Services

  lead OTHER

Principal Investigators

• Anthony C Sciscione, DO · Christiana Care Health Services

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-30

Primary Completion

2022-06-30

Completion

2022-06-30

FDA Device

Yes