Cervical Ripening With Foley Bulb Versus Dilapan-S at Home

NAWithdrawnINTERVENTIONAL
0
Timeline

Start Date

June 30, 2022

Primary Completion Date

June 30, 2022

Study Completion Date

June 30, 2022

Conditions
Induced; BirthInduction 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
All Listed Sponsors
collaborator

Medicem International CR s.r.o.

INDUSTRY

collaborator

Medicem Technology s.r.o.

OTHER

lead

Christiana Care Health Services

OTHER