Foley Catheter Compared to the Foley Catheter Alone for Cervical Ripening
Condition: Cervical Ripening; Induction of Labor
Study type: Interventional

Summary: 
      In term women presenting for labor induction, combined use of the controlled release
      dinoprostone vaginal insert and Foley catheter for cervical ripening will decrease the median
      time from induction to vaginal delivery by at least four hours compared to the Foley catheter
      alone.
    

Detailed description: 
      Those who provide informed consent will be allocated by an online randomization system either
      to placement of a transcervical Foley catheter and an intravaginal dinoprostone controlled
      release insert or a Foley catheter alone. Randomization will be stratified by parity
      (nulliparous or parous).

      In both study groups, the balloon on the end of the Foley catheter will be inflated with 30
      mL of sterile water, pulled back against the internal os of the cervix, and taped to the
      maternal thigh under minimal tension. Also in both groups, the Foley catheter will be removed
      if any of the following occurs: 1) expulsion, 2) fetal heart rate tracing mandating
      evaluation for membrane rupture and placement of internal monitors, 3) spontaneous membrane
      rupture, or 4) if 12 hours has elapsed since placement. The dinoprostone insert will be
      removed if: 1) the fetal heart rate tracing mandates evaluation for membrane rupture and
      placement of internal monitors, 2) tachysystole develops (more than 5 contractions per 10
      minutes averaged over 30 minutes, 3) spontaneous membrane rupture, or 4) 12 hours has elapsed
      since placement. Though these are the criteria for insert removal, in keeping with the
      pragmatic design of this trial, the decision regarding removal will be left to the discretion
      of the attending physician.

      Women will remain recumbent for 30 minutes after agent placement and, except for trips to the
      restroom, will undergo continuous monitoring of uterine contractions and fetal heart rate.
      Oxytocin, according to standard intravenous protocol, will be allowed only after removal of
      cervical ripening agent(s). After specified cervical ripening, labor management will be at
      the discretion of the attending obstetrician, in keeping with the pragmatic nature of the
      study design.

      Antibiotics will be administered if indicated for prophylaxis against early-onset neonatal
      infection with group B streptococci or for treatment of chorioamnionitis. Cesarean delivery
      will be performed, per the discretion of the attending obstetrician, for standard maternal or
      fetal indications.

      Medical records will be reviewed no less than 30 days after delivery. Demographic,
      intrapartum, and outcome data will be entered into a computerized database.
    

Intervention name(s): Cervidil 10 MG Vaginal Insert; Foley Catheter
Intervention type(s): Drug; Device
Intervention description(s): Dinoprostone vaginal insert is a thin, flat, polymeric slab which is rectangular in shape with rounded corners contained within the pouch of an off-white knitted polyester retrieval system, an integral part of which is a long tape. Each slab is buff colored, semitransparent and contains 10 mg of dinoprostone in a hydrogel insert. An integral part of the knitted polyester retrieval system is a long tape designed to aid retrieval at the end of the dosing interval or earlier if clinically indicated. The finished product is a controlled release formulation which has been found to release dinoprostone in vivo at a rate of approximately 0.3 mg/hr.; The balloon on the end of the Foley catheter will be inflated with 30 mL of sterile water, pulled back against the internal os of the cervix, and taped to the maternal thigh under minimal tension.
Other intervention name(s): Dinoprostone
Intervention MeSH terms: Dinoprostone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cervical Ripening; Induction of Labor