Double-balloon catheter
The Cook double-balloon catheter for CR is meant to create pressure on both sides of the cervix, facilitating CR. Studies have reported that the Cook double-balloon catheter can be used for outpatient CR. In one study, 48 women with a low-risk pregnancy, at 37 to 42 weeks’ gestation and a Bishop score <7 were randomly assigned to outpatient or inpatient double-balloon CR.8 Both balloons were filled with 70 to 80 mL of sterile water. CTG monitoring was performed for 20 minutes before and after balloon placement. The women in the outpatient CR group were instructed to return to the labor unit the next day at 8 AM for IOL or earlier if they had regular uterine contractions, rupture of membranes, or vaginal bleeding. Seven percent of the women in the outpatient group returned to the labor unit before 8 AM. After removal of the balloon catheter, women in the outpatient and inpatient groups needed additional misoprostol CR in 12% and 13% of cases, respectively. Outcomes were similar in the two groups, but the study was not powered to identify small differences between the groups.
In another study of outpatient CR with the Cook double-balloon catheter, 695 women with a Bishop score <7, at ≥37 weeks’ gestation, were randomly assigned to outpatient CR with a double-balloon catheter or inpatient CR with dinoprostone (PGE2) (2 mg dinoprostone vaginal gel [Prostin] or dinoprostone 10 mg controlled-release tape (Cervidil).9 Women assigned to dinoprostone CR had CTG monitoring prior to commencing PGE2 CR and at least 30 min of CTG monitoring after insertion of the vaginal PGE2. Women assigned to balloon CR were not admitted to the hospital. CTG was performed prior to insertion of the balloon. After insertion, the two balloons on the catheter were each filled with 80 mL of saline. After catheter insertion CTG monitoring was not routinely performed. The women in the double-balloon catheter group returned to the labor unit 12 hours after insertion to initiate IOL. The primary outcome was composite neonatal morbidity and mortality, including admission to a neonatal intensive care unit (NICU), intubation, cardiac compressions, acidemia, hypoxic ischemic encephalopathy, seizure, infection, pulmonary hypertension, stillbirth, or death.
There was no significant difference in the rate of the primary outcome in the catheter versus the PGE2 group (18.6% and 25.8%; P = .07). Admission to the NICU occurred at rates of 12.6% and 15.5% in the catheter and PGE2 groups. Umbilical cord arterial pH <7.00 at birth occurred at a rate of 3.5% in the catheter group and 9.2% in the PGE2 group. The cesarean delivery rates in the catheter and PGE groups were 32.6% and 25.8%, respectively (P = .24). The investigators concluded that outpatient CR using a double-balloon catheter is safe and feasible for nulliparous women.
Two systematic reviews and meta-analyses reported that outcomes were similar when using the Foley or double-balloon catheter for CR.10,11 The Cook double-balloon CR kit includes a stylet, which can facilitate passing the catheter through the cervix.
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