Major Finding: The mean interval from catheter withdrawal to delivery time was 9 hours for the CRDB catheter vs. 14 hours for the Foley catheter in multiparous women in the first study, a nonsignificant difference. Time from insertion to delivery was significantly less at a mean of 19 hours with the Foley vs. a mean of 23 hours with the CRDB in the second study.
Data Source: Two prospective, randomized studies comparing the CRDB catheter with the Foley catheter, the first in 200 women and the second in 188 women.
Disclosures: None was reported.
CHICAGO — The cervical-ripening double-balloon catheter has a more favorable effect on cervical ripening than a Foley catheter in nulliparous, but not multiparous, women, according to a prospective randomized trial in 200 women.
Israeli investigators compared the two devices after noting that labor induction rates had risen to 27% of pregnancies in their hospital and that the cervical ripening double-balloon catheter (Cook Medical) costs about 10 times more than a Foley catheter. It has a uterine balloon located at the distal end of the device and a second cervicovaginal balloon located 1.5 cm proximal to the first one.
A total of 100 nulliparous and 100 multiparous women, aged 18-45 years, with singleton pregnancies at at least 37 weeks' gestation and intact membranes were randomized to labor induction by Foley catheter or the cervical ripening double-balloon (CRDB) catheter. Data were evaluable in 180 women.
In nulliparous women, the increment in the Bishop score from catheter insertion until withdrawal or expulsion was significantly higher at a mean of 4.4 in the CRDB group, compared with a mean of 3.4 in the Foley group, Dr. Ido Solt and associates reported in a poster at the annual meeting of the Society for Maternal-Fetal Medicine.
The mean interval from catheter withdrawal to delivery time was significantly shorter at 15 hours in the CRDB group vs. 23 hours in the Foley group.
Nine of 45 (20%) nulliparous women in the CRDB group had a cesarean section, compared with 20 of 50 (40%) nulliparous women in the Foley group, which was statistically significant.
No significant differences were observed in multiparous women between the two catheters, reported Dr. Solt of the department of obstetrics and gynecology at Western Galilee Hospital in Nahariya, Israel.
The mean interval from catheter withdrawal to delivery time was 9 hours for the CRDB catheter vs. 14 hours for the Foley catheter.
Cesarean sections occurred in 17% of the 41 multiparous women who received a CRDB, vs. 16% of 44 multiparous women receiving a Foley.
A second poster presented at the same meeting reported that the Foley catheter with extra-amniotic saline infusion was a faster cervical-ripening device than the CRDB in a randomized trial involving 93 nulliparous and 95 multiparous women.
The primary outcome of time from insertion to delivery was significantly less at a mean of 19 hours with the Foley catheter vs. a mean of 23 hours with the CRDB, reported Dr. Elad Mei-Dan of Hillel Yaffe Medical Center in Hadera, Israel, and associates. Mean insertion to expulsion time was also significantly shorter at 7 hours with the Foley vs. 10 hours with the CRDB.
Ripening success was similar at 97% with the Foley and 99% with the CRDB. Cesarean section rates were also similar at 21% and 20%.
Patient satisfaction on a 10-point scale was 7 with the Foley catheter and 6.6 with the CRDB catheter, which was not statistically different.
In light of the findings and the significant cost difference between the two devices, a Foley catheter should be preferred initially, Dr. Mei-Dan said in an interview. He put the price at $3.50 for a Foley set and at $41 for the CRDB.
He noted that he and his associates still use the CRDB when a Foley catheter fails to achieve cervical ripening or when the preinduction cervical dilation is too big to hold the Foley balloon, but can still hold the Cook balloons.