[Clinical analysis of double-balloon catheter for cervical ripening in 66 cases]

To evaluate the efficacy and safety for cervical ripening by double-balloon catheter among full-term pregnancy women underwent labor induction.

It was a prospective non-randomly controlled research. Totally 128 singleton-pregnancy women in full-term who had to undergo labor induction because of pregnancy complications or comorbidities from August 2011 to April 2013 in Peking University First Hospital were selected as study subjects. Participants were allocated to preinduction cervical ripening with either a double-balloon catheter (66 participants, study group) or prostaglandin vaginal insert (62 participants, control group). Compare the efficacy for cervical ripening and adverse reactions between the two groups.

The efficacy for cervical ripening (Bishop scores improved by ≥ 2) had no significant differences between study and control groups [82% (54/66) compared with 81% (50/62), P > 0.05]. The time interval between intervention and parturiency was significantly higher in the double balloon catheter group than in the prostaglandin vaginal insert group [(24.2 ± 8.5) compared with (14.5 ± 8.0) hours, P < 0.05]. The proportion of women who achieved parturiency within 12 hours was significantly lower in the double-balloon catheter group than that in the control group [9% (6/66) compared with 21% (13/62), P < 0.05]. The cesarean section rate showed no significant differences [41% (27/66) compared with 43% (27/62), P > 0.05]. The prevalence of intrauterine infection demonstrated by clinical diagnosis was significantly higher in the double- balloon catheter group [11% (7/66) compared with 6% (4/62), P < 0.05]. The double-balloon catheter group had significantly lower rates of contraction over frequency [0(0/66) compared with 42% (26/62), P < 0.05], hyperthermia [3% (2/66) compared with 19% (12/62), P < 0.05], fetal heart rate abnormalities before removing the device or drug [5% (3/66) compared with 19% (12/62), P < 0.05], as well as precipitate labour [2% (1/66) compared with 16% (10/62), P < 0.05].

The efficacy of a double- balloon transcervical catheter is similar to that of a prostaglandin vaginal insert. However, the double- balloon catheter cannot significantly reduce the cesarean section rate while it increases the risk of intrauterine infection. The maternal and fetal safety of transcervical catheter is superior to the prostaglandin vaginal insert. In cases of oligohydramnios, fetal growth restriction, pregnancy complicated with asthma, hypertension and scar uterine are in favor of a balloon catheter using for cervical ripening on account of high risk of using prostaglandin.