Accidental rupture of membranes and neonatal infection after labor induction with silicone or latex balloon catheters: A retrospective cohort study.

Objective(s): Accidental rupture of membranes (acROM), an insertion-related complication of the balloon catheter for labor induction, may prolong the duration of ruptured membranes. Prolonged rupture of membranes is associated with an increased risk of intra-uterine infection with possibly neonatal infection as result. Little is known about safety profiles of different catheters regarding the occurrence of these complications. This study compares the incidence of neonatal early-onset sepsis (EOS) and acROM in women receiving either silicone or latex balloon catheters.

Study Design: A retrospective cohort study was performed including 2200 women (silicone balloon catheter, n = 1100 vs. latex balloon catheter, n = 1100). The primary outcomes were the incidence of acROM, and suspected and proven neonatal EOS. Secondary outcomes were: prolonged rupture of membranes, intrapartum fever, pre- or postnatal neonatal exposure to antibiotics, and perinatal outcomes. A subgroup analysis was performed between women with and without acROM.

Results: No statistically significant difference with regard to suspected or proven EOS was seen between the silicone and latex groups. The acROM rate was significantly higher in the silicone group compared to the latex group (2.9 % and 0.3 %, p < 0.01). Prolonged rupture of membranes was significantly more common in the silicone group compared to the latex group (5.0 % and 2.4 %, p < 0.01), as was the use of intrapartum antibiotics (12.7 % and 9.6 %, p = 0.02). Neonates were significantly more often exposed to pre- or postnatal antibiotics in the silicone group compared to the latex group (17.6 % and 13.6 %, p = 0.01). Subgroup analysis showed significantly more suspected and proven neonatal EOS when catheter-insertion was complicated with acROM (11.4 % and 20.0 %), compared to cases without acROM (3.8 % and 2.5 %), irrespective of the type of catheter used.

Conclusion(s): The use of silicone balloon catheters for labor induction results in higher rates of acROM, prolonged rupture of membranes and use of intrapartum antibiotics, compared to latex balloon catheters. No statistically significant differences were found in the occurrence of suspected or proven neonatal EOS, however neonates from the silicone group were more often exposed to pre- or postnatal antibiotics. When acROM occurs, irrespective of type of catheter used, suspected and proven neonatal EOS was seen more often.