Objective
Although unequivocal benefits to ripening exist in the setting of intact membranes, ripening remains controversial in the setting of prelabor rupture of membranes (PROM). PROM complicates 8% of term pregnancies, which translates to approximately 270,000 births in the United States annually. We undertook a systematic review and meta-analysis (which adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines) of randomized controlled trials (RCT) where an intracervical balloon catheter (ICBC) was compared with a pharmacologic agent for the induction of labor (IOL) after PROM, including preterm PROM.
Study Design
This study was exempt from the institutional review board and was registered on the International Prospective Register of Systematic Reviews on January 28, 2020 (CRD42020166936). MEDLINE (1966 to date), Cochrane, and ClinicalTrials.gov databases were searched in January 2020 and May 2020 to identify eligible trials. Randomized trials comparing balloon catheter with or without pharmacologic agents with pharmacologic agents for IOL after PROM at or near term were included. The included articles were assessed for risk of bias using the Cochrane risk-of-bias tool for RCTs (RoB 2), of which 3 articles were considered high risk of bias: 2 articles because of the deviation from intended intervention and 1 article because of the measurement of the outcome. The primary outcome was intra-amniotic infection (IAI) as defined by the individual RCTs. Secondary outcomes included time to vaginal delivery, cesarean delivery and indication for cesarean delivery, postpartum hemorrhage, endometritis, and neonatal outcomes (suspected neonatal infection or culture-proven neonatal sepsis, neonatal intensive care unit admission, and 5-minute Apgar score of <7). Random effects meta-analyses were used to report the risk ratio (RR) and 95% confidence interval (CI). Data were independently abstracted by multiple authors. Authors of the included trials were contacted to provide additional clarifications or data when applicable. Preplanned subgroup analyses included a sensitivity analysis excluding studies considered at high risk of bias, comparison of ICBC with or without pharmacologic agent vs oxytocin, vs misoprostol, and vs dinoprostone, to be separately analyzed by route of delivery. In addition, we planned to analyze ICBC without an additional pharmacologic agent vs individual pharmacologic agents.
Results
A total of 9 studies assessed patients with PROM who were randomized to ICBC (with or without pharmacologic agents) vs pharmacologic agents for IOL ( Table 1 ): 4 studies contributed data for analysis (605 women). We were unable to procure data specific to those induced for PROM in 5 studies, , , and therefore, these studies were excluded from the analysis. There was an increased risk of IAI in those treated with ICBC vs pharmacologic agents, although the CI crossed 1 (RR, 1.84; 95% CI, 0.91–3.73). When comparing ICBC with oxytocin (without ICBC) for IOL in PROM, there was a 3.2-fold increased risk of IAI in the ICBC arm (15 of 154 [9.7%]) compared with the oxytocin arm (5 of 174 [2.9%]; 95% CI, 1.17–8.70) ( Table 2 ). There were no significant differences in other outcomes, including endometritis and suspected neonatal infection, nor were there any differences with respect to preplanned subgroup analyses. Many of the planned subgroup analyses could not be conducted as there was no more than 1 trial available for a given medication, with the exception of oxytocin.
| Characteristic | Amorosa et al, 2016 a | El Khouly, 2017 | Greybush et al, 2001 | Kehl et al, 2011 | Kruit et al, 2016 a | Mackeen et al, 2018 a | Prager et al, 2008 a | Rust et al, 2001 | Sheiker et al, 2009 |
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| Participants | 127 women with PROM | 108 women, including 11 women with PROM | 205 women, including 14% with PROM | 122 women, including 22 women with PROM | 188 women with PROM | 201 women with PROM | 592 women, including 89 women with PROM | 81 women, including 10 women with PROM | 90 women, including 17% with PROM |
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| Primary outcome | IOL to delivery interval, hours, median (IQR) | Success of IOL | IOL to delivery interval, hours, mean (SD) | Rate of failure of IOL | Cesarean delivery rate; maternal and neonatal infections | IOL to delivery interval, hours, mean (SD) | IOL to delivery interval, hours, median (IQR) | IOL to delivery interval, hours, mean (SD) | Not specified |
| Defined unfavorable cervix | Cervical dilation of <3 cm or <3 contractions in 10 mins when initial exam was deferred | Bishop score≤5 | Bishop score≤5 | Bishop score<8 | Bishop score<6 | Cervical dilation of <2 or 80% effaced | Bishop score≤6 | Bishop score≤5 | Bishop score≤5 |
| Gestational age for inclusion, wks | ≥34 | >28 | N/A | ≥37 | ≥37 | ≥34 | ≥37 | N/A | 37–42 |
| Overall risk of bias | Low | Low | Low | High | High | Low | Low | Low | High |
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