1. A comparison of balloon catheters and vaginal prostaglandins for cervical ripening prior to labour induction.
- Author
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Jones M., Palmer K., Pathirana M.M., Cecatti J.G., Moraes Filho O.B., Marions L., Prager M., Edlund M., Jozwiak M., Eikelder M.T., Rengerink K.O., Bloemenkamp K.W.M., Henry A., Beckmann M., Kumar S., Diguisto C., Le Gouge A., Perrotin F., Symonds I., O'Leary S., Rolnik D.L., Mol B.W., Li W., Jones M., Palmer K., Pathirana M.M., Cecatti J.G., Moraes Filho O.B., Marions L., Prager M., Edlund M., Jozwiak M., Eikelder M.T., Rengerink K.O., Bloemenkamp K.W.M., Henry A., Beckmann M., Kumar S., Diguisto C., Le Gouge A., Perrotin F., Symonds I., O'Leary S., Rolnik D.L., Mol B.W., and Li W.
- Abstract
Objective: Induction of labor (IOL) is one of the most common obstetric interventions, with cervical ripening required for half of all inductions. Randomized clinical trials comparing balloon catheters and vaginal prostaglandins are generally underpowered for safety outcomes. We aim to compare effectiveness and safety by re-analyzing individual participant data from numerous trials comparing these two methods of cervical ripening. Study Design: Raw data was sought from eligible RCTs comparing balloon catheters and vaginal prostaglandins (PGE1 and/or PGE2). The primary outcomes were caesarean section (CS) and its indications (i.e., fetal compromise or failure to progress), a composite of adverse perinatal outcome (Apgar < 7 at 5 min, arterial umbilical cord pH < 7.1, admission to NICU, seizures, severe respiratory compromise, infection, neonatal death, or stillbirth), and a composite of adverse maternal outcome (admission to ICU, infection, severe postpartum hemorrhage, or death). The analysis followed intention-to-treat and considered clustering within trials. Result(s): We identified 13 eligible RCTs of which data was available from eight (3772 participants) with the data from three PROBAAT combined (PROBAAT 1+M+P). IOL with balloon catheters and vaginal prostaglandins did not have significantly different rates of CS (RR 1.09, 95% CI 0.97-1.22). However, balloon catheters were associated with significantly higher rates of CS for failure to progress (RR 1.23, 95% CI 1.01-1.51; Figure 1). CS for fetal compromise occurred less often, although the difference was not statistically significant (RR 0.85, 95% CI 0.66-1.09). Balloon catheters were associated with reduced composite adverse perinatal outcomes (Figure 2) compared to vaginal prostaglandins (RR 0.80, 95% CI 0.67-0.97). There were no differences noted for composite adverse maternal outcomes between the two methods (RR 1.00, 95% CI 0.86-1.16). Conclusion(s): For cervical ripening in IOL, balloon catheters and vagi
- Published
- 2021