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Intrauterine Foley catheter for 48 versus 24 hours for cervical ripening: A randomized controlled trial
Author(s) -
Wickramasinghe Ruwan P. T. B.,
Senanayake Hemantha,
De Silva Chandu
Publication year - 2020
Publication title -
international journal of gynecology and obstetrics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.895
H-Index - 97
eISSN - 1879-3479
pISSN - 0020-7292
DOI - 10.1002/ijgo.13109
Subject(s) - medicine , odds ratio , randomized controlled trial , chorioamnionitis , confidence interval , gestation , gestational age , foley catheter , obstetrics , catheter , pregnancy , surgery , biology , genetics
Objective To compare the safety of keeping an intrauterine Foley catheter for 48 hours versus 24 hours for cervical ripening. Methods A randomized controlled trial was conducted at the De Soysa Hospital for Women, Sri Lanka from April 1 to December 31, 2014 (trial registration: SLCTR /2014/006). Low‐risk women with a Bishop score ≤5 at 40 weeks + 5 days of gestation were allocated to either 24‐hour (n=107; Group A) or 48‐hour (n=94; Group B) groups. Proportions developing spontaneous onset of labor ( SOL ), neonatal status, pre‐ and post‐procedure C‐reactive protein ( CRP ), cervical smears, and placental histology in those who experienced SOL were compared. Results In Group A, 35 (32.7%) experienced SOL , against 54 (57.4%) in Group B ( P <0.001, odds ratio 2.78, 95% confidence interval 1.56–4.93). There was no difference in mean length of active labor (7.48 vs 7.69 hours), cesarean delivery (16% vs 14%), bacterial vaginosis rates in post‐induction cervical smear (10.3% vs 6.7%), mean CRP increase (4.08 vs 3.91 IU ), evidence of chorioamnionitis (5.7% vs 11.1%), mean 1 and 5‐minute Apgars, number of neonates with pyrexia (8.4 vs 8.5%), and admission to the Special Care Baby Unit (15% vs 12.8%). Conclusion Group B experienced a statistically significant increase in SOL , without increasing infectious and neonatal morbidity.