Six versus twelve hours of single-balloon catheter placement with oxytocin administration for labor induction: a randomized controlled trial.
Am J Obstet Gynecol
; 224(6): 611.e1-611.e8, 2021 06.
Article
en En
| MEDLINE
| ID: mdl-33771496
BACKGROUND: Induction of labor is common in the United States. Multiple previous studies have tried to outline a faster time to delivery to improve maternal and fetal outcomes. OBJECTIVE: This study aimed to evaluate whether women who undergo induction of labor with a single-balloon catheter and oxytocin have a shorter time to delivery with planned removal of the catheter at 6 vs 12 hours. STUDY DESIGN: In this randomized controlled trial, induction of labor was performed using a combination of single-balloon catheter and oxytocin. Term women, both nulliparous and multiparous, aged 18 to 50 years old with cephalic singletons were included if they were undergoing induction of labor with a Bishop score of <6 and cervical dilation of <2 cm. Women were randomized to planned removal of the single-balloon catheter at 6 hours vs 12 hours. The primary outcome was time from catheter insertion to delivery. We were powered to show a 4-hour time difference with a sample size of 89 women per group (n=178). Planned sensitivity analyses were performed to account for cesarean delivery in labor. RESULTS: From February 2019 to June 2020, 237 women were screened, 178 women were randomized, and 177 women were included in the final analysis (89 women in the 6-hour group and 88 women in the 12-hour group). Insertion to delivery time was significantly shorter in the 6-hour group (19.2 vs 24.3 hours; P=.04), and the proportion of women delivered by 24 hours was significantly greater in the 6-hour group (67.4% vs 47.4%; P<.01). There was no difference in the Bishop score at removal of the catheter or secondary maternal or neonatal outcomes. In a Cox proportional-hazards model censoring for cesarean delivery, the 6-hour group had a significantly shorter insertion to delivery time (hazard ratio, 0.67; P=.02). CONCLUSION: Induction of labor with a single-balloon catheter and oxytocin with planned removal of the catheter at 6 hours rather than 12 hours results in a shorter time from insertion to delivery without increasing the rate of cesarean delivery. Decreasing the length of time a single-balloon catheter is in place should be considered in clinical protocols.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Oxitócicos
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Oxitocina
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Cateterismo
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Trabajo de Parto Inducido
Tipo de estudio:
Clinical_trials
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Guideline
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Observational_studies
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Prognostic_studies
Límite:
Adolescent
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Adult
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Female
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Humans
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Middle aged
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Pregnancy
Idioma:
En
Revista:
Am J Obstet Gynecol
Año:
2021
Tipo del documento:
Article
Pais de publicación:
Estados Unidos