Foley Catheter for Induction of Labor at Term: An Open-Label, Randomized Controlled Trial

PloS One
Ning GuYali Hu

Abstract

This study aimed to determine the optimal Foley catheter balloon volume (30-mL vs. 80-mL) and the maximum time for cervical ripening (12 hours vs. 24 hours) to improve vaginal delivery rate within 24 hours of induction. We conducted an open-label, randomized controlled trial in a teaching hospital in China. Women with a term singleton pregnancy, cephalic presentation, intact membrane and an unfavorable cervix (Bishop score <6) were randomly allocated, in 1:1:1:1 ratio, to receive either one of the four treatments: (1) 30-mL balloon for a maximum of 12 hours, (2) 30-mL balloon for a maximum of 24 hours, (3) 80-mL balloon for a maximum of 12 hours, and (4) 80-mL balloon for a maximum of 24 hours. The primary outcome was vaginal delivery within 24 hours. Secondary outcomes included cesarean section rate and maternal/neonatal morbidity. Data were analyzed on a per-protocol basis. Five hundred and four women were recruited and randomized (126 women in each group); nine women did not receive the assigned intervention. More women achieved vaginal delivery within 24 hours in 12-hour Foley catheter groups than in the 24-hour Foley catheter groups (30-mL/12 hours: 54.5%, 30-mL/24 hours: 33.1%, 80-mL/12 hours: 46.4%, 80-mL/24 hours: 24.0%...Continue Reading

References

May 10, 2003·Obstetrics and Gynecology·Roy M Pitkin
Nov 18, 2004·American Journal of Obstetrics and Gynecology·Roni LevyZion J Hagay
Aug 5, 2008·American Journal of Obstetrics and Gynecology·Jennifer HeinemannAndrew M Kaunitz
Aug 22, 2008·BJOG : an International Journal of Obstetrics and Gynaecology·M PragerL Marions
Jul 23, 2009·Obstetrics and Gynecology·UNKNOWN ACOG Committee on Practice Bulletins -- Obstetrics
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Mar 28, 2013·BJOG : an International Journal of Obstetrics and Gynaecology·G J van BaarenK W M Bloemenkamp

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Citations

May 16, 2017·International Journal of Gynaecology and Obstetrics : the Official Organ of the International Federation of Gynaecology and Obstetrics·Yihui ZhangYimin Dai
Mar 7, 2017·European Journal of Obstetrics, Gynecology, and Reproductive Biology·Evelien M SandbergWim J van Wijngaarden
Apr 3, 2018·Acta Obstetricia Et Gynecologica Scandinavica·Corina N SchoenVincenzo Berghella
Oct 18, 2019·The Cochrane Database of Systematic Reviews·Marieke Dt de VaanMichel Boulvain
Feb 23, 2021·Journal of Medical Devices·Mallory WhalenAlissa Dangel
Sep 1, 2021·Acta Obstetricia Et Gynecologica Scandinavica·Mukhri HamdanPeng Chiong Tan

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Methods Mentioned

BETA
cesarean section
cesarean sections

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