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

Gu N, Ru T, Wang Z, Dai Y, Zheng M, Xu B, Hu Y - PLoS ONE (2015)

Bottom Line: After adjustment for confounding factors, both ripening time and balloon size did not affect the proportion of women delivered vaginally within 24 hours of induction.For women with an unfavorable cervix at term, induction of labor with a Foley catheter is safe and effective.Higher balloon volume (80-mL vs. 30-mL) and longer ripening time (24 hours vs. 12 hours) would not shorten induction to delivery interval or reduce cesarean section rate.

View Article: PubMed Central - PubMed

Affiliation: Department of Obstetrics and Gynecology, Nanjing Drum Tower Hospital, Affiliated to Nanjing Medical University, Nanjing, China.

ABSTRACT

Objective: 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.

Methods: 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.

Results: 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%, p < 0.001). Cesarean section rates and the incidence of chorioaminonitis were comparable among four groups. After adjustment for confounding factors, both ripening time and balloon size did not affect the proportion of women delivered vaginally within 24 hours of induction.

Conclusion: For women with an unfavorable cervix at term, induction of labor with a Foley catheter is safe and effective. Higher balloon volume (80-mL vs. 30-mL) and longer ripening time (24 hours vs. 12 hours) would not shorten induction to delivery interval or reduce cesarean section rate.

Trial registration: Chinese Clinical trial registry (ChiCTR-TRC-13003044).

No MeSH data available.


Time from start of induction to vaginal delivery (excluding cesarean deliveries).
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pone.0136856.g003: Time from start of induction to vaginal delivery (excluding cesarean deliveries).

Mentions: Kaplan-Meier survival curves illustrated the fraction of women who progressed to the active phase and gave birth vaginally at a given time after the initiation of cervical ripening in each group (Figs 2 and 3). It demonstrated that the median time from initiation of ripening to active phase and to vaginal delivery was significantly shorter in the two 12-hour Foley catheter groups than in the other two 24-hour Foley catheter groups (Log-rank test, p<0.001). However, on COX multiple regression, variables independently associated with the induction to delivery interval were parity and gestational age.


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

Gu N, Ru T, Wang Z, Dai Y, Zheng M, Xu B, Hu Y - PLoS ONE (2015)

Time from start of induction to vaginal delivery (excluding cesarean deliveries).
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4556187&req=5

pone.0136856.g003: Time from start of induction to vaginal delivery (excluding cesarean deliveries).
Mentions: Kaplan-Meier survival curves illustrated the fraction of women who progressed to the active phase and gave birth vaginally at a given time after the initiation of cervical ripening in each group (Figs 2 and 3). It demonstrated that the median time from initiation of ripening to active phase and to vaginal delivery was significantly shorter in the two 12-hour Foley catheter groups than in the other two 24-hour Foley catheter groups (Log-rank test, p<0.001). However, on COX multiple regression, variables independently associated with the induction to delivery interval were parity and gestational age.

Bottom Line: After adjustment for confounding factors, both ripening time and balloon size did not affect the proportion of women delivered vaginally within 24 hours of induction.For women with an unfavorable cervix at term, induction of labor with a Foley catheter is safe and effective.Higher balloon volume (80-mL vs. 30-mL) and longer ripening time (24 hours vs. 12 hours) would not shorten induction to delivery interval or reduce cesarean section rate.

View Article: PubMed Central - PubMed

Affiliation: Department of Obstetrics and Gynecology, Nanjing Drum Tower Hospital, Affiliated to Nanjing Medical University, Nanjing, China.

ABSTRACT

Objective: 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.

Methods: 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.

Results: 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%, p < 0.001). Cesarean section rates and the incidence of chorioaminonitis were comparable among four groups. After adjustment for confounding factors, both ripening time and balloon size did not affect the proportion of women delivered vaginally within 24 hours of induction.

Conclusion: For women with an unfavorable cervix at term, induction of labor with a Foley catheter is safe and effective. Higher balloon volume (80-mL vs. 30-mL) and longer ripening time (24 hours vs. 12 hours) would not shorten induction to delivery interval or reduce cesarean section rate.

Trial registration: Chinese Clinical trial registry (ChiCTR-TRC-13003044).

No MeSH data available.