Induction of labour in mid-trimester pregnancy using double-balloon catheter placement within 12 hours versus within 12-24 hours

Abstract Background This study aims to evaluate the efficacy and safety of the induction of labour in mid-trimester pregnancy using double-balloon catheter (DBC) within 12 hours versus within 12–24 hours. Methods In this retrospective study, a total of 58 pregnant women with gestation age of 14 + 0 weeks to 27 + 6 weeks were enrolled as research objects, and they underwent intended termination of pregnancy at our birth center from January 1, 2017, to June 31, 2019. Based on the duration time of DBC, the cases were divided into two groups (DBC group within 12 hours and DBC group within 12–24 hours). Results All of the 58 cases were successful vaginal delivery and no one chose cesarean section. The success rate of induction (successful abortion of fetus and placenta without the implementation of dilatation and evacuation) was higher in the DBC group within 12–24 hours (96.3%, 29/31) than that in DBC group within 12 hours (71.0%, 18/27) (p < 0.05). At the same time, the time from DBC removal to delivery in 12–24 hours DBC group was significantly shorter than that in DBC group within 12 hours (3.0 h versus 17.8 h) (p < 0.05), the degree of cervical dilation after DBC removal in DBC group within 12–24 hours was larger than that in DBC group within 12 hours (p < 0.05). Conclusion In the clinic, the placement time of DBC is generally lasting for about 12 hours. However, considering the cervical condition is immature in the mid-trimester, properly extending the placement time of DBC to 24 hours will benefit for cervical ripening and lead to reduce chance of dilatation and evacuation.

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Induction of labour in mid-trimester pregnancy using double-balloon catheter placement within 12 h versus within 12–24 h

BMC Pregnancy and Childbirth ◽

10.1186/s12884-020-03513-7 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Jing Peng ◽

Ruobing Li ◽

Shuguo Du ◽

Heng Yin ◽

Min Li ◽

...

Keyword(s):

Retrospective Study ◽

Balloon Catheter ◽

Induction Of Labour ◽

Cervical Ripening ◽

Efficacy And Safety ◽

Research Subjects ◽

Cervical Dilation ◽

Double Balloon ◽

Trimester Pregnancy ◽

Vaginal Deliveries

Abstract Background This study aims to evaluate the efficacy and safety of the induction of labour in mid-trimester pregnancy using a double-balloon catheter (DBC) within 12 h versus within 12–24 h. Methods In this retrospective study, a total of 58 pregnant women at 14 + 0 weeks to 27 + 6 weeks of gestation were enrolled as research subjects, and they underwent the intended termination of pregnancy at our birth centre from January 1, 2017, to June 31, 2019. Based on the duration of DBC, the patients were divided into two groups, namely, the DBC group within 12 h and the DBC group within 12–24 h. Results All 58 cases were successful vaginal deliveries, and no one chose to undergo caesarean section. The success rate of induction (successful abortion of the foetus and placenta without the implementation of dilation and evacuation) was higher in the DBC group within 12–24 h (96.3%, 29/31) than in the DBC group within 12 h (71.0%, 18/27) (p < 0.05). Additionally, the time from DBC removal to delivery in the DBC group within 12–24 h was significantly shorter than that in the DBC group within 12 h (3.0 h versus 17.8 h) (p < 0.05), and the degree of cervical dilation after DBC removal in the DBC group within 12–24 h was larger than that in the DBC group within 12 h (p < 0.05). Conclusion In the clinic, the placement time of DBC generally lasts for approximately 12 h. However, considering that the cervical condition is immature in the mid-trimester, properly extending the placement time of DBC to 24 h will benefit cervical ripening and reduce the chance of dilation and evacuation.

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Cervical ripening in prolonged pregnancies by silicone double balloon catheter versus vaginal dinoprostone slow release system: The MAGPOP randomised controlled trial

PLoS Medicine ◽

10.1371/journal.pmed.1003448 ◽

2021 ◽

Vol 18 (2) ◽

pp. e1003448

Author(s):

Caroline Diguisto ◽

Amélie Le Gouge ◽

Chloé Arthuis ◽

Norbert Winer ◽

Olivier Parant ◽

...

Keyword(s):

Slow Release ◽

Controlled Trial ◽

Balloon Catheter ◽

Induction Of Labour ◽

Cervical Ripening ◽

Double Balloon ◽

Vaginal Pessary ◽

Maternal And Neonatal Outcomes ◽

Randomised Controlled ◽

Mechanical Ripening

Background Prolonged pregnancies are a frequent indication for induction of labour. When the cervix is unfavourable, cervical ripening before oxytocin administration is recommended to increase the likelihood of vaginal delivery, but no particular method is currently recommended for cervical ripening of prolonged pregnancies. This trial evaluates whether the use of mechanical cervical ripening with a silicone double balloon catheter for induction of labour in prolonged pregnancies reduces the cesarean section rate for nonreassuring fetal status compared with pharmacological cervical ripening by a vaginal pessary for the slow release of dinoprostone (prostaglandin E2). Methods and findings This is a multicentre, superiority, open-label, parallel-group, randomised controlled trial conducted in 15 French maternity units. Women with singleton pregnancies, a vertex presentation, ≥41+0 and ≤42+0 weeks’ gestation, a Bishop score <6, intact membranes, and no history of cesarean delivery for whom induction of labour was decided were randomised to either mechanical cervical ripening with a Cook Cervical Ripening Balloon or pharmacological cervical ripening by a Propess vaginal pessary serving as a prostaglandin E2 slow-release system. The primary outcome was the rate of cesarean for nonreassuring fetal status, with an independent endpoint adjudication committee determining whether the fetal heart rate was nonreassuring. Secondary outcomes included delivery (time from cervical ripening to delivery, number of patients requiring analgesics), maternal and neonatal outcomes. Between January 2017 and December 2018, 1,220 women were randomised in a 1:1 ratio, 610 allocated to a silicone double balloon catheter, and 610 to the Propess vaginal pessary for the slow release of dinoprostone. The mean age of women was 31 years old, and 80% of them were of white ethnicity. The cesarean rates for nonreassuring fetal status were 5.8% (35/607) in the mechanical ripening group and 5.3% (32/609) in the pharmacological ripening group (proportion difference: 0.5%; 95% confidence interval (CI) −2.1% to 3.1%, p = 0.70). Time from cervical ripening to delivery was shorter in the pharmacological ripening group (23 hours versus 32 hours, median difference 6.5 95% CI 5.0 to 7.9, p < 0.001), and fewer women required analgesics in the mechanical ripening group (27.5% versus 35.4%, difference in proportion −7.9%, 95% CI −13.2% to −2.7%, p = 0.003). There were no statistically significant differences between the 2 groups for other delivery, maternal, and neonatal outcomes. A limitation was a low observed rate of cesarean section. Conclusions In this study, we observed no difference in the rates of cesarean deliveries for nonreassuring fetal status between mechanical ripening with a silicone double balloon catheter and pharmacological cervical ripening with a pessary for the slow release of dinoprostone. Trial registration ClinicalTrials.gov NCT02907060.

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