Safety of the balloon catheter for cervical ripening in outpatient care: complications during the period from insertion to expulsion of a balloon catheter in the process of labour induction: a systematic review

2018 ◽  
Vol 125 (9) ◽  
pp. 1086-1095 ◽  
Author(s):  
M Diederen ◽  
JSM Gommers ◽  
C Wilkinson ◽  
D Turnbull ◽  
BWJ Mol
2019 ◽  
Vol 74 (1) ◽  
pp. 5-7
Author(s):  
M. Diederen ◽  
J. S. M. Gommers ◽  
C. Wilkinson ◽  
D. Turnbull ◽  
B. W. J. Mol

2020 ◽  
Author(s):  
Amarnath Bhide ◽  
Christine McCourt ◽  
Barbara Barrett ◽  
Georgina Cupples ◽  
Rose Coates ◽  
...  

Abstract BackgroundThe aim was to assess the feasibility of conducting a randomised controlled trial (RCT) of induction of labour comparing use of two methods in the out-patient setting.MethodsAn open-label feasibility RCT was conducted in two UK maternity units from October 2017 to March 2019. Women aged ≥16 years, undergoing Induction of labour (IoL) at term, with intact membranes and deemed suitable for out-patient IoL according to local guidelines were considered eligible. They were randomised to cervical ripening balloon catheter (CRB) or vaginal Dinoprostone (Propess). The participants completed a questionnaire and a sub-group underwent detailed interview. Health economics data were collected. Women who declined to participate were also requested to complete a decliners’ questionnaire.ResultsDuring the study period 274 eligible women were identified. 230 (83.9%) were approached for participation of whom 84 (36.5%) agreed. Of these, 38 were randomised to Propess (n=20) and CRB (n=18). The intended sample size of 120 was not reached due to restrictive criteria for suitability for out-patient IoL. The intervention as randomised was received by 29/38 (76%) women. Five of the 29 participants could not go home after intervention. Spontaneous vaginal delivery was observed in 9/20 (45%) women in the Dinoprostone group, and 11/18 (61%) women in the CRB group. Severe maternal adverse events were recorded in one woman in each group. All babies were born with good condition (5-minute Apgar score >7) and all except one (37/38, 97.4%) remained with the mother after delivery. No deaths were recorded.Full health economics data were available for 36 out of the 38 participants. 21% of women in the Dinoprostone group were re-admitted prior to diagnosis of active labour compared to 12% in the CRB group. The patient questionnaire was complete and available for analysis for 37/38 (97.4%) women. Interviews were undertaken for 21/38 women.ConclusionsA third of the approached eligible women agreed for randomisation. An RCT is not feasible using existing criteria and further modifications to the eligibility criteria for out-patient IoL would be needed to reach sufficient numbers in the current service context.


Author(s):  
Nnabugwu Alfred Adiele ◽  
Christian C. Mgbafulu ◽  
Arinze Chidiebere Ikeotuonye ◽  
Christian Chidebe Anikwe ◽  
Joshua Adeniyi Adebayo ◽  
...  

Background: The ripeness of the cervix is an important prerequisite to a successful labour induction. Use of extra-amniotic Foley catheter is a mechanical method of cervical ripening with proven efficacy. This study compared the difference in efficacy between 30 ml and 60 ml of water for inflation of Foley catheter balloon when used for cervical ripening during induction of labour.Methods: A single-blind randomized controlled study where 260 term pregnant women with intact membranes and unfavourable cervix were selected for induction of labour and randomized into two equal groups (30 ml- and 60 ml- groups) from October, 2019 to July 2020. Each participant had cervical ripening with the catheter bulb inflated with either 30 ml or 60 ml of sterile water (as assigned to the individual). After achieving favourable cervix (BS ≥6), oxytocin titration was commenced and the labour monitored with the outcomes well documented and statistically analysed.Results: Mean duration to favourable Bishop Score significantly reduced in the 60 ml group (10.8 hours±2.99) as against 12.7 hours±10.0 in 30ml group (p=0.038). Mean duration of active phase of labour was significantly reduced in 60 ml group (5.6 hours±2.4) as against 8.4 hours±3.2 in 30 ml group (p=0.010). Caesarean delivery rate was significantly reduced in the 60 ml groups (p=0.027).Conclusions: The use of 60 ml inflated Foley’s balloon catheter when compared with 30mls to ripen the cervix effectively reduced the duration to favourable Bishop Score, duration of the active phase of labour and the rate of Caesarean sections.  


2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Xiyao Liu ◽  
Yu Wang ◽  
Fan Zhang ◽  
Xiaoni Zhong ◽  
Rong Ou ◽  
...  

Abstract Background The induction of labour is an increasingly common procedure in the obstetrics field. Various methods have been used to induce labour, among which balloon catheters play an important role. Whether the specifically designed double-balloon catheter is better than the single-balloon device in terms of efficacy, efficiency, safety and patient satisfaction remains controversial. Identifying even small differences between these two devices could be useful to guide clinical practices, to further explore their mechanisms, and to promote a better understanding of the optimal methods for inducing labour. Methods Using the population, intervention, comparison, outcomes and study designs (PICOS) principle, we searched the PubMed, EMBASE, OVID, SCI, CENTRAL, ClinicalTrial.gov, and CDSR databases to identify relevant randomised controlled trials (RCTs) from inception through February 14, 2018. The primary outcome was the caesarean delivery rate, and the secondary outcomes focused on efficacy, efficiency, safety, and patient satisfaction. The relative risks or mean differences, including their 95% confidence intervals, were calculated using fixed-effects or random-effects models. All statistical analyses were completed with RevMan version 5.3. Results From a total of 1326 articles, 7 RCTs involving 1159 women were included. There were no significant differences in primary outcomes (RR, 0.88 [0.65, 1.2]; p-value, 0.43) or secondary outcomes identified between single- and double-balloon catheters. However, heterogeneity existed for some aspects. Conclusion Both kinds of balloon catheter have similar levels of efficacy, efficiency, safety and patient satisfaction; however, the single-balloon method is considered to be more cost-effective.


Author(s):  
Eric Devillard ◽  
Fanny Petillon ◽  
Marion Rouzaire ◽  
Bruno Pereira ◽  
Marie Accoceberry ◽  
...  

Objective: To demonstrate that a double balloon catheter combined with oxytocin decreases time between induction of labour and delivery (TID) as compared to a vaginal dinoprostone insert in cases of PROM at term. Design: Prospective, randomized, controlled trial. Setting: French university hospital Population: Patients undergoing labour induction for PROM at term with unfavorable cervix. Methods: We compared the double balloon catheter over a period of 12 hours with adjunction of oxytocin 6 hours after catheter insertion, versus dinoprostone vaginal insert. After device ablation, cervical ripening continued only with oxytocin. Main outcome measures: The primary outcome was TID. Secondary outcomes concerned delivery mode, maternal and fetal outcome and were adjusted for parity. Results: 40 patients per group were randomized. Each group had similar baseline characteristics. The study failed to demonstrate reduced TID (16.2 vs 20.2 hours, ES = 0.16 (-0.27 to 0.60), p=0.12) in catheter group versus dinoprostone except in nulliparous women (17.0 vs 26.5 hours, ES = 0.62 (0.10 to 1.14), p=0.006). The rate of vaginal delivery <24h significantly increased with combined induction (88.5% vs 66.6%, p=0.03). No statistical difference was observed concerning caesarean rate (12.5% vs 17.5%, p>0.05), chorioamnionitis (0% vs 2.5%, p=1), postpartum endometritis, maternal or neonatal outcomes. Procedure-related pain and tolerance to devices were found to be similar for the two methods. Conclusion: The double balloon catheter combined with oxytocin is an alternative for cervical ripening in case of PROM at term, and may reduce TID in nulliparous women.


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