Transcervical Balloon Research Articles

Comparing transcervical balloon with osmotic dilators for cervical preparation prior to procedural abortion: A noninferiority randomized trial

ObjectivesThis study aimed to compare cervical preparation with transcervical balloon to osmotic dilators for second-trimester procedural abortions. Study designWe performed an unblinded, randomized, noninferiority trial of people undergoing second-trimester procedural abortion at 18 + 0 to 23 + 6 weeks' gestation. We randomized participants to either overnight osmotic dilators (Dilapan-S) or transcervical balloon (Foley). Both groups received overnight mifepristone and preprocedural misoprostol. We powered the study on mean difference in procedure duration, a noninferiority limit of 5 minutes. We compared preprocedure cervical dilation and the need for additional dilation and, using a 100-point visual analog scale, measured physician satisfaction and ease of procedure, and participant pain and satisfaction. ResultsWe recruited 32 participants at a single academic center. Although procedure time (minutes) was similar (balloon: 22.6 ± 8.9 vs Dilapan-S: 22.4 ± 12.8, p = 0.96), noninferiority was not met (mean difference, 0.2 minutes; 95% CI, −7.8 to 8.2). Cervical dilation >2 cm was more likely after Dilapan-S (100% vs 62.5%, p = 0.02). Placement was well tolerated with similar time (minutes) for insertion (balloon: 4.8 ± 1.0, Dilapan-S: 5.1 ± 2.3, p = 0.64) and maximum pain (median) with insertion (balloon 39 [5–78], Dilapan-S: 39 [0–100], p = 0.92). Pain immediately postinsertion was higher for Dilapan-S (33 [0–100] vs 18 [0–50], p = 0.046) and similar for maximum pain overnight, participant satisfaction, and likelihood to recommend. Complications were minor and similar between groups (p = 0.60). ConclusionWhile significantly more people with transcervical balloon required mechanical dilation, the difference in operative time was clinically negligible. The transcervical balloon was well tolerated and acceptable by participants. ImplicationsClinicians experienced in mechanical dilation may consider a transcervical balloon as a lower-cost tool for second-trimester abortion cervical preparation. Clinical Trial RegistrationClinicalTrials.gov: NCT05099991

237 Mifepristone as an adjunct to transcervical balloon for labor induction (MiLI): a randomized controlled trial

237 Mifepristone as an adjunct to transcervical balloon for labor induction (MiLI): a randomized controlled trial

Cervical preparation for second-trimester procedural abortion.

To review the evidence-informed options for cervical preparation prior to second-trimester dilation and evacuation (D&E). As abortion restrictions increase and the number of abortion clinics and providers decreases, pregnant people are facing more barriers to abortion access. Those in need are now often required to travel for second-trimester abortion care, only to be faced with additional restrictions, such as mandatory waiting periods. Cervical preparation is recommended prior to D&E and takes time for effect. Given the increasing time required to obtain an abortion, patients and providers may prefer same-day cervical preparation to decrease the total time required. Options for same-day cervical preparation include misoprostol alone with single or serial doses, and misoprostol combined with osmotic dilators or transcervical balloon (Foley catheter). Same-day preparation may require additional clinical space to accommodate people after initiation of cervical preparation to manage side-effects and timing of the abortion. Overnight options are also used and more frequently later in the second trimester. Overnight options include mifepristone, osmotic dilators, and transcervical balloon and are often combined with same-day misoprostol. Medication alone preparation is well tolerated and effective in the second trimester, with the addition of mechanical methods with advancing gestation. With many options and combinations being safe and effective, providers can be dynamic and alter approach with supply shortages, adjust to different clinical settings, consider patient medical and surgical factors, and accommodate provider and patient preferences. Multiple pharmacologic and mechanical options have been shown to be safe and effective for cervical preparation prior to D&E. Consideration for multiple factors should influence the method of cervical preparation and methods may vary by patient, provider and setting.

Comparison of Vaginal Dinoprostone Pessary With Transcervical Balloon Catheter Plus Vaginal Misoprostol for Pre-induction Cervical Ripening: A Randomized Trial.

Aims and Objectives To compare the safety and efficacy of dinoprostone pessary with Foley plus vaginal misoprostol for cervical ripening. Materials and Methods We randomized 115 women to the pessary or Foley plus misoprostol group. Pessary was inserted for 24 hours, and in the Foley plus misoprostol group, intravaginal misoprostol 25 mcg was administered along with trans-cervical Foley insertion and repeated every six hours to a maximum dose of 100 mcg. Singleton pregnancies requiring labor induction at more than 34 weeks with a Bishop score of <6 were included. Study outcomes included induction-delivery interval (IDI), mode of delivery, change in the Bishop score, need for oxytocin augmentation, and patient discomfort as assessed by visual analog score. Results The IDI was similar between the groups (pessary vs Foley plus misoprostol; 21.27 vs 21.10 hours, p = 0.9). The mean change in the Bishop score and need for augmentation with oxytocin was significantly more in the Foley plus misoprostol group compared to pessary (2.72 vs 1.94, p = 0.001; 89.7% vs 57.9%, p = 0.0001). Pessary was better tolerated compared to Foley plus misoprostol (VAS 7.8 vs 6.68, p = 0.0001). Mode of delivery and maternal and neonatal outcomes showed no difference. Conclusion There was no significant difference between pessary and Foley plus misoprostol in the IDI and mode of delivery. Pessary was better tolerated, andaugmentation with oxytocin was required less often. Foley plus misoprostol caused a faster change in the Bishop score, but oxytocin augmentation was used more often. Maternal and neonatal outcomes were similar.

Efficacy of Transcervical Balloon Catheter Versus Hygroscopic Dilator for Outpatient Prelabor Cervical Ripening [ID: 1382587

INTRODUCTION: Outpatient preinduction cervical ripening with mechanical agents has been associated with reduced length of stay and cesarean delivery rates. This study aimed to demonstrate equivalence in efficacy and patient satisfaction between balloon catheter and hygroscopic dilators for outpatient cervical ripening. METHODS: This randomized control equivalence trial compared the 30-cc silicone Foley catheter (off-label) to Dilapan-S. Inclusion criteria were elective induction, low risk, group B streptococcus negative, and Bishop score of less than 6. The primary outcome was time from admission to delivery. Secondary outcomes included cesarean delivery rates, pain scores, and patient satisfaction. A power calculation determined 150 patients per arm were needed. Ochsner Health IRB approved CR00003326. RESULTS: Between March 1, 2019, and May 31, 2021, 8,150 deliveries occurred, with 1,605 patients meeting screening criteria and 175 completing the study. Time from admission to delivery for balloon was 17.7 hours versus 17.9 hours for dilators. The mean time difference was −0.1524 hours (90% CI –2.4617 to 2.1569), which was statistically significantly equivalent within the specified symmetrical 3-hour equivalence margin (P=.0215). Pain scores with insertion were 3.52 with balloon versus 3.87 with dilators. Satisfaction with outpatient cervical ripening was 91.7% with balloon versus 97.4% with dilators. Cesarean delivery rate of primiparous patients was 31% with balloon versus 25.3% with dilators. CONCLUSION: Although the enrollment goal was unmet, metrics suggested outpatient cervical ripening with balloon catheter and hygroscopic dilators were equivalent in time from admission to delivery and patient-reported pain scores. Further research is needed to assess a potential trend toward improved satisfaction and cesarean delivery rate with dilators.

Perinatal outcome and risk factors of precipitate labor in term primipara: an analysis of 381 cases.

To investigate the perinatal outcome and risk factors of precipitate labor in term primipara. A total of 6951 full-term singleton primiparas with cephalic vaginal delivery in Women's Hospital, Zhejiang University School of Medicine from January 2020 to December 2020 were enrolled, among whom 381 cases of precipitate labor were classified as the precipitate labor group and 762 cases of normal labor were randomly selected as the control group. The perinatal outcomes of the two groups were compared, and the risk factors of precipitate labor were analyzed by multivariate logistic regression. The incidence of precipitate labor in full-term, singleton pregnancy and cephalic primiparas was 5.48% (381/6951). The durations of the first and second stages of labor in the precipitate labor group were significantly shorter than that in the control group ( P<0.01); while there was no significant difference in the duration of the third stage of labor between the two groups ( P>0.05). Compared with the control group, the incidence of soft birth canal laceration in the precipitate labor group was increased ( P<0.01). However, there was no significant difference in postpartum hemorrhage and neonatal related perinatal outcomes between the two groups (all P>0.05). Multivariate logistic regression analysis showed that maternal height ( OR=1.038, 95% CI: 1.010-1.067, P<0.01), gestational age at delivery ( OR=0.716, 95% CI: 0.618-0.829, P<0.01), late miscarriage ( OR=1.986, 95% CI: 1.065-3.702, P<0.05), membrane rupture before labor ( OR=1.802, 95% CI: 1.350-2.406, P<0.01), labor induction by transcervical balloon ( OR=3.230, 95% CI: 2.027-5.147, P<0.01), labor induction by propess ( OR=2.332, 95% CI: 1.632-3.334, P<0.01) and labor induction by oxytocin ( OR=0.291, 95% CI: 0.219-0.386, P<0.01) were independently associated with precipitate labor. The incidence of precipitate labor in full-term, singleton pregnancy was not low. Precipitate labor could lead to a significant increase in perineal laceration. Maternal height, history of late miscarriage, membrane rupture before labor and labor induction by transcervical balloon, labor induction by propess are risk factors, while labor induction by oxytocin and late gestational time of delivery are protective factors for precipitate labor in term primipara.

Does adjunctive oxytocin infusion during balloon cervical ripening improve labor induction?

Evidence-Based Answer: Yes. Compared to the use of a transcervical balloon alone, combined cervical ripening with a balloon catheter and oxytocin shortens the time to overall delivery by 3 hours and the time to vaginal delivery by 4 hours, without altering the rate of cesarean section (strength of recommendation [SOR]: A, network meta-analysis). The effect is more pronounced in nulliparous patients (SOR: A, meta-analysis).When combined therapy is used, 6 hours of balloon time may result in faster delivery than 12 hours (SOR: B, single randomized controlled trial [RCT]). Fixed-dose oxytocin and titrated oxytocin appear to have similar effect when combined with a cervical ripening balloon (SOR: C, underpowered RCT).

A Novel Simulation Model for Resident Education in Mechanical Cervical Ripening.

This study aims to evaluate resident satisfaction with a novel simulation model for learning transcervical balloon catheter placement for mechanical cervical ripening. A descriptive pretest and post-test survey study of Obstetrics and Gynecology (OBGYN) residents was conducted at a single academic medical center using a low-cost model. Of 28 residents, 14 (50%) were recruited. 100% of participants completed the pretest and post-test survey. Residents agreed that both learning and achieving correct placement of a transcervical balloon catheter are difficult. Pretest and post-test comparisons were statistically different with respect to comfort (2.8 ± 1.5 vs. 4.0 ± 1.0, p = 0.03) and ease of learning (3.1 ± 0.8 vs. 4.1 ± 0.6, p ≤ 0.001). We present a novel simulation model that can be used by OBGYN residents in training for learning transcervical balloon catheter placement for mechanical cervical ripening. · There is no current validated model for teaching placement of mechanical cervical ripening.. · This study outlines a novel and simple simulation model.. · This model is easily made, accessible, and of a low cost design..

Prostaglandin insert dinoprostone versus trans-cervical balloon catheter for outpatient labour induction: a randomised controlled trial of feasibility (PROBIT-F)

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 outpatient 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 outpatient 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. Service use and cost data were collected via the Adult Service Use Schedule (AD-SUS). Women who declined to participate were requested to complete a decliners’ questionnaire.ResultsDuring the study period, 274 eligible women were identified. Two hundred thirty (83.9%) were approached for participation of whom 84/230 (36.5%) agreed and 146 did not. Of these, 38 were randomised to Propess (n = 20) and CRB (n = 18). Decliner data were collected for 93 women. The reasons for declining were declining IOL (n = 22), preference for inpatient IOL (n = 22) and preference for a specific method, Propess (n = 19). The intended sample size of 120 was not reached due to restrictive criteria for suitability for outpatient IOL, participant preference for Propess and shortage of research staff.The intervention as randomised was received by 29/38 (76%) women. 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 and all except one (37/38, 97.4%) remained with the mother after delivery. No deaths were recorded. − 21% of women in the dinoprostone group were re-admitted prior to diagnosis of active labour compared to 12% in the CRB group.ConclusionsA third of the approached eligible women agreed for randomisation. An RCT is not feasible in the current service context. Modifications to the eligibility criteria for outpatient IOL, better information provision and round the clock availability of research staff would be needed to reach sufficient numbers.Trial registrationNCT03199820. Registered on June 27, 2017

Cesarean during labor: Is induction a risk factor for complications?

IntroductionEvaluate the impact of labor induction on maternal complications following caesarean section during labor. Material and methodsRetrospective, single-center study between 2015 and 2017. Were included singleton pregnancies who had cesarean section during labor after 37WG. Labor induction procedures included either transcervical balloon catheters or prostaglandins. Degree of emergency of the cesarean was decided according to color code (green, orange and red). We identified and compared intra and postoperative complications according to the mode of labor onset, and then to the mode of labor induction. Results882 patients were included, 416 with spontaneous labor and 464 with labor induction. No significant difference was found for postoperative complications between the two groups. Patients with spontaneous labor had fewer green-code caesareans than patients with elective induction (29.3% vs. 40.3% p<0.001) and had more uterine pedicle injuries (6.3% vs. 3.0% p=0.022). Nevertheless, no difference was found for postpartum hemorrhage (PPH) between these two groups (41.59% vs. 43.32% p=0.60). The subgroup study of patients with labor induction showed that those necessitating 2 methods of labor induction had more severe PPH (22.2% vs. 8.1% p after Bonferroni correction = 0.002). ConclusionsElective induction does not result in an increased risk of cesarean section during labor complications. Only the use of prostaglandin following transcervical balloon catheter increased the risk of severe postpartum hemorrhage.

Outpatient Cervical Ripening: A Cost-Minimization and Threshold Analysis.

To evaluate cost of outpatient (OP) versus inpatient (IP) ripening with transcervical balloons, and determine circumstances in which each strategy would be cost saving. We created a decision model comparing OP and IP balloon ripening in term (≥37 weeks) singleton pregnancies with unfavorable cervix. We performed a cost-minimization analysis and threshold analyses comparing two OP ripening strategies (broad and limited use) to IP ripening from a health system perspective. Base case estimates of probability, utilization, and cost were derived from the literature. The primary outcome was incremental cost of OP versus IP ripening from a hospital perspective. One- and two-way sensitivity analyses explored uncertainty in the model. Both OP ripening strategies were cost saving compared with IP ripening: incremental cost -$228.40/patient with broad use and -$73.48/patient with limited use. OP ripening was no longer cost saving if hours saved on labor and delivery (L&D) were <3.5, insertion visit cost >$714, or facility cost/hour on L&D <$61. Two-way sensitivity analyses showed that OP ripening was cost saving under the most plausible clinical circumstances. In patients with unfavorable cervix, OP transcervical balloon ripening was cost saving under a wide range of circumstances, particularly if OP ripening can shorten time spent on L&D by 3.5 hours.

Induction and Augmentation of Labor

Certain maternal and fetal conditions require induction of labor for the safety and well-being of either the mother or baby. Similarly, once fetal maturity has been reached, elective induction of labor remains an option for delivery timing and patient request. A thorough understanding of the physiologic mechanisms of labor onset and maintenance has allowed obstetrical providers to induce labor from the quiescent state and augment spontaneous labor in the latent or prolonged state. The goal of labor induction and augmentation is the successful and expedited delivery of the neonate in a manner that is safe to both the mother and the infant. Positive maternal outcomes include a shortened admission to onset of labor time, shortened first stage of labor, successful vaginal delivery, and avoidance of intraamniotic infection or postpartum hemorrhage. Positive fetal outcomes include absence of meconium amniotic fluid staining, regular newborn nursery admission, and hospital discharge with the mother. In this review, we outline the various mechanical, chemical, and natural methods of labor induction and augmentation, including a detailed assessment of the risks and benefits of each method for both the mother and baby. This review contains 7 figures, 4 tables, and 33 references. Key Words: amniotomy, augmentation of labor, cervical ripening, induction of labor, oxytocin, membrane sweeping, nipple stimulation, prostaglandins, transcervical balloon catheter

Transcervical Balloon Catheter for Cervical Ripening: Weighted Traction or Tension [23D

INTRODUCTION: The goal of induction or augmentation of labor is to achieve vaginal delivery, while balancing both maternal and fetal safety. The rate of induction of labor has more than doubled since 1990, with more than 22% of all gravid women undergoing induction of labor. Several randomized controlled trials have investigated labor outcomes when comparing transcervical balloon catheters to use of prostaglandins or oxytocin. Few studies have investigated methods of transcervical bulb set up. At our institution, mechanical cervical dilation is accomplished with the use of transcervical balloon catheters, which are inflated with 60mL of saline. It is up to provider discretion to place the balloon catheters on traction or tension. METHODS: The objective of this study is to compare pre- and post- transcervical balloon catheter cervical dilations and time from placement to expulsion. Patients were randomized to either the leg or bag group and Bishop score was required to be less than 6. We hypothesized that the use of transcervical balloon catheter on weighted traction would result in a larger cervical dilation and a shorter balloon catheter placement to expulsion time. RESULTS: A total of 73 patients were randomized, with 43 in the bag group and 30 patients in the leg group. Results showed that the intervention of the bag saved 74 minutes of time and was statistically significant, with a p value &lt;.05. Bishop score change between the two groups was not statistically significant, with a p value = .74. At our hospital average cost for labor and delivery is $326 per hour. Average cost savings per patient using bag over leg is $400.98. CONCLUSION: In conclusion, out study demonstrated statistically significant shorter time to delivery in the bag group. This resulted in a shorter induction process, as well as a cost saving to the labor and delivery unit and will be utilized to add evidence to the most efficient method of cervical ripening. Additional research points will analyze time to active phase of labor and time to delivery of the infant

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.

It has been suggested that cervical ripening with a balloon catheter for labour induction can be done in an outpatient setting in low-risk pregnancies. Introduction of such an approach needs to be accompanied with monitoring of potential complications. Therefore the existence and frequency of any associated adverse event during cervical ripening needs to be established. To assess the complication rate during cervical ripening with balloon induction. We searched Embase, Medline, Cochrane Collaboration and CINAHL using keywords 'induction of labour', 'cervical ripening', 'balloon catheter', 'Foley balloon', 'transcervical balloon'. We included randomized controlled trials and cohort studies containing original data on fetal and maternal morbidity in pregnant women during cervical ripening with a balloon catheter. Only articles for which authors were able to give data for this exact time frame were included. Two reviewers assessed independently the eligibility of included studies, extracted data and performed a quality assessment. A meta-analysis was performed to calculate the estimated prevalence of the adverse events. In total 26 studies were included reporting on 8292 women. The estimated prevalence of the analysed adverse events in the random effects model was between 0.0 and 0.26%, of which 'pain/discomfort' had the highest prevalence. This study suggests the risk of adverse events during the period between insertion and expulsion of a balloon catheter in cervical ripening to be low. These data facilitate further evaluation and implementation of this procedure in an outpatient setting for low-risk pregnancies. Balloon catheter for cervical ripening appears to be safe enough to evaluate its use in the outpatient setting.

Current Resources for Evidence-Based Practice, January 2018

Current Resources for Evidence-Based Practice, January 2018

Mifepristone vs balloon catheter for labor induction in previous cesarean: a randomized controlled trial.

To compare oral mifepristone (400mg) with trans-cervical balloon catheter for induction of labor (IOL) in post date women with previous one cesarean section (CS). In this randomized trial, post date pregnant women (gestation 40weeks 5days), with previous one low segment CS (no previous vaginal delivery) were induced either with oral mifepristone (400mg) or balloon catheter [Foley's catheter (16 Fr); bulb filled with 30ml normal saline]. They were re-assessed 24 and 48h later. If at any time Bishop Score was >6; amniotomy was done, followed by oxytocin infusion. Primary outcome of the study was labor onset after first manoeuvre. Secondary outcomes were cervical ripening, need of oxytocin, vaginal delivery and CS, in two groups. From June 2012 to September 2015, we enrolled 107 women. Out of these, 57 received oral tablet mifepristone (400mg) and 50 were inserted with balloon catheter. Labor onset after first manoeuvre was statistically significantly more in mifepristone group (37/57 vs. 13/50, respectively; p value 0.000). Bishop Score after 24h was better in balloon catheter (p value 0.000). More women with balloon catheter required oxytocin for IOL (37/50 vs. 20/57, respectively; p value 0.000) along with higher dose [840 (320) mU vs 560 (120) mU, respectively, p value 0.000]. Failure of induction was statistically significantly higher in balloon catheter group (8 out of 50 vs. 2 out of 57, respectively, p value 0.043). There was no statistically significant difference in normal delivery or CS in either group (p value 0.242 and 0.331, respectively). Oral mifepristone (400mg) is associated with statistically significantly higher incidence of labor onset in post date pregnant women with previous one CS, as compared to balloon catheter. Both methods are primarily for cervical ripening and oxytocin should not be delayed in the absence of onset of labor. Clinical Trials Registry-India, www.ctri.nic.in , CTRI/2012/05/003634.

Parity and Foley Catheter Using Tension or No Tension: A Randomized Controlled Trial [12L

INTRODUCTION: A secondary analysis of a randomized controlled trial was performed to determine the effects of parity on the use of a Foley transcervical balloon catheter for cervical ripening and the effects of tension on each group. METHODS: 73 nulliparous and 67 multiparous women underwent cervical ripening with a Bishop score ≤ 6. Tension was created by securing the catheter to the thigh and replacing tension in 30 minute increments. Major outcomes included time from insertion to delivery, time from insertion to catheter expulsion, and mode of delivery. A p value of &lt; 0.05 denoted statistical significance. RESULTS: Nulliparous patients had a higher rate of Cesarean delivery (CD) (39.7% vs 22.4%, p = 0.027). They had a longer median time to delivery (17.5 vs 14.6 hours, p=0.054). Applied tension did not shorten times from catheter insertion to delivery or to expulsion. A significantly shorter median time from catheter insertion to expulsion was found in the tension group in multiparous women (2.88 vs 4.61 hours, p= 0.003). Multiparous women in the no tension group had a higher rate of CD than women in the tension group (31.6 % vs 10.3%, p= 0.039). CONCLUSION: Within multiparous patients, applied tension decreased the time to expulsion of the catheter, whereas no tension may increase the likelihood of CD. Further studies to evaluate these findings are needed. As expected, nulliparity increased the risk of CD and there was a trend towards longer delivery times compared to multiparous patients.

Second dose of PGE2 vaginal insert versus Foley transcervical balloon for induction of labor after failure of cervical ripening with PGE2 vaginal insert

Purpose: To determine the success rate of induction of labor (IOL) using Foley transcervical balloon (FTB) versus prostaglandin E2 (PGE2) vaginal insert, following failure of cervical ripening with PGE2 vaginal insert. Materials and methods: A retrospective cohort study of all pregnant women admitted for IOL with either FTB or PGE2 vaginal insert. Either second dose of PGE2 vaginal insert or FTB was used as a second line treatment after failure (not giving birth in 24 h from insertion) of first PGE2 vaginal insert. Results: During the study period, 1162 women were admitted for IOL. Failure was reported in 322/852 (37.8%) in the FTB versus 162/310 (52.2%) in the PGE2 group (p < 0.001). Among 162 patients treated with PGE2 as first line who did not deliver after 24 h, 14 had spontaneous rupture of membranes, 15 underwent stripping and 42 were in still in active labor. The remainder were allocated to either second trial of PGE2 treatment (n = 58) or FTB (n = 33) with failure rate higher in the PGE2 group, not statistically significant (p = 0.23). Conclusion: IOL with FTB was not superior to PGE2 vaginal insert for IOL following failure of cervical ripening with PGE2 vaginal insert.

Tension compared to no tension on a Foley transcervical catheter for cervical ripening: a randomized controlled trial

Cervical ripening of an unfavorable cervix can be achieved by placement of a transcervical catheter. Advantages of this method include both lower cost and lower risk of tachysystole than other methods. Despite widespread use with varying degrees of applied tension, an unanswered question is whether there is an advantage to placing the transcervical catheter to tension compared with placement without tension. The purpose of this study was to determine whether tension placed on a transcervical balloon catheter that is inserted for cervical ripening results in a faster time to delivery. This was a prospective, randomized controlled trial; 140 women who underwent cervical ripening (Bishop score, ≤6) were assigned randomly to a balloon catheter with applied tension vs no tension. Tension was created when the catheter was taped to the patient's thigh and tension was reapplied in 30-minute increments. There were 67 patients in the tension group and 73 patients in the no tension group. Low-dose oxytocin (maximum, 6 mU/min) was administered after catheter placement. The primary outcome was time from catheter insertion to delivery. A secondary outcome was time from insertion to catheter expulsion. The Kolmogorov-Smirnov test was used to determine whether the data were distributed normally. Survival curves that used lifetables were constructed from time of catheter insertion to delivery and from time of catheter insertion to catheter expulsion and were compared with the use of the Wilcoxon (Gehan) Breslow statistic. A probability value of <.05 was set to denote statistical significance. Baseline characteristics were similar between groups. The median time from catheter insertion to delivery was not significantly different between the tension group and the no tension group (16.2 vs 16.9 hours; P=.814). The median time from catheter insertion to expulsion, however, was significantly less in the tension group vs the no tension group (2.6 vs 4.6 hours; P<.001), respectively. Vaginal delivery within 24 hours was not significantly different between the tension and no tension groups (41/52 [79%] vs 37/52 [71%]; P=.365) nor were there significant differences in cesarean delivery rates between the tension and no tension groups (17/67 [25%] vs 27/73 [37%]; P=.139). Application of tension did not result in faster delivery times but did result in faster times to catheter expulsion.

Maturation cervicale par méthodes mécaniques en France : évaluation de pratiques professionnelles

ObjectiveMechanical methods for cervical ripening are as effective as prostaglandins for the rate of vaginal delivery. Our aim was to study professional practices of mechanical cervical ripening in France. MethodsA declarative survey was conducted among two groups of maternity units: a sample representative of French maternity units (group 1) and on the whole of type 3 maternity units (group 2). A questionnaire was emailed to physicians of these obstetric units between May and July 2014. ResultsForty-three of the 104 units (41.3%) in the first group and 43 of the 64 units in the second group (67.2%) answered the questionnaire. Among these maternity units, mechanical methods were used respectively in 44.2 and 69.8% of the establishments. The two main devices used were the trans-cervical balloon catheter and the Foley catheter. The main indication for mechanical methods was induction of labor with prior caesarean. In case of induction of labor, a prior caesarean and a Bishop score < 7, in the first group, 46.6% of the maternity units did a caesarean, 32.3% performed an induction of labor with mechanical methods, 13.9% with oxytocin and 6.9% with prostaglandins. In the second group, 25.6% of maternity units performed a caesarean, 53.6% used mechanical methods, 9.3% used oxytocin and 11.6% used prostaglandins. ConclusionIn France nearly half of the maternity units and nearly three-quarters of type 3 maternity units say they use mechanical cervical ripening, mainly used in case of prior caesarean.