Efficacy of Dilapan S compared to foley balloon in preinduction cervical ripening-a noninferiority trial.

Background: The need for induction of labor is increasing in present obstetric practice. The available non-pharmacological methods for cervical ripening at term are Foley balloon and Dilapan-S. With the gaining popularity of Dilapan-S worldwide, there are very few clinical trials conducted in India to evaluate its effectiveness. Objective: To compare the efficacy of Dilapan-S and Foley balloons for pre-induction cervical ripening. Study design: This single-center randomized non-inferiority trial included primi- and multi-gravida women between 37 and 41 weeks of gestation and unfavourable cervix with a Bishop's score between 0 and 2. Using a random number table, patients were assigned to study Group 1 Dilapan-S and to control Group 2 Foley balloon. Dilapan-S or Foley balloon was inserted intracervically and assessed for dilation after 12 hours. Patients with unfavourable dilatation were further provided prostaglandins (PgE 1 and 2) for further augmentation of induction. Primary outcome measures included improvement in Bishop's score, and mode of delivery, followed by time to delivery from intervention, use of other augmentation methods, and maternal and neonatal outcomes. Results: After screening, 296 patients with Bishop score less than 2, (148 in each group) were enrolled in the study. The number of patients who had vaginal delivery was comparable between both groups (p=.72), and so were the maternal outcomes. Two cases of cord prolapse occurred with Foley balloon. Group 2 showed significant improvement in Bishop's score (p<.001), and Group 1 had a significantly higher use of augmentation with PgE1 (p-.01) and PgE2 (p<.001). The number of contractions was significantly lower in Group 1 (p<.001), and contraction intensity was higher in Group 2. There was no significant difference in cesarean delivery for failed induction of labor between the groups (p=.72). Based on the primary outcome measure, Dilapan-S was found to be non-inferior to the Foley balloon. Conclusion: Dilapan-S is non-inferior to Foley balloon in achieving pre-induction cervical ripening in term pregnancies, and therefore Dilapan-S can be suggested as an alternative in clinical practice with minimal risks.

Methods for the induction of labor: efficacy and safety.

This review assessed the efficacy and safety of pharmacologic agents (prostaglandins, oxytocin, mifepristone, hyaluronidase, and nitric oxide donors) and mechanical methods (single- and double-balloon catheters, laminaria, membrane stripping, and amniotomy) and those generally considered under the rubric of complementary medicine (castor oil, nipple stimulation, sexual intercourse, herbal medicine, and acupuncture). A substantial body of published reports, including 2 large network meta-analyses, support the safety and efficacy of misoprostol (PGE1) when used for cervical ripening and labor induction. Misoprostol administered vaginally at doses of 50 µg has the highest probability of achieving vaginal delivery within 24 hours. Regardless of dosing, route, and schedule of administration, when used for cervical ripening and labor induction, prostaglandin E2 seems to have similar efficacy in decreasing cesarean delivery rates. Globally, although oxytocin represents the most widely used pharmacologic agent for labor induction, its effectiveness is highly dependent on parity and cervical status. Oxytocin is more effective than expectant management in inducing labor, and the efficacy of oxytocin is enhanced when combined with amniotomy. However, prostaglandins administered vaginally or intracervically are more effective in inducing labor than oxytocin. A single 200-mg oral tablet of mifepristone seems to represent the lowest effective dose for cervical ripening. The bulk of the literature assessing relaxin suggests this agent has limited benefit when used for this indication. Although intracervical injection of hyaluronidase may cause cervical ripening, the need for intracervical administration has limited the use of this agent. Concerning the vaginal administration of nitric oxide donors, including isosorbide mononitrate, isosorbide, nitroglycerin, and sodium nitroprusside, the higher incidence of side effects with these agents has limited their use. A synthetic hygroscopic cervical dilator has been found to be effective for preinduction cervical ripening. Although a pharmacologic agent may be administered after the use of the synthetic hygroscopic dilator, in an attempt to reduce the interval to vaginal delivery, concomitant use of mechanical and pharmacologic methods is being explored. Combining the use of a single-balloon catheter with dinoprostone, misoprostol, or oxytocin enhances the efficacy of these pharmacologic agents in cervical ripening and labor induction. The efficacy of single- and double-balloon catheters in cervical ripening and labor induction seems similar. To date, the combination of misoprostol with an intracervical catheter seems to be the best approach when balancing delivery times with safety. Although complementary methods are occasionally used by patients, given the lack of data documenting their efficacy and safety, these methods are rarely used in hospital settings.

The use of adjunctive mechanical dilation at the time of induction termination and adverse health outcomes: a systematic review.

OBJECTIVE: This study aimed to assess if the use of mechanical dilation at the time of induction termination is associated with changes in the time from initiation of labor to expulsion of the fetus (induction-to-expulsion interval) and with the frequency of health complications when compared with medication management alone. DATA SOURCES: PubMed, CINAHAL, Scopus, and the Cochrane Central Register of Controlled Trials were queried from January 2000 to May 2023. STUDY ELIGIBILITY CRITERIA: We included randomized controlled trials of individuals who were assigned to undergo mechanical dilation (ie, laminaria, Dilapan-S, and intracervical Foley balloon catheter) in combination with the use of medication and compared it with the outcomes of medication use (eg, prostaglandins, antiprogestins, oxytocin) alone. METHODS: The primary outcome was the induction-to-expulsion interval. The secondary outcomes were the incidence of clinical chorioamnionitis, sepsis, hemorrhage, the need for blood transfusion and uterotonics, cervical laceration, the need for adjunctive procedures (eg, dilation and curettage), failed induction termination, uterine rupture, intensive care unit admission, or death. Assessment of bias was performed using the Cochrane Risk of Bias tool. A subgroup analysis was performed among studies deemed to be at low risk of bias. RESULTS: Of 864 abstracts identified, 11 met the inclusion criteria. Five studies demonstrated a shorter induction-to-expulsion interval among those randomized to mechanical dilation, whereas 6 studies demonstrated a similar or longer induction-to-expulsion interval. There were no significant differences reported in the frequency of any adverse outcomes between the trial arms. In addition, most studies (8/11) exhibited moderate to high levels of bias. In an analysis of the 3 studies deemed to have a low risk of bias, 1 (n=60) demonstrated a longer induction-to-expulsion interval with adjunctive laminaria, 1 (n=60) demonstrated a shorter induction-to-expulsion interval with adjunctive intracervical Foley balloon catheter use, and 1 demonstrated no difference in the induction-to-expulsion interval with adjunctive Dilapan-S use (n=180). CONCLUSION: Only a small number of studies, most of which were of low quality, assessed mechanical dilation for induction termination. The results of these studies were inconsistent in terms of the induction-to-expulsion interval of adjunctive mechanical methods in comparison with medication management alone. Studies did not reveal significant differences between the groups in adverse outcomes. Further research should investigate the use of mechanical dilation at the time of induction termination using high-quality methods.

Synthetic Osmotic Dilators for Pre-Induction Cervical Ripening - an Evidence-Based Review.

Mechanical methods have gained growing interest for pre-induction cervical ripening in women with an unripe cervix, since they have a better safety profile compared to prostaglandins. Balloon catheters have been the gold standard method for decades, while there was a lack of data on synthetic osmotic cervical dilators. Not until 2015, when Dilapan-S was approved by the Food and Drug Administration (FDA) for induction of labor, numerous studies have been published on the use of Dilapan-S in this field. The rate of vaginal deliveries associated with the use of Dilapan-S ranges from 61.6 to 81.7%, and no serious complications needing further interventions have been reported to this date. Dilapan-S was shown to be as effective as the Foley balloon catheter as well as the 10 mg PGE 2 vaginal insert and orally applied misoprostol (25 µg every 2 hours) in achieving vaginal delivery, but patient's satisfaction during the cervical ripening process was significantly higher compared to the other methods and the rate of uterine hyperstimulation was significantly lower compared to prostaglandins (PGs). Minor complications (e.g. vaginal bleeding) associated with the use of Dilapan-S were < 2%, and maternal infectious morbidity was not higher compared to Foley balloon and vaginal PGE 2 or misoprostol. Due to these beneficial properties Dilapan-S might be an ideal option for outpatient cervical ripening, as shown in a recent randomized clinical trial comparing inpatient to outpatient cervical ripening. Furthermore, according to the manufacturers' product information, Dilapan-S is the only cervical ripening method that is not contraindicated for induction of labor in women with a previous cesarean section. Upcoming guidelines should consider synthetic osmotic cervical dilators as an effective and safe method for cervical ripening/induction of labor acknowledging that more evidence-based data are mandatory, particularly in patients with a previous cesarean section.

Comparison of Efficacy of Vaginal Misoprostol versus a Synthetic Osmotic Dilator (Dilapan-S) for Cervical Preparation before Operative Hysteroscopy: A Randomized Controlled Study.

Objectives: To compare the need for mechanical cervical dilatation following vaginal misoprostol or synthetic osmotic dilator (Dilapan-S) usage for cervical preparation before operative hysteroscopy. Materials and Methods: Fifty-five premenopausal women scheduled for operative hysteroscopic procedures with a 26 Fr resectoscope were included in this randomized, controlled clinical trial. After randomization, either 400 µg of vaginal misoprostol or intracervical synthetic osmotic dilator (Dilapan-S) was inserted 12 h before operative hysteroscopy. The need for additional mechanical cervical dilatation before insertion of the resectoscope was compared between the two groups. Initial cervical diameter before mechanical dilatation, intraoperative complications (cervical tears, creation of a false passage), and ease of dilatation were also compared between the two groups. Results: In the misoprostol group, 92% of women required additional mechanical cervical dilatation, whereas only 36% of women in the Dilapan-S group required additional dilatation (P < 0.05). The median initial cervical diameter achieved with Dilapan was 9 mm (Q1: 7 mm; Q3: 10 mm), and with misoprostol, it was 6 mm (Q1: 4.5 mm; Q3: 8 mm) (P < 0.05). There was no significant difference in other outcome parameters between the two groups. Conclusion: Synthetic osmotic dilator (Dilapan-S) is more efficacious than vaginal misoprostol at ripening the cervix before operative hysteroscopy.

Longitudinal Ultrasound Evaluation of Dilapan-S During Cervical Ripening.

OBJECTIVE: To assess the diameter change of hygroscopic rod dilation during 12 hours of cervical ripening. METHODS: This was an observational, prospective study of term women undergoing labor induction with a bishop score ≤ 6. Women were allocated into two groups (soaked gauze or no gauze) stratified by parity. Using transvaginal ultrasound, maximal rod diameters were obtained in a longitudinal plane. Measurements were taken at four pre-specified time points (3, 6, 8, and 12 hours). All rods were removed at 12 hours from insertion. Patient satisfaction scores between the groups were assessed. To evaluate if measures were significantly different among the four time points, a generalized linear model was used. Independent t-tests were used to compare mean rod diameter values and pain measures between the two groups. Fisher Exact tests were used to evaluate categorical satisfaction measures. RESULTS: Forty-four women were recruited with a total of 178 hygroscopic rods placed. Mean rod diameters (mm) were significantly different among the four time periods (3 hour: 7.9 mm [SD 0.9]; 6 hour: 9.4 mm [SD 0.9]; 8 hour: 10.0 mm [SD 0.9]; 12 hour: 10.9 mm [SD 0.8]; P-value <.001). After stratifying by the use of gauze, there was no difference in rod diameters at 3, 6, 8, and 12 hours respectively. There was no difference in patient satisfaction scores between the two groups. CONCLUSION: The majority of hygroscopic rod dilation occurs within the first 8 hours of cervical ripening. Placement of saturated gauze does not accelerate rod dilation.

A randomised open-label trial to assess outpatient induction of labour (HOMEIND) and compare efficacy of Propess vs Dilapan-S® for induction of labour at 39 weeks' gestation in normal risk nulliparous women: study protocol for a randomised controlled trial.

BACKGROUND: Induction of labour (IOL) at 39 weeks has been shown to decrease maternal and neonatal adverse outcomes. Given the growing demand for 39-week IOL, it is imperative that effective methods be assessed for induction in the outpatient setting. The aim of this study is to answer the clinical question as to whether Dilapan-S® vs Propess® as a method of cervical ripening is non-inferior in the outpatient setting at 39 weeks and to ascertain whether Dilapan-S® 12 h is non-inferior to Dilapan-S® 24 h. METHODS: This study is an open-label parallel group single-centre randomised trial. Participants are normal risk nulliparous women who have no pregnancy-related or medical contraindication to IOL. Women will be randomised to one of three induction groups-Dilapan-S® (12-h insertion or 24-h insertion) or Propess. Induction will be initiated between 39+0 and 39+4 weeks' gestation and participants will return home for either 12 or 24 h. They will be readmitted 12/24 h later in order to continue with induction of labour. Patient recruitment will take place over 30 months within a single centre. The study will recruit a maximum 109 women for each study arm. Total duration of participants' involvement in the trial will be 8 weeks to allow for postpartum follow-up. DISCUSSION: This study will definitively answer whether Dilapan-S is non-inferior to Propess® as a method of induction of labour in the outpatient setting and whether cervical ripening with Dilapan-S over a 12-h timeframe is non-inferior to cervical ripening with Dilapan-S over a 24-h timeframe. TRIAL REGISTRATION: EudraCT Number 2019-004697-25 Registered 14 September 2020.

Sonoelastography for the comparative assessment of cervical maturation after different approaches to cervical preparation ahead of labor induction.

AIM: To compare the efficacy of different approaches to cervical preparation to labor induction using the ultrasound cervical elastography. MATERIALS AND METHODS: This prospective open-label study included 200 pregnant women aged between 23 and 38 years eligible for labor pre-induction. Patients were divided into four groups (n = 50 per group). In Group I, four osmotic Dilapan-S cervical dilators combined with two doses of oral mifepristone (200 mg each) 24 h apart were used. The dilators were inserted for up to 12 h. In Group II, only the Dipalan-S dilators were used. In Group III, a Foley catheter was positioned intracervically for 12 h. In Group IV, we used two doses of intracervical prostaglandin E2 gel (0.5 mg each) 6 h apart. Cervical maturation was assessed using the Bishop scoring system and the ultrasound cervicometry with the color mapping and calculation of SR ratio. At baseline, all participants were also divided into three subgroups depending on the Bishop score before the pre-induction. Subgroup А (n = 66) included patients with the Bishop score between 0‒2 points, subgroup B (n = 69) between 3-4 points, and subgroup С (n = 65) between 4-6 points. RESULTS: Our study showed that the efficacy of Dilapan-S combined with mifepristone for cervical preparation to labor induction was higher than Dilapan-S, Foley catheter and intracervical prostaglandin E2 gel. In this group, the Bishop score after the pre-induction was the highest (11.4 (0.21) points versus 10.2 (0.2), 9.4 (0.3) и 9.67 (0.25) in Groups II, III and IV respectively (p < .05 for all). The lowest SR values were also observed among the patients receiving the combination of Dilapan-S and mifepristone: 1.23 (0.04) versus 1.63 (0.07), 1.7 (0.08) and 1.83 (0.1) in Groups II, III and IV respectively (p < .05 for all). The sonoelastographic SR values in subgroups B and C were statistically lower compared with subgroup A across all groups studied. Ultrasound elastography of the cervix allowed to perform a more objective assessment of cervical maturation compared with the Bishop scoring. CONCLUSION: Dilapan-S combined with mifepristone had higher efficacy for cervical preparation to labor induction compared with other approaches investigated.

Comparing the efficacy of dilapan with extra-amniotic saline infusion and oral misoprostol for cervical ripening in term pregnancies.

INTRODUCTION: Labor induction is an important issue in modern obstetrics. One of the important factors for the success of induction of labor is the Bishop score of cervix. OBJECTIVE: The purpose of the present study was to evaluate and compare the efficacy of dilapan with extra-amniotic saline infusion and oral misoprostol for cervical ripening in term pregnancies. METHODS: This clinical trial study was performed on 120 nulliparous pregnant women with the Bishop score of less than 5. Group one, group two and group three received dilapan, extra amniotic saline infusion (EASI) and misoprostol respectively. All three groups were compared for duration from beginning of the intervention up to cervical ripening and Bishop Score of ≥7, duration of active phase and the second stage of labor, number of deliveries in the first 24 h, duration from beginning of the intervention up to delivery, rout of delivery as well as neonatal weight, neonatal Apgar score; hyper- stimulation, and need for oxytocin and oxytocin doses administered after 12 h of intervention. RESULTS: The number of deliveries in the first 24 h after intervention were not significantly different between the three groups. There was no significant difference between the three groups according to duration from beginning of the intervention up to cervical ripening and Bishop Score of ≥7, duration of active phase and the second stage of labor, duration from beginning of the intervention up to delivery, rout of delivery as well as neonatal weight, neonatal Apgar score; and hyperstimulation. The Bishop Score was higher in the misoprostol group 6 h after intervention [dilapan: 4.32 ± 1.38, EASI: 5.47 ± 1.28, and misoprostol: 6.72 ± 1.61 (p = .000)], Oxytocin requirement [dilapan: 38 (95%) women, EASI: 37 (92.50%) and misoprostol: 30 (75%) women, p = .013], and required dose [dilapan: 7543 ± 2465 miu/ml, EASI: 5758 ± 1615miu/ml and misoprostol: 4930 ± 2589miu/ml, p = .000] were lower in misoprostol group. CONCLUSION: Dilapan is an effective and safe method for cervical ripening in full term gestations. In cases where misoprostol and EASI cannot be used or are not desirable, dilapan can be used as an alternative.Trial registration number and registry website: IRCT20091023002624N25.

Cervical priming before surgical abortion between 14 and 24 weeks: a systematic review and meta-analyses for the National Institute for Health and Care Excellence-new clinical guidelines for England.

OBJECTIVE: This study aimed to determine the optimal cervical priming regimen before surgical abortion between 14+0 and 24+0 weeks' gestation. DATA SOURCES: Embase, MEDLINE, and the Cochrane Library were searched for publications up to February 2020. Experts were consulted for any ongoing or missed trials. STUDY ELIGIBILITY CRITERIA: Randomized controlled trials, published in English after 1985, that compared (1) mifepristone, misoprostol, and osmotic dilators against each other, alone or in combination; (2) different doses of mifepristone and misoprostol; (3) different intervals between priming and abortion; or (4) different routes of administration of misoprostol were included. METHODS: Risk of bias was assessed using the Cochrane Collaboration checklist for randomized controlled trials, and data were meta-analyzed in Review Manager 5.3. Dichotomous outcomes were analyzed as risk ratios using the Mantel-Haenszel method, and continuous outcomes were analyzed as mean differences using the inverse variance method. Fixed effects models were used when there was no significant heterogeneity (I2<50%), random effects models were used for moderate heterogeneity (I2≤50% and <80%), and evidence was not pooled when there was high heterogeneity (I2≥80%). Subgroup analyses were undertaken based on parity where available. The overall quality of the evidence was assessed using Grades of Recommendation Assessment, Development, and Evaluation. RESULTS: A total of 15 randomized controlled trials (N=2454) were included and showed decreased difficulty of procedure and/or increased cervical dilation and decreased patient acceptability with regimens that included dilators compared with those that did not include dilators; increased preoperative expulsion of the pregnancy with sublingual misoprostol and mifepristone compared with sublingual misoprostol alone; increased difficulty of procedure with dilators and misoprostol compared with dilators and mifepristone; decreased difficulty of procedure with dilators and mifepristone compared with dilators alone; and increased cervical dilation when dilators were placed the day before abortion compared with the same day. CONCLUSION: Considered alongside clinical expertise, the published data support the use of osmotic dilators, misoprostol, or mifepristone before abortion for pregnancies at 14+0 to 16+0 weeks' gestation; osmotic dilators or misoprostol for pregnancies at 16+1 to 19+0 weeks' gestation; and osmotic dilators alone or with mifepristone for pregnancies at 19+1 to 24+0 weeks' gestation. The effectiveness of pharmacologic agents alone beyond 16+0 weeks' gestation and the optimal timing of dilator placement remain important questions for future research.

Leukocytosis during cervical preparation with osmotic dilators for dilation and evacuation.

OBJECTIVES: To describe leukocytosis trends during cervical preparation with osmotic dilators for second-trimester dilation and evacuation procedures, and to determine whether there is a difference in leukocytosis seen with laminaria versus Dilapan-S. METHODS: We conducted a retrospective cohort study of 986 women presenting for dilation and evacuation from April 2008 through March 2009 at an outpatient clinic network. We included all procedures at ⩾14 weeks' gestation where laminaria or Dilapan-S dilators were used for overnight dilation. All women had routine white blood cell testing during the study period. RESULTS: There was a median increase of 2.4 × 103/µL white blood cell count (95% confidence interval 2.2-2.7 × 103/µL) from beginning of cervical preparation to the day of procedure (95% confidence interval and p value). Women receiving laminaria (n = 805) versus Dilapan-S (n = 181) had a greater increase in white blood cell count from baseline (median increase 2.7 versus 1.2 × 103/µL, p < 0.001), including when adjusting for age, gestational age, parity, baseline white blood cell count, and number of dilators placed. CONCLUSION: There is increased leukocytosis during the course of cervical preparation with osmotic dilators, and this is increased with use of laminaria versus Dilapan-S. Rates of clinically recognized infection in second-trimester abortion are low regardless of dilator type used.

A comparison between labor induction with only Dilapan-S and a combination of mifepristone and Dilapan-S in nulliparous women: a prospective pilot study.

OBJECTIVE: The aim of our study was to determine whether the combination of mifepristone and the osmotic dilator Dilapan-S improves the labor induction outcomes as compared to Dilapan-S alone. METHODS: This prospective comparative study included 127 eligible women, of whom 58 underwent cervical ripening with Dilapan-S (12-h exposure, the control group) and 69 with Dilapan-S, with a concurrent pretreatment of 200 mg oral mifepristone (the study group), 8 h before Dilapan-S insertion. RESULTS: The vaginal delivery rate in the control group and the study group was 60.3 and 76.8% (p = .045), respectively; the induction to delivery interval was 22.74 ± 3.01 h and 19,890 ± 2.42 h (p < .001), respectively; and the number of births within 24 h was 43.1 and 73.9% (p < .001), respectively. There was no difference in the rate of failed labor induction (6.9 versus 8.7%, p = .939). The Bishop's score improved significantly after the combined treatment as compared to with Dilapan alone (3.10 ± 0.58 versus 4.03 ± 1.35, p < .001). Moreover, in the study group, labor started earlier and proceeded faster with a lower additional oxytocin usage for labor induction or augmentation. There were no differences in the operative delivery rate and the perinatal outcomes. There were no adverse side effects of both mifepristone and Dilapan-S. CONCLUSION: Our study is the first one to show that in comparison to labor induction using only osmotic dilators Dilapan-S, the combination of mifepristone and Dilapan-S is more efficient in terms of improving cervical ripening and vaginal delivery rate and reducing labor duration and frequency of oxytocin augmentation. The results revealed that this combined method is safe and has no immediate adverse effects on newborns. More studies are needed to evaluate what clinical cases are the most appropriate for the application of this combined method, considering the parity, degree of cervical ripening, and indication for labor induction.

A single-blinded randomized controlled trial evaluating pain and opioid use after dilator placement for second-trimester abortion.

OBJECTIVES: To compare pain levels and medication needs after placement of laminaria vs Dilapan-S, and after dilation and evacuation (D&E). STUDY DESIGN: We conducted a single-blinded randomized control trial of patients undergoing D&E at 15 0/7 to 23 6/7 weeks gestation, randomizing to cervical preparation with laminaria or Dilapan-S. We compared pain levels and medication usage following dilator placement (5 minutes; 2, 4, and 8 hours; the following morning) and D&E (1, 4, 24, and 48 hours). Our primary outcome was median change from baseline pain, and secondary outcomes included maximum pain timing and overall narcotic use. We compared baseline characteristics, median pain increases and quantities of narcotics used. RESULTS: We analyzed 67 participants with laminaria (n = 34) and Dilapan-S (n = 33). More Dilapan-S users had a prior vaginal delivery (n = 20, 60.6%) than laminaria users (n = 11, 32.4%), p = 0.02. Maximum median pain was not statistically different (Laminaria: +3.5 (interquartile range [IQR] +0.5, +6.5); Dilapan-S: +3 (IQR +1, +5); p = 0.42. Thirty-seven (63.8%) participants reported higher levels of pain following dilator placement than D&E. Overall, 26 (42.6%) participants used narcotics during their abortion episode, with no difference in median number of tablets between laminaria (2, range 1-8) and Dilapan-S (4.5, range 1-15) participants (p = 0.34). CONCLUSIONS: Median pain increase did not differ in participants receiving laminaria or Dilapan-S for cervical preparation prior to D&E. The majority of patients will use a small amount of narcotics if available. IMPLICATIONS: The lack of difference in pain between laminaria and Dilapan-S enhances the applicability of pain intervention research across dilator types. With over half of participants using a small amount of narcotics during their D&E episode, pain management should be individualized to patient needs.

Predictors of vaginal delivery after cervical ripening using a synthetic osmotic dilator.

OBJECTIVE: To evaluate the determinants of vaginal delivery and safety in women undergoing cervical ripening with a synthetic osmotic dilator (Dilapan-S) prior to induction of labor. METHODS: We conducted a secondary analysis of an international multicenter prospective observational study of Dilapan-S for cervical ripening in pregnancies greater than 32 weeks. Data were obtained in a standardized fashion and entered into a centralized electronic data capture system. The association between Bishop score and vaginal delivery was further evaluated with a multivariate receiver-operating characteristic (ROC) curve analysis. A Wilcoxon rank test and multivariable logistic regression were used for statistical analysis (significance: P < .05). RESULTS: Between May 2015 and July 2016, 444 pregnant women were included. Three hundred ten (70 %) delivered vaginally. Compared to patients who underwent cesarean delivery, those who delivered vaginally were more likely to have a history of prior vaginal delivery. Vaginal delivery rates were significantly correlated with Bishop scores of pre and post Dilapan-S and difference. After adjusting for age, BMI, number of dilators, cervical ripening time, and gestational age, both prior vaginal delivery and post-Dilapan-S Bishop scores were strong predictors of vaginal delivery (estimate coefficient: 0.1275 ± 0.03 P = .0002; 0.049 ± 0.01 P = .0001; respectively). Aggregate ROC accounting for these variables further supported these findings (AUC = 0.734). The lower confidence interval limit of vaginal delivery rates was above 50 % when post-Dilapan-S Bishop scores were ≥ 5. Cox regression analyses demonstrated that the duration of labor was significant shorter in women that had vaginal delivery. CONCLUSION: Bishop scores after cervical ripening with Dilapan-S are good predictors of vaginal delivery. Bishop scores < 5 post Dilapan-S may warrant further cervical ripening. Further level 1 trials are needed to compare osmotic dilators to other ripening methods.

A randomized controlled trial of Dilapan-S vs Foley balloon for preinduction cervical ripening (DILAFOL trial).

OBJECTIVE: The objective of the study was to test the hypothesis that Dilapan-S is not inferior to the Foley balloon for preinduction cervical ripening at term. STUDY DESIGN: Pregnant women ≥37 weeks scheduled for induction with unfavorable cervix (≤3 cm dilated and ≤60% effaced) were randomly assigned to 12 hours of either Foley balloon inflated with 60 mL saline or Dilapan-S for cervical ripening. If the cervix remained unfavorable, then 1 more round of the assigned dilator was used. Management following ripening was left up to the clinical providers. The primary outcome was vaginal delivery. A satisfaction survey was also obtained after the preinduction period. Sample size was based on a noninferiority margin of 10%, 90% power, and an estimated frequency of vaginal delivery of 71% in Foley balloon and 76% in Dilapan-S. RESULTS: From November 2016 through February 2018, 419 women were randomized (209 to Foley balloon; 210 to Dilapan-S). In the intent-to-treat analysis, vaginal delivery was more common in Dilapan-S vs Foley balloon (81.3% vs 76.1%), with an absolute difference with respect to the Foley balloon of 5.2% (95% confidence interval, -2.7% to 13.0%) indicating noninferiority for the prespecified margin. The difference was not large enough to show superiority. Noninferiority was confirmed in the per-protocol population (n = 204 in the Foley balloon, n = 188 in Dilapan-S), supporting the robustness of the results. Secondary outcomes were not different between groups, except for a longer time the device remained in place in Dilapan-S compared with the Foley balloon. Maternal and neonatal adverse events were not significantly different between groups. A priori interaction analyses showed no difference in the effect on vaginal delivery by cervical dilation at randomization, parity, or body mass index >30 kg/m2. Patients with Dilapan-S were more satisfied than patients with the Foley balloon as far as sleep (P = .01), relaxing time (P = .001), and performance of desired daily activities (P = .001). CONCLUSION: Dilapan-S is not inferior to the Foley balloon for preinduction cervical ripening at term. Advantages of Dilapan-S over Foley include Food and Drug Administration approval, safe profile, no protrusion from the introitus, no need to keep under tension, and better patient satisfaction.

Synthetic osmotic dilators in the induction of labour-An international multicentre observational study.

INTRODUCTION: To evaluate the effects of synthetic osmotic dilators (Dilapan-S/ Dilasoft) in women who required induction of labour in a large prospective multicentre international observational study. MATERIALS AND METHODS: Primary outcomes were duration of Dilapan-S/Dilasoft insertion (hours), total induction - delivery interval (hours) and the rate of vaginal deliveries within 24 h (%). Secondary outcomes were the number of dilators inserted, Bishop score increase after extraction of Dilapan-S/Dilasoft, complications during induction (uterine contractions, uterine tachysystole and hyperstimulation, effect on the fetus) and post induction (infections and neonatal outcomes), agents / procedures used for subsequent induction of labour, immediate rate of spontaneous labours following cervical ripening period, rate of spontaneous vaginal deliveries, rate of instrumental vaginal deliveries and caesarean sections. RESULTS: Total of 543 women were recruited across 11 study sites, of which, 444 women were eligible for analysis. With Dilapan-S/Dilasoft use of <12 h (n = 188) the overall vaginal delivery rate was 76.6% with 45.7% of these births occurring within 24 h, 66% within 36 h and 75.5% within 48 h from insertion of Dilapan-S/Dilasoft. The mean insertion-delivery interval for this group was 24.3(±10.4) hours. With Dilapan-S/Dilasoft use of >12 h (n = 256), the overall vaginal delivery rate was 64.8%, with 16% of these births occurring within 24 h, 48.4% within 36 h and 54.7% within 48 h from insertion of Dilapan-S/Dilasoft. The mean insertion-delivery interval for this group was 39.1(±29.2) hours. The mean gain in the Bishops score was +3.6(±2.3). The mean number of Dilapan-S/Dilasoft dilators used was 3.8 (±1.1). The overall rate of caesarean section was 30.1%. The overall complication rate was low including infection risk. No adverse neonatal outcome was attributable to the use of Dilapan-S/Dilasoft. CONCLUSION: Dilapan-S/Dilasoft are safe and effective methods for cervical ripening. Their use is associated with low maternal and neonatal complication rates. Future research should aim at level I clinical trials comparing Dilapan-S to other mechanical or pharmacological cervical ripening agents. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT02318173.

Synthetic osmotic dilators for cervical preparation prior to abortion-An international multicentre observational study.

OBJECTIVES: To evaluate the outcomes with the use of Dilapan-S for cervical preparation prior to medical or surgical abortion. STUDY DESIGN: International, multicentre, prospective observational study in women between 6 + 0-24 + 0 weeks' gestation. The study was conducted across 7 study sites in 4 countries, between 1/5/2015 to 31/12/2016. The primary outcomes studied were the number of dilators used and the duration required for cervical preparation prior to abortion. Secondary outcomes were complications of dilator use and infection. Participants were followed-up for 4 weeks post procedure to capture any delayed complications. RESULTS: A total of 483 women were enrolled with 439 women eligible for analysis. Medical abortion was performed in 38% (n = 165) women and surgical abortion in 62% (n = 274). For medical abortions and surgical abortions, an average of 3 osmotic dilators for time interval of 4-7 hours provided effective cervical preparation. Medical abortions were performed as day-case procedures (<12 h) in 81% of women. There was no difference in using either adjunctive misoprostol or Dilapan-S followed by misoprostol for cervical ripening effect to achieve complete medical abortion. Dilapan-S permitted surgical abortions to be performed as same-day procedures (<12 h), in 85% of women regardless of gestational age and without the need to use adjunctive or additional misoprostol. There were no serious adverse events reported with the use of Dilapan-S, including in women with a previous caesarean section. The overall infectious morbidity was 0.9% of cases with no causal relationship with the use of synthetic osmotic dilator use (for a length <24 h). In addition, Dilapan-S was reported as easy to insert and remove in over 90% of women. CONCLUSION: Dilapan-S is a safe and effective method for cervical preparation for medical and surgical abortions up to 24 weeks' gestation. It allows medical and surgical abortions to be performed as day case procedures and is associated with a low complication rate. Future research should aim at directly comparing Dilapan-S and preferred pharmacological agents in a randomised controlled trial.

Comparison of the Induction-to-Delivery Interval in Terminations of Pregnancy with or without Dilapan-S®.

OBJECTIVE: In France, terminations of pregnancy (TOP) for medical reasons beyond the second trimester use mifepristone and misoprostol. We sought to determine the effectiveness of Dilapan-S®, an osmotic cervical dilator, in shortening the induction-to-delivery interval (IDI). MATERIALS AND METHODS: This retrospective study of TOP in 2010-2012 compared the results from 2 hospitals with different TOP protocols starting at 16 weeks' gestation, one (164 women) with and one (106) without Dilapan-S®. The principal endpoint was the IDI. Results were analyzed according to 2 definitions of induction onset: definition 1, first dose of misoprostol in both centers, or definition 2, dilator placement if used, and otherwise first dose of misoprostol. RESULTS: With definition 1, the IDI was shorter with dilators (5 h 48 min vs. 10 h 18 min, p < 0.001); the rates of uterine evacuation within 12 and 24 h were higher (94.5 and 100 vs. 68.9 and 91.5%, p < 0.001), and the time between first misoprostol dose and amniotomy was shorter (0 h 47 min vs. 4 h 30 min, p < 0.001). Under definition 2, the IDI was longer with dilators (18 h 24 min vs. 10 h 18 min, p < 0.001), but the rate of evacuation within 24 h did not differ significantly. CONCLUSION: Dilapan-S® acts on cervical ripening and dilatation, thereby allowing early amniotomy. Assessing potential side effects and women's satisfaction requires prospective trials.

Cervical dilation before first-trimester surgical abortion (<14 weeks' gestation).

First-trimester surgical abortion is a common, safe procedure with a major complication rate of less than 1%. Cervical dilation before suction abortion is usually accomplished using tapered mechanical dilators. Risk factors for major complications in the first trimester include increasing gestational age and provider inexperience. Cervical priming before first-trimester surgical abortion has been studied using osmotic dilators and pharmacologic agents, most commonly misoprostol. Extensive data demonstrate that a variety of agents are safe and effective at causing preoperative cervical softening and dilation; however, given the small absolute risk of complications, the benefit of routine use of misoprostol or osmotic dilators in first-trimester surgical abortion is unclear. Although cervical priming results in reduced abortion time and improved provider ease, it requires a delay of at least 1 to 3 h and may confer side effects. The Society of Family Planning does not recommend routine cervical priming for first-trimester suction abortion but recommends limiting consideration of cervical priming for women at increased risk of complications from cervical dilation, including those late in the first trimester, adolescents and women in whom cervical dilation is expected to be challenging.