Digital versus speculum insertion of Foley catheter for labor induction: A systematic review and meta-analysis of randomized controlled trials.

OBJECTIVE: To compare Foley catheter insertion by digital blind method to its placement with a sterile speculum in women with unripe cervix for induction of labor. METHODS: A systematic search was conducted in Cochrane Library, PubMed, Web of Science, and Scopus databases for randomized clinical trials (RCTs) from inception to July 2023. Included studies compared digital to speculum placement of the Foley catheter for labor induction. Data from the included studies were extracted and pooled using RevMan software for meta-analysis. The primary outcome was pain score during the procedure measured by the Visual Analog Scale (VAS). Secondary outcomes included Foley catheter insertion duration, cesarean delivery rate, induction to delivery interval, Bishop score, need for other cervical ripening methods, maternal satisfaction, and maternal fever. RESULTS: Four RCTs involving a total of 600 patients met the inclusion criteria. Pain during the procedure and Foley catheter insertion duration were significantly reduced in the digital insertion group compared to the speculum-guided group (p < 0.05). The Bishop score showed a significant improvement in the digital Foley catheter placement group. However, there were no statistically significant differences in the cesarean delivery rate or the requirement for additional cervical ripening methods between the two groups. Maternal satisfaction with the delivery process was significantly improved in the digital insertion group (p < 0.001). Induction to delivery interval and maternal fever were comparable between both groups. CONCLUSIONS: Digital placement of Foley catheter can be considered as an alternative to the sterile speculum method for pre-induction cervical ripening. More trials are required to confirm our findings.

Comparison of digital and speculum-guided methods of transcervical Foley catheter insertion in primigravida undergoing cervical ripening at term gestation: a noninferiority randomized clinical trial.

BACKGROUND: Foley catheter insertion is frequently used for cervical ripening during the induction of labor. However, the insertion failure, safety, maternal side effects, complications, and satisfaction of digital compared with speculum-guided Foley catheter placement have not been evaluated in a large trial involving primigravida. OBJECTIVE: The study aimed to compare the insertion failure rate of digital and speculum-based transcervical Foley catheter placement in primigravida. The co-primary outcome was insertion-associated pain. The secondary outcomes were the time required for successful insertion, maternal satisfaction, and maternal complications within 24 hours of Foley insertion. STUDY DESIGN: This randomized, open-label, parallel-arm, noninferiority clinical trial was performed in a large tertiary care university hospital. Primigravida aged >18 years with term gestation (≥37 weeks) were included in this study. Additional inclusion criteria for enrollment in this study were singleton pregnancy with a cephalic presentation, intact membrane, a Bishop score of ≤5, and reassuring preinduction fetal heart rate tracing. All women planned for cervical ripening were assessed for eligibility and were randomized into digital or speculum arms. Foley catheter insertion was performed in a supine lithotomy position. Vaginal and cervical cleaning were performed before insertion. A 22-French Foley balloon catheter was guided digitally or via speculum to position the bulb at the level of the internal os using water-soluble lubricant. Insertion-associated pain was measured using a visual numeric rating scale, and maternal satisfaction was assessed using a set of questions. RESULTS: Four hundred and sixty-nine pregnant women were assessed for eligibility, and 446 patients were enrolled and randomized. The median age of the parturients was 24 (19-40) and 24 (18-38) years, respectively. The body mass index, gestational age at randomization, the incidence of postdated pregnancy, and prerandomization Bishop scores were comparable. Insertion failure was observed in 24 (10.8%) and 17 (7.6%) women in digital and speculum arms, respectively (relative risk=1.41 [95% confidence interval, 0.78-2.55]; P=.25). Requirements of >1 attempt (5.4% vs 3.6%) followed by the change in hands (3.6% vs 2.7%) were the most common reasons for insertion failure. The median (interquartile range) visual numeric rating scale was comparable (6 [2-9] vs 5 [2-10]; P=.15). The time taken for successful insertion was similar (58 [12-241] vs 54 [10-281]; P=.30). 9.4% and 10.8% of women required additional methods of cervical ripening. More women in the speculum group (41.7% vs 33.2%; P=.06) felt a medium level of discomfort than the digital group. CONCLUSION: Insertion failure and insertion-related pain in the digital approach were comparable to the speculum-guided approach for transcervical Foley catheter insertion in primigravida for cervical ripening. Nevertheless, maternal satisfaction was higher in the digital group because of a lesser level of discomfort.

Outpatient Cervical Ripening with Balloon Catheters: A Systematic Review and Meta-analysis.

OBJECTIVE: To evaluate whether outpatient cervical ripening with a balloon catheter results in a shorter amount of time in the labor and delivery unit when compared with use in the inpatient setting. DATA SOURCES: PubMed, Scopus, Cochrane Library, and ClinicalTrials.gov were searched from their inception until December 2020. No restrictions for language or geographic location were applied. METHODS OF STUDY SELECTION: Using a predefined protocol and search strategy, 1,152 titles were identified and screened. Randomized controlled trials that compared outpatient and inpatient cervical ripening with balloon catheters were included. TABULATION, INTEGRATION, AND RESULTS: Data extraction and risk of bias assessments were performed by two reviewers. Meta-analysis was performed to produce mean difference for continuous data and risk ratio (RR) for dichotomous data, both with a 95% CI. The primary outcome was the amount of time from admission to the labor ward until delivery. Additional secondary maternal and neonatal outcomes were evaluated. Eight trials (740 patients) were included; six studies (571 patients) reported on our primary outcome. Compared with the inpatient group, outpatient balloon cervical ripening was associated with significantly less time in the labor and delivery unit (outpatient 16.3±9.7 hours vs inpatient 23.8±14.0 hours; mean difference -7.24 hours, 95% CI -11.03 to -3.34). There were no differences in total induction time or total hospital admission. The outpatient group was significantly less likely than the inpatient group to undergo cesarean delivery (21% vs 27%), RR 0.76 (95% CI 0.59-0.98). There were no differences in other maternal or neonatal outcomes. There were no deliveries outside of the hospital and no stillbirths. CONCLUSION: Outpatient balloon cervical ripening in low-risk patients is associated with a decreased amount of time from admission to labor and delivery until delivery. Outpatient balloon cervical ripening is a safe alternative for low-risk patients and has the potential for significant benefits to patients, and labor and delivery units. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42019140503.

Misoprostol plus isosorbide mononitrate versus misoprostol alone for cervical ripening during labor induction: A systematic review and meta-analysis of randomized controlled trials.

AIM: To conduct a systematic review and meta-analysis of all randomized controlled trials (RCTs) that examined the maternal and neonatal outcomes of misoprostol+isosorbide mononitrate (ISMN) versus misoprostol alone (control) in promoting cervical ripening during labor induction. METHODS: We searched five databases from inception until 05-May-2021. We assessed risk of bias of RCTs, meta-analyzed 23 endpoints, and pooled them as mean difference or risk ratio with 95% confidence interval. RESULTS: Overall, five RCTs met the inclusion criteria, comprising 850 patients (426 and 424 patients were allocated to misoprostol+ISMN and misoprostol group, respectively). Overall, the RCTs had a low risk of bias. Pertaining to maternal delivery-related outcomes, there was no significant difference between both groups regarding the mean interval from drug administration to delivery, rate of vaginal delivery, rate of cesarean section delivery, and rate of need for oxytocin augmentation. Pertaining to maternal drug-related side effects, the rate of maternal headache was significantly higher in disfavor of the misoprostol+ISMN compared with misoprostol alone. However, the rates of maternal nausea, hypotension, flushing, palpitation, dizziness, postpartum hemorrhage, and uterine tachysystole did not differ between both groups. Pertaining to neonatal outcomes, there was no significant difference between both groups regarding rates of NICU admission, meconium-stained amniotic fluid, and Apgar score <7 at five minutes. CONCLUSION: Compared with misoprostol alone, co-administration of misoprostol+ISMN did not correlate with superior maternal delivery-related outcomes. The rate of maternal headache was significantly higher in disfavor of the misoprostol+ISMN group. There was no significant difference between both groups regarding neonatal endpoints.

Contribution of ultrasonography to the prediction of the induction-delivery interval: The ECOLDIA prospective multicenter cohort study.

INTRODUCTION: To evaluate the ability of preinduction ultrasonographic cervical length to predict the interval between induction and delivery in women at term with a Bishop score of 4 to 6 at induction. STUDY DESIGN: This multicenter prospective observational cohort recruited 334 women from April 2010 to March 2014. Inclusion criteria were women with singleton pregnancies at a gestational age ≥37 weeks, with no previous caesarean, a medical indication for induction of labor, and a Bishop score of 4, 5, or 6. All women underwent cervical assessment by both transvaginal ultrasound and digital examination (Bishop score). The induction protocol was standardized. The primary outcome measure was the induction-delivery interval. Hazard ratios (HR) and their 95% confidence intervals (95% CI) were used to assess potential predictors. RESULTS: Mean gestational age at induction was 40.1 weeks, 60.8% of the women were nulliparous, and the cesarean rate was 13.4%. The mean induction-delivery interval was 20.8 h (± 10.6). Delivery occurred within 24 h for 56.9% (n=190) of the women. An ultrasonographic cervical length measurement less than 25 mm (HR=1.50, 95% CI 1.18-1.91, P<0.01) and parity (HR=1.41, 95% CI 1.21-1.65, P<0.01) appeared to predict induction-delivery interval. The cervical length cutoff to reduce the induction-delivery interval was 25 mm. CONCLUSION: A cervical length cutoff of 25 mm was associated with shorter induction-delivery interval in women at term with a Bishop score of 4 to 6.

Six versus twelve hours of single-balloon catheter placement with oxytocin administration for labor induction: a randomized controlled trial.

BACKGROUND: Induction of labor is common in the United States. Multiple previous studies have tried to outline a faster time to delivery to improve maternal and fetal outcomes. OBJECTIVE: This study aimed to evaluate whether women who undergo induction of labor with a single-balloon catheter and oxytocin have a shorter time to delivery with planned removal of the catheter at 6 vs 12 hours. STUDY DESIGN: In this randomized controlled trial, induction of labor was performed using a combination of single-balloon catheter and oxytocin. Term women, both nulliparous and multiparous, aged 18 to 50 years old with cephalic singletons were included if they were undergoing induction of labor with a Bishop score of <6 and cervical dilation of <2 cm. Women were randomized to planned removal of the single-balloon catheter at 6 hours vs 12 hours. The primary outcome was time from catheter insertion to delivery. We were powered to show a 4-hour time difference with a sample size of 89 women per group (n=178). Planned sensitivity analyses were performed to account for cesarean delivery in labor. RESULTS: From February 2019 to June 2020, 237 women were screened, 178 women were randomized, and 177 women were included in the final analysis (89 women in the 6-hour group and 88 women in the 12-hour group). Insertion to delivery time was significantly shorter in the 6-hour group (19.2 vs 24.3 hours; P=.04), and the proportion of women delivered by 24 hours was significantly greater in the 6-hour group (67.4% vs 47.4%; P<.01). There was no difference in the Bishop score at removal of the catheter or secondary maternal or neonatal outcomes. In a Cox proportional-hazards model censoring for cesarean delivery, the 6-hour group had a significantly shorter insertion to delivery time (hazard ratio, 0.67; P=.02). CONCLUSION: Induction of labor with a single-balloon catheter and oxytocin with planned removal of the catheter at 6 hours rather than 12 hours results in a shorter time from insertion to delivery without increasing the rate of cesarean delivery. Decreasing the length of time a single-balloon catheter is in place should be considered in clinical protocols.

Transcervical Foley Balloon Plus Vaginal Misoprostol versus Vaginal Misoprostol Alone for Cervical Ripening in Nulliparous Obese Women: A Multicenter, Randomized, Comparative-Effectiveness Trial.

OBJECTIVE: Nulliparous obese women are at increased risk of labor induction and cesarean delivery (CD). We sought to determine whether the combination of a transvaginal Foley balloon plus misoprostol prostaglandin E1 (PGE1) is superior to misoprostol alone in reducing the risk for CD. STUDY DESIGN: We undertook a multicenter, open-label, comparative-effectiveness randomized clinical trial of nulliparous obese women with unfavorable cervix (Bishop's score ≤ 6) undergoing labor induction from January 2016 to June 2018 at three tertiary centers. Those at <32 weeks' gestation, premature rupture of membranes, stillbirth, and major fetal anomalies were excluded. Women were randomized 1:1 to either a combination of Foley balloon and misoprostol or misoprostol alone. Once Bishop's score was >6, further management was deferred to treating physicians. Primary outcome was the rate of CD. Secondary maternal outcomes included duration of induction-to-delivery interval, occurrence of tachysystole, clinical chorioamnionitis, need for operative vaginal delivery, as well as a composite of maternal morbidity (postpartum endometritis, surgical-site infection, venous thromboembolism, need for transfusion, intensive care unit admission, and maternal death). Secondary neonatal outcomes included need for neonatal intensive care unit admission, transient tachypnea of the newborn, respiratory distress syndrome, meconium aspiration syndrome, culture-proven sepsis, neonatal seizures, and a composite of neonatal morbidity (Apgar's score ≤7 at 5 minutes, umbilical artery cord pH ≤7.10, birth injury, perinatal death). With the rate of CD rate being 53% at Children's Memorial Herman Hospital among nulliparous obese women who underwent induction of labor at ≥32 weeks and met our inclusion criteria; 250 women (125 women per group) were required to answer the study question. All analyses were by intention to treat. RESULTS: Of the 236 women randomized, 113 (48%) were allocated to group 1 (combined Foley and PGE1) and 123 (52%) to group 2 (PGE1 alone). The rate of CD was similar between the groups (45 vs. 43%, p = 0.84, relative risk [RR]: 1.03, 95% CI: 0.75-1.42). There was no difference in the occurrence of tachysystole that resulted in fetal heart rate abnormalities between the groups (8.8 vs. 16.2%, p = 0.09, RR: 0.54, 95% CI: 0.27-1.11). The total duration of the induction-to-delivery interval was also similar between the groups (24.8 ± 13.8 vs. 24.5 ± 14.0 hours, p = 0.87) regardless of the mode of delivery. No differences were seen in the indications for CD and secondary maternal or neonatal outcomes. CONCLUSION: In this trial of nulliparous obese women undergoing labor induction, cervical ripening with combined Foley balloon and PGE1 resulted in similar CD rates than ripening with vaginal PGE1 alone. KEY POINTS: · Nulliparous obese women are at increased risk for cesarean delivery.. · Combined intravaginal misoprostol-Foley balloon versus misoprostol alone resulted in similar rates of cesarean delivery.. · Further research is warranted to determine the optimal cervical ripening strategy in this population..

Foley Bulb Insertion by Blind Placement Compared With Direct Visualization: A Randomized Controlled Trial.

OBJECTIVE: To test the hypothesis that digital placement of a balloon catheter is not inferior to the speculum method in terms of rate of maternal infection. METHODS: In an open-label noninferiority randomized trial, pregnant women who were undergoing induction of labor with unfavorable cervix (less than 3 cm dilated and less than 60% effaced) were randomly assigned to balloon catheter that was placed either digitally or using a sterile speculum. The primary outcome was a composite of maternal infection, defined by occurrence of fever (temperature 38°C or higher), chorioamnionitis, or endometritis (diagnoses were made by the managing obstetric physician or midwife). Prespecified secondary outcomes included outcomes in the primary composite, cesarean delivery rates, and maternal and neonatal outcomes. A patient satisfaction survey was also obtained. On the basis of a noninferiority margin of 10% and an expected primary outcome frequency of 10%, a sample size of 372 women was needed (90% power to confirm noninferiority with 90% protocol adherence). RESULTS: From February 2018 through February 2019, 372 women were randomized (185 digital placement, 187 sterile speculum). Baseline characteristics were similar between groups. The composite maternal infection rate was not different between groups (digital placement arm: 15.7% vs speculum arm: 12.8%), with an absolute difference with respect to the sterile speculum arm of 2.8% (95% CI -4.3 to 9.9%), indicating noninferiority for the prespecified margin. Secondary outcomes were not different between groups, except for a higher need for a second balloon catheter in the sterile speculum arm. Maternal and neonatal adverse events were not different between groups. Irrespective of method of placement, women were equally satisfied with the explanation of the method before placement, anxiety regarding the procedure, and pain during placement. More women in the sterile speculum group would choose the digital placement method for the subsequent pregnancy (37.6% vs 25.7%; P=.02.). CONCLUSION: Digital placement of a balloon catheter for preinduction cervical ripening is noninferior to the sterile speculum method, in terms of maternal infection. Women in the sterile speculum group more frequently required a second round of the mechanical dilator. The blind digital approach is a reasonable option for balloon placement for cervical ripening. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03450408.

Can we induce labor by mechanical methods following preterm premature rupture of membranes?

OBJECTIVE: To evaluate the use of the intracervical balloon compared with locally applied prostaglandins for cervical ripening for induction in patients with preterm premature rupture of membranes. METHODS: Monocentric, retrospective (from 2002 to 2017) observational cohort study of singleton pregnancies complicated by preterm premature rupture of membranes and induced between 34 and 37 weeks. The primary outcome measure was balloon catheter efficiency evaluated by Cesarean section rate. Secondary outcomes were : interval from induction to delivery, labor duration, oxytocin use, intrauterine infection rate, maternal complications (i.e., postpartum hemorrhage and endometritis), and neonatal complications. RESULTS: 60 patients had cervical ripening with prostaglandins alone and 58 had balloon catheter. Demographic characteristics were similar between the groups, except for induction term and neonatal weight. There was not a significant difference in occurrence of Cesarean section rate (p = 0.14). Nor were there significant differences in time from induction to birth (p = 0.32) or in intrauterine infection rate (p = 0.95). Labor duration was shorter (p = 0.006) and total oxytocin dose lower (p = 0.005) in patients induced by prostaglandins alone. Concerning neonatal outcomes, there were more transfers to intensive care (p = 0.008) and more respiratory distress (p = 0.005) among newborns induced by prostaglandins. CONCLUSION: Compared with locally applied prostaglandins, balloon catheter induction is not associated with an increase of Cesarean section rate in patients with preterm premature rupture of membranes.

Outpatient balloon catheter vs inpatient prostaglandin for induction of labour (OBLIGE): a randomised controlled trial.

BACKGROUND: Approximately one in four pregnant women undergo an induction of labour. The purpose of this study is to investigate the clinical effectiveness, safety, and cost-effectiveness for mothers and babies of two methods of cervical ripening - inpatient care for women starting induction with vaginal prostaglandin E2 hormones, or allowing women to go home for 18 to 24 h after starting induction with a single-balloon catheter. METHODS/DESIGN: This is a multi-centre randomised controlled trial in New Zealand. Eligible pregnant women, with a live singleton baby in a cephalic presentation who undergo a planned induction of labour at term, will be randomised to outpatient balloon-catheter induction or in-hospital prostaglandin induction. The primary outcome is caesarean section rate. To detect a 24% relative risk reduction in caesarean rate from a baseline of 24.8%, with 80% power and 5% type 1 error, will require 1552 participants in a one to one ratio. DISCUSSION: If outpatient balloon-catheter induction reduces caesarean section rates, has additional clinical benefits, and is safe, cost-effective, and acceptable to women and clinicians, we anticipate change in induction of labour practice around the world. We think that home-based balloon-catheter induction will be welcomed as part of a patient-centred labour-induction care package for pregnant women. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry (ANZCTR), ACTRN: 12616000739415. Registered on 6 June 2016.

Factores maternos y fetales asociados a la inducción del trabajo de parto, Hospital Vicente Corral Moscoso, Cuenca 2019 / Maternal and fetal factors associated with induction of labor, Hospital Vicente Corral Moscoso, Cuenca 2019

Antecedentes: La inducción del parto es una práctica frecuente en obstetricia, observándose un aumento de sus cifras en las últimas décadas a nivel mundial. Objetivo: Determinar los factores maternos y fetales asociados a la inducción del parto en pacientes hospitalizadas en el departamento de Ginecología y Obstetricia del hospital Vicente Corral Moscoso, Cuenca, 2019. Métodos: Estudio analítico realizado a 208 gestantes ingresadas en el área de Ginecología y Obstetricia. La información se procesó en el programa SPSS versión 15. Para el análisis utilizamos estadística descriptiva en base a frecuencias y porcentajes, se midió la asociación estadística con la prueba Chi 2 y Razón de Prevalencia (RP), intervalo de confianza 95%, considerando estadísticamente significativo p < 0,05. Resultados: La edad media fue 24,7 (DS± 5,93), predominó la instrucción secundaria, estado civil estable. Hubo asociación y significancia estadística de factores materno fetales a inducción como: ruptura prematura de membranas RP 2,97 (IC95%: 2,09­4,24 valor p 0,000); preeclampsia RP 2,13 (IC95%: 1,46­3,10 valor p 0,000); embarazo término tardío RP 2,91 (IC95%: 2,12­3,99 valor p 0,000); restricción del crecimiento RP 3,22 (IC95%: 2,62-3,95 valor p 0,000). No así para corioamnionitis RP 3,08 (IC95%: 2,53­3,76 valor p 0,33) y muerte fetal RP 1,55 (IC95%: 0,68­3,54 valor p 0,31). Conclusiones: Se encontró asociación y significancia estadística con factores materno fetales e inducción como: ruptura prematura de membranas, preeclampsia, embarazo término tardío, restricción del crecimiento. No para corioamnionitis y muerte fetal.

Background: Induction of labor is a frequent practice in obstetrics, with an increase in its numbers being observed in recent decades worldwide. Objective: To determine the maternal and fetal factors associated with labor induction in hospitalized patients in the Gynecology and Obstetrics department of the Vicente Corral Moscoso hospital, Cuenca, 2019. Methods: Analytical study carried out on 208 pregnant women admitted to the Gynecology and Obstetrics area who met the inclusion criteria. The information was processed in the SPSS version 15 program. For the analysis we used descriptive statistics based on frequencies and percentages, the statistical association was measured with the Chi 2 test and Prevalence Ratio (RP), 95% confidence interval, considering statistically significant p <0.05. Results: The mean age was 24.7 (SD ± 5.93), secondary education, stable marital status predominated. There was association and statistical significance of maternal-fetal factors to induction of labor such as: premature rupture of membranes RP 2.97 (95% CI: 2.09­4.24 p-value 0.000); preeclampsia RP 2.13 (95% CI: 1.46­3.10 p-value 0.000); late term pregnancy RP 2.91 (95% CI: 2.12­3.99 p-value 0.000); intrauterine growth restriction RP 3.22 (95% CI: 2.62-3.95 p-value 0.000). Not so for chorioamnionitis RP 3.08 (95% CI: 2.53­3.76 p value 0.33) and fetal death RP 1.55 (95% CI: 0.68­3.54 p value 0.31). Conclusions: There was an association and statistical significance with maternal-fetal factors associated with induction such as: premature rupture of membranes, pre-eclampsia, late-term pregnancy, intrauterine growth restriction. Not so for chorioamnionitis and fetal death.

Double-balloon catheter compared with single-balloon catheter for induction of labor with a scarred uterus.

BACKGROUND: In obstetrics, labor induction is a common procedure. It has been proved that both single balloon catheters (Foley's catheter) and double balloon catheters (Cook cervical ripening balloon) are effective and relatively safe in cervical ripening and labor induction. This research aimed to compare the efficacy of single and double balloon catheter in the induction of labor with scarred uterus. METHODS: 120 pregnant women who had prior cesarean delivery participated in this research and were randomized into single-balloon catheter group (n = 60) and double-balloon catheter group (n = 60). The cervical ripening effect, security, and influence to the process of childbirth were analyzed in each group. RESULTS: The validity of cervical ripening in single balloon group was better than double balloon group. Double balloon catheters increased the time between insertion and expulsion of the catheter and decreased spontaneous catheter expulsion rate. All the neonatal outcomes in these two groups were comparable. CONCLUSION: Based on our data, the two different catheters both have their pros and cons in the labor induction of pregnant women with scarred uterus. The appropriate catheter used based on specific circumstance will improve the quality of labor induction.

Affordable and low-maintenance obstetric devices.

OBJECTIVE: Adequate obstetric care requires the availability of essential diagnostic and management equipment; however, for centers with budget restrictions, the acquisition and maintenance of these devices can pose major challenges. The purpose of the present paper is to disseminate knowledge about the availability of affordable and low-maintenance obstetric devices, which might help to save lives in low- and medium-resource countries. METHOD: Over the course of 2015-2018, the International Federation of Gynecology and Obstetrics (FIGO) Safe Motherhood and Newborn Health Committee acquired information from different clinical and commercial sources regarding the availability of affordable and low-maintenance essential obstetric devices. RESULTS: The Committee identified several devices that met the criteria of low cost and ease of maintenance: a winding handheld Doppler device for intermittent auscultation; a portable continuous fetal heart rate monitor; a validated semi-automated blood pressure monitor; the Foley catheter balloon for labor induction in women with an unfavorable cervix; reusable metal and plastic vacuum cups and manual pumps; an intrauterine tamponade balloon; and the non-pneumatic anti-shock garment. CONCLUSION: Several affordable and low-maintenance obstetric devices are currently available that offer the potential to save lives in resource-constrained settings.

Is Foley Catheter Use during a Trial of Labor after Cesarean Associated with Uterine Rupture?

OBJECTIVE: We sought to assess the safety of transcervical Foley catheter (TCF) placement for cervical ripening in women undergoing induction of labor (IOL) after prior cesarean by evaluating the risk of uterine rupture. STUDY DESIGN: We performed a secondary analysis of the Maternal-Fetal Medicine Unit's Cesarean Section Registry, a prospective observational cohort study. We included women with a history of ≤2 low-transverse cesarean deliveries who underwent IOL at ≥24 weeks of gestational age with a live singleton fetus without major anomalies. We excluded those who received prostaglandins or laminaria. We performed multinomial logistic regression to calculate adjusted odds ratios (aORs) for uterine rupture and dehiscence. Relevant confounders included prior vaginal delivery, pregnancy-induced hypertension, chorioamnionitis, and cervical effacement and dilation on admission. RESULTS: A total of 2,564 women were eligible. Unadjusted analysis demonstrated no increased risk of uterine rupture with TCF (1.9 vs. 0.9%; p = 0.10) but an increased risk of uterine dehiscence (1.9 vs. 0.6%; p = 0.02). After adjustment, TCF was not associated with an increased risk of uterine rupture (aOR: 2.02; 95% confidence interval [CI]: 0.71-5.78) or uterine scar dehiscence (aOR: 1.32; 95% CI: 0.37-4.72). CONCLUSION: Foley catheter is a safe tool for mechanical dilation in women undergoing IOL after prior cesarean.

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.

Single versus Double-Balloon Transcervical Catheter for Labor Induction: A Systematic Review and Meta-Analysis.

OBJECTIVE: To evaluate for difference in outcomes between single- and double-balloon catheters for labor induction. STUDY DESIGN: We searched CINAHL, Embase, Cochrane Register, MEDLINE, ISI Web of Sciences, LILACs, and Google Scholar and retrieved studies through May 2017. Selection criteria included randomized controlled trials comparing single- versus double-balloon catheters. The primary outcome was time from catheter insertion to delivery. Heterogeneity of the results among studies was tested with the quantity I2 . For I2 values ≥50%, a random effects model was used to pool data across studies. Summary measures were reported as adjusted odds ratios (aORs) or as a mean difference (MD) with 95% confidence interval (CI). RESULTS: Four trials including a total of 682 patients were included: 340 patients were randomized to induction with a single-balloon catheter and 342 to induction with a double-balloon catheter. There was no significant difference between groups with respect to time to delivery (18.8 vs. 19.6 hours; MD: 0.40; 95% CI: -1.56 to 0.76), vaginal delivery rate (65.3 vs. 62.3%; aOR: 1.04; 95% CI: 0.56-1.92), cesarean delivery rate (25.6 vs. 27.5%; aOR: 0.98; 95% CI: 0.55-1.73), or epidural use (58.4 vs. 62%; aOR: 0.81; 95% CI: 0.56-1.18). CONCLUSION: Double-balloon catheters have no apparent advantage over single-balloon catheters for labor induction.

Foley catheter silicone versus latex for term outpatient induction of labour: A randomised trial.

BACKGROUND: Both silicone and latex single-balloon Foley catheters are available for cervical ripening but no literature exists to compare them. Local experience suggested more frequent insertion-related accidental rupture of the membranes (acROM) with silicone. AIMS: To compare the performance of silicone versus latex catheters with respect to acROM and other outcomes. MATERIALS AND METHODS: Women undergoing outpatient Foley catheter cervical ripening were randomised to a silicone or latex catheter. Data were collected on the primary outcome, acROM, and secondary outcomes including catheter insertion failure, unplanned hospital admission and patient-reported discomfort, together with intrapartum fever and antibiotics for suspected chorioamnionitis along with general obstetric and neonatal outcomes. RESULTS: Among 534 recruited women, acROM was significantly more common with a silicone compared to a latex catheter at 7.2% (19/265) versus 1.5% (4/269) (relative risk (RR) 4.8; 95% CI 1.7-14.0). Insertion failure was significantly less common with silicone than latex at 2.6% (7/265) versus 9.3% (25/269) (RR 0.3; 95% CI 0.1-0.6). However, when the alternative catheter was subsequently tried, the final failure rates were 1.9% silicone (5/265) versus 2.6% latex (7/269). Insertion-related hospital admission was higher with silicone at 9.4% (25/265) than latex at 4.8% (13/269) (RR 2.1; 95% CI 1.1-4.1). All other obstetric outcomes were similar between the groups. CONCLUSION: When used for cervical ripening, a silicone Foley catheter is associated with a higher rate of acROM than a latex catheter but a lower rate of insertion failure. It may, therefore, be reasonable to attempt insertion with a latex catheter initially and manage insertion failures with a silicone catheter.