BACKGROUND: Induction of labor with mechanical methods or pharmacological agents is used in about 20-30% of all pregnant women. We specialized in comparing the effectiveness and safety of dinoprostone versus transcervical Foley catheter for induction of labor in term pregnant women with an unfavorable cervix with adequate samples.
OBJECTIVE: To compare the effectiveness and safety of dinoprostone versus transcervical Foley catheter for induction of labor in term pregnant women with an unfavorable cervix.
METHODS: This is a parallel, open-label randomized controlled trial in two maternal centers in Shanghai, China between October 2019 and July 2022. Women with a singleton pregnancy in cephalic presentation at term and an unfavorable cervix (Bishop score < 6) scheduled for induction of labor were eligible. 1,860 women were randomly allocated to cervical ripening with either a dinoprostone vaginal insert (10mg) or a 60cc Foley catheter for up to 24 hours. The primary outcomes were vaginal delivery rate and time to vaginal delivery. Secondary outcomes included time to delivery and maternal and neonatal morbidity. Analysis was done from an intention-to-treat perspective. The trial was registered with the China trial registry (CTR2000038435).
RESULTS: The vaginal birth rates were 72.8% (677/930) vs. 69.9% (650/930) in vaginal dinoprostone and Foley catheter, respectively (aRR 1.04, 95% CI 0.98 to 1.10, risk difference: 0.03). Time to vaginal delivery was not significantly different between the two groups (sub-distribution hazard ratio 1.11, 95% CI 0.99-1.24). Vaginal dinoprostone was more likely complicated with hyperstimulation with fetal heart rate changes (5.8% vs. 2.8%, aRR 2.09, 95% CI 1.32-3.31) and placenta abruption (0.9% vs. 0.1%, aRR: 8.04, 95% CI 1.01-64.15), while Foley catheter was more likely complicated with suspected intrapartum infection (5.1% vs. 8.2 %, aRR: 0.62, 95% CI 0.44-0.88) and postpartum infection (1.4% vs. 3.7%, aRR: 0.38, 95% CI 0.20-0.72). The composite of poor neonatal outcomes was not significantly different between the two groups (4.5% vs. 3.8%, aRR 1.21, 95% CI 0.78 to 1.88), while more neonatal asphyxia occurred in the dinoprostone group (1.2% vs. 0.2%, aRR 5.39, 95% CI 1.22 to 23.92). In a subgroup analysis, vaginal dinoprostone decreased vaginal birth rate slightly in multiparous women (90.6% vs. 97.0%, aRR 0.93, 95% CI 0.88 to 0.99).
CONCLUSIONS: In term pregnant women with an unfavorable cervix, induction of labor with vaginal dinoprostone or Foley catheter has similar effectiveness. Foley catheter leads to better safety for neonates, while it may result in a higher risk of maternal infection. Furthermore, Foley catheter should be preferred in multiparous women.

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Background: Induction of labor (IOL) in nulliparas with premature rupture of membranes (PROM) and an unfavorable cervix at term poses challenges. Our study sought to investigate the impact of prostaglandin E2 (PGE2) compared to oxytocin on the duration of IOL in this specific group of parturients. Methods: This was retrospective matched-case study. All nulliparas with term PROM who underwent induction between January 2006 to April 2023 at Shaare Zedek Medical Center were identified. Cases induced by either PGE2 or oxytocin were matched by the following criteria: (1) time from PROM to IOL; (2) modified Bishop score prior to IOL ≤ 5; (3) newborn birthweight; and (4) vertex position. The primary outcome was time from IOL to delivery. Results: Ninety-five matched cases were identified. All had a modified Bishop score ≤ 5. Maternal age (26 ± 4.7 years old, p = 0.203) and gestational age at delivery (38.6 ± 0.6, p = 0.701) were similar between the groups. Matched factors including time from PROM to IOL (23.5 ± 19.2 versus 24.3 ± 21.4 p = 0.780), birth weight of the newborn (3111 g versus 3101 g, p = 0.842), and occiput anterior position (present on 98% in both groups p = 0.687) were similar. Time from IOL to delivery was significantly shorter by 3 h and 36 min in the group induced with oxytocin than in the group induced with PGE2 (p = 0.025). Within 24 h, 55 (58%) of those induced with PGE2 delivered, compared to 72 (76%) of those induced with oxytocin, (p = 0.033). The cesarean delivery rates [18 (19%) versus 17 (18%)], blood transfusion rates [2 (2%) versus 3 (3%)], and Apgar scores (8.8 versus 8.9) were similar between the groups (PGE2 versus oxytocin, respectively), p ≥ 0.387. Conclusions: Induction with oxytocin, among nulliparas with term PROM and an unfavorable cervix, was associated with a shorter time from IOL to delivery and a higher rate of vaginal delivery within 24 h, with no difference in short-term maternal or neonatal adverse outcomes.

BACKGROUND: Previous studies had found that the mechanical methods were as effective as pharmacological methods in achieving vaginal delivery. However, whether balloon catheter induction is suitable for women with severe cervical immaturity and whether it will increase the related risks still need to be further explored.
OBJECTIVE: To evaluate the efficacy and safety of Foley catheter balloon for labor induction at term in primiparas with different cervical scores.
METHODS: A total of 688 primiparas who received cervical ripening with a Foley catheter balloon were recruited in this study. They were divided into 2 groups: Group 1 (Bishop score ≤ 3) and Group 2 (3 < Bishop score < 7). Detailed medical data before and after using of balloon were faithfully recorded.
RESULTS: The cervical Bishop scores of the two groups after catheter placement were all significantly higher than those before (Group 1: 5.49 ± 1.31 VS 2.83 ± 0.39, P<0.05; Group 2: 6.09 ± 1.00 VS 4.45 ± 0.59, P<0.05). The success rate of labor induction in group 2 was higher than that in group 1 (P<0.05). The incidence of intrauterine infection in Group 1 was higher than that in Group 2 (18.3% VS 11.3%, P<0.05).
CONCLUSIONS: The success rates of induction of labor by Foley catheter balloon were different in primiparas with different cervical conditions, the failure rate of induction of labor and the incidence of intrauterine infection were higher in primiparas with severe cervical immaturity.

OBJECTIVE: If a small for gestational age (SGA) foetus needs to be delivered because of severity (<3rd centile) attempting induction of labor theoretically increases the risk of caesarean section and neonatal acidosis, but these risks are poorly understood. This article aims to assess the risk of caesarean section and neonatal acidosis in attempted vaginal birth of a moderately preterm foetus in the setting of severe SGA.
METHODS: A single-centre hospital-based observational study conducted over a period of 17 consecutive years in mothers with a single foetus in cephalic presentation with severe SGA (<3rd centile) needing foetal extraction. Neonatal acidosis was considered moderate if pH<7.10 and severe if pH<7.0. The degree of severity of SGA was estimated according to the birth weight ratio.
RESULTS: Four hundred and thirty-four foetuses with severe SGA were included during the period, 140 of whom were born after induction (32.3%). In this group, 66.4% of women achieved a vaginal birth (66.4%; 95% CI [58.0-74.2]) and the risk of moderate or severe acidosis was doubled compared with the group of foetuses who had undergone a planned caesarean section (7.9% vs. 3.1%, OR=2.7 [1.1-6.7]). Neither gestational age nor the degree of growth restriction was significantly related to the risk of caesarean section or to the risk of moderate or severe neonatal acidosis.
CONCLUSIONS: In cases of severe SGA before 37weeks\' gestation, induction of labour allows vaginal delivery in two-thirds of cases. It is accompanied by a doubling of the risk of moderate or severe neonatal acidosis.

BACKGROUND: The prevalence and risk factors of posttraumatic stress disorder after cesarean delivery, outside high-risk contexts, remain unclear.
OBJECTIVE: This study aimed to assess posttraumatic stress disorder prevalence and risk factors at 2 months postpartum among a general population of women with cesarean delivery.
METHODS: This was a prospective ancillary cohort study of the Tranexamic Acid for Preventing Postpartum Hemorrhage after Cesarean Delivery (TRAAP2) trial, conducted in 27 French hospitals from 2018 to 2020, enrolling women expected to undergo cesarean delivery before or during labor at ≥34 weeks of gestation. After randomization, characteristics of the cesarean delivery and postpartum blood loss were prospectively collected. Two months after childbirth, posttraumatic stress disorder profile (presence of posttraumatic stress disorder symptoms) and provisional diagnosis (positive screening for diagnosis consistent with a posttraumatic stress disorder) were assessed by 2 self-administered questionnaires (Impact of Event Scale - Revised and Traumatic Event Scale). The corrected posttraumatic stress disorder prevalence was estimated with inverse probability weighting to take nonresponse into account. Associations between potential risk factors and posttraumatic stress disorder were analyzed by multivariate logistic or linear regression modeling according to the type of dependent variable.
RESULTS: In total, 2785 of 4431 women returned the Impact of Event Scale - Revised questionnaire and 2792 the Traumatic Event Scale (response rates of 62.9% and 63.0%). The prevalence of posttraumatic stress disorder profile was 9.0% (95% confidence interval, 7.8%-10.3%) and of provisional diagnosis 1.7% (95% confidence interval, 1.2%-2.4%). Characteristics associated with a higher risk of posttraumatic stress disorder profile were prepregnancy vulnerability factors (young age, high body mass index, and African-born migrant) and cesarean delivery-related obstetrical factors (cesarean delivery after induced labor [adjusted odds ratio, 1.81; 95% confidence interval, 1.14-2.87], postpartum hemorrhage [adjusted odds ratio, 1.61; 95% confidence interval, 1.04-2.46] and high-intensity pain during the postpartum stay [adjusted odds ratio, 1.90; 95% confidence interval, 1.17-3.11]). Women who had immediate skin-to-skin contact with their newborn were at lower risk of posttraumatic stress disorder (adjusted odds ratio, 0.66; 95% confidence interval, 0.46-0.98), and women with bad memories of delivery on day 2 postpartum were at higher risk (adjusted odds ratio, 3.20; 95% confidence interval, 1.97-5.12). The Impact of Event Scale - Revised and the Traumatic Event Scale yielded consistent results.
CONCLUSIONS: Approximately 1 in 11 women with cesarean deliveries had posttraumatic stress disorder symptoms at 2 months postpartum. Some obstetrical interventions and components of cesarean delivery management may influence this risk.

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.
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.
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.
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.
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.

OBJECTIVE: Large-for-gestational-age (LGA) is associated with several adverse maternal and neonatal outcomes. Although many studies have found that early induction of labor (eIOL) in LGA reduces the incidence of shoulder dystocia (SD), no current guidelines recommend this particular strategy, due to concerns about increased rates of cesarean delivery (CD) and neonatal complications. The purpose of this study was to assess whether the timing of IOL in LGA fetuses affects maternal and neonatal outcomes in a single center; and to combine these results with the evidence reported in the literature.
METHODS: This study comprised two parts. The first was a retrospective cohort study that included: consecutive patients with singleton pregnancy, an estimated fetal weight (EFW) ≥90th percentile on ultrasound (US) between 35+0 and 39+0 weeks of gestation (WG), who were eligible for normal vaginal delivery. The second part was a systematic review of literature and meta-analysis that included the results of the first part as well as all previously reported studies that have compared IOL to expectant management in patients with LGA. The perinatal outcomes were CD, operative vaginal delivery (OVD), SD, brachial plexus palsy, anal sphincter injury, postpartum hemorrhage (PPH), APGAR score, umbilical arterial pH, neonatal intensive care unit (NICU) admission, use of continuous positive airway pressure (CPAP), intracranial hemorrhage (ICH), phototherapy, and bone fracture.
RESULTS: Retrospective cohort: of the 547 patients, 329 (60.1%) were induced and 218 (39.9%) entered spontaneous labor. Following covariate balancing, CD was significantly higher in the IOL group in comparison to the spontaneous labor group. This difference only became apparent beyond 40WG (hazard ratio: 1.9, p=0.030). The difference between both groups for shoulder dystocia was not statistically significant. Systematic review and metanalysis: 17 studies were included in addition to our own results giving a total sample size of 111,300 participants. When IOL was performed <40+0WG, the risk for SD was significantly lower in the IOL group (OR: 0.64, 95%CI: 0.42-0.98, I2 =19%). There was no significant difference in CD rate between IOL and expectant management after pooling the results of these 17 studies. However, when removing the studies in which IOL was done exclusively before 40+0WG, the risk for CD in the remaining studies (IOL not exclusively <40+0WG) was significantly higher in the IOL group (odds ratio [OR]: 1.46, 95% confidence interval [95%CI]: 1.02-2.09, I2 =56%). There were no statistically significant differences between IOL and expectant management for the remaining perinatal outcomes. Nulliparity, history of CD, and low Bishop score but not methods of induction were independent risk factors for intrapartum CD in patients who were induced for LGA.
CONCLUSIONS: Timing of IOL in patients with suspected macrosomia significantly impacts perinatal adverse outcomes. IOL has no impact on rates of SD but does increase CD when considered irrespective of gestational age, but it may decrease the risk of SD without increasing the risk of other adverse maternal outcomes, in particular cesarean section when performed before 40+0 WG. (GRADE: Low/Very low). This article is protected by copyright. All rights reserved.

The decision to pursue a trial of labor after cesarean delivery is complex and depends on patient preference, the likelihood of successful vaginal birth after cesarean delivery, assessment of the risks vs benefits of trial of labor after cesarean delivery, and available resources to support safe trial of labor after cesarean delivery at the planned birthing center. The most feared complication of trial of labor after cesarean delivery is uterine rupture, which can have catastrophic consequences, including substantial maternal and perinatal morbidity and mortality. Although the absolute risk of uterine rupture is low, several clinical, historical, obstetrical, and intrapartum factors have been associated with increased risk. It is therefore critical for clinicians managing patients during trial of labor after cesarean delivery to be aware of these risk factors to appropriately select candidates for trial of labor after cesarean delivery and maximize the safety and benefits while minimizing the risks. Caution is advised when considering labor augmentation and induction in patients with a previous cesarean delivery. With established hospital safety protocols that dictate close maternal and fetal monitoring, avoidance of prostaglandins, and careful titration of oxytocin infusion when induction agents are needed, spontaneous and induced trial of labor after cesarean delivery are safe and should be offered to most patients with 1 previous low transverse, low vertical, or unknown uterine incision after appropriate evaluation, counseling, planning, and shared decision-making. Future research should focus on clarifying true risk factors and identifying the optimal approach to intrapartum and induction management, tools for antenatal prediction, and strategies for prevention of uterine rupture during trial of labor after cesarean delivery. A better understanding will facilitate patient counseling, support efforts to improve trial of labor after cesarean delivery and vaginal birth after cesarean delivery rates, and reduce the morbidity and mortality associated with uterine rupture during trial of labor after cesarean delivery.

OBJECTIVE: Cervical ripening is commonly performed before oxytocin administration during labor induction in pregnant women with an unfavorable cervix. In Japan, a controlled-release Dinoprostone vaginal insert (CR-DVI) was approved in 2020. Although many studies have compared the mechanical methods of ripening and prostaglandins, few have examined the impact of additional options for labor induction. This study aimed to assess the impact of CR-DVI as an additional option for labor induction in women with an unfavorable cervix.
METHODS: In this single-center retrospective study conducted in Japan, 265 participants were divided into two groups: before (January 2018 to May 2020) and after (June 2020 to November 2022) CR-DVI introduction. Before CR-DVI was introduced, hygroscopic dilators were used for all cases instead. On the other hand, after the introduction of CR-DVI, the first choice for cervical ripening was CR-DVI. The CR-DVI was retained vaginally for up to 12 hours after insertion. However, if hyper-stimulation or non-reassuring fetal status was suspected, or if a new membrane rupture occurred, it was removed immediately according to the removal criteria. Oxytocin infusions were used during both periods if needed. We compared delivery and neonatal outcomes between the groups.
RESULTS: The 265 participants were divided into two groups: before (n=116) and after (n=149) CR-DVI introduction. There were no significant differences in maternal characteristics except for the primiparous proportion. CR-DVI was used in 93% of cases after introduction. Hygroscopic dilators also continued to be used; however, their use decreased to about 34%. The vaginal delivery rate was significantly higher after the introduction of CR-DVI than before its introduction (50.9% vs. 66.4%; p=0.01). Multivariable analysis revealed a significantly higher rate of vaginal delivery after CR-DVI introduction. Of the 149 cases in which a CR-DVI was used, 111 (79.9%) were removed before 12 hours. There were no significant differences in neonatal outcomes.
CONCLUSIONS: The rate of vaginal delivery was higher after CR-DVI introduction than before its introduction, and adverse pregnancy outcomes did not increase. Therefore, introducing CR-DVI as an option for labor induction may increase the probability of vaginal delivery. Safety can also be ensured by adhering to the removal criteria.