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To assess whether outpatient cervical ripening with a synthetic osmotic dilator shortens the length of hospital stay in term pregnancies undergoing labor induction. Pregnant participants scheduled for labor induction at term with unfavorable cervix (less than 3-cm dilated and less than 60% effaced) and not requiring inpatient maternal or fetal monitoring were consented, and synthetic osmotic dilator rods were inserted on the day of scheduled induction. After reassuring fetal heart tracing, patients randomized to the outpatient group were asked to return 12 hours after insertion or sooner if needed. Those randomized to the inpatient group remained in the hospital. After the first round of ripening, additional ripening, oxytocin, and labor management were left up to the clinical health care professionals. The primary outcome was the proportion of participants with hospital stays longer than 48 hours. We estimated that a sample size of 338 would provide 85% power to detect a 30% difference between groups. From November 2018 to November 2021, 339 participants were randomized (171 inpatient, 167 outpatient, one withdrawal). Four patients in the outpatient group were admitted before12 hours for suspected labor and rupture of membranes, and 19 in the inpatient group had the device removed before 12 hours. The proportion of participants with hospital stays longer than 48 hours was lower in the outpatient group compared with the inpatient group (89 [53%] vs 152 [89%], relative risk [RR] 0.60, 95% CI 0.52-0.70). Patients in the outpatient group had a shorter total length of stay and time from admission to active labor. They were more likely to have a vaginal delivery within 24 hours of admission and were less likely to receive analgesics during ripening. Route of delivery and other maternal and neonatal outcomes were not significantly different between groups. Outpatient cervical ripening with a cervical osmotic dilator decreased hospital stay compared with inpatient ripening, without significant adverse outcomes. Medicem Technology s.r.o., Czech Republic. ClinicalTrials.gov, NCT03665688.
43A cost-minimization analysis of intracervical prostaglandin E 2 for cervical ripening in an outpatient versus inpatient setting
A cost-minimization analysis of intracervical prostaglandin E 2 for cervical ripening in an outpatient versus inpatient setting
Read more56A randomised controlled trial of outpatient compared with inpatient cervical ripening with prostaglandin E₂ (OPRA study).
To compare clinical outcomes from outpatient with inpatient cervical prostaglandin E2 ripening for low risk labour induction. Randomised controlled trial. Two tertiary hospitals in Adelaide, Australia. Women with uncomplicated term pregnancies, scheduled for induction of labour for reasons of post-dates or for social reasons. Eight hundred and twenty-seven women were randomised at induction decision to an outpatient or inpatient group. All women had CTG monitoring before and after vaginal PgE2 administration. The inpatient women were admitted and the outpatient group was discharged home overnight with instructions to return if labour established or rupture of membranes occurred. Next morning, outpatient women were admitted for rupture of membranes or further ripening. After membrane rupture, both groups received routine care. Oxytocin use, maternal and fetal outcomes, and whether planned outpatient management was achievable. There were no significant differences in oxytocin use (2.5% difference, CI-4.3 to 9.4), caesarean sections (-0.59% difference, CI-6.3 to 5.1), epidural use (1.5% difference, CI-5.1 to 8.2), vaginal delivery within 24 hours (-8.2% difference, CI-17.6 to 1.3) or labour complications. More than half of the randomised women did not receive the intervention as they laboured spontaneously, or did not require ripening. The post-hoc analysis of women who received ripening also indicated no statistically significant differences in the patterns or results, with the exception of outpatient women having a longer mean length of active labour (mean difference 66 minutes, CI 4-128 minutes). Outpatient women who received ripening were diagnosed more frequently with non-reassuring CTG monitoring and hyperstimulation, with less than half of the women going home and remaining home overnight. This study demonstrated no clinical advantage or disadvantage in prostaglandin E2 outpatient cervical ripening. Uterine stimulation following prostaglandins may preclude a woman from going home or remaining at home overnight and may not be the best agent for outpatient ripening.
Read more2Inpatient versus outpatient transcervical Foley catheter use for cervical ripening: a randomized controlled trial
Inpatient versus outpatient transcervical Foley catheter use for cervical ripening: a randomized controlled trial
6Cervical ripening as an outpatient procedure in the pandemic- minimizing the inpatient days and lowering the socioeconomic costs.
With an increasing incidence of labor induction the socioeconomic costs are increasing and the burden on hospital capacities is rising. In addition, the worldwide SARS-CoV-2 pandemic asks for improvements in patient care during pregnancy and delivery while decreasing the patient-staff contact. Here, we are retrospectively analyzing and comparing a mechanical ripening device that is utilized as an outpatient procedure to misoprostol and dinoprostone as inpatient induction methods in a low risk cohort. This is a retrospective comparative analysis of obstetric data on patients who presented for cervical ripening and labor induction. Ninety-six patients received a mechanical ripening agent as an outpatient procedure. As a control group, we used 99 patients with oral misoprostol (PGE1) and 42 patients with vaginal dinoprostone (PGE2) for cervical ripening in an inpatient setting. Data from 2016 until 2020 were analysed. Baseline characteristics showed no significant differences. Delivery modes were similar in all groups. The time period from patient admission to onset of labor was significantly shorter in the outpatient group (p<0.001): 10.9h/0.5days (±13.6/0.6) for osmotic dilator vs. 17.9h/0.7days (±13.1/0.5) for oral misoprostol vs. 21.8h/0.8days (±15.9/0.7) for vaginal dinoprostone. With 20.4h/0.8days (±14.3/0.6) the osmotic dilator group displayed significantly the shortest inpatient stay from admission to delivery (p=0.027). The patient subgroup of misoprostol had 25.7h/1.1days (±14.9/0.6) of inpatient stay from admission to delivery and the patient group of dinoprostone 27.5h/1.1days (±16.0/0.7). There were fewer hospital days in the outpatient group: 84.9h/3.5days vs. 88.9h/3.7days vs. 93.6h/3.9days (outpatient osmotic dilator vs. inpatient misoprostol and dinoprostone, respectively). New approaches are required to decrease individual contacts between patients and staff while maintaining a high quality patient care in obstetrics. This analysis reveals that outpatient mechanical cervical ripening can be as safe and effective as inpatient cervical ripening with PGE1/PGE2, while lowering patient-staff contact and total hospital stays and therefore decreasing the socioeconomic costs.
Read moreOutpatient Hematopoietic Stem Cell Transplant for Adult Sickle Cell Disease Patients Is Safe, Reduce Inpatient Bed Utilization and Improve Access to Care
Outpatient Hematopoietic Stem Cell Transplant for Adult Sickle Cell Disease Patients Is Safe, Reduce Inpatient Bed Utilization and Improve Access to Care
Read moreReported Experience With Intracervical Ripening Bulb for Outpatient Induction of Labor at Term [18I
INTRODUCTION: Outpatient cervical ripening using an intracervical balloon catheter offers promise for outpatient preinduction of labor. Published studies are limited by small sample sizes. METHODS: We searched Medline, Web of Science™, Cochrane database, and clinicaltrials.gov for meta-analysis of studies evaluating outpatient cervical ripening with intracervical balloon catheters. We included randomized, controlled trials comparing outpatient intracervical balloon versus inpatient cervical ripening. Outcomes of interest were time spent hospitalized before delivery, total induction time, cesarean delivery rate, need for oxytocin, and 5-minute APGAR score. Our search yielded three studies for inclusion. All three were performed at different institutions and met the following criteria: gestational age 37 weeks or more and suitable for outpatient cervical ripening, initial Bishop score less than 7, no intrauterine growth restriction, intact membranes, and reassuring initial fetal heart rate tracing. All groups were analyzed in an intention-to-treat fashion. RESULTS: The three studies totaled 260 women who were randomized into outpatient (n=144) and inpatient (n=116) groups. Maternal age, parity, and gestational age did not differ between groups. The total induction time, mean total time on oxytocin, rate of epidural use, 5-minute APGAR scores, rate of delivery within 24 hours of induction, and rate of post-partum hemorrhage did not differ between groups. The outpatient group spent an average of 8.6 fewer hours in the hospital before delivery (P=.001) but were more likely to require oxytocin (OR 2.74, P=.032). CONCLUSION: Outpatient cervical ripening with an inflatable bulb catheter appears to be acceptable in a low-risk, term population with an unfavorable cervix.
Read moreColorectal Post-polypectomy Bleeding in Outpatient versus Inpatient Treatment: Propensity Score Matching Analysis
Delayed bleeding is the most frequent adverse event associated with endoscopic mucosal resection (EMR) and hot snare polypectomy (HSP) of colorectal polyps. However, whether the incidence of delayed bleeding differs between outpatient and inpatient treatment is unknown. Therefore, in this study, we aimed to evaluate delayed bleeding rates between outpatient and inpatient endoscopic treatments and clarify the safety of outpatient treatment. We enrolled 469 patients (1077 polyps) and 420 patients (1080 polyps) in the outpatient and inpatient groups, respectively, who underwent EMR or HSP for colorectal polyps at our institution between April 2020 and May 2023. Using propensity score matching, we evaluated the delayed bleeding rates between the two groups. Delayed bleeding was defined as a hemorrhage requiring endoscopic hemostasis occurring within 14 days of the procedure. Propensity score matching created 376 (954 polyps) matched patient pairs. The median maximum diameter of polyps removed was 10 mm in both groups. Delayed bleeding rates per patients were 1.3% (5/376) in the outpatient group and 2.9% (11/376) in the inpatient group (P=0.21). In term of per polyp, early delayed bleeding (occurring within 24 hours) rates were higher in the inpatient group than outpatient group (0.2% [2/954] vs. 1.1% [10/954], respectively; P=0.04). No severe bleeding requiring a transfusion occurred in either group. Outpatient endoscopic treatment did not increase delayed bleeding compared with inpatient treatment. Outpatient treatment would be safe and common for the removal of colorectal polyps.
Read more6Synthetic 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 10mg PGE 2 vaginal insert and orally applied misoprostol (25µg 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.
Read more3Feasibility of day-case pediatric cochlear implantation.
Pediatric cochlear implantation is performed on an outpatient basis in an inconstant way. The aim of this study is to assess the feasibility of day-case pediatric cochlear implantation by determining the acceptability of outpatient-to-inpatient conversion rate (acceptability threshold of 5%) and to assess the safetyby comparing outpatient and inpatient postoperative events. We also want to identify conversion predictive factors. We conducted a monocentric retrospective study including 267 cases aged 6months to 18years who underwent unilateral cochlear implantation between 2016 and 2020. This population was divided into two groups: outpatient group (190 cases) and inpatient group (77 cases). Among the 190 cases scheduled as day surgery, 9 cases required conversion to conventional hospitalization which leads to an outpatient-to-inpatient conversion rate of 4.7%. Postoperative nausea and vomiting (PONV) were involved in all cases of conversion. Conversion predictive factors were the presence of an inner ear malformation at risk of gusher (OR 32.51, 95% CI [4.98-370.27], p 0.001) and the intraoperative administration of morphine (OR 8.52, 95% CI [1.38-86.84], p 0.035). There was no statistically significant difference in immediate postoperative complications (outpatient 14.2% vs inpatient 16.9% p 0.715), early-stage complications (outpatient 12.6% vs inpatient 10.4% p 0.812) and early-stage unplanned consultations (outpatient 4.7% vs inpatient 3.9% p 0.748) between outpatient and inpatient groups. Unplanned readmissions were found only in the outpatient group. Day-case pediatric cochlear implantation is a feasible and safe procedure even in infants. The outpatient-to-inpatient conversion rate of 4.7% is considered acceptable but requires anticipation of human and accommodation needs. No causes of conversion were life-threatening. The risk of postoperative complications and unplanned consultations are not influenced by the mode of hospitalization. Special attention should be paid to the prevention of PONV and the presence of inner ear malformations.
Read more133 Association between simplified bishop score after cervical ripening and delivery outcome
133 Association between simplified bishop score after cervical ripening and delivery outcome
5Outpatient elective induction of labour at 39 weeks’ gestation (HOME INDUCTION): an open-label, randomised, controlled, phase III, non-inferiority trial
Outpatient elective induction of labour at 39 weeks’ gestation (HOME INDUCTION): an open-label, randomised, controlled, phase III, non-inferiority trial
Read more30Placement of lumen-apposing metal stents to drain pseudocysts and walled-off pancreatic necrosis can be safely performed on an outpatient basis: A multicenter study
Backgrounds and Objectives:No study on the use of lumen-apposing fully covered self-expanding metal stent (LAMS) to drain pancreatic fluid collections (PFCs) has evaluated outcomes of patients in the outpatient setting. The objective of this multicenter study was to evaluate the clinical outcomes, success rate, and adverse events of the LAMS for endoscopic ultrasound (EUS)-guided transmural drainage of patients with symptomatic PFCs on an inpatient versus an outpatient basis.Methods:This was a multicenter, retrospective study conducted at 4 tertiary care centers.Results:We identified eighty patients with PFCs in whom EUS-guided transmural drainage using the LAMS was performed. The mean age of the patients was 53.1 years old. Mean size of the PFC was 11.8 ± 5.1 cm. A total of 33 patients had PFCs drained in an outpatient setting while 47 patients underwent PFC drainage as inpatients. The overall technical success (ability to access and drain a PFC by placement of transmural stents) was 98.7% (79 patients). There was no statistically significant difference in the technical success rate between the inpatient and outpatient groups (100% vs. 98%, respectively, P = 1). There was no significant difference in resolution of PFCs in the inpatient and outpatient groups (91% vs. 87% respectively; P = 1). The number of procedures required for PFC resolution was significantly lower in the inpatient group as compared to the outpatients (2.3 vs. 3.1 respectively, P = 0.025). Procedure-related adverse events were significantly lower in the inpatient group compared to the outpatient group (P < 0.01). There was no significant difference in the 2 groups in terms of development of adverse events requiring endoscopic reintervention within 30 days of initial stent placement (P = 0.69).Conclusion:This study shows that LAMS placement for PFCs can be performed safely on an outpatient basis with overall technical and clinical outcomes that are comparable to those seen in inpatients.
Read moreA Comparative Study on the Effects of Vaginal Misoprostol and Vaginal Misoprostol Plus Estradiol on Labor Induction
Background: Cervical ripening is an important factor in predicting successful labor induction. In an unfavorable cervix, ripening should be done before induction. In this study, the effect of misoprostol and that of misoprostol plus estradiol on cervical ripening were compared. Methods: This randomized, double-blinded study included a total of 190 pregnant women who were identified for pregnancy termination due to maternal or fetal cause at 37 weeks with Bishop score of less than 4. The patients were assessed between April 2015 to April 2016 in two university hospitals at northeast Iran (Omol-Banin Hospital and Emam Reza Hospital, Mashhad). The patients who met the inclusion criteria were randomly assigned to two groups: the intervention group (Group A), who received 25 micrograms of vaginal misoprostol plus 50 micrograms of estradiol, and the control group (Group B), who received 25 micrograms of vaginal misoprostol only. Misoprostol was administered at 4-hour intervals until cervical ripening (Bishop score ? 8) or upon initiation of active phase in both the groups. The maximum dosage of misoprostol was three doses, whereas estradiol was administered only once. Results: In this study, the main causes of pregnancy termination were ROM and post-term. There was no significant statistical difference in the Bishop score between the two groups (P = 0.13). In addition, no significant difference was observed in the duration of time for cervical ripening (Bishop ? 8) between the two groups (P = 0.7). The duration between drug administration to the initiation of active phase and also from active phase to delivery showed no significant differences between the two groups (P = 0.49 and 0.24, respectively). There was also no significant difference in the delivery route (operative vaginal delivery or Cesarean section) (P = 0.2 and P = 0.91, respectively). Conclusion: From this study, the use of misoprostol plus estradiol did not improve cervical ripening or decrease the induction time. Further studies are recommended to investigate complementary results.
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9Double Balloon Catheter (Plus Oxytocin) versus Dinoprostone Vaginal Insert for Term Rupture of Membranes: A Randomized Controlled Trial (RUBAPRO)
Background: The aim of this study is to demonstrate that a double balloon catheter combined with oxytocin decreases time between induction of labor and delivery (TID) as compared to a vaginal dinoprostone insert in cases of premature rupture of membranes at term. Methods: This is a prospective, randomized, controlled trial including patient undergoing labor induction for PROM at term with an unfavorable cervix in Clermont-Ferrand university hospital. We compared the double balloon catheter over a period of 12 h with adjunction of oxytocin 6 h after catheter insertion versus dinoprostone vaginal insert. After device ablation, cervical ripening continued only with oxytocin. The main outcome was TID. Secondary outcomes concerned delivery mode, as well as maternal and fetal outcome, and were adjusted for parity. Results: 40 patients per group were randomized. Each group had similar baseline characteristics. The study failed to demonstrate reduced TID (16.2 versus 20.2 h, ES = 0.16 (−0.27 to 0.60), p = 0.12) in the catheter group versus dinoprostone except in nulliparous women (17.0 versus 26.5 h, ES = 0.62 (0.10 to 1.14), p = 0.006). The rate of vaginal delivery <24 h significantly increased with combined induction (88.5% versus 66.6%, p = 0.03). No statistical difference was observed concerning caesarean rate (12.5% versus 17.5%, p > 0.05), chorioamnionitis (0% versus 2.5%, p = 1), postpartum endometritis, or maternal or neonatal outcomes. Procedure-related pain and tolerance to devices were found to be similar for the two methods. Interpretation: The double balloon catheter combined with oxytocin is an alternative for cervical ripening in case of PROM at term, and may reduce TID in nulliparous women.
Read more2Predictive Factors for Successful Cervical Ripening among Women with Gestational Diabetes Mellitus at Term: A Prospective Study.
The purpose of this prospective cohort study is to identify the predictive factors for vaginal delivery among women (n = 146) who underwent cervical ripening using a dinoprostone insert (PG) alone (13.7%), cervical ripening balloon (CRB) alone (52.7%), oral misoprostol (M) alone (4.1%), or repeated methods (R, 29.5%) for gestational diabetes mellitus (GDM) at term, and to analyze maternal and neonatal morbidity outcomes according to the method for cervical ripening. After cervical ripening, vaginal delivery occurred in 84.2% (n = 123) and was similar among groups (90.0% after PG, 83.1% after CRB, 83.3% after M, and 83.7% after R; p = 0.89). After a multivariable logistic regression analysis adjusted for potential confounders, the internal cervical os being open before cervical ripening was a predictor of vaginal delivery (adjusted odds ratio (OR) of 4.38, 95% confidence index (CI) of 1.62-13.3, p = 0.03), and previous cesarean delivery was a predictor of cesarean delivery (aOR of 7.67, 95% CI of 2.49-24.00, p < 0.01). Birthweight was also significantly associated with cesarean delivery (aOR of 1.15, 95% CI of 1.03-1.31, p = 0.02). The rates of maternal and neonatal morbidity outcomes were 10.9% (n = 16) and 19.9% (n = 29), respectively, and did not differ according to the mode of delivery and to the method used for cervical ripening. Identifying these specific high-risk women (previous cesarean delivery and internal cervical os being closed before cervical ripening) for cesarean delivery among women who underwent cervical ripening for GDM at term is important and practical for all physicians to make a decision in partnership with women.
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