Effect of a mobility-encouragement protocol during induction of labor with an extraamniotic balloon compared with routine care: a randomized controlled trial.

INTRODUCTION: Induction of labor (IOL) with extraamniotic balloon (EAB) catheter is a procedure commonly associated with maternal discomfort, pain, and anxiety. We aimed to investigate the distractive effect of virtual reality (VR) technology on pain and anxiety in pregnant women who undergo IOL with EAB. METHODS: In this randomized controlled trial, pregnant women intended for IOL with EAB at term, were recruited, signed a consent form, and randomized into two groups. The control group received the institutional standard care for EAB insertion, while women in the VR group were exposed to a VR clip during the procedure. Pain scores (expressed by Visual Analog Scale [VAS]) were obtained before, during, and after EAB insertion. Anxiety levels (expressed by validated State-Trait-Anxiety Inventory Scale [STAI-S]) were obtained before and after the procedure. Maternal satisfaction was also recorded. The primary outcome was the VAS score during EAB insertion. RESULTS: Total of 145 women were recruited 1:1 ratio. There were no differences between groups in terms of age, body mass index, gestational age at enrollment, indication for IOL, or preprocedural VAS score and anxiety levels. VAS score during the procedure was significantly lower in the VR group compared to the control group (4.62±2.89 versus 5.95±3.18, P=.04). In addition, the VR group benefited from a higher rate of anxiety relief expressed by the difference between preprocedure and postprocedure STAI score (7.09±10.45 versus 2.84±8.65, P=.039). Women in the VR group reported an overall very high (93%) satisfaction score. CONCLUSION: In this randomized controlled trial, we demonstrated that the use of VR technology in women undergoing IOL with EAB was associated with lower VAS scores during the procedure, with significant anxiety reduction, and a higher satisfaction score, compared to women who received standard care.

To compare perinatal outcomes in pregnancies with fetal growth restriction (FGR) undergoing induction of labor by extra-amniotic balloon (EAB) versus prostaglandin E2 (PGE2 ). A retrospective cohort study of women with singleton pregnancies and FGR, undergoing induction at term via EAB, PGE2 , or both, at a single medical center (2014-2017). Primary outcome was rate of cesarean deliveries (CDs). Secondary outcomes included composite maternal and neonatal outcomes. Overall, 266 women met the inclusion criteria. Among them, 131 (49.2%) underwent induction by PGE2 , 116 (43.6%) by EAB, and 19 (7.14%) by both methods. No differences were noted in baseline characteristics. Rate of CD (17.24% vs. 6.11% vs. 10.53%, P= 0.022) and maternal composite outcome (18.97% vs. 6.11% vs. 10.53%, P< 0.01) were higher among women who underwent induction by EAB compared with PGE2 or both. No difference was noted between groups in neonatal outcomes. In a multivariable logistic regression, rates of cesarean delivery and composite maternal outcome were no longer higher in the EAB group (adjusted odds ratio [aOR] 1.68, 95% confidence interval [CI] 0.68-4.16, P= 0.260; and aOR 1.94, 95% CI 0.84-4.45, P= 0.120, respectively). EAB and PGE2 have comparable maternal and neonatal outcomes when used for induction of labor due to FGR.

The use of virtual reality during extra-amniotic balloon insertion for pain and anxiety relief—a randomized controlled trial

Objective: To determine and compare the safety and efficacy of different methods of induction of labor in twin gestations and their effect on maternal and neonatal outcomes. Methods: A retrospective observational cohort study was conducted at a single university-affiliated medical center. Patients with a twin gestation undergoing induction of labor at >32 + 0 weeks comprised the study group. Outcomes were compared to patients with a twin gestation at >32 + 0 weeks who went into labor spontaneously. The primary outcome was cesarean delivery. Secondary outcomes included operative vaginal delivery, postpartum hemorrhage, uterine rupture, 5 min APGAR < 7, and umbilical artery pH < 7.1. A subgroup analysis comparing outcomes for the induction of labor with oral prostaglandin E1 (PGE1), IV Oxytocin ± artificial rupture of membranes (AROM), and extra-amniotic balloon (EAB)+ IV Oxytocin was performed. Data were analyzed using Fisher’s exact test, ANOVA, and chi-square tests. Results: 268 patients who underwent induction of labor with a twin gestation comprised the study group. 450 patients with a twin gestation who went into labor spontaneously comprised the control group. There were no clinically significant differences between the groups for maternal age, gestational age, neonatal birthweight, birthweight discordancy, and non-vertex second twin. There were significantly more nulliparas in the study group compared to the control group (23.9% vs. 13.8% p < 0.001). The study group was significantly more likely to undergo a cesarean delivery of at least one twin (12.3% vs. 7.5% OR, 1.7 95% CI 1.04–2.85 p = 0.03). However, there was no significant difference in the rate of operative vaginal delivery (15.3% vs. 19.6% OR, 0.74, 95% CI 0.5–1.1 p = 0.16), PPH (5.2% vs. 6.9% OR, 0.75 95% CI 0.39–1.42 p = 0.37), 5-min APGAR scores < 7 (0% vs. 0.2% OR, 0.99 95%CI 0.99–1.00 p = 0.27), umbilical artery pH < 7.1 (1.5% vs. 1.3% OR, 1.12 95% CI 0.3–4.0), or combined adverse outcome (7.8% vs. 8.7% OR, 0.93 95% CI 0.6–1.4 p = 0.85). Furthermore, there were no significant differences in the rates of cesarean delivery or combined adverse outcomes in patients undergoing induction with oral PGE1 compared to IV Oxytocin ± AROM (13.3% vs. 12.5% OR, 1.1 95% CI 0.4–2.0 p = 1.0) (7% vs. 9.3% OR, 0.77 95% CI 0.5–3.5 p = 0.63 ) or EAB+ IV Oxytocin (13.3% vs. 6.9% OR, 2.1 95% CI 0.1–2.1 p = 0.53) (7% vs. 6.9% OR, 1.4 95% CI 0.15–3.5 p = 0.5) or between patients undergoing induction of labor with IV Oxytocin ± AROM and EAB+ IV Oxytocin (12.5% vs. 6.9% OR, 2.1 95% CI 0.1–2.4 p = 0.52) (9.3% vs. 6.9% OR, 0.98 95% CI 0.2–4.7 p = 0.54). There were no cases of uterine rupture in our study. Conclusions: Induction of labor in twin gestations is associated with a two-fold increased risk of cesarean delivery, although this is not associated with adverse maternal or neonatal outcomes. Furthermore, the method of induction of labor used does not affect the chances of success nor the rate of adverse maternal or neonatal outcomes.

To compare pregnancy outcomes following induction of labor with prostaglandins versus extra-amniotic balloon catheter indicated for term isolated oligohydramnios. Retrospective cohort study of all women who underwent induction of labor due to term isolated oligohydramnios at a university affiliated medical center (2007-2016). The cohort was divided into two subgroups, according to induction method: vaginal prostaglandins E2 versus extra-amniotic balloon catheter. Primary outcomes were successful cervical ripening, defined as a Bishop score ≥ 8, and vaginal delivery rate. Secondary outcomes were neonatal adverse events. Five hundred and ten women were included, of whom 454 (89%) underwent induction by prostaglandins and 56 (11%) by extra-amniotic balloon. Cervical ripening success rate was significantly higher in the prostaglandins group (89.4 vs. 76.79%, p = 0.006), as was the rate of vaginal delivery (77.53 vs. 48.21%, p < 0.0001). Induction with prostaglandins remained superior to extra-amniotic balloon in vaginal delivery rate following adjustment to potential confounders (aOR 3.470, 95% CI 1.296-9.296, p < 0.0001). Neonates delivered following induction with extra-amniotic balloon catheter were more often admitted to the neonatal intensive care unit (14.55 vs. 3.39%, p = 0.002). Both prostaglandins and extra-amniotic balloon catheter are reasonable interventions for isolated term oligohydramnios. Prostaglandins were superior to extra-amniotic balloon both in cervical ripening success and in vaginal delivery rates.

Balloon cervical ripening with extra-amniotic infusion of saline or prostaglandin e 2: a double-blind, randomized controlled study

In Brief Objective To compare extra-amniotic infusion of diluted prostaglandin (PG) E2 solution with saline infusion in balloon cervical ripening and labor induction. Methods Women with pregnancy complications and Bishop scores of 3 or lower (n = 116) were assigned randomly to receive extra-amniotic infusion (1 mL/minute) of normal saline or PGE2 in saline (0.5 μg/mL) through a Foley catheter with a 30-mL inflated balloon. We induced labor using intravenous oxytocin only when labor had not developed by 6 hours after balloon expulsion. Analysis was by intent-to-treat. We assessed ripening efficiency and course of labor in women who had spontaneous balloon expulsion (n = 110) and trial of labor (n = 107), respectively. Results Ripening with PGE2 was associated with significantly shorter mean (± standard error of the mean [SEM]) time for balloon expulsion (4.7 ± 0.4 versus 6.5 ± 0.6 hours) and with significantly higher Bishop scores (P < .002), compared with ripening with saline. In the PGE2 group, rates of labor induction (15%) and oxytocin use (37%) were significantly lower than in the saline group (51% and 72%, respectively). The groups did not differ significantly in other labor abnormalities, labor duration, mode of delivery, birth weight, Apgar scores, and puerperal morbidity. Conclusion Cervical ripening by extra-amniotic balloon and PGE2 infusion is faster and more effective than by balloon and saline infusion, resulting in a higher rate of spontaneous labor and a lower rate of oxytocin use. Extra-amniotic prostaglandin E2 infusion is more rapid and effective than saline infusion for balloon cervical ripening, and has a higher rate of spontaneous, unaugmented labor.

Complementary therapy and alternative medicine: effects on induction of labour and pregnancy outcome in low risk post-dates women

966: Perinatal outcomes following induction for suspected intrauterine growth restriction: Extra-amniotic balloon versus prostaglandin E2

INTRODUCTIONThe association of induction of labor with poor maternal satisfaction on analgesia is retrospectively studied in a cohort of parturients delivering with neuraxial analgesia.METHODSSatisfaction on analgesia was measured within 1–2 days postpartum and considered as poor (<8/10), fair to good (8–9/10), or excellent (10/10). The incidence of poor maternal analgesia satisfaction was compared by logistic regression following induced (n=2654) or spontaneous onset (n=5222) labors in parturients who delivered with neuraxial analgesia in Helsinki, Finland area hospitals in 2022. Body mass index (BMI), primiparity, diagnosed fear of childbirth (FOC), other modes of labor analgesia, partogram data, and labor outcome were accounted for as cofactors. The association of cofactors within induced cohort was studied by ordinal regression.RESULTSThe incidence of poor analgesia satisfaction was 24.5% and 19.5% following induction of labor and spontaneous labor, respectively. Adjustment for cofactors (BMI, primiparity, FOC, additional analgesia, cervical dilatation at the time of neuraxial analgesia, intrapartum cesarean delivery) resulted in an AOR for poor satisfaction of 1.19 (95% CI: 1.06–1.34, p<0.001), following induced labor versus spontaneous onset labor. During induced labor, FOC (AOR=1.25; 95% CI: 1.03–1.52), prior opioid labor analgesia (AOR=1.27; 95% CI: 1.09–1.48), cervical dilatation (cm) at the time of neuraxial analgesia (AOR=1.07; 95% CI: 1.02–1.12) and labor resulting in operative vaginal (AOR=1.30; 95% CI: 1.05–1.60) or cesarean delivery (AOR=1.30; 95% CI: 1.06–1.59) were found to be associated with worsening satisfaction, using ordinal regression.CONCLUSIONSInduction of labor is associated with higher risk of poor satisfaction on analgesia, and in particular with neuraxial analgesia. Earlier provision of neuraxial analgesia may help mitigate the risk, particularly when additional risk factors are present.

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

Mechanical induction of labor and ecbolic-less vaginal birth after cesarean section: A cohort study

Six vs 12 hours of Foley catheter balloon placement in the labor induction of multiparas with unfavorable cervixes: a randomized controlled trial

Women with gestational diabetes mellitus (GDM) have higher rates of adverse perinatal outcomes compared with women without GDM, including an increased risk for having labor induced and for cesarean section. The findings from previous studies analyzing duration of labor in women with GDM are contradictory. The aim of the study was to evaluate the impact of GDM on time in spontaneous and induced active labor. This was a population-based cohort study including 247 524 primiparous women who gave birth to a singleton fetus with cephalic presentation, ≥34+0 (completed gestational weeks + additional days) between January 2014 and May 2020 in Sweden. Data was obtained from the Swedish Pregnancy Register. Time in active labor was compared between women with GDM and without GDM with a spontaneous labor onset or induction of labor using Kaplan Meier survival analysis and Cox regression analysis. Women with GDM had significantly longer time in active labor, both with a spontaneous onset and induction of labor compared to women without GDM. Women with GDM had a decreased chance of vaginal delivery at a certain time-point compared to women without GDM, with adjusted hazard ratio of 0.92 (0.88-0.96) and 0.83 (0.76-0.90) for those with spontaneous onset and induction of labor, respectively. Women with GDM had increased risk for time in active labor ≥12 h both in spontaneous labor onset (adjusted odds ratio 1.14 [1.04-1.25]) and in induction of labor (adjusted odds ratio 1.55 [1.28-1.87]). Women with GDM seem to spend a longer time in active labor, both in spontaneous and induced active labor compared to women without GDM. To be able to individualize care intrapartum, there is a need for more studies demonstrating the impact of hyperglycemia during pregnancy on outcomes during childbirth.

Extra-amniotic balloon with PGE 2 versus extra-ovular Foley catheter with PGF 2α in mid-trimester pregnancy termination