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Introduction: Our objective was to compare the performance of the first vaginal examination at 8 vs 4 h after amniotomy following Foley ripening in nulliparous labor induction. Material and Methods: A randomized controlled trial was conducted from June 2021 to January 2022. 210 nulliparas at term for labor induction were randomized: 105 each to first vaginal examination at 8 or 4 h after Foley balloon ripening and amniotomy. Titrated oxytocin infusion was routinely commenced after amniotomy to expedite labor. Primary outcomes were the amniotomy‐to‐delivery interval (non‐inferiority hypothesis) and maternal satisfaction with their allocated labor care (superiority hypothesis) within 24 h after delivery. Analyses performed using t‐test, Mann–Whitney U test, and Chi‐squared test as appropriate. Results: The amniotomy‐to‐delivery interval was mean ± standard deviation 8.7 ± 3.4 vs 8.4 ± 3.7, mean difference 0.4 (97.5% CI: −0.7 to 1.5) hours, p = 0.442 within the pre‐specified 2‐hour non‐inferiority margin, and maternal satisfaction score with allocated labor care was median [interquartile range] 8[7.5–10] vs 8[7.0–10], p = 0.248 for 8 vs 4 h arms, respectively. The amniotomy to first vaginal examination intervals was 5.9 ± 2.3 vs 3.6 ± 1.0 h, p < 0.001, and the number of vaginal examinations was 2[1–2.5] vs 3 [2, 3], p < 0.001 for 8 vs 4 h, respectively. The first vaginal examination was less likely to have been performed as scheduled, more likely to be indicated by the urge to bear down, and non‐reassuring cardiotocography for the 8 h arm (p < 0.001). Spontaneous vaginal delivery was significantly more likely and instrumental vaginal delivery less likely, but cesarean rate was not significantly different for the 8 h arm (p = 0.017). Conclusions: A routine first vaginal examination at 8 h compared to 4 h is non‐inferior for the time to birth but does not increase maternal satisfaction although the number of vaginal examinations is fewer. The increase in spontaneous vaginal delivery and reduction in instrumental vaginal delivery rates warrant further powered primary evaluation. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate expectant compared to immediate return to hospital upon outpatient Foley catheter expulsion predicated on maternal satisfaction and amniotomy‐titrated oxytocin infusion to delivery interval. Methods: This randomized trial was conducted in a tertiary university hospital in Malaysia from September 2020 to February 2022. A total of 330 nulliparous women at term with unripe cervices (Bishop score ≤5), singleton viable fetus in cephalic presentation, reassuring preinduction fetal heart rate tracing and intact membranes who underwent planned outpatient Foley catheter induction of labor (IOL) were included. Women were randomized to expectant or immediate return to hospital if the Foley was spontaneously expelled at home before their scheduled hospital admission the following day. Primary outcomes were amniotomy‐titrated oxytocin infusion to delivery interval and maternal satisfaction on the induction process (assessed by 0–10 visual numerical rating scale [VNRS]). Results: Amniotomy‐titrated oxytocin infusion to delivery interval was 8.7 ± 4.1 versus 8.9 ± 3.9 h, P = 0.605 (mean difference − 0.228 95% CI: −1.1 to +0.6 h) and maternal satisfaction VNRS score was median (interquartile range) 8 (7–9) versus 8 (7–9), P = 0.782. Early return to hospital rates were 37/165 (22.4%) versus 72/165 (43.6%), RR 0.51 (95% CI: 0.37–0.72), P ≤ 0.001, Cesarean delivery rates were 80/165 (48.5%) versus 80/165 (48.5%), RR 1.00 (95% CI: 0.80–1.25), P = 1.00 and duration of hospital stay was 54.4 ± 22.9 versus 56.7 ± 22.8 h, P = 0.364 for the expectant versus immediate return groups respectively. Conclusion: In outpatient Foley catheter IOL, expectant compared to immediate return to hospital following Foley dislodgement results in similarly high maternal satisfaction. The amniotomy‐titrated oxytocin to delivery duration is non‐inferior with expectant management. Synopsis: Expectant or immediate return to hospital after Foley expulsion in nulliparas outpatient labor induction shows good acceptability and comparable outcomes. [ABSTRACT FROM AUTHOR]

Objective: To evaluate immediate oxytocin and early amniotomy compared with delayed amniotomy after Foley catheter cervical ripening in nulliparous women on intervention‐to‐delivery interval. Methods: A randomized trial was conducted from September 2020 to March 2021. A total of 140 term nulliparas (70 early amniotomy, 70 delayed amniotomy) with Foley catheter–ripened cervices (dilatation ≥3 cm achieved), singleton fetus, cephalic presentation with intact membranes, and reassuring fetal heart rate tracing were recruited. Women were randomized to immediate titrated intravenous oxytocin infusion and early amniotomy or delayed amniotomy (after 4 h of oxytocin). The primary outcome was intervention (oxytocin)‐to‐delivery interval (h). Results: Intervention‐to‐delivery intervals (h) were mean ± standard deviation 9.0 ± 3.6 versus 10.6 ± 3.5 h (mean difference of 1.4 h) (P = 0.004) for the early versus delayed amniotomy arms, respectively. Birth rates at 6 h after oxytocin infusion were 19 of 70 (27.1%) versus 8 of 70 (11.4%) (relative risk, 2.38 [95% confidence interval (CI), 1.11–5.06]; number needed to treat: 7 [95% CI, 3.5–34.4]) (P = 0.03), cesarean delivery rates were 29 of 70 (41.4%) versus 33 of 70 (47.1%) (relative risk, 0.88; 95% CI, 0.61–1.28) (P = 0.50), and maternal satisfaction on birth process were a median of 7 (interquartile range, 7–8) versus 7 (interquartile range, 7–8) (P = 0.40) for the early versus delayed amniotomy arms, respectively. Conclusion: In term nulliparas with cervices ripened by Foley catheter, immediate oxytocin and early amniotomy compared with a planned 4‐h delay to amniotomy shortened the intervention‐to‐delivery interval but did not significantly reduce the cesarean delivery rate. Synopsis: Immediate oxytocin and early amniotomy compared with delayed amniotomy after cervical ripening with Foley catheter in nulliparas shorten the intervention‐to‐delivery interval. [ABSTRACT FROM AUTHOR]

Aim: To explore digital insertion in dorsal recumbent position of 16F, 22F, or 28F catheter bores on insertion failure, duration, and pain in unripe cervix labor induction. Methods: A randomized trial was performed in a University hospital in Malaysia. Term women scheduled for labor induction, Bishop score ≤ 5, singleton, cephalic presentation, intact membrane, and reassuring pre‐induction fetal heart rate tracing were recruited. Women with known gross fetal anomaly, allergy to latex and inability to consent or language difficulty were excluded. Participants were randomized to 16F, 22F, or 28F Foley catheter. Primary outcome was insertion failure and main secondary outcomes were insertion duration and pain (assessed by a Visual Numerical Rating Scale [VNRS] 0–10, higher score more pain). Analysis is done by analysis of variance (ANOVA), Kruskal–Wallis, and chi square test across the three arms and by t test and Mann–Whitney U test for pair wise comparisons. Results: One hundred twenty‐seven participants' data were analyzed. The insertion failure 7/43(16%) versus 4/42(10%) versus 5/42(12%), p = 0.64, insertion duration median [IQR] 2.8 [1.8–4.8] versus 2.8 [1.7–3.7] versus 2.8 [1.7–4.3] min, p = 0.68 and insertion pain VNRS mean {SD} 4.2 {2.5} versus 3.4 {2.3} versus 3.6 {2.2}, p = 0.26, insertion to delivery interval 26.0 {9.7} versus 25.6 {9.1} versus 22.8 {7.4} h, p = 0.45, and spontaneous vaginal delivery 20/43 (45%) versus 23/42(55%) versus 25/42(60%), p = 0.48 for 16F versus 22F versus 28F arms, respectively. Pairwise comparisons were not different. Conclusion: Foley catheter 16F versus 22F versus 28F resulted in similar digital insertion performance in the dorsal recumbent position for unripe cervix labor induction. Clinical Trial Registration: https://doi.org/10.1186/ISRCTN21224268. [ABSTRACT FROM AUTHOR]

Objective: To evaluate immediate oxytocin and early amniotomy compared with delayed amniotomy after Foley catheter cervical ripening in multiparous women on intervention‐to‐delivery interval. Methods: This randomized trial was conducted in Malaysia in 232 term multiparous women with balloon catheter–ripened cervixes (dilatation ≥3 cm), singleton fetus, cephalic presentation with intact membranes, and reassuring fetal heart rate tracing. They were randomized to immediate titrated intravenous oxytocin infusion and early amniotomy (116) or delayed amniotomy after 4 h of oxytocin (116). Primary outcome was intervention (oxytocin initiation)‐to‐delivery interval. Results: Oxytocin‐to‐delivery intervals were a median of 4.99 h (interquartile range [IQR], 3.21–7.82 h) versus 6.23 h (IQR, 4.50–8.45 h) (P < 0.001) for the early versus delayed amniotomy arms, respectively. Delivery rate at 4 h and 6 h after oxytocin infusion were 40 of 116 (35%) versus 22 of 116 (19%) (relative risk [RR], 1.82 [95% confidence interval (CI), 1.16–2.86], P = 0.011) and 77 of 116 (66%) versus 54 of 116 (47%) (RR, 1.43 [95% CI, 1.13–1.80], P = 0.003) for the early versus delayed amniotomy arms, respectively. Maternal satisfaction on birth process were 7 (IQR, 6–8) versus 7 (IQR, 7–8) (P = 0.006), uterine hyperstimulation rates were 10 of 116 (9%) versus 14 of 116 (12%) (RR, 0.71 [95% CI, 0.33–1.54]) (P = 0.519), and Cesarean delivery rates were 17 of 116 (15%) versus 19 of 116 (16%) (RR, 0.90 [95% CI, 0.49–1.63], P = 0.856) for the early versus delayed amniotomy arms, respectively. Conclusion: In multiparas at term following cervical ripening by Foley catheter, immediate oxytocin and early amniotomy compared with a scheduled 4‐h delay to amniotomy shortens the interval to birth and decreases uterine hyperactivity in labor but lowers maternal satisfaction. The cesarean delivery rate is not significantly reduced. Clinical Trial Registration: This study was registered with the International Standard Randomised Controlled Trial Number (ISRCTN) on September 29, 2020, with trial identification number: ISRCTN87066007 (https://doi.org/10.1186/ISRCTN87066007). The first participant was recruited on September 29, 2020, after ISRCTN registry confirmation was received. Synopsis: Immediate oxytocin and early amniotomy compared with delayed amniotomy after cervical ripening with Foley catheter in multiparous women hasten delivery. [ABSTRACT FROM AUTHOR]