MATERIAL AND METHODS: A randomized trial was conducted in the University of Malaya Medical Center. A total of 163 term multiparas (no dropouts) with unripe cervixes (Bishop score ≤5) scheduled for labor induction were randomized to outpatient or inpatient Foley catheter. Primary outcomes were delivery during "working hours" 08:00-18:00 h and maternal satisfaction on allocated care (assessed by 11-point visual numerical rating score 0-10, with higher score indicating more satisfied).
CLINICAL TRIAL REGISTRATION: ISRCTN13534944.
RESULTS: Comparing outpatient and inpatient arms, delivery during working hours were 54/82 (65.9%) vs. 48/81 (59.3%) (relative risk 1.1, 95% CI 0.9-1.4, p = 0.421) and median maternal satisfaction visual numerical rating score was 9 (interquartile range 9-9) vs. 9 (interquartile range 8-9, p = 0.134), repectively. Duration of hospital stay and membrane rupture to delivery interval were significantly shorter in the outpatient arm: 35.8 ± 20.2 vs. 45.2 ± 16.2 h (p = 0.001) and 4.1 ± 2.9 vs. 5.3 ± 3.6 h (p = 0.020), respectively. Other maternal and neonatal secondary outcomes were not significantly different.
CONCLUSIONS: The trial failed to demonstrate the anticipated increase in births during working hours with outpatient compared with inpatient induction of labor with Foley catheter in parous women with an unripe cervix. Hospital stay and membrane rupture to delivery interval were significantly shortened in the outpatient group. The rate of maternal satisfaction was high in both groups and no significant differences were found.
OBJECTIVE: This study aimed to compare Foley balloon catheter placement for 6 vs 12 hours in induction of labor after 1 previous cesarean delivery.
STUDY DESIGN: A randomized controlled trial was conducted in a university hospital in Malaysia from January 2022 to February 2023. Eligible women with 1 previous cesarean delivery admitted for induction of labor were enrolled. Participants were randomized after balloon catheter insertion for 6 or 12 hours of passive ripening before balloon deflation and removal to check cervical status for amniotomy. The primary outcome was the induction of labor to delivery interval. The secondary outcomes were largely derived from the core outcome set for trials on induction of labor (Core Outcomes in Women's and Newborn Health [CROWN]). The Student t test, Mann-Whitney U test, chi-square test, and Fisher exact test were used as appropriate for the data.
RESULTS: Overall, 126 women were randomized, 63 to each intervention. The mean induction of labor to delivery intervals were 23.0 (standard deviation, ±8.9) in the 6-hour arm and 26.6 (standard deviation, ±7.1) in the 12-hour arm (mean difference, -3.5 hours; 95% confidence interval, -6.4 to -0.7; P=.02). The median induction of labor (Foley balloon catheter insertion) to Foley balloon catheter removal intervals were 6.0 hours (interquartile range, 6.0-6.3) in the 6-hour arm and 12.0 hours (interquartile range, 12.0-12.5) in the 12-hour arm (P
OBJECTIVE: This study aimed to evaluate immediate oral full feeding vs on-demand oral full feeding after unplanned cesarean delivery in labor on vomiting and maternal satisfaction.
STUDY DESIGN: A randomized controlled trial was conducted in a university hospital. The first participant was enrolled on October 20, 2021, the last participant was enrolled on January 14, 2023, and follow-up was completed on January 16, 2023. Women were assessed for full eligibility on arrival at the postnatal ward after their unplanned cesarean delivery. The primary outcomes were vomiting in the first 24 hours (noninferiority hypothesis and 5% noninferiority margin) and maternal satisfaction with their feeding regimen (superiority hypothesis). The secondary outcomes were time to first feed; food and beverage quantum consumed at first feed; nausea, vomiting, and bloating at 30 minutes after first feed, at 8, 16, and 24 hours after the operation, and at hospital discharge; parenteral antiemetic and opiate analgesia use; first breastfeeding and satisfactory breastfeeding, bowel sound, and flatus; second meal; cessation of intravenous fluid; removal of a urinary catheter; urination; ambulation; vomiting during the rest of hospital stay; and serious maternal complications. Data were analyzed using the t test, Mann-Whitney U test, chi-square test, Fisher exact test, and repeated measures analysis of variance as appropriate.
RESULTS: Overall, 501 participants were randomized into immediate or on-demand oral full feeding (sandwich and beverage). Vomiting in the first 24 hours were reported by 5 of 248 participants (2.0%) in the immediate feeding group and 3 of 249 participants (1.2%) in the on-demand feeding group (relative risk, 1.7; 95% confidence interval, 0.4-6.9 [0.48%-8.28%]; P=.50), and the maternal satisfaction scores from 0 to 10 were 8 (6-9) for the immediate feeding group and 8 (6-9) for the on-demand feeding groups (P=.97). The times from cesarean delivery to the first meal were 1.9 hours (1.4-2.7) vs 4.3 hours (2.8-5.6) (P
OBJECTIVE: This study aimed to evaluate 6- vs 12-hour Foley balloon placement for cervical ripening in the labor induction of nulliparas.
STUDY DESIGN: A randomized controlled trial was conducted at the Universiti Malaya Medical Centre from January 2022 to August 2022. Nulliparas aged ≥18 years, with a term, singleton pregnancy in cephalic presentation, with intact membranes, with reassuring fetal heart rate tracing, with an unripe cervix, and without any significant contractions, were recruited at admission for labor induction. Participants were randomized after successful Foley balloon insertion, for the balloon to be left passively in place for 6 or 12 hours and then removed to check for a ripened cervix. Amniotomy was performed once the cervix had ripened, followed by titrated oxytocin infusion to expedite labor and delivery. The primary outcome was the labor induction to delivery interval. The secondary outcomes were mostly from the core outcome set for trials on labor induction of labor trial reporting, such as change in the Bishop score after the intervention, use of an additional method for cervical ripening, time to delivery after double-balloon device removal, mode of delivery, indication for cesarean delivery, duration of oxytocin infusion, blood loss during delivery, presence of a third- or fourth-degree perineal tear, maternal infection, maternal satisfaction regional analgesia in labor, length of hospital stay, intensive care unit admission, cardiorespiratory arrest, need for hysterectomy. The neonatal outcomes were Apgar score at 1 and 5 minutes, neonatal intensive care unit admission, cord pH, neonatal sepsis, fetal birthweight, birth trauma, hypoxic-ischemic encephalopathy, or need for therapeutic hypothermia. Data were analyzed using the t test, Mann-Whitney U test, chi-square test, and Fisher exact test, as appropriate for the data type.
RESULTS: Overall, 240 women were randomized, 120 to each arm. The median labor induction to delivery intervals were 21.3 hours (interquartile range, 16.2-27.9) for the 6-hour balloon catheter placement and 26.0 hours (interquartile range, 21.5-30.9) for the 12-hour balloon catheter placement (P
OBJECTIVE: This study aimed to compare Foley balloon placement for 6 vs 12 hours in the labor induction of multiparas with unfavorable cervixes.
STUDY DESIGN: A randomized controlled trial was conducted in a university hospital in Malaysia from January to October of 2022. Eligible multiparous women admitted for induction of labor for various indications were enrolled. Participant inclusion criteria were multiparity (at least 1 previous vaginal delivery of ≥24 weeks' gestation), age ≥18 years, term pregnancy >37 weeks' gestation, singleton pregnancy, cephalic presentation, intact membranes, normal fetal heart rate tracing, no significant contractions (< 2 in 10 minutes), and unfavorable cervix (Bishop score < 6). Participants were randomized after successful Foley balloon insertion for the balloon to be left in place for 6 or 12 hours of passive ripening before removal to check cervical suitability for amniotomy. The primary outcomes were the induction-to-delivery interval and maternal satisfaction with the allocated intervention assessed using a visual numerical rating scale (0-10). Secondary outcomes were derived in part from the core outcome set for trials on induction of labor (Core Outcomes in Women's and Newborn Health [CROWN]). Maternal outcomes were change in first Bishop score after intervention, use of additional method for cervical ripening, time to delivery after balloon removal, mode of delivery, indication for cesarean delivery, duration of oxytocin infusion, blood loss during delivery, presence of third- or fourth-degree perineal tear, maternal infection, use of regional analgesia in labor, length of hospital stay, intensive care unit (ICU) admission, cardiorespiratory arrest, and need for hysterectomy. The secondary neonatal outcomes were Apgar score at 1 and 5 minutes, neonatal intensive care unit (NICU) admission, cord blood pH, neonatal sepsis, birthweight, birth trauma, hypoxic-ischemic encephalopathy, or need for therapeutic hypothermia. Analyses were conducted with the t-test, Mann-Whitney U test, chi-square test, and Fisher exact test, as appropriate.
RESULTS: A total of 220 women were randomized (110 to each intervention). Regarding the 2 primary outcomes, the induction-to-delivery intervals were a median (interquartile range) of 15.9 (12.0-24.0) and 21.6 (17.3-26.0) hours (P
OBJECTIVE: This study aimed to evaluate repeated applications of cold vs room temperature (placebo control) compress to the repaired primiparous perineum on pain upon movement.
STUDY DESIGN: A randomized controlled trial was conducted in a university hospital in Malaysia from May 2022 to February 2023. A total of 224 women with a repaired episiotomy or spontaneous second-degree tear sustained at normal delivery were randomized as follows: 113 to frozen gel pack and 111 to room temperature gel pack, as wound compress. The compress was applied to the perineal repair site at 3 timepoints: immediately after repair, and at 4 and 8 hours after delivery, for 20 minutes at each application. The primary outcomes were pain during movement at 12 and 24 hours after delivery, scored using the 0 to 10 numerical rating scale. The secondary outcomes include duration of hospital stay; analgesic consumption; recovery and functional metrics of reestablishing flatus, mobilization, and urination, breastfeeding; maternal satisfaction with the allocated compress; and after hospital discharge for up to 6 weeks after birth through telephone interview, analgesic consumption, perineal pain, resumption of vaginal sex, and women's perception of perineal wound healing.
RESULTS: The median (interquartile range) of pain at movement scores were 4 (4-5) vs 5 (4-5) (P=.018) at 12 hours and 2 (1-3) vs 2 (2-3) (P=.173) at 24 hours after birth for cold vs room temperature compress, respectively. Maternal satisfaction scores were 8 (7-9) vs 7 (6-8) (P=.119), oral analgesic for perineal pain while at the postnatal ward was taken by 94 of 113 (83.2%) vs 85 of 109 (78.0%) (relative risk, 1.07; 95% confidence interval, 0.94-1.21), and time to the first satisfactory breastfeeding episode was 11.6 (7.9-15.5) vs 13.0 (8.0-20.7) hours (P=.303) for cold vs room temperature compress, respectively. At 2 weeks telephone follow-up, analgesic intake and perineal pain were not different. At 6 weeks, analgesic intake, perineal pain, resumption of vaginal sex, exclusive breastfeeding, and maternal perception of perineal healing were not different.
CONCLUSION: Intermittent cold compress in the first 8 hours to the repaired perineum reduces pain at 12 hours but the effect attenuates by 24 hours. Maternal satisfaction with their allocated compress was not different. There was no suggestion of harm or benefit on the other secondary outcomes.
OBJECTIVE: This study aimed to evaluate the first vaginal examination at 8 vs 4 hours after amniotomy-oxytocin after Foley ripening in multiparous labor induction.
STUDY DESIGN: A randomized controlled trial was conducted from October 2021 to September 2022 at the University Malaya Medical Center, Kuala Lumpur, Malaysia. Multiparas at term were recruited at admission for labor induction. Participants were randomized to a first routine vaginal examination at 8 or 4 hours after Foley balloon ripening and amniotomy. Titrated oxytocin infusion was routinely commenced after amniotomy to initiate contractions. The 2 primary outcomes were the time from amniotomy to delivery (noninferiority hypothesis) and maternal satisfaction (superiority hypothesis). Data were analyzed using the Student t test, Mann-Whitney U test, and chi-square test (or Fisher exact test), as suitable for the data.
RESULTS: A total of 204 women were randomized, 102 to each arm. Amniotomy to birth intervals were 4.97±2.47 hours in the 8-hour arm and 5.79±3.17 hours in the 4-hour arm (mean difference, -0.82; 97.5% confidence interval, -1.72 to 0.08; P=.041; Bonferroni correction), which were noninferior within the prespecified 2-hour upper margin, and the maternal satisfaction scores (11-point 0-10 numerical rating scale) with allocated labor care were 9 (interquartile range, 8-9) in the 8-hour arm and 8 (interquartile range, 7-9) in the 4-hour arm (P=.814). In addition, oxytocin infusion to birth interval difference was noninferior within the 97.5% confidence interval (-1.59 to 0.23) margin of 1.3 hours. Of the maternal outcomes, the amniotomy to first vaginal examination intervals were 3.9±1.8 hours in the 8-hour arm and 3.4±1.3 hours in the 4-hour arm (P=.026), and the numbers of vaginal examinations were 2.00 (interquartile range, 2.00-3.00) in the 8-hour arm and 3.00 (interquratile range, 2.00-3.25) in the 4-hour arm (P
OBJECTIVE: This study aimed to evaluate mechanical massage using an electric massage chair on labor pain in nulliparous women.
STUDY DESIGN: A randomized counterbalanced crossover trial was conducted in a university hospital in Malaysia from August 2022 to February 2023. Eligible nulliparas in labor with a minimum labor pain score of 5 (0-10 numerical rating scale) were enrolled. Participants were randomized to 30 minutes on the massage chair with mechanical massage followed by 30 minutes on the massage chair without mechanical massage or the other way around in the massage sequence. The primary outcome was a change in pain score comparing pain with and without mechanical massage as a paired comparison for the entire trial participants. The secondary outcomes were across arms analyses of maternal and neonatal outcomes. The paired t test, t test, Mann-Whitney U test, chi-square test, and Fisher exact test were used as appropriate for the data.
RESULTS: Overall, 208 women were randomized: 104 to each intervention. Data were available from 204 participants (103 randomized to massage first and 101 to no massage first). The primary outcomes of change in labor pain scores (0-10 numerical rating scale) after massage and no massage (all participants included after crossover, paired t test analysis) were 4.51±2.30 and 5.38±2.10, respectively (mean difference, -0.87; 95% confidence interval, -1.14 to -0.59; P
OBJECTIVE: The aim of this study was to evaluate regular (4-hourly prior to each oral misoprostol dose with amniotomy when feasible) compared with restricted (only if indicated) vaginal assessments during labor induction with oral misoprostol in term nulliparous women MATERIALS AND METHODS: We performed a randomized trial between November 2016 and September 2017 in a university hospital in Malaysia. Our oral misoprostol labor induction regimen comprised 50 μg of misoprostol administered 4 hourly for up to 3 doses in the first 24 hours. Participants assigned to regular assessment had vaginal examinations before each 4-hourly misoprostol dose with a view to amniotomy as soon as it was feasible. Participants in the restricted arm had vaginal examinations only if indicated. Primary outcomes were patient satisfaction with the birth process (using an 11-point visual numerical rating scale), induction to vaginal delivery interval, and vaginal delivery rate at 24 hours.
RESULTS: Data from 204 participants (101 regular, 103 restricted) were analyzed. The patient satisfaction score with the birth process was as follows (median [interquartile range]): 7 [6-9] vs 8 [6-10], P = .15. The interval of induction to vaginal delivery (mean ± standard deviation) was 24.3 ± 12.8 vs 31.1 ± 15.0 hours (P = .013). The vaginal delivery rate at 24 hours was 27.7% vs 20.4%; (relative risk [RR], 1.4; 95% confidence interval [CI], 0.8-2.3; P = .14) for the regular vs restricted arms, respectively. The cesarean delivery rate was 50% vs 43% (RR, 1.1; 95% CI, 0.9-1.5; P = .36). When assessed after delivery, participants' fidelity to their assigned vaginal examination schedule in a future labor induction was 45% vs 88% (RR, 0.5; 95% CI, 0.4-0.7; P < .001), and they would recommend their assigned schedule to a friend (47% vs 87%; RR, 0.6; 95% CI, 0.5-0.7; P < .001) in the regular compared with the restricted arms, respectively.
CONCLUSION: Despite a shorter induction to vaginal delivery interval with regular vaginal examination and a similar vaginal delivery rate at 24 hours and birth process satisfaction score, women expressed a higher preference for the restricted examination schedule and were more likely to recommend such a schedule to a friend.
OBJECTIVE: This study aimed to evaluate if visual feedback focusing on the perineum reduced the length of the active second stage of labor in comparison with the control.
STUDY DESIGN: A randomized controlled trial was conducted in the University Malaya Medical Centre from December 2021 to August 2022. Nulliparous women about to commence the active second stage, at term, with singleton gestation, reassuring fetal status, and no contraindication for vaginal delivery were randomized to live viewing of the maternal introitus (intervention) or maternal face (sham/placebo control) as visual biofeedback during their pushing. A video camera Bluetooth-linked to a tablet computer display screen was used; in the intervention arm, the camera was focused on the introitus, and in the control arm, on the maternal face. Participants were instructed to watch the display screen during their pushing. The primary outcomes were the intervention-to-delivery interval and maternal satisfaction with the pushing experience assessed using a 0-to-10 visual numerical rating scale. Secondary outcomes included mode of delivery, perineal injury, delivery blood loss, birthweight, umbilical cord arterial blood pH and base excess at birth, Apgar score at 1 and 5 minutes, and neonatal intensive care unit admission. Data were analyzed with the t test, Mann-Whitney U test, chi-square test, and Fisher exact test, as appropriate.
RESULTS: A total of 230 women were randomized (115 to intervention and 115 to control arm). The active second stage duration (intervention-to-delivery interval) was a median (interquartile range) of 16 (11-23) and 17 (12-31) minutes (P=.289), and maternal satisfaction with the pushing experience was 9 (8-10) and 7 (6-7) (P
OBJECTIVE: This study aimed to evaluate the pragmatic approach of permitting free access to water up to the call to dispatch to the operating theater vs fasting from midnight in preoperative oral intake restriction for planned cesarean delivery under spinal anesthesia on perioperative vomiting and maternal satisfaction.
STUDY DESIGN: A randomized controlled trial was conducted in the obstetrical unit of the University of Malaya Medical Centre from October 2020 to May 2022. A total of 504 participants scheduled for planned cesarean delivery were randomized: 252 undergoing preoperative free access to water up to the call to dispatch to the operating theater (intervention group) and 252 undergoing fasting from midnight (fasting arm). The primary outcomes were perioperative vomiting and maternal satisfaction. Analyses were performed using t test, Mann-Whitney U test, and chi-square test, as appropriate.
RESULTS: Of note, 9 of 252 patients (3.6%) in the intervention group and 24 of 252 patients (9.5%) in the control group had vomiting at up to 6 hours after completion of cesarean delivery (relative risk, 0.38; 95% confidence interval, 0.18-0.79; P=.007), and the maternal satisfaction scores (0-10 visual numerical rating scale) were 9 (interquartile range, 8-10) in the intervention group and 5 (interquartile range, 3-7) in the control group (P
METHODS: A randomized controlled trial was carried out in a university hospital in Malaysia. Women with lifestyle-controlled gestational diabetes scheduled to receive clinically indicated antenatal corticosteroids (dexamethasone) were randomized to 12-mg 12 hourly for one day (2 × 12-mg) or 6-mg 12-hourly for two days (4 × 6-mg). 6-point (pre and 2-h postprandial) daily self-monitoring of capillary blood sugar profile for up to 3 consecutive days was started after the first dexamethasone injection. Hyperglycemia is defined as blood glucose pre-meal ≥ 5.3 or 2 h postprandial ≥ 6.7 mmol/L. The primary outcome was a number of hyperglycemic episodes in Day-1 (first 6 BSP points). A sample size of 30 per group (N = 60) was planned.
RESULTS: Median [interquartile range] hyperglycemic episodes 4 [2.5-5] vs. 4 [3-5] p = 0.3 in the first day, 3 [2-4] vs. 1 [0-3] p = 0.01 on the second day, 0 [0-1] vs. 0 [0-1] p = 0.6 on the third day and over the entire 3 trial days 7 [6-9] vs. 6 [4-8] p = 0.17 for 6-mg vs. 12-mg arms, respectively. 2/30 (7%) in each arm received an anti-glycemic agent during the 3-day trial period (capillary glucose exceeded 11 mmol/L). Mean birth weight (2.89 vs. 2.49 kg p
METHODS: A randomized trial was conducted in a university hospital in Malaysia from December 2018 to May 2019. Term nulliparas with unfavorable cervix (Bishop score ≤ 5) scheduled for labor induction were randomized to Foley catheter and controlled release dinoprostone insert simultaneously or Foley catheter alone. Primary outcomes were induction to delivery interval (hours) and maternal satisfaction on birth experience (assessed by 11-point Visual Numerical Rating Scale VNRS 0-10, higher score more satisfied).
RESULTS: Induction to vaginal delivery intervals was mean ± standard deviation 22.5 ± 10.4 vs. 35.1 ± 14.9 h, P =
METHODS: This study consisted of 53 subjects diagnosed with GDM and 43 normal glucose tolerance (NGT) pregnant women. Serum leptin and SLeptinR were measured at 24-28 weeks, prior and after delivery, and post-puerperium.
RESULTS: Lower levels of leptin and SLeptinR were observed in GDM compared to NGT. Leptin [OR 0.97 (95% CI 0.94-1.0)] and SLeptinR [OR 0.86 (95% CI 0.79-0.93]) were inversely associated with GDM. Participants in the lowest tertile for leptin and SLeptinR had a 2.8-fold (95% CI 1.0-7.6) and a 5.7-fold (95% CI 1.9-17.3) higher risk of developing GDM compared with the highest tertile, respectively. These relationships were attenuated after adjustment for covariates. In both the groups, peak leptin was observed at 24-28 weeks, decreasing continuously during pregnancy (p > 0.05) and after delivery (p