Short stature and vaginal dinoprostone as independent predictors of composite maternal-newborn adverse outcomes in induction of labor after one previous cesarean: a retrospective cohort study.

BACKGROUND: The rates of labor induction and cesarean delivery is rising worldwide. With the confluence of these trends, the labor induction rate in trials of labor after cesarean can be as high as 27-32.7%. Induction of labor after one previous cesarean (IOLAC) is a high-risk procedure mainly due to the higher risk of uterine rupture. Nevertheless, the American College of Obstetricians and Gynecologists considers IOLAC as an option in motivated and informed women in the appropriate care setting. We sought to identify predictors of a composite of maternal and newborn adverse outcomes following IOLAC. METHODS: The electronic medical records of women who delivered between January 2018 to September 2022 in a Malaysian university hospital were screened to identify cases of IOLAC. A case is classified as a composite adverse outcome if at least one of these 11 adverse outcomes of delivery blood loss ≥ 1000 ml, uterine scar complications, cord prolapse or presentation, placenta abruption, maternal fever (≥ 38 0C), chorioamnionitis, intensive care unit (ICU) admission, Apgar score < 7 at 5 min, umbilical artery cord artery blood pH < 7.1 or base excess ≤-12 mmol/l, and neonatal ICU admission was present. An unplanned cesarean delivery was not considered an adverse outcome as the practical management alternative for a clinically indicated IOLAC was a planned cesarean. Bivariate analysis of participants' characteristics was performed to identify predictors of their association with composite adverse outcome. Characteristics with crude p < 0.10 on bivariate analysis were incorporated into a multivariable binary logistic regression analysis model. RESULTS: Electronic medical records of 19,064 women were screened. 819 IOLAC cases and 98 cases with composite adverse outcomes were identified. Maternal height, ethnicity, previous vaginal delivery, indication of previous cesarean, indication for IOLAC, and method of IOLAC had p < 0.10 on bivariate analysis and were incorporated into a multivariable binary logistic regression analysis. After adjustment, only maternal height and IOLAC by vaginal dinoprostone compared to Foley balloon remained significant at p < 0.05. Post hoc adjusted analysis that included all unplanned cesarean as an added qualifier for composite adverse outcome showed higher body mass index, short stature (< 157 cm), not of Chinese ethnicity, no prior vaginal delivery, prior cesarean indicated by labor dystocia, and less favorable Bishop score (< 6) were independent predictors of the expanded composite adverse outcome. CONCLUSION: Shorter women and IOLAC by vaginal dinoprostone compared to Foley balloon were independently predictive of composite of adverse outcome.

Shorter stature and dinoprostone labor induction are independent predictors of a composite maternal-newborn adverse outcome excluding unplanned cesarean delivery.

Sexual activity, vaginal symptoms, maternal perineal hygiene behavior, and constipation on ano-vaginal colonization of group B streptococcus in near term pregnancy.

BACKGROUND: Maternal Group B Streptococcus (GBS) colonization is influenced by many factors but results are inconsistent. Consideration of antenatal risk factors may help inform decision making on GBS microbiological culture screening where universal screening is not standard of care. We sought to identify independent predictors of GBS colonization at 34-37 weeks gestation incorporating vaginal symptoms, perineal hygiene measures, sexual activity, and a potential novel factor, constipation. METHODS: In this prospective cross-sectional study, 573 women at 34-37 weeks gestation had an ano-vaginal swab taken and sent for selective culture for GBS. Women were asked about vaginal bleeding, discharge, irritation and candidiasis, antibiotic use during pregnancy, ano-vaginal hygiene practices such as douching and perineal cleansing after toileting, sexual intercourse related activities, and a potential novel factor for GBS carriage, constipation. Maternal basic demographics and obstetric-related characteristics were also collected. Bivariate analyses were performed to identify associates of GBS colonization. All variables with p < 0.05 found on bivariate analysis were then included into a model for multivariable binary logistic regression analysis to identify independent risk factors for GBS colonization. RESULTS: GBS colonization was found in 235/573 (41.0%) of participants. Twenty six independent variables were considered for bivariate analysis. Eight were found to have p < 0.05. Following adjusted analysis, six independent predictors of GBS colonization were identified: ethnicity, previous neonatal GBS prophylaxis, antenatal vaginal irritation, antibiotic use, recent panty liner use, and frequency of sexual intercourse. Vaginal discharge and perineal cleansing were not associated after adjustment. Recent douching and constipation were not associated on bivariate analysis. CONCLUSION: The identification of independent predictors of GBS colonization in late pregnancy may inform the woman and care provider in their shared decision making for microbiological screening at 35-38 weeks gestation in locations where universal GBS screening is not standard of care. ETHICS OVERSIGHT: This study was approved by the Medical Ethics Committee of University Malaya Medical Centre (UMMC) on August 9, 2022, reference number 2022328-11120.

Preoperative free access to water compared to fasting for planned cesarean under spinal anesthesia: a randomized controlled trial.

BACKGROUND: Contemporary guidance for preoperative feeding allows solids up to 6 hours and clear fluids up to 2 hours before anesthesia. Clinical trial evidence to support this approach for cesarean delivery is lacking. Many medical practitioners continue to follow conservative policies of no intake from midnight to the time of surgery, especially in pregnant women. 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<.001). Assessed before dispatch to the operating theater, feeling of thirst was reported by 69 of 252 patients (27.4%) in the intervention group and 134 of 252 patients (53.2%) in the control group (relative risk, 0.52; 95% confidence interval, 0.41-0.65; P<.001), capillary glucose levels were 4.8±0.7 mmol/L in the intervention group and 4.9±0.8 mmol/L in the control group (P=.048), and preoperative intravenous fluid hydration was commenced in 49 of 252 patients (19.4%) in the intervention group and 76 of 252 patients (30.2%) in the control group (relative risk, 0.65; 95% confidence interval, 0.47-0.88; P=.005). In the operating theater, ketone was detected in the catheterized urine in 38 of 252 patients (15.1%) in the intervention group and 78 of 252 patients (31.0%) in the control group (relative risk, 0.49; 95% confidence interval, 0.25-0.59; P<.001), and the numbers of doses of vasopressors needed to correct hypotension were 2.3±1.7 in the intervention group and 2.7±2.2 in the control (P=.009). The recommendation rates for preoperative oral intake regimen to a friend were 95.2% (240/252) in the intervention group and 39.7% (100/252) in the control group (relative risk, 2.40; 95% confidence interval, 2.06-2.80; P<.001), in favor of free access to water. Other assessed maternal and neonatal outcomes were not different. CONCLUSION: Compared with fasting, free access to water in planned cesarean delivery reduced perioperative vomiting and was strongly favored by women. In addition, several pre- and intraoperative secondary outcomes were improved. However, postcesarean delivery recovery and neonatal outcomes were not different.

Electric massage chairs reduce labor pain in nulliparous patients: a randomized crossover trial.

BACKGROUND: Labor pain varies significantly among pregnant women, ranging from mild to extremely distressing. Nonpharmacologic pain relief methods during vaginal birth are increasingly popular, either as a complement to pharmacologic agents or, at times, as the primary method of pain relief. Multiple trials have reported that manual or by-hand massage reduces labor pain. The effectiveness of full-body mechanical massage using electric massage chairs on labor pain remains unexplored. 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<.001), a significant reduction in pain score after electric chair mechanical massage compared with no massage. On the across randomized arms secondary analyses, labor pain scores after their first massage chair session were 4.35±2.52 (randomized to massage first, received massage as initial intervention) and 5.66±1.73 (randomized to no massage first, received no massage as initial intervention) (mean difference, -1.31; 95% confidence interval, -1.91 to -0.748; P<.001), a significant reduction after mechanical massage. Other distal maternal outcomes (mode of delivery, labor analgesia, duration of labor, and maternal agreement that mechanical massage is effective for labor pain) and neonatal outcomes (Apgar scores at 1 and 5 minutes, cord artery blood pH and base excess, and neonatal admission) were not different across randomized arms. CONCLUSION: Mechanical massage using an electric massage chair significantly reduced labor pain, offering a potential nonpharmacologic pain management option during labor.

Polyethylene glycol compared to lactulose for constipation in pregnancy: A randomized controlled trial.

OBJECTIVE: To compare polyethylene glycol 4000 versus lactulose in chronic constipation during pregnancy. METHODS: Women at 28-32 weeks' gestation attending antenatal clinic for routine care were screened using the Rome IV chronic constipation criterion. Eligible women were approached and consented. Participants were randomized to oral polyethylene glycol (10 g/day) or lactulose (10 g/day) for 4 weeks. A bowel movement diary was kept and outcomes using the Patient Assessment of Constipation Symptoms questionnaire (PAC-SYM), Patient Assessment of Constipation Quality of Life questionnaire (PAC-QoL) and Bristol Stool Form Scale (BSFS), which were evaluated at the start and end of the four-week period. Relative risks (RR) were determined for the coprimary outcomes of complete spontaneous bowel movement (CSBM) and PAC-SYM mean score improvement (decrease in score of >1 from the baseline). RESULTS: A total of 4323 women underwent screening, of which 780 fulfilled the Rome IV criterion, and 360 consented to participate (180 randomized to PEG and lactulose, respectively). Data from 247 women who completed the study were analyzed. CSBM was achieved in 107/124 (86.3%) versus 102/123 (82.9%) (RR 1.04, 95% CI: 0.93-1.16, P = 0.464) for PEG and lactulose trial arms, respectively. PAC-SYM mean score improvement was 62/118 (52.5%) in the PEG arm versus 44/118 (37.3%) in the lactulose arm (RR 1.40, 95% CI: 1.05-1.88). Of secondary outcomes, a significant difference was found in favor of PEG, with respect to PAC-SYM abdominal symptoms subscale, normal stool versus loose stool consistency and side effects of vomiting and diarrhea. After controlling for parity, baseline PAC-SYM, PAC-QoL scores, characteristics different at baseline, only diarrhea and loose stools remained significant. CONCLUSION: Both PEG 4000 and lactulose are effective laxatives in pregnancy with similar performance after adjusted analysis. Diarrhea and loose stools are less frequently reported with PEG.

Cold compared with room temperature compress on the repaired primiparous perineum following injury at normal vaginal delivery: a randomized controlled trial.

BACKGROUND: The perineum is typically injured at the first vaginal birth. The application of a cold compress to the perineal repair site can reduce pain; however, the effect usually dissipates after a couple of hours. Repeated applications may be needed for sustained analgesia. However, the medium-term effect of repeated applications of cold compress on the perineal repair site on the recovery of sexual function and perineal healing is not known. 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.

Induction of labor after one previous cesarean: Predictors of vaginal birth.

Objective: To identify independent predictors for vaginal delivery after induction of labor after one cesarean (IOLAC). Study design: In this retrospective cohort study, the electronic medical record of 19064 women who delivered from January 2018-September 2022 in a university hospital in Malaysia were individually searched to identify cases of IOLAC. Preselected data points on characteristics and the outcome of mode of delivery were retrieved. Bivariate analysis was performed to identify predictor characteristics for the dichotomous outcomes of vaginal delivery vs unplanned cesarean delivery. Variables with crude p < 0.05 were incorporated into a multivariable binary logistic regression analysis to identify independent predictors of vaginal delivery after IOLAC. Results: 819 IOLAC cases were identified. There were 465/819 (56.5 %) unplanned cesareans deliveries. Of the 14 selected characteristics, eight had p < 0.05 on bivariate analysis. After adjustment, six characteristics, body mass index, height, ethnicity, parity, previous cesarean indication and Bishop score were independently predictive of vaginal birth but not maternal age or method of labor induction. Birthweight, labor induction indication, gestational age, haemoglobin level, diabetes and hypertension in pregnancy were not significant at the level of bivariate analysis. Conclusion: Obesity, short stature, no prior vaginal delivery, previous cesarean indicated by failure to progress, unfavorable Bishop score and ethnicity were independent predictors for unplanned cesarean after IOLAC. These predictors should help guide women and their care providers in their shared decision-making about IOLAC.

Induction of labor via Foley balloon catheter placement for 6 vs 12 hours in women with 1 previous cesarean delivery and unfavorable cervices: a randomized controlled trial.

BACKGROUND: Induction of labor in women with 1 previous cesarean delivery and unripe cervices is a high-risk process, carrying an increased risk of uterine rupture and the need for cesarean delivery. Balloon ripening is often chosen as prostaglandin use is associated with an appreciable risk of uterine rupture in vaginal birth after cesarean delivery. A shorter duration of placement of the balloon typically expedites delivery; however, this has not been evaluated in induction of labor after 1 previous cesarean delivery. 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<.001). The median induction of labor to amniotomy intervals were 14.1 hours (interquartile range, 9.3-21.8) in the 6-hour arm and 19.0 hours (interquartile range, 15.9-22.0) in the 12-hour arm (P=.02). The usage rates of epidural analgesia in labor were 46.0% (29/63) in the 6-hour arm and 65.1% (41/63) in the 12-hour arm (relative risk, 0.71; 95% confidence interval, 0.51-0.98; P=.03). Spontaneous balloon catheter expulsion rates were 22.2% (14/63) in the 6-hour arm and 17.5% (11/63) in the 12-hour arm (relative risk, 1.27; 95% confidence interval, 0.63-2.58; P=.50), and additional ripening use rates (Foley reinsertion) were 46.0% (29/63) in the 6-hour arm and 31.7% (20/63) in the 12-hour arm (relative risk, 1.45; 95% confidence interval, 0.92-2.27; P=.10). The results were not different. Moreover, maternal satisfaction scores (0-10 numerical rating scale) of 9 (range, 8-10) in the 6-hour arm and 9 (range, 8-10) in the 12-hour arm (P=.41) were not different. Other secondary maternal and neonatal outcomes were not significantly different either. CONCLUSION: Foley balloon catheter placement for 6 hours hastened birth and reduced epidural analgesia use in labor without a change in maternal satisfaction.

Six compared with 12 hours of Foley balloon placement for labor induction in nulliparous women with unripe cervices: a randomized controlled trial.

BACKGROUND: Compared with a planned 12-hour placement of a double-balloon catheter, a planned 6-hour placement of a double-balloon catheter shortens the labor induction to delivery interval. The Foley catheter is low cost. Moreover, it has at least comparable effectiveness to the proprietary double-balloon labor induction devices. Of note, a 6-hour placement of a Foley balloon catheter in nulliparas has not been evaluated. 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<.001). Of the secondary outcomes, for 6- vs 12-hour balloon catheter placement, the sequential use of additional cervical ripening agent (mostly Foley reinsertion) was 33 of 119 (27.5%) vs 17 of 120 (14.2%) (relative risk, 1.94; 95% confidence interval, 1.15-3.29; P=.011), Bishop score increase was 3 (interquartile range, 2.00-3.75) vs 3 (2.25-4.00) (P=.002), and the rate of recommendation to a friend was 83 of 118 (70.3%) vs 101 of 119 (84.9%) (relative risk, 0.83; 95% confidence interval; 0.72-0.95; P=.007), respectively. Cesarean delivery rates were 52 of 119 (43.7%) for the 6-hour balloon catheter placement and 64 of 120 (53.3%) for the 12-hour balloon catheter placement (relative risk, 0.82; 95% confidence interval, 0.63-0.07; P=.136), and maternal satisfaction scores (0-10 numerical rating scale) were 7 (interquartile range, 6-9) for the 6-hour balloon catheter placement and 7 (interquartile range, 7-9) for the 12-hour balloon catheter placement (P=.880). CONCLUSION: Compared with a planned 12-hour Foley balloon catheter placement, a planned 6-hour Foley balloon placement shortens the time to birth, despite less cervical ripening at Foley balloon catheter removal and more additional cervical ripening agent use. However, the 6-hour balloon catheter placement was less likely to be recommended to a friend than the 12-hour balloon catheter placement.

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

BACKGROUND: Planned 6- vs 12-hour placement of the double-balloon catheter for cervical ripening in labor induction hastens delivery. The Foley catheter is low-priced and typically performs at least as well as the proprietary double-balloon devices in labor induction. Maternal satisfaction with labor induction is usually inversely related to the speed of the process. 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<.001), and maternal satisfaction scores were 7 (6-8) and 7 (6-8) (P=.734) for 6- and 12-hour placement, respectively. The following rates were observed for 6- and 12-hour placement, respectively: sequential use of additional cervical ripening agent (Foley reinsertion)-29 per 110 (26.4%) and 13 per 110 (11.8%) (relative risk, 2.23; 95% confidence interval, 1.23-4.10; P=.006); spontaneous balloon expulsion-22 per 110 (20.0%) and 37 per 110 (33.6%) (relative risk, 0.60; 95% confidence interval, 0.38-0.94; P=.022); and recommendation of the allocated intervention to a friend-61 per 110 (73.6%) and 87 per 110 (79.1%) (relative risk, 0.90; 95% confidence interval, 0.80-1.08; P=.341). Other secondary outcomes, including cesarean delivery, were not significantly different. CONCLUSION: Foley balloon placement for 6 hours for cervical ripening in parous women hastens birth but does not increase maternal satisfaction relative to 12-hour placement. Foley reinsertion for additional ripening was more frequent in the 6-hour group.

Eye-mask and earplugs compared with sleep advice leaflet to improve night sleep duration in pregnancy: a randomized controlled trial.

STUDY OBJECTIVES: To evaluate at-home use of eye-mask and earplugs (EMEP) versus sleep hygiene advice leaflet (AL) on actigraphy-derived night sleep duration in sleep-deprived pregnant women. METHODS: A randomized controlled trial was conducted in the antenatal clinic of University Malaya Medical Centre from June 2021 to June 2022. Women at 34-36 weeks gestation with self-reported night sleep duration ≤6 hours were recruited. Participants wore an actigraphy device at night for seven consecutive nights (Observation/Baseline week). Only women whose actigraphy-derived night sleep duration was confirmed to be ≤360 minutes were randomized to use EMEP or AL. Actigraphy was continued for another week (Intervention week). Primary outcome was change in actigraphy-derived night sleep duration from observation to intervention week across trial arms. Secondary outcomes include participants' sleep quality, labor, and neonatal outcome. Comparisons were by Student t-test, Mann-Whitney U test, and chi-square test. RESULTS: A total of 210 women were randomized: 105 each to EMEP and AL. The increase in night sleep duration over baseline was significantly longer with both EMEP (mean ±â€…SD) 23 ±â€…41 minutes, p < .001, and AL 10 ±â€…35 minutes, p = .007. Night sleep duration was longer by 12.9 (95% CI = 2.2 to 23.7) minutes, p = .019 with EMEP over AL. Sleep quality (Global Pittsburgh Sleep Quality Index score) was significantly improved with EMEP (mean ±â€…SD) -2.0 ±â€…2.5, p < .001, but not with AL -0.3 ±â€…2.2, p = .246. Labor and neonatal outcomes were not significantly different. CONCLUSION: EMEP significantly lengthened night sleep duration in sleep-deprived women in late pregnancy and is superior to AL. CLINICAL TRIAL INFORMATION: "Use of eye masks and earplugs compared with standard advice to improve sleep in pregnancy". https://doi.org/10.1186/ISRCTN19061849. Registered with ISRCTN on 07 May 2021, trial identification number: ISRCTN19061849.

Immediate vs on-demand maternal oral full feeding after unplanned cesarean section during labor: a randomized controlled trial.

BACKGROUND: The adoption of Enhanced Recovery After Cesarean is increasing, but evidence supporting individual interventions having a specific benefit to Enhanced Recovery After Cesarean is lacking. A key element in Enhanced Recovery After Cesarean is early oral intake. Maternal complications are more frequent in unplanned cesarean delivery. In planned cesarean delivery, immediate full feeding enhances recovery, but the effect of unplanned cesarean delivery during labor is not known. 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<.001), first bowel sound 2.7 hours (1.5-7.5) vs 3.5 hours (1.8-8.7) (P=.02), and second meal 7.8 hours (6.0-9.6) vs 9.7 hours (7.2-13.0) (P<.001). These intervals were shorter with immediate feeding. The participants were more likely to agree to recommend immediate feeding to a friend (228 [91.9%] in the immediate feeding group vs 210 [84.3%] in the on-demand feeding group; relative risk, 1.09; 95% confidence interval, 1.02-1.16; P=.009). However, at first feed for food, ate "nothing at all" rates were 10.4% (26/250) in the immediate group and 3.2% (8/247) in the on-demand group, and "eaten all" rates were 37.5% (93/249) in the immediate group and 42.8% (106/250) in the on-demand group (P=.02). Other secondary outcomes were not different. CONCLUSION: Compared with on-demand oral full feeding, immediate oral full feeding after unplanned cesarean delivery in labor did not increase the maternal satisfaction score and was not noninferior on postoperation vomiting. On-demand feeding with its emphasis on patient autonomy could be preferred, but the earliest full feeding should be encouraged and provided.

Predictors of maternal satisfaction with labor induction: A prospective observational cohort study.

OBJECTIVE: To identify independent predictors of maternal satisfaction with labor induction. METHOD: In this prospective observational cohort study, 769 women prior to their labor induction had sleep and psychological well-being assessed using Pittsburgh Sleep Quality Index and Depression, Anxiety and Stress Scales. Women were asked about the adequacy of labor induction information provided and their involvement and time pressure felt in the decision-making for their labor induction. Maternal characteristics, induction and intrapartum care measures, and labor and neonatal outcomes were also assessed. Prior to discharge, women rated their satisfaction with their birth experience. RESULTS: A total of 34 variables were considered for bivariate analysis, with 15 found to have P < 0.05. Following adjusted analysis, 10 independent predictors of maternal satisfaction were identified: maternal education, previous cesarean delivery, maternal involvement, information provided, and decision-making time pressure regarding labor induction, amniotomy, induction to delivery interval, mode of delivery, postpartum hemorrhage, and neonatal admission. Maternal satisfaction was not associated with sleep, depression, anxiety, or stress. CONCLUSION: The identification of independent predictors of maternal satisfaction allows for patient selection, targeting of specific preinduction and intrapartum care, and focus on induction methods that can reduce induction to delivery interval, cesarean birth, and delivery blood loss to maximize women's satisfaction with labor induction.