The Relationship between Placental Shear Wave Elastography and Fetal Weight-A Prospective Study.

Background/Objectives: The utility of shear wave elastography (SWE) as an adjunct to ultrasound biometry and Doppler velocimetry for the examination of placental dysfunction and suboptimal fetal growth is unclear. To date, limited data exist correlating the mechanical properties of placentae with fetal growth. This study aimed to investigate the relationship between placental shear wave velocity (SWV) and ultrasound estimated fetal weight (EFW), and to ascertain if placental SWV is a suitable proxy measure of placental function in the surveillance of small-for-gestational-age (SGA) pregnancies. Methods: This prospective, observational cohort study compared the difference in placental SWV between SGA and appropriate-for-gestational-age (AGA) pregnancies. There were 221 women with singleton pregnancies in the study cohort-136 (61.5%) AGA and 85 (38.5%) SGA. Fetal biometry, Doppler velocimetry, the deepest vertical pocket of amniotic fluid, and mean SWV were measured at 2-4-weekly intervals from recruitment to birth. Results: There was no difference in mean placental SWV in SGA pregnancies compared to AGA pregnancies, nor was there any relationship to EFW. Conclusions: Although other studies have shown some correlation between increased placental stiffness and SGA pregnancies, our investigation did not support this. The mechanical properties of placental tissue in SGA pregnancies do not result in placental SWVs that are apparently different from those of AGA controls. As this study did not differentiate between constitutionally or pathologically small fetuses, further studies in growth-restricted cohorts would be of benefit.

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.

Real-time imaging as visual biofeedback in active second stage of labor among nulliparas: a randomized controlled trial.

BACKGROUND: A prolonged second stage of labor increases the risk of severe perineal laceration, postpartum hemorrhage, operative delivery, and poor Apgar score. The second stage is longer in nulliparas. Maternal pushing during the second stage of labor is an important contributor to the involuntary expulsive force developed by uterine contraction to deliver the fetus. Preliminary data indicate that visual biofeedback during the active second stage hastens birth. 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<.001) for the intervention and control arm, respectively. Women randomized to the intervention arm were more likely to agree to recommend their management to a friend (88/115 [76.5%] vs 39/115 [33.9%]; relative risk, 2.26 [95% confidence interval, 1.72-2.97]; P<.001) and more likely to have less severe perineal injury (P=.018). CONCLUSION: Real-time viewing of the maternal introitus as visual biofeedback during pushing resulted in higher maternal satisfaction compared with the sham control of viewing the maternal face; however, the time to delivery was not significantly shortened.

Eye-masks and earplugs compared to headband in nulliparas on increasing spontaneous vaginal delivery: a randomized trial.

BACKGROUND: A majority of pregnant women experience sleep disruption during pregnancy, especially in the third trimester. Lack of sleep is associated with preterm birth, prolonged labor and higher cesarean section rate. Six or less hours of night sleep in the last month of pregnancy is associated with a higher rate of caesarean births. Eye-masks and earplugs compared to headband improve night sleep by 30 or more minutes. We sought to evaluate eye-mask and earplugs compared to sham/placebo headbands on spontaneous vaginal delivery. METHODS: This randomized trial was conducted from December 2019-June 2020. 234 nulliparas, 34-36 weeks' gestation with self-reported night sleep < 6 h were randomized to eye-mask and earplugs or sham/placebo headband (both characterized as sleep aids) to be worn each night to delivery. After two weeks, interim outcome data of the average night sleep duration and the trial sleep related questionnaire was answered through the telephone. RESULTS: Spontaneous vaginal delivery rates were 60/117(51.3%) vs. 52/117(44.4%) RR 1.15 95% CI 0.88-1.51 P = 0.30 for eye-mask and earplugs or headband respectively. At 2-weeks into the intervention period, the eye-mask and earplugs arm reported longer night sleep duration 7.0 ± 1.2 vs. 6.6 ± 1.5 h P = 0.04, expressed increased satisfaction with the allocated aid 7[6.0-8.0] vs. 6[5.0-7.5] P < 0.001, agreed they slept better 87/117(74.4%) vs. 48/117(41.0%) RR 1.81 95% CI 1.42-2.30 NNTb 4 (2.2-4.7) P < 0.001 and higher compliance median[interquartile range] 5[3-7] vs. 4[ 2-5] times per week of sleep aid use P = 0.002. CONCLUSION: Eye-mask and earplugs use at home in late third trimester do not increase the spontaneous vaginal delivery rate even though self-reported night sleep duration, sleep quality, satisfaction and compliance with allocated sleep aid were significantly better than for sham/placebo headband. Trial registration This trial was registered with ISRCTN on June 11, 2019 with trial identification number: ISRCTN99834087 .

Early versus delayed amniotomy with immediate oxytocin after Foley catheter cervical ripening in multiparous women with labor induction: A randomized controlled trial.

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.

HbA1c at term delivery and adverse pregnancy outcome.

BACKGROUND: There are no obvious thresholds at which the risk of adverse pregnancy outcomes increases as a result of maternal hyperglycemia. HbA1c level which is representative of average blood glucose levels over the last 2-3 months is not as strongly predictive of adverse outcome compared to blood glucose values of oral glucose tolerance test. Data is sparse on the predictive value of HbA1c at term just prior to delivery on adverse outcome. We sought to evaluate HbA1c taken on admission for delivery at term on adverse outcomes of Cesarean delivery and large (≥ 90th centile) for gestational age (LGA) infants. METHODS: A prospective cross-sectional study was conducted in a university hospital in Malaysia from December 2017-August 2018. 1000 women at term whose deliveries were imminent were enrolled. Blood were drawn and immediately sent for HbA1c analysis at our hospital laboratory. Primary outcomes were Cesarean delivery and LGA. RESULTS: On crude analyses, Cesarean births (vs. vaginal births) were associated with significantly higher HbA1c (%) levels 5.4[5.2-5.7] vs. 5.3[5.1-5.6] P = < 0.001 but not for LGA vs. non-LGA 5.4[5.1-5.6] vs. 5.3[5.1-5.6] P = 0.17. After controlling for significant confounders identified on crude analysis (diabetes in pregnancy, parity, ethnicity, body mass index (BMI), previous cesarean, labor induction, Group B streptococcus (GBS) carriage and birth weight), HbA1c is independently predictive of Cesarean birth, adjusted odds ratio (AOR) 1.47 95% CI 1.06-2.06 P = 0.023 per HbA1c 1% increase. Following adjustment for significant confounders (BMI, predelivery anemia [hemoglobin < 11 g/dl] and GBS carriage), the impact of raised HbA1c level on LGA is AOR 1.43 95% CI 0.93-2.18 P = 0.101 per HbA1c 1% increase and non-significant. CONCLUSION: Raised HbA1c level at term births in the general pregnant population is independently predictive of Cesarean delivery after adjustment for potential confounders including diabetes in pregnancy.

Three Days Compared to One Day Per Week of Self-Monitoring of Blood Glucose in Mild Gestational Diabetes: A Randomized Trial.

Background: The International Diabetes Federation estimates that 16.2% of livebirths in 2017 were affected by hyperglycemia in pregnancy, with 85.1% due to gestational diabetes mellitus (GDM). Daily blood glucose monitoring compared with alternate day testing in mild GDM is associated with similar pregnancy outcomes. Data are sparse on the ideal frequency for self-monitoring of blood glucose (SMBG) in mild GDM for glycemic control. A higher HbA1c at late pregnancy is associated with adverse pregnancy outcomes. We sought to evaluate three days compared to one day per week of four-point self-monitoring of blood glucose (SMBG) in gestational diabetes mellitus (GDM) controlled by lifestyle changes for glycemic control. Methods: This randomized trial was conducted from February−December 2018. A total of 106 women with lifestyle-controlled GDM were randomized to three days (SMBG3) or one day (SMBG1) per week of four-point (fasting and two-hours post-meal) SMBG. The primary outcome was the change in the HbA1c level at recruitment and 36-weeks gestation within and across trial arms. The student t-test was used for between-arm analyses and a paired t-test for within-arm analyses. Results: The HbA1c level through pregnancy increased significantly in both trial arms: mean increase of 0.21% ± 0.26%, p < 0.001 (SMBG3), and 0.19% ± 0.24%, p < 0.001 (SMBG1), but the 0.02% difference across trial arms was not significant (p = 0.79). Maternal weight gain (3.1 ± 2.1 kg vs. 3.3 ± 3.0 kg, p = 0.72), cesarean delivery (24/52 (48%) vs. 23/53 (43%), RR 1.06, 95% CI: 0.69−1.62, p = 0.77), neonatal birthweight (3.1 ± 0.4 kg vs. 3.0 ± 0.4 kg, p = 0.53) and neonatal intensive care unit admission (4/52 (8%) vs. 3/53 (6%), RR 1.36, 95% CI: 0.32−5.78, p = 0.68) were not significantly different for SMBG3 vs. SMBG1, respectively. Other maternal and neonatal secondary outcomes were not significantly different. Conclusion: In mild GDM, three days compared to one day per week showed a similar HbA1c levels change at 36-weeks gestation. Maternal and neonatal outcomes were also not significantly different. Less frequent monitoring of SMBG as a standard of care in mild GDM deserves further study and consideration.

Early versus delayed amniotomy with immediate oxytocin after Foley catheter cervical ripening in nulliparous labor induction: A randomized trial.

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.

Combined perineal massage and warm compress compared to massage alone during active second stage of labour in nulliparas: A randomised trial.

OBJECTIVE: To evaluate the effect of combined perineal massage and warm compress to the perineum (MassComp) compared to perineal massage alone during pushing in the second stage of labour in reducing perineal trauma requiring suturing in nulliparas. STUDY DESIGN: A randomised trial was performed in a University hospital, Malaysia from June 2020 to May 2021. 281 term nulliparas who were about to start pushing in the second stage of labour were randomised to combined perineal massage and warm compress or perineal massage alone to the perineum. Primary outcome was suturing for perineal injury (episiotomy or tear). The Chi-square test was used to analyse categorical data, Student t test to compare means and distributions for normally distributed continuous data and Mann Whitney U test for appropriate ordinal data. RESULTS: Data from 277 participants (140 MassComp arm, 137 perineal massage alone arm) were analysed based on modified intention to treat basis. Perineal suturing rates were 133/140(95.0%) [MassComp] vs. 128/137(93.4%) [perineal massage alone] RR 1.02(95%CI 0.96-1.08), P = 0.615. Of the secondary outcomes, Likert scale response to recommend allocated treatment to a friend was 103/140(73.6%) vs. 84/137(61.3%) RR 1.20(95%CI 1.02-1.42)NNTb 9(95%CI 4.3-76.4) P = 0.029, participants' satisfaction with care (visual numerical rating scale 0-10) median [interquartile range] 6[6-8] vs. 6[5-8] P = 0.392, intervention to delivery intervals were 25[15-35] vs. 19[14-30] minutes P = 0.012, major perineal injury (episiotomy, second degree or higher tears) rates 116/140(82.9%) vs. 119/137(86.9%) RR 0.95(95%CI 0.86-1.05), P = 0.404, episiotomy rates 97/140(69.3%) vs. 97/140(70.8%) RR 0.98(95%CI 0.84-1.14), P = 0.795, and spontaneous vaginal delivery rates 103/140(73.6%) vs. 106/137(77.4%) RR 0.95(95%CI 0.83-1.09), P = 0.488 for MassComp vs. perineal massage alone respectively. Other maternal and neonatal outcomes were not significantly different. CONCLUSION: Massage and warm compress during pushing did not decrease the likelihood of perineal injury requiring suturing in nulliparas when compared to perineal massage alone. Women were more likely to recommend massage and warm compress during pushing to a friend.

Foley catheter and controlled release dinoprostone versus foley catheter labor induction in nulliparas: a randomized trial.

PURPOSE: To evaluate Foley catheter and controlled release dinoprostone insert compared to foley catheter alone on induction to delivery interval and maternal satisfaction. 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 = < 0.001 but maternal satisfaction on birth experience was not significantly different median[interquartile range] VNRS 8[7-9] vs. 8[7-9], P = 0.12 for Foley catheter-controlled-release dinoprostone and Foley catheter alone arms, respectively. Cesarean delivery rates were 35/102(34.3%) vs. 50/101(49.5%), P = 0.02 RR 0.7 95% CI 0.5-0.9 NNTb 6.3 95% CI 3.5-39.4, pain score at 6 h after catheter insertion 5[2-8] vs. 1[1-3], P < 0.001, Bishop score at trial devices removal 9[9-10] vs. 8[7-9], P = 0.001, requirement for oxytocin induction or augmentation 39/102(38.2%) vs. 76/101(75.2%) NNTb 3 95% CI 2.0-4.1, P < 0.001 and amniotomy rates 73/99(73.7%) vs. 81/95(85.3%), P = 0.052 RR 0.9 85% CI 0.8-1.0 in Foley catheter-controlled-release dinoprostone and Foley catheter alone arms respectively. CONCLUSION: In nulliparas with unripe cervixes at term, combined Foley catheter and controlled release dinoprostone vaginal insert compared to Foley catheter alone reduces the induction to vaginal delivery interval and cesarean delivery rate but satisfaction was not significantly increased. CLINICAL TRIAL REGISTRATION: ISRCTN2282883, 03/12/2018, "prospectively registered" ( https://doi.org/10.1186/ISRCTN12282883 ).

Outpatient vs inpatient Foley catheter induction of labor in multiparas with unripe cervixes: A randomized trial.

INTRODUCTION: Multiparous labor inductions are typically successful, and the process can be rapid, starting from a ripened cervix with a predictable response to amniotomy and oxytocin infusion. Outpatient Foley catheter labor induction in multiparas with unripe cervixes is a feasible option as the mechanical process of ripening is usually without significant uterine contractions and well tolerated. Labor contractions can be initiated by amniotomy and titrated oxytocin infusion in the hospital for well-timed births during working hours as night birth are associated with adverse events. We sought to evaluate outpatient compared with inpatient Foley catheter induction of labor in multiparas for births during working hours and maternal satisfaction. 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.

Induction of labour from 39 weeks in low-risk multiparas with ripe cervixes: A randomised controlled trial.

BACKGROUND: Induction of labour (IOL) in low-risk nulliparas at 39 weeks reduces caesarean delivery. Multiparas with ripe cervixes typically have vaginal delivery within eight hours. Delivery at night and weekend are associated with higher maternal and neonatal mortality. AIMS: To evaluate IOL in full-term multiparas with ripe cervixes to achieve delivery at normal working hours and improve maternal satisfaction. METHODS: A randomised trial was performed in a tertiary hospital in Malaysia. Low-risk multiparas with ripe cervixes (Bishop score ≥6) were recruited at 38+4 -40+0  weeks, then randomised to planned labour induction at 39+0  weeks or expectant care. Primary outcomes were delivery during 'normal working hours' 09:00-17:00 hours, Monday-Friday and patient satisfaction by visual numerical rating scale. RESULTS: For IOL (n = 80) vs expectant care (n = 80) arms respectively, primary outcomes of delivery at normal working hours was 27/80 (34%) vs 29/78 (37%), relative risk (RR) 0.9, 95% CI 0.5-1.7, P = 0.41, patient satisfaction was 8.0 ± 1.8 vs 7.8 ± 1.6, P = 0.41; presentation for spontaneous labour or rupture of membranes were 27/80 (34%) vs 70/79 (89%), RR 0.4, 95% CI 0.3-0.5, P < 0.001; and for labour induction 52/80 (65%) vs 15/79 (19%), RR 3.4, 95% CI 2.1-5.5, P < 0.001. Caesarean delivery was 8/80 (10%) vs 4/79 (5%), RR 2.0, 95% CI 0.62-6.3, P = 0.25; and mean birthweight was 3.1 ± 0.3 vs 3.3 ± 0.4 kg, P = 0.06 for IOL vs expectant care, respectively. CONCLUSION: Labour induction in low-risk multiparas does not increase births during working hours or improve patient satisfaction. Antenatal clinic visits and non-birth hospitalisation were significantly reduced.

Rating of four different foods in women with hyperemesis gravidarum: a randomised controlled trial.

OBJECTIVE: To evaluate four foods in women with hyperemesis gravidarum (HG) on their agreeability and tolerability. DESIGN: Prospective, randomised, within-subject cross-over trial. SETTING: Single-centre, tertiary, university hospital in Malaysia. PARTICIPANTS: 72 women within 24-hour of first admission for HG who were 18 years or above, with confirmed clinical pregnancy of less than 16 weeks' gestation were recruited and analysed. Women unable to consume food due to extreme symptoms, known taste or swallowing disorder were excluded. INTERVENTIONS: Each participant chewed and swallowed a small piece of apple, watermelon, cream cracker and white bread in random order and was observed for 10 min after each tasting followed by a 2 min washout for mouth rinsing and data collection. OUTCOME MEASURES: Primary outcome was food agreeability scored after 10 min using an 11-point 0-10 Visual Numerical Rating Scale (VNRS). Nausea was scored at baseline (prior to tasting) and 2 and 10 min using an 11-point VNRS. Intolerant responses of gagging, heaving and vomiting were recorded. RESULTS: On agreeability scoring, apple (mean±SD 7.2±2.4) ranked highest followed by watermelon (7.0±2.7) and crackers (6.5±2.6), with white bread ranked lowest (6.0±2.7); Kruskal-Wallis H test, p=0.019. Apple had the lowest mean nausea score and mean rank score, while white bread had the highest at both 2 and 10 min; the Kruskal-Wallis H test showed a significant difference only at 10 min (p=0.019) but not at 2 min (p=0.29) in the ranking analyses. The intolerant (gagged, heaved or vomited) response rates within the 10 min study period were apple 3/72 (4%), watermelon 7/72 (10%), crackers 8/72 (11%) and white bread 12/72 (17%): χ2 test for trend p=0.02. CONCLUSION: Sweet apple had the highest agreeability score, the lowest nausea severity and intolerance-emesis response rate when tasted by women with HG. White bread consistently performed worst.

Prophylactic metformin after antenatal corticosteroids (PROMAC): a double blind randomized controlled trial.

BACKGROUND: Antenatal corticosteroids (ACS) are increasingly used to improve prematurity-related neonatal outcome. A recognized and common adverse effect from administration of antenatal corticosteroid is maternal hyperglycemia. Even normal pregnancy is characterized by relative insulin resistance and glucose intolerance. Treatment of maternal hyperglycemia after ACS might be indicated due to the higher risk of neonatal acidosis which may coincide with premature birth. Metformin is increasingly used to manage diabetes mellitus during pregnancy as it is effective and more patient friendly. There is no data on prophylactic metformin to maintain euglycemia following antenatal corticosteroids administration. METHODS: A double blind randomized trial. 103 women scheduled to receive two doses of 12-mg intramuscular dexamethasone 12-hour apart were separately randomized to take prophylactic metformin or placebo after stratification according to their gestational diabetes (GDM) status. First oral dose of allocated study drug was taken at enrolment and continued 500 mg twice daily for 72 hours if not delivered. Six-point blood sugar profiles were obtained each day (pre- and two-hour post breakfast, lunch and dinner) for up to three consecutive days. A hyperglycemic episode is defined as capillary glucose fasting/pre-meal ≥ 5.3 mmol/L or two-hour post prandial/meal ≥ 6.7 mmol/L. Primary outcome was hyperglycemic episodes on Day-1 (first six blood sugar profile points) following antenatal corticosteroids. RESULTS: Number of hyperglycemic episodes on the first day were not significantly different (mean ± standard deviation) 3.9 ± 1.4 (metformin) vs. 4.1 ± 1.6 (placebo) p = 0.64. Hyperglycemic episodes markedly reduced on second day in both arms to 0.9 ± 1.0 (metformin) vs. 1.2 ± 1.0 (placebo) p = 0.15 and further reduced to 0.6 ± 1.0 (metformin) vs. 0.7 ± 1.0 (placebo) p = 0.67 on third day. Hypoglycemic episodes during the 3-day study period were few and all other secondary outcomes were not significantly different. CONCLUSIONS: In euglycemic and diet controllable gestational diabetes mellitus women, antenatal corticosteroids cause sustained maternal hyperglycemia only on Day-1. The magnitude of Day-1 hyperglycemia is generally low. Prophylactic metformin does not reduce antenatal corticosteroids' hyperglycemic effect. TRIAL REGISTRATION: The trial is registered in the ISRCTN registry on May 4 2017 with trial identifier https://doi.org/10.1186/ISRCTN10156101 .

Glycemic control following two regimens of antenatal corticosteroids in mild gestational diabetes: a randomized controlled trial.

PURPOSE: To compare 3 consecutive days of hyperglycemic response following antenatal dexamethasone regimens of 12-mg or 6-mg doses 12 hourly in diet-controlled gestational diabetes. 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 < 0.01) and gestational age at delivery (37.7 vs. 36.6 weeks p = 0.03) were higher and median delivery blood loss (300 vs. 400 ml p = 0.02) was lower in the 12-mg arm; all other secondary outcomes were not significantly different. CONCLUSION: In gestational diabetes, 2 × 12-mg could be preferred over 4 × 6-mg dexamethasone as hyperglycemic episodes were fewer on Day-2, fewer injections were needed and the regimen was completed sooner. CLINICAL TRIAL REGISTRATION: http://www.isrctn.com/ISRCTN16613220 .

Combined massage and warm compress to the perineum during active second stage of labor in nulliparas: A randomized trial.

OBJECTIVE: To evaluate the combined effect of massage and warm compress to the perineum (MassComp) compared with standard "hands-off" in the second stage of labor. METHODS: A randomized trial was conducted in a University hospital in Malaysia. Nulliparous women at term who were about to start pushing were randomized to massage during pushing and warm compress to the perineum in between pushes or to standard "hands-off" care. Primary outcome was suturing for perineal injury (episiotomy or tear). RESULTS: A total of 156 participants were analyzed based on intention to treat. Perineal repair rates were 53/79 (67%) for MassComp versus 70/77 (91%) for control (relative risk [RR] 0.72, 95% confidence interval [CI] 0.61-0.98, number needed to treat for an additional beneficial outcome [NNTb ] 5, 95% CI 2.83-8.62, P < 0.001). Of the secondary outcomes, participants' satisfaction with care (visual numerical rating scale 0-10; 8.3 ± 1.2 vs 7.8 ± 1.2, P = 0.014), major perineal injury (second degree or higher) rates 34/79 (43%) versus 51/77 (66%) (RR 0.72, 95% CI 0.58-0.97, NNTb 5, 95% CI 2.61-12.56, P = 0.004), episiotomy rates 28/79 (37%) versus 40/77 (53%) (RR 0.72, 95% CI 0.52-0.98, NNTb 8, 95% CI 3.63-36.46, P = 0.043), intervention to delivery intervals 29.5 ± 13.6 versus 27.9 ± 13.8 minutes (P = 0.472) and spontaneous vaginal delivery rates 63/79 (79.7%) versus 56/77 (72.7%) (RR 1.11, 95% CI 0.92-1.34, P = 0.306) for MassComp versus control, respectively. CONCLUSION: Massage and warm compress during pushing decreased the perineal suturing, major perineal injury, and episiotomy rates and improved maternal satisfaction. CLINICAL TRIAL REGISTRATION: https://doi.org/10.1186/ISRCTN42773879.