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Introduction: Our objective was to compare the performance of the first vaginal examination at 8 vs 4 h after amniotomy following Foley ripening in nulliparous labor induction., Material and Methods: A randomized controlled trial was conducted from June 2021 to January 2022. 210 nulliparas at term for labor induction were randomized: 105 each to first vaginal examination at 8 or 4 h after Foley balloon ripening and amniotomy. Titrated oxytocin infusion was routinely commenced after amniotomy to expedite labor. Primary outcomes were the amniotomy-to-delivery interval (non-inferiority hypothesis) and maternal satisfaction with their allocated labor care (superiority hypothesis) within 24 h after delivery. Analyses performed using t-test, Mann-Whitney U test, and Chi-squared test as appropriate., Results: The amniotomy-to-delivery interval was mean ± standard deviation 8.7 ± 3.4 vs 8.4 ± 3.7, mean difference 0.4 (97.5% CI: -0.7 to 1.5) hours, p = 0.442 within the pre-specified 2-hour non-inferiority margin, and maternal satisfaction score with allocated labor care was median [interquartile range] 8[7.5-10] vs 8[7.0-10], p = 0.248 for 8 vs 4 h arms, respectively. The amniotomy to first vaginal examination intervals was 5.9 ± 2.3 vs 3.6 ± 1.0 h, p < 0.001, and the number of vaginal examinations was 2[1-2.5] vs 3 [2, 3], p < 0.001 for 8 vs 4 h, respectively. The first vaginal examination was less likely to have been performed as scheduled, more likely to be indicated by the urge to bear down, and non-reassuring cardiotocography for the 8 h arm (p < 0.001). Spontaneous vaginal delivery was significantly more likely and instrumental vaginal delivery less likely, but cesarean rate was not significantly different for the 8 h arm (p = 0.017)., Conclusions: A routine first vaginal examination at 8 h compared to 4 h is non-inferior for the time to birth but does not increase maternal satisfaction although the number of vaginal examinations is fewer. The increase in spontaneous vaginal delivery and reduction in instrumental vaginal delivery rates warrant further powered primary evaluation., (© 2024 The Author(s). Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).)

Introduction: The aim of this study was to evaluate the association between placental abnormalities, placental biomarkers, and fetoplacental Dopplers in a cohort of pregnancies complicated by fetal growth restriction (FGR). We also ascertained the risk of perinatal mortality, severe neurological morbidity, and severe non-neurological morbidity by type of placental abnormality., Methods: This was a prospective cohort study. Multivariable logistic regression was used to evaluate the effect of early vs. late FGR, placental biomarkers and fetoplacental Dopplers on Maternal Vascular Malperfusion (MVM) which was the commonest placental abnormality identified., Results: There were 161 (53.5 %) early FGR and 140 (46.5 %) late FGR cases. MVM abnormalities were present in 154 (51.2 %), VUE in 45 (14.6 %), FVM in 16 (5.3 %), DVM in 14 (4.7 %) and CHI in 4 (1.3 %) cases. The odds of MVM were higher in early compared to late FGR cohort (OR 1.89, 95%CI 1.14, 3.14, p = 0.01). Low maternal PlGF levels <100 ng/L (OR 2.34, 95%CI 1.27,4.31, p = 0.01), high sFlt-1 level (OR 2.13, 95%CI 1.35, 3.36, p = 0.001) or elevated sFlt-1/PlGF ratio (OR 3.48, 95%CI 1.36, 8.91, p = 0.01) were all associated with MVM. Increased UA PI > 95th centile (OR 2.91, 95%CI 1.71, 4.95, p=<0.001) and mean UtA PI z-score (OR 1.74, 95%CI 1.15, 2.64, p = 0.01) were associated with higher odds of MVM. Rates of severe non-neurological morbidity were highest in the MVM, FVM, and CHI cohorts (44.8 %, 50 %, and 50 % respectively)., Conclusion: MVM was the commonest placental abnormality in FGR, particularly in early-onset disease. Low maternal PlGF levels, high sFlt-1 levels, elevated sFlt-1/PlGF ratio, and abnormal fetoplacental Dopplers were also significantly associated with MVM. MVM, FVM, and CHI abnormalities were associated with lower median birthweight, higher rates of preterm birth, operative birth for non-reassuring fetal status, and severe neonatal non-neurological morbidity., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this article., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

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.

Objective: To compare insertion failure rates for Pipelle endometrial sampling with a full bladder compared with the standard process (not taking into account bladder status) without cervical manipulation., Methods: A single-masked randomized trial was conducted in a single tertiary care center from July 2021 to January 2022. Two hundred fourteen participants aged 18 years or older who were scheduled for outpatient Pipelle endometrial sampling were randomized: 107 each to having a full bladder (by oral water intake) or standard process (without delayed sampling and bladder status not taken into account). Women with known cervical stenosis, gynecologic malignancy, uterine anomalies, leiomyoma distorting the uterine cavity, acute cervicitis, urge bladder dysfunction, intense anxiety, need for anesthesia or analgesic before the procedure, positive pregnancy test, or previous failed office endometrial sampling were excluded. The primary outcome was the insertion failure rate of endometrial sampling at first attempt. Secondary outcomes were pain during procedure, satisfaction score, analgesia use, procedure duration, and need for cervical manipulation. Factoring in a baseline insertion failure rate of 30.0%, relative risk of 0.45, α of 0.05, 80.0% power, and a dropout rate of 10.0%, we needed 107 participants in each arm., Results: The insertion failure rate was significantly lower in the full bladder group compared with standard process: 25 of 107 (23.4%) compared with 45 of 107 (42.1%) (relative risk 0.56, 95% CI, 0.37-0.84; number needed to treat to benefit 6.0, 95% CI, 3.20-15.70). Pain score (median) during the procedure (interquartile range) was 4 (3-6) compared with 5 (3-8) ( P =.004); patient satisfaction score was 8 (7-9) compared with 7 (4-8) ( P <.001); and mean±SD procedure duration was 3.0±2.4 compared with 4.7±2.9 minutes ( P <.001) for the full bladder and standard process arm, respectively. Other secondary outcomes of cervical laceration, analgesia use, and adequacy of endometrial tissue for histopathologic assessment were not significantly different between groups., Conclusion: Pipelle endometrial sampling with a full bladder reduces the initial insertion failure rate, procedure-related pain, and duration of sampling and increases patient satisfaction compared with the standard process., Clinical Trial Registration: ISRCTN, ISRCTN33938192., Competing Interests: Financial Disclosure The authors did not report any potential conflicts of interest., (Copyright © 2024 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To assess the utility of placental growth factor (PlGF) levels and the soluble fms-like tyrosine kinase-1/placental growth factor (sFlt-1/PlGF) ratio to predict preterm birth (PTB) for infants with fetal growth restriction (FGR) and those appropriate for gestational age (AGA)., Design: Prospective, observational cohort study., Setting: Tertiary maternity hospital in Australia., Population: There were 320 singleton pregnancies: 141 (44.1%) AGA, 83 (25.9%) early FGR (<32 +0  weeks) and 109 (30.0%) late FGR (≥32 +0  weeks)., Methods: Maternal serum PlGF and sFlt-1/PlGF ratio were measured at 4-weekly intervals from recruitment to delivery. Low maternal PlGF levels and elevated sFlt-1/PlGF ratio were defined as <100 ng/L and >5.78 if <28 weeks and >38 if ≥28 weeks respectively. Cox proportional hazards models were used. The analysis period was defined as the time from the first measurement of PlGF and sFlt-1/PlGF ratio to the time of birth or censoring., Main Outcome Measures: The primary study outcome was overall PTB. The relative risks (RR) of birth within 1, 2 and 3 weeks and for medically indicated and spontaneous PTB were also ascertained., Results: The early FGR cohort had lower median PlGF levels (54 versus 229 ng/L, p < 0.001) and higher median sFlt-1 levels (2774 ng/L versus 2096 ng/L, p < 0.001) and sFlt-1/PlGF ratio higher (35 versus 10, p < 0.001). Both PlGF <100 ng/L and elevated sFlt-1/PlGF ratio were strongly predictive for PTB as well as PTB within 1, 2 and 3 weeks of diagnosis. For both FGR and AGA groups, PlGF <100 ng/L or raised sFlt-1/PlGF ratio were strongly associated with increased risk for medically indicated PTB. The highest RR was seen in the FGR cohort when PlGF was <100 ng/L (RR 35.20, 95% CI 11.48-175.46)., Conclusions: Low maternal PlGF levels and elevated sFlt-1/PlGF ratio are potentially useful to predict PTB in both FGR and AGA pregnancies., (© 2024 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)

Introduction: To assess the rate of change in soluble fms-like tyrosine kinase-1/placental growth factor (sFlt-1/PlGF) ratio and PlGF levels per week compared to a single sFlt-1/PlGF ratio or PlGF level to predict preterm birth for pregnancies complicated by fetal growth restriction., Material and Methods: A prospective cohort study of pregnancies complicated by isolated fetal growth restriction. Maternal serum PlGF levels and the sFlt-1/PlGF ratio were measured at 4-weekly intervals from recruitment to delivery. We investigated the utility of PlGF levels, sFlt-1/PlGF ratio, change in PlGF levels per week or sFlt-1/PlGF ratio per week. Cox-proportional hazard models and Harrell's C concordance statistic were used to evaluate the effect of biomarkers on time to preterm birth., Results: The total study cohort was 158 pregnancies comprising 91 (57.6%) with fetal growth restriction and 67 (42.4%) with appropriate for gestational age controls. In the fetal growth restriction cohort, sFlt-1/PlGF ratio and PlGF levels significantly affected time to preterm birth (Harrell's C: 0.85-0.76). The rate of increase per week of the sFlt-1/PlGF ratio (hazard ratio [HR] 3.91, 95% confidence interval [CI]: 1.39-10.99, p = 0.01, Harrell's C: 0.74) was positively associated with preterm birth but change in PlGF levels per week was not (HR 0.65, 95% CI: 0.25-1.67, p = 0.37, Harrell's C: 0.68)., Conclusions: Both a high sFlt-1/PlGF ratio and low PlGF levels are predictive of preterm birth in women with fetal growth restriction. Although the rate of increase of the sFlt-1/PlGF ratio predicts preterm birth, it is not superior to either a single elevated sFlt-1/PlGF ratio or low PlGF level., (© 2024 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).)

Background: The aim of this study was to detail incidence rates and relative risks for severe adverse perinatal outcomes by birthweight centile categories in a large Australian cohort of late preterm and term infants., Methods: This was a retrospective cohort study of singleton infants (≥34 +0 weeks gestation) between 2000 and 2018 in Queensland, Australia. Study outcomes were perinatal mortality, severe neurological morbidity, and other severe morbidity. Categorical outcomes were compared using Chi-squared tests. Continuous outcomes were compared using t-tests. Multinomial logistic regression investigated the effect of birthweight centile on study outcomes., Findings: The final cohort comprised 991,042 infants. Perinatal mortality occurred in 1944 infants (0.19%). The incidence and risk of perinatal mortality increased as birthweight decreased, peaking for infants <1st centile (perinatal mortality rate 13.2/1000 births, adjusted Relative Risk Ratio (aRRR) of 12.96 (95% CI 10.14, 16.57) for stillbirth and aRRR 7.55 (95% CI 3.78, 15.08) for neonatal death). Severe neurological morbidity occurred in 7311 infants (0.74%), with the highest rate (19.6/1000 live births) in <1st centile cohort. There were 75,243 cases of severe morbidity (7.59% livebirths), with the peak incidence occurring in the <1st centile category (12.3% livebirths). The majority of adverse outcomes occurred in infants with birthweights between 10 and 90th centile. Almost 2 in 3 stillbirths, and approximately 3 in 4 cases of neonatal death, severe neurological morbidity or other severe morbidity occurred within this birthweight range., Interpretation: Although the incidence and risk of perinatal mortality, severe neurological morbidity and severe morbidity increased at the extremes of birthweight centiles, the majority of these outcomes occurred in infants that were apparently "appropriately grown" (i.e., birthweight 10th-90th centile)., Funding: National Health and Medical Research Council, Mater Foundation, Royal Australian College of Obstetricians and Gynaecologists Women's Health Foundation - Norman Beischer Clinical Research Scholarship, Cerebral Palsy Alliance, University of Queensland Research Scholarship., Competing Interests: The authors report no conflict of interest., (© 2024 The Author(s).)

Background: Vaginal examination to monitor labor progress is recommended at least every 4 hours, but it can cause pain and embarrassment to women. Trial data are limited on the best intensity for vaginal examination. Vaginal examination is not needed for oxytocin dose titration after an amniotomy has been performed and oxytocin infusion started. The Foley balloon commonly ripens the cervix without strong contractions. Amniotomy and oxytocin infusion are usually required to drive labor., 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<.001). For the 8-hour arm, the first vaginal examination was less likely to be as scheduled and more likely to be indicated by sensation to bear down (P<.001), and the epidural analgesia rates were lower (13/102 participants [12.7%] in the 8-hour arm vs 28/102 participants [27.5%] in the 4-hour arm; relative risk, 0.46; 95% confidence interval, 0.26-0.84; P=.009). Other outcomes of the mode of delivery, indications for cesarean delivery, and delivery blood loss were not different. Neonatal outcomes were not different., Conclusion: Routine first vaginal examination at 8 hours compared with that at 4 hours was noninferior for the time to birth but did not improve maternal satisfaction., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objectives: To evaluate expectant compared to immediate return to hospital upon outpatient Foley catheter expulsion predicated on maternal satisfaction and amniotomy-titrated oxytocin infusion to delivery interval., Methods: This randomized trial was conducted in a tertiary university hospital in Malaysia from September 2020 to February 2022. A total of 330 nulliparous women at term with unripe cervices (Bishop score ≤5), singleton viable fetus in cephalic presentation, reassuring preinduction fetal heart rate tracing and intact membranes who underwent planned outpatient Foley catheter induction of labor (IOL) were included. Women were randomized to expectant or immediate return to hospital if the Foley was spontaneously expelled at home before their scheduled hospital admission the following day. Primary outcomes were amniotomy-titrated oxytocin infusion to delivery interval and maternal satisfaction on the induction process (assessed by 0-10 visual numerical rating scale [VNRS])., Results: Amniotomy-titrated oxytocin infusion to delivery interval was 8.7 ± 4.1 versus 8.9 ± 3.9 h, P = 0.605 (mean difference - 0.228 95% CI: -1.1 to +0.6 h) and maternal satisfaction VNRS score was median (interquartile range) 8 (7-9) versus 8 (7-9), P = 0.782. Early return to hospital rates were 37/165 (22.4%) versus 72/165 (43.6%), RR 0.51 (95% CI: 0.37-0.72), P ≤ 0.001, Cesarean delivery rates were 80/165 (48.5%) versus 80/165 (48.5%), RR 1.00 (95% CI: 0.80-1.25), P = 1.00 and duration of hospital stay was 54.4 ± 22.9 versus 56.7 ± 22.8 h, P = 0.364 for the expectant versus immediate return groups respectively., Conclusion: In outpatient Foley catheter IOL, expectant compared to immediate return to hospital following Foley dislodgement results in similarly high maternal satisfaction. The amniotomy-titrated oxytocin to delivery duration is non-inferior with expectant management., (© 2023 International Federation of Gynecology and Obstetrics.)

Background Preterm birth (PTB) is defined as neonates that are born alive >22 weeks of gestation and <37 weeks of gestation. Because of the immaturity of different organ systems, 14.84 million newborns worldwide are born prematurely, which is the largest contributing factor to mortality and morbidity. Although studies have been conducted in this field, the magnitude of PTB is a major issue in most developing countries including Malaysia. Objective To assess the prevalence of PTB and the perinatal outcome among women delivered in a tertiary university hospital in Malaysia.  Methods This was a cross-sectional study evaluating all singleton live births weighing>500g and delivered at >22 +1  weeks of gestation between January 2015 and December 2019 in Universiti Malaya Medical Centre (UMMC), Kuala Lumpur, Malaysia. Data were collected from the hospital's recorded birth registry. The primary outcome was the PTB rate. Data were entered and analysed using Statistical Product and Service Solutions (SPSS) (version 28.0; IBM SPSS Statistics for Windows, Armonk, NY). Results A total of 26,022 singleton live births were reported for the period 2015-2019. PTB rates showed a sharp 6% decrease from 2015 to 2016, after which the trend was inconsistent until 2019. The risk of preterm babies being admitted to the neonatal intensive care unit (NICU) or the ward compared to the risk of neonatal mortality increases for babies of identified sex, delivered via caesarean, and with a birth weight between 2 and 3 kgs. Babies born at a gestational age between 22 +1  and 33 +6  have a higher risk of neonatal mortality compared to late preterm babies. Conclusions The PTB incidence trend was inconsistent from 2015 to 2019 in a tertiary university hospital in Malaysia, with a far higher prevalence compared to national data. The high NICU admission and mortality rates among preterm infants mean urgent strategies and policies are needed to improve perinatal outcomes., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2024, Mohamed Rasheed et al.)

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., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: The aim of this study was to ascertain risks of neonatal mortality, severe neurological morbidity and severe non-neurological morbidity related to the 5-min Apgar score in early term (37 +0 -38 +6 weeks), full term (39 +0 -40 +6 weeks), late term (41 +0 -41 +6 weeks), and post term (≥42 +0 weeks) infants., Methods: This was a retrospective cohort study of 941,221 term singleton births between 2000 and 2018 in Queensland, Australia. Apgar scores at 5-min were categorized into five groups: Apgar 0 or 1, 2 or 3, 4-6, 7 or 8 and 9 or 10. Gestational age was stratified into 4 groups: Early term, full term, late term and post term. Three specific neonatal study outcomes were considered: 1) Neonatal mortality 2) Severe neurological morbidity and 3) Severe non-neurological morbidity. Poisson multivariable regression models were used to determine relative risk ratios for the effect of gestational age and Apgar scores on these severe neonatal outcomes. We hypothesized that a low Apgar score of <4 was significantly associated with increased risks of neonatal mortality, severe neurological morbidity and severe non-neurological morbidity., Findings: Of the study cohort, 0.04% (345/941,221) were neonatal deaths, 0.70% (6627/941,221) were infants with severe neurological morbidity and 4.3% (40,693/941,221) had severe non-neurological morbidity. Infants with Apgar score <4 were more likely to birth at late term and post term gestations and have birthweights <3rd and <10th percentiles. The adjusted relative risk ratios (aRRR) for neonatal mortality and severe neurological morbidity were highest in the Apgar 0 or 1 cohort. For infants in the Apgar 0 or 1 group, neonatal mortality increased incrementally with advancing term gestation: early term (aRRR 860.16, 95% CI 560.96, 1318.94, p < 0.001); full term (aRRR 1835.77, 95% CI 1279.48, 2633.91, p < 0.001); late term (aRRR 1693.61, 95% CI 859.65, 3336.6, p < 0.001) and post term (aRRR 2231.59, 95% CI 272.23, 18293.07, p < 0.001) whilst severe neurological morbidity decreased as gestation progressed: early term (aRRR 158.48, 95% CI 118.74, 211.51, p < 0.001); full term (aRRR 112.99, 95% CI 90.56, 140.98, p < 0.001); late term (aRRR 87.94, 95% CI 67.09, 115.27, p < 0.001) and post term (aRRR 52.07, 95% CI 15.17, 178.70, p < 0.001). Severe non-neurological morbidity was greatest in the full term, Apgar 2-3 cohort (aRRR 7.36, 95% CI 6.2, 8.74, p < 0.001)., Interpretation: A 5-min Apgar score of <4 was prognostic of neonatal mortality, severe neurological morbidity, and severe non-neurological morbidity in infants born >37 weeks' gestation with the risk greatest in the early term cohort., Funding: National Health and Medical Research Council and Mater Foundation., Competing Interests: None., (© 2024 The Authors.)

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 ± SD) 23 ± 41 minutes, p < .001, and AL 10 ± 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 ± SD) -2.0 ± 2.5, p < .001, but not with AL -0.3 ± 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., (© The Author(s) 2023. Published by Oxford University Press on behalf of Sleep Research Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Many risk factors for stillbirth are linked to placental dysfunction, which leads to suboptimal intrauterine growth and small for gestational age infants. Such infants also have an increased risk for stillbirth., Objective: This study aimed to investigate the effect of known causal risk factors for stillbirth, and to identify those that have a large proportion of their risk mediated through small for gestational age birth., Study Design: This retrospective cohort study used data from all births in the state of Queensland, Australia between 2000 and 2018. The total effects of exposures on the odds of stillbirth were determined using multivariable, clustered logistic regression models. Mediation analysis was performed using a counterfactual approach to determine the indirect effect and percentage of effect mediated through small for gestational age. For risk factors significantly mediated through small for gestational age, the relative risks of stillbirth were compared between small for gestational age and appropriate for gestational age infants. We also investigated the proportion of risk mediated via small for gestational age for late stillbirths (≥28 weeks)., Results: The initial data set consisted of 1,105,612 births. After exclusions, the final study cohort constituted 925,053 births. Small for gestational age births occurred in 9.9% (91,859/925,053) of the study cohort. Stillbirths occurred in 0.5% of all births (4234/925,053) and 1.5% of small for gestational age births (1414/91,859). Births at ≥28 weeks occurred in 99.4% (919,650/925,053) of the study cohort and in 98.9% (90,804/91,859) of all small for gestational age births. Of the ≥28-week births, stillbirths occurred in 0.2% (2156/919,650) of all births and 0.8% (677/90,804) of the small for gestational age births. Overall, increased odds of stillbirth were significantly mediated through small for gestational age for age <20 years, low socioeconomic status, Indigenous ethnicity, birth in sub-Saharan and North Africa or the Middle East, smoking, nulliparity, multiple pregnancy, assisted conception, previous stillbirth, preeclampsia, and renal disease. Preeclampsia had the largest proportion mediated through small for gestational age (66.7%), followed by nulliparity (61.6%), smoking (29.4%), North-African or Middle Eastern ethnicity (27.6%), multiple pregnancy (26.3%), low socioeconomic status (25.8%), and Indigenous status (18.7%). Sensitivity analysis showed that for late stillbirths, the portions mediated through small for gestational age remained very similar for many of the risk factors., Conclusion: Although small for gestational age is an important mediator between many pregnancy risk factors and stillbirth, mitigating the risk of small for gestational age is likely to be of value only when it is a major contributor in the pathway to fetal demise., (Copyright © 2023 Elsevier Inc. All rights reserved.)

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., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objective: To evaluate 4-point per day self-monitoring of blood glucose (SMBG) every 2 weeks compared with every week., Methods: A total of 104 patients with lifestyle-controlled gestational diabetes (GDMA1) were randomized to 2-weekly or weekly 4-point per day (fasting on awakening and 2-h post-meals) SMBG. Primary outcome was the change in glycated hemoglobin (HbA1c) level from enrollment to 36 weeks of pregnancy across trial arms. The non-inferiority margin was an HbA1c increase of 0.2%., Results: The mean difference for change in HbA1c from enrollment to 36 weeks was 0.003% (95% confidence interval [CI] -0.098% to +0.093%), within the 0.2% non-inferiority margin. The change in HbA1c level increased significantly within both trial arms-0.275% ± 0.241% (P < 0.001) in 2-weekly arm versus 0.277% ± 0.236% (P < 0.001) in the weekly arm. Participants randomized to 2-weekly SMBG were significantly less likely to receive anti-glycemic treatment-5/52 (9.6%) versus 14/50 (28.0%) (relative risk 0.34, 95% CI 0.13-0.88; P = 0.017). All secondary outcomes-maternal weight gain, preterm delivery, cesarean delivery, birthweight, and neonatal admission-were not significantly different., Conclusions: In GDMA1, 2-weekly is non-inferior to weekly SMBG on the change in HbA1c level. Two-weekly SMBG appeared to be adequate for monitoring women with GDMA1., Clinical Trial Registration: This study was registered in ISRCTN registry on March 25, 2022 with trial identification number: ISRCTN13404790 (https://doi.org/10.1186/ISRCTN13404790). The first participant was recruited on April 12, 2022., (© 2023 International Federation of Gynecology and Obstetrics.)

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., (Copyright © 2023 Elsevier Inc. All rights reserved.)

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., (Copyright © 2023 Elsevier Inc. All rights reserved.)

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., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Determining the optimal time of birth at term is challenging given the ongoing risks of stillbirth with increasing gestation vs the risks of significant neonatal morbidity at early-term gestations. These risks are more pronounced in small infants., Objective: This study aimed to evaluate the risks of stillbirth, neonatal mortality, and severe neonatal morbidity by comparing expectant management with delivery from 37 +0 weeks of gestation., Study Design: This was a retrospective cohort study evaluating women with singleton, nonanomalous pregnancies at 37 +0 to 40 +6 weeks' gestation in Queensland, Australia, delivered from 2000 to 2018. Rates of stillbirth, neonatal death, and severe neonatal morbidity were calculated for <3rd, 3rd to <10th, 10th to <25th, 25th to <90th, and ≥90th birthweight centiles. The composite risk of mortality with expectant management for an additional week in utero was compared with rates of neonatal mortality and severe neonatal morbidity., Results: Of 948,895 singleton, term nonanomalous births, 813,077 occurred at 37 +0 to 40 +6 weeks' gestation. Rates of stillbirth increased with gestational age, with the highest rate observed in infants with birthweight below the third centile: 10.0 per 10,000 (95% confidence interval, 6.2-15.3) at 37 +0 to 37 +6 weeks, rising to 106.4 per 10,000 (95% confidence interval, 74.6-146.9) at 40 +0 to 40 +6 weeks' gestation. The rate of neonatal mortality was highest at 37 +0 to 37 +6 weeks for all birthweight centiles. The composite risk of expectant management rose sharply after 39 +0 to 39 +6 weeks, and was highest in infants with birthweight below the third centile (125.2/10,000; 95% confidence interval, 118.4-132.3) at 40 +0 to 40 +6 weeks' gestation. Balancing the risk of expectant management and delivery (neonatal mortality), the optimal timing of delivery for each birthweight centile was evaluated on the basis of relative risk differences. The rate of severe neonatal morbidity sharply decreased in the period between 37 +0 to 37 +6 and 38 +0 to 38 +6 weeks, particularly for infants with birthweight below the third centile., Conclusion: Our data suggest that the optimal time of birth is 37 +0 to 37 +6 weeks for infants with birthweight <3rd centile and 38 +0 to 38 +6 weeks' gestation for those with birthweight between the 3rd and 10th centile and >90th centile. For all other birthweight centiles, birth from 39 +0 weeks is associated with the best outcomes. However, large numbers of planned births are required to prevent a single excess death. The healthcare costs and acceptability to women of potential universal policies of planned birth need to be carefully considered., (Copyright © 2023 Elsevier Inc. All rights reserved.)

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., (Copyright © 2023 Elsevier Inc. All rights reserved.)

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 NNT b 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 ., (© 2023. The Author(s).)

Fetal growth restriction (FGR) leading to low birth weight (LBW) is a major cause of neonatal morbidity and mortality worldwide. Normal placental development involves a series of highly regulated processes involving a multitude of hormones, transcription factors, and cell lineages. Failure to achieve this leads to placental dysfunction and related placental diseases such as pre-clampsia and FGR. Early recognition of at-risk pregnancies is important because careful maternal and fetal surveillance can potentially prevent adverse maternal and perinatal outcomes by judicious pregnancy surveillance and careful timing of birth. Given the association between a variety of circulating maternal biomarkers, adverse pregnancy, and perinatal outcomes, screening tests based on these biomarkers, incorporating maternal characteristics, fetal biophysical or circulatory variables have been developed. However, their clinical utility has yet to be proven. Of the current biomarkers, placental growth factor and soluble fms-like tyrosine kinase 1 appear to have the most promise for placental dysfunction and predictive utility for FGR., (© 2023 The Author(s).)

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., (© 2022 International Federation of Gynecology and Obstetrics.)

Background Women experience significant sleep disruption throughout pregnancy. Lack of sleep during the last month of pregnancy is associated with longer labor, a higher rate of Cesarean births, gestational diabetes, hypertension, and preterm birth. Eye-mask and earplugs through sensory deprivation increase sleep duration and quality in patients in the intensive care environment but their impact at home or during pregnancy is not known. We sought to evaluate eye-mask and earplugs compared to sham/placebo headbands on night sleep duration in pregnancy. Materials and methods A randomized trial was performed in a university hospital in Malaysia. Nulliparas between 34 and 36 weeks of gestation with self-reported night sleep of fewer than six hours were randomized to the use of eye-mask and earplugs or "sham" headbands during night sleep (both introduced as sleep aids). Night sleep duration was measured through a wrist actigraphy monitor during non-intervention week one and intervention week two with the allocated sleep aid. Results Data from 56 participants were analyzed on an intention-to-treat basis. Mean night sleep duration increased in intervention week two compared to non-intervention week one in both trial arms, which were 279 ± 19 vs. 304 ± 19 minutes (mean increase of 25 minutes) p = <0.001 and 286 ± 21 vs. 302 ± 22 minutes (mean increase of 16 minutes) p = <0.001 for eye-masks-earplugs and headband respectively. However, the mean increase in night sleep duration across trial arms (p=0.13) was not significant. A higher proportion of participants in the eye-masks and earplugs arm had their night sleep duration increased by at least 30 minutes, 13/29 (45%) vs. 5/26 (19%), relative risk (RR) 2.3 (95% CI 1.0-5.6) p = 0.04, more likely to agree that they slept better 19/29 (66%) vs. 7/27 (26%), RR 2.2 (95% CI 1.1-4.6) p = 0.03, expressed higher satisfaction score with their sleep aid 7 (7.0-7.5) vs. 6 (5-7), p = 0.003 and had lower induction of labor rates 4/29 (14%) vs. 12/27 (44%), RR 0.3 (95%CI 0.1-0.8) p = 0.02. Conclusion Eye masks and earplugs use in nulliparas with short night sleep duration in late pregnancy, lengthen their night sleep duration over baseline. Sleep is reportedly better and maternal satisfaction is higher with eye masks and earplugs use., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2022, Teo et al.)

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., (© 2022 International Federation of Gynecology and Obstetrics.)

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 )., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

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 (≥ 90 th 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., (© 2022. The Author(s).)

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.

Objective: To evaluate the impact of preemptive metformin on the level of glycosylated hemoglobin (HbA1c) at 36 weeks of pregnancy in women with gestational diabetes mellitus controlled by diet change (GDMA1)., Methods: A randomized, double-blind, placebo-controlled trial was performed in a university hospital. Women with GDMA1 were recruited at 16-30 weeks of pregnancy and randomized to oral metformin 500 mg twice daily or identical placebo tablets to delivery. Level of HbA1c was taken at recruitment and at 36 weeks of pregnancy. The primary outcome was the change in level of HbA1c at recruitment and 36 weeks of pregnancy., Results: Data from 106 participants were analyzed. The level of HbA1c during pregnancy increased significantly with a mean increase of 0.20% ± 0.31% (P < 0.001; metformin) versus 0.27% ± 0.31% (P < 0.001; placebo). An increment of 0.07% across trial arms was not significant (P = 0.310). Mean birth weight was significantly lower in the metformin group (2.81 ± 0.41 kg vs 2.98 ± 0.37 kg; P = 0.030). Rates of macrosomia (≥3.5 kg; 0/53 [0%] vs 4/53 [8%]; P = 0.123) and low birth weight (<2.5 kg; 11/53 [21%] vs 5/53 [9%]; P = 0.102) were not significantly different., Conclusion: Preemptive metformin did not prevent the level of HbA1c at 36 weeks of pregnancy from rising nor significantly reduce the increase of HbA1c. Mean birth weight was significantly lower in the metformin arm with a non-significant trend to low birth weight, which is concerning., Isrctn: ISRCTN10845466., (© 2021 International Federation of Gynecology and Obstetrics.)

Aim: To explore digital insertion in dorsal recumbent position of 16F, 22F, or 28F catheter bores on insertion failure, duration, and pain in unripe cervix labor induction., Methods: A randomized trial was performed in a University hospital in Malaysia. Term women scheduled for labor induction, Bishop score ≤ 5, singleton, cephalic presentation, intact membrane, and reassuring pre-induction fetal heart rate tracing were recruited. Women with known gross fetal anomaly, allergy to latex and inability to consent or language difficulty were excluded. Participants were randomized to 16F, 22F, or 28F Foley catheter. Primary outcome was insertion failure and main secondary outcomes were insertion duration and pain (assessed by a Visual Numerical Rating Scale [VNRS] 0-10, higher score more pain). Analysis is done by analysis of variance (ANOVA), Kruskal-Wallis, and chi square test across the three arms and by t test and Mann-Whitney U test for pair wise comparisons., Results: One hundred twenty-seven participants' data were analyzed. The insertion failure 7/43(16%) versus 4/42(10%) versus 5/42(12%), p = 0.64, insertion duration median [IQR] 2.8 [1.8-4.8] versus 2.8 [1.7-3.7] versus 2.8 [1.7-4.3] min, p = 0.68 and insertion pain VNRS mean {SD} 4.2 {2.5} versus 3.4 {2.3} versus 3.6 {2.2}, p = 0.26, insertion to delivery interval 26.0 {9.7} versus 25.6 {9.1} versus 22.8 {7.4} h, p = 0.45, and spontaneous vaginal delivery 20/43 (45%) versus 23/42(55%) versus 25/42(60%), p = 0.48 for 16F versus 22F versus 28F arms, respectively. Pairwise comparisons were not different., Conclusion: Foley catheter 16F versus 22F versus 28F resulted in similar digital insertion performance in the dorsal recumbent position for unripe cervix labor induction., Clinical Trial Registration: https://doi.org/10.1186/ISRCTN21224268., (© 2022 Japan Society of Obstetrics and Gynecology.)

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)NNT b 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., (Copyright © 2022 Elsevier B.V. All rights reserved.)

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 [NNT b ] 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, NNT b 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, NNT b 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., (© 2021 International Federation of Gynecology and Obstetrics.)

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., (© 2021 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.)

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., (© 2021 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).)

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 ., (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH, DE part of Springer Nature.)

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%): χ 2 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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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 .