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 .

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.

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 .

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.

Speculum versus digital insertion of Foley catheter for induction of labor in Nulliparas with unripe cervix: a randomized controlled trial.

BACKGROUND: Induction of labor (IoL) is an increasingly common obstetric procedure. Foley catheter IoL is recommended by WHO. It is associated with the lowest rate of uterine hyperstimulation syndrome and similar duration to delivery and vaginal delivery rate compared to other methods. Insertion is typically via speculum but digital insertion has been reported to be faster, better tolerated and with similar universal insertion success compared to speculum insertion in a mixed population of nulliparas and multiparas. Transcervical procedure is more challenging in nulliparas and when the cervix is unripe. We evaluated the ease and tolerability of digital compared to speculum insertion of Foley catheter for induction of labor in nulliparas with unripe cervixes. METHODS: A randomized trial was performed in a university hospital in Malaysia. Participants were nulliparas at term with unripe cervixes (Bishop Score ≤ 5) admitted for IoL who were randomized to digital or speculum-aided transcervical Foley catheter insertion in lithotomy position. Primary outcomes were insertion duration, pain score [11-point Visual Numerical Rating Scale (VNRS)], and failure. All primary outcomes were recorded after the first insertion. RESULTS: Data from 86 participants were analysed. Insertion duration (with standard deviation) was 2.72 ± 1.85 vs. 2.25 ± 0.55 min p = 0.12, pain score (VNRS) median [interquartile range] 3.5 [2-5] vs. 3 [2-5] p = 0.72 and failure 2/42 (5%) vs. 0/44 (0%) p = 0.24 for digital vs speculum respectively. There was no significant difference found between the two groups for all three primary outcomes. Induction to delivery 30.7 ± 9.4 vs 29.6 ± 11.5 h p = 0.64, Cesarean section 25/60 (64%) vs 28/64 (60%) RR 0.9 95% CI p = 0.7 and maternal satisfaction VNRS score with the birth process 7 [IQR 6-8] vs 7 [7-8] p = 0.97 for digital vs. speculum arms respectively. Other labor, delivery and neonatal secondary outcomes were not significantly different. CONCLUSION: Digital and speculum insertion in nulliparas with unripe cervixes had similar insertion performance. As digital insertion required less equipment and consumables, it could be the preferred insertion method for the equally adept and the insertion technique to train towards. TRIAL REGISTRATION: This trial was registered with ISRCTN registration number 13804902 on 15 November 2017.

Vaginal assessment and expedited amniotomy in oral misoprostol labor induction in nulliparas: a randomized trial.

BACKGROUND: Labor is induced in 20-30% of maternities, with an increasing trend of use. Labor induction with oral misoprostol is associated with reduced risk of cesarean deliveries and has a safety and effectiveness profile comparable to those of mechanical methods such as Foley catheter use. Labor induction in nulliparous women continues to be challenging, with the process often quite protracted. The eventual cesarean delivery rate is high, particularly when the cervix is unfavorable and ripening is required. Vaginal examination can cause discomfort and emotional distress particularly to nulliparous women, and plausibly can affect patient satisfaction with the induction and birth process. OBJECTIVE: The aim of this study was to evaluate regular (4-hourly prior to each oral misoprostol dose with amniotomy when feasible) compared with restricted (only if indicated) vaginal assessments during labor induction with oral misoprostol in term nulliparous women MATERIALS AND METHODS: We performed a randomized trial between November 2016 and September 2017 in a university hospital in Malaysia. Our oral misoprostol labor induction regimen comprised 50 µg of misoprostol administered 4 hourly for up to 3 doses in the first 24 hours. Participants assigned to regular assessment had vaginal examinations before each 4-hourly misoprostol dose with a view to amniotomy as soon as it was feasible. Participants in the restricted arm had vaginal examinations only if indicated. Primary outcomes were patient satisfaction with the birth process (using an 11-point visual numerical rating scale), induction to vaginal delivery interval, and vaginal delivery rate at 24 hours. RESULTS: Data from 204 participants (101 regular, 103 restricted) were analyzed. The patient satisfaction score with the birth process was as follows (median [interquartile range]): 7 [6-9] vs 8 [6-10], P = .15. The interval of induction to vaginal delivery (mean ± standard deviation) was 24.3 ± 12.8 vs 31.1 ± 15.0 hours (P = .013). The vaginal delivery rate at 24 hours was 27.7% vs 20.4%; (relative risk [RR], 1.4; 95% confidence interval [CI], 0.8-2.3; P = .14) for the regular vs restricted arms, respectively. The cesarean delivery rate was 50% vs 43% (RR, 1.1; 95% CI, 0.9-1.5; P = .36). When assessed after delivery, participants' fidelity to their assigned vaginal examination schedule in a future labor induction was 45% vs 88% (RR, 0.5; 95% CI, 0.4-0.7; P < .001), and they would recommend their assigned schedule to a friend (47% vs 87%; RR, 0.6; 95% CI, 0.5-0.7; P < .001) in the regular compared with the restricted arms, respectively. CONCLUSION: Despite a shorter induction to vaginal delivery interval with regular vaginal examination and a similar vaginal delivery rate at 24 hours and birth process satisfaction score, women expressed a higher preference for the restricted examination schedule and were more likely to recommend such a schedule to a friend.

Induction of labor compared to expectant management in term nulliparas with a latent phase of labor of more than 8 hours: a randomized trial.

BACKGROUND: Prolonged latent phase of labor is associated with adverse maternal and neonatal outcomes. Preliminary data indicate that labor induction for prolonged latent phase may reduce cesarean delivery. We performed a study powered to Cesarean delivery to evaluate labor induction compared to expectant management in full term nulliparas hospitalized for persistent contractions but non-progressive to established labor after an overnight stay. METHODS: From 2015 and 2017, nulliparas, ≥ 39 weeks' gestation with prolonged latent phase of labor (persistent contractions after overnight hospitalization > 8 h), cervical dilation ≤3 cm, intact membranes and reassuring cardiotocogram were recruited. Participants were randomized to immediate induction of labor (with vaginal dinoprostone or amniotomy or oxytocin as appropriate) or expectant management (await labor for at least 24 h unless indicated intervention as directed by care provider). Primary outcome measure was Cesarean delivery. RESULTS: Three hundred eighteen women were randomized (159 to each arm). Data from 308 participants were analyzed. Cesarean delivery rate was 24.2% (36/149) vs. 23.3%, (37/159) RR 1.0 95% CI 0.7-1.6; P = 0.96 in induction of labor vs. expectant arms. Interval from intervention to delivery was 17.1 ± 9.9 vs. 40.1 ± 19.8 h; P < 0.001, intervention to active labor 9.6 ± 10.2 vs. 29.6 ± 18.5 h; P < 0.001, active labor to delivery 7.6 ± 3.6 vs. 10.5 ± 7.2 h; P < 0.001, intervention to hospital discharge 2.4 ± 1.2 vs. 2.9 ± 1.4 days; P < 0.001 and dinoprostone use was 19.5% (29/149) vs. 8.2% (13/159) RR 2.4 95% CI 1.3-4.4; P = 0.01 in IOL compared with expectant arms respectively. Intrapartum oxytocin use, epidural analgesia and uterine hyperstimulation syndrome, postpartum hemorrhage, patient satisfaction on allocated intervention, during labor and delivery and baby outcome were not significantly different across trial arms. CONCLUSIONS: Induction of labor did not reduce Cesarean delivery rates but intervention to delivery and to hospital discharge durations are shorter. Patient satisfaction scores were similar. Induction of labor for prolonged latent phase of labor can be performed without apparent detriment to expedite delivery. TRIAL REGISTRATION: Registered in Malaysia National Medical Research Register (NMRR-15-16-23,886) on 6 January 2015 and the International Standard Randomised Controlled Trials Number registry, registration number ISRCTN14099170 on 5 Nov 2015.

Leptin and soluble leptin receptor in association with gestational diabetes: a prospective case-control study.

PURPOSE: To assess the association of serum leptin and its receptor (SLeptinR) with the risk of gestational diabetes mellitus (GDM) and to evaluate the longitudinal circulation of these peptides in pregnancy. METHODS: This study consisted of 53 subjects diagnosed with GDM and 43 normal glucose tolerance (NGT) pregnant women. Serum leptin and SLeptinR were measured at 24-28 weeks, prior and after delivery, and post-puerperium. RESULTS: Lower levels of leptin and SLeptinR were observed in GDM compared to NGT. Leptin [OR 0.97 (95% CI 0.94-1.0)] and SLeptinR [OR 0.86 (95% CI 0.79-0.93]) were inversely associated with GDM. Participants in the lowest tertile for leptin and SLeptinR had a 2.8-fold (95% CI 1.0-7.6) and a 5.7-fold (95% CI 1.9-17.3) higher risk of developing GDM compared with the highest tertile, respectively. These relationships were attenuated after adjustment for covariates. In both the groups, peak leptin was observed at 24-28 weeks, decreasing continuously during pregnancy (p > 0.05) and after delivery (p < 0.017). SLeptinR level increased (p < 0.001) during pregnancy and decreased (p < 0.005) after delivery in GDM, however, levels remained the same in NGT. In GDM, leptin and SLeptinR was positively and inversely correlated with BMI and HOMA-IR at 24-28 weeks and post-puerperium, respectively. The cord levels of both leptin and SLeptinR were lower than maternal levels. There were no significant differences in serum cord leptin and SLeptinR levels between the groups. CONCLUSION: Leptin and SLeptinR are independently and inversely associated with GDM. Lower levels of these peptides may play an important role in the pathophysiology of GDM and pre-diabetic state in post-puerperium.

Protein Profiling of Women with Spontaneous Preterm Birth.

BACKGROUND: Preterm birth (PTB) is the largest cause of neonatal mortality and morbidity in the world. Ethnicity disparity in the occurrence of PTB has been associated with the cytokine function. In this study, we aimed at examining cytokine levels in women with spontaneous preterm and term births. METHOD: Women with spontaneous preterm birth (SPTB) between 24 and 31 weeks (n = 40) and women with spontaneous term birth between 37 and 41 weeks (n = 40) admitted to the University of Malaya Medical Centre from 2011 to 2013 were involved in this study. Plasma proteins were determined for 35 cytokines using ProcartaPlex™ immunoassay. Protein levels were compared between women with SPTB and women with term birth. RESULT: Six specific cytokines were significantly high among women with SPTB. This includes TNFA (odds ratio (OR) 3.4, 95% confidence interval (CI) 2.0-6.0, p = 0.001), MCP-3 (OR 2.5, 95% CI 1.29-4.67, p = 0.007), IL16 (OR 2.4, 95% CI 1.34-4.30, p = 0.003), IL17A (OR 2.3, 95% CI 1.28-4.06, p = 0.005), IFNG (OR 3.8, 95% CI 2.0-8.0, p = 0.001), and farctalkine (OR 2.1, 95% CI 1.17-4.22, p = 0.031), respectively. CONCLUSION: This study identifies high levels of specific cytokines in women with PTB. These inflammatory biomarkers may play an important role in the mechanisms that result in uterine contraction and PTB.

Impact of low oxygen tension on stemness, proliferation and differentiation potential of human adipose-derived stem cells.

Adipose-derived stem cells (ASCs) have been found adapted to a specific niche with low oxygen tension (hypoxia) in the body. As an important component of this niche, oxygen tension has been known to play a critical role in the maintenance of stem cell characteristics. However, the effect of O2 tension on their functional properties has not been well determined. In this study, we investigated the effects of O2 tension on ASCs stemness, differentiation and proliferation ability. Human ASCs were cultured under normoxia (21% O2) and hypoxia (2% O2). We found that hypoxia increased ASC stemness marker expression and proliferation rate without altering their morphology and surface markers. Low oxygen tension further enhances the chondrogenic differentiation ability, but reduces both adipogenic and osteogenic differentiation potential. These results might be correlated with the increased expression of HIF-1α under hypoxia. Taken together, we suggest that growing ASCs under 2% O2 tension may be important in expanding ASCs effectively while maintaining their functional properties for clinical therapy, particularly for the treatment of cartilage defects.

Talcum powder or aqueous gel to aid external cephalic version: a randomised controlled trial.

BACKGROUND: External cephalic version (ECV) is offered to reduce the number of Caesarean delivery indicated by breech presentation which occurs in 3-4% of term pregnancies. ECV is commonly performed aided by the application of aqueous gel or talcum powder to the maternal abdomen. We sought to compare gel with powder during ECV on achieving successful version and increasing tolerability. METHOD: We enrolled 95 women (≥ 36 weeks gestation) on their attendance for planned ECV. All participants received terbutaline tocolysis. Regional anaesthesia was not used. ECV was performed in the standard fashion after the application of the allocated aid. If the first round (maximum of 2 attempts) of ECV failed, crossover to the opposing aid was permitted. RESULTS: 48 women were randomised to powder and 47 to gel. Self-reported procedure related median [interquartile range] pain scores (using a 10-point visual numerical rating scale VNRS; low score more pain) were 6 [5-9] vs. 8 [7-9] P = 0.03 in favor of gel. ECV was successful in 21/48 (43.8%) vs. 26/47 (55.3%) RR 0.6 95% CI 0.3-1.4 P = 0.3 for powder and gel arms respectively. Crossover to the opposing aid and a second round of ECV was performed in 13/27 (48.1%) following initial failure with powder and 4/21 (19%) after failure with gel (RR 3.9 95% CI 1.0-15 P = 0.07). ECV success rate was 5/13 (38.5%) vs. 1/4 (25%) P = 0.99 after crossover use of gel or powder respectively. Operators reported higher satisfaction score with the use of gel (high score, greater satisfaction) VNRS scores 6 [4.25-8] vs 8 [7-9] P = 0.01. CONCLUSION: Women find gel use to be associated with less pain. The ECV success rate is not significantly different. TRIAL REGISTRATION: The trial is registered with ISRCTN (identifier ISRCTN87231556).

Prevalence of Preterm Birth and Perinatal Outcomes in a Tertiary Hospital in Malaysia.

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.

Quadratus Lumborum Block for Ovarian Cystectomy Surgery in a Patient With Severe Kyphoscoliosis.

Quadratus lumborum block (QLB) has been described as a regional analgesic technique in various abdominal surgeries. We present a case report of a high-risk patient who underwent ovarian cystectomy with QLB and deep sedation after failed neuraxial anesthesia. A 29-year-old female patient with comorbidities osteogenesis imperfecta, severe kyphoscoliosis with restrictive lung disease, and cervical syringomyelia with cranio-cervical junction stenosis (C2/C3). The patient had large ovarian cysts with associated dyspnea. She accepted surgery-an open bilateral ovarian cystectomy-despite being advised that general anesthesia would be high-risk. Regional anesthetic options were limited and challenging, given her anatomy and difficulty in positioning. Neuraxial anesthesia was attempted but was unsuccessful. The patient safely underwent surgery (lower midline laparotomy) using QLB. This clinically challenging case demonstrates the feasibility of QLB as the mainstay multimodal anesthetic approach (without general and neuraxial anesthesia) for abdominal surgery under exceptional circumstances.

A quantitative approach to measure women's sexual function using electromyography: a preliminary study of the Kegel exercise.

BACKGROUND: Currently, the reference standard used to clinically assess sexual function among women is a qualitative questionnaire. Hence, a generalised and quantitative measurement tool needs to be available as an alternative. This study investigated whether an electromyography (EMG) measurement technique could be used to help quantify women's sexual function. MATERIAL AND METHODS: A preliminary intervention study was conducted on 12 female subjects, who were randomised into a control (n=6) and an intervention (n=6) group. Intervention involved a set regimen of pelvic floor muscle exercises (Kegel) and the control group did not have any treatment. All subjects were asked to answer a validated, self-rated Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ). EMG measurements of the pelvic floor muscles (PFM) and the abdominal muscles were taken from all women at recruitment and 8 weeks after study commencement. RESULTS: After 8 weeks, most of the subjects in the control group did not display any noted positive difference in either PISQ score (4/6) or in their muscle strength (4/6). However, a noted progressive difference were observed in subjects who were placed in the Kegel group; PISQ score (5/6) and muscles strength (4/6). CONCLUSIONS: The noted difference in the Kegel group subjects was that if progress is observed in the sexual function, improvement is also observed in the strength of at least 2 types of muscles (either abdominal or PFM muscles). Thus, EMG measurement is a potential technique to quantify the changes in female sexual function. Further work will be conducted to validate this assumption.

Development and validation of a food frequency questionnaire to estimate the intake of genistein in Malaysia.

OBJECTIVE: To develop and validate a food frequency questionnaire (FFQ) to estimate the genistein intake in a Malaysian population of pregnant women. METHOD: A single 24-h dietary recall was obtained from 40 male and female volunteers. A FFQ of commonly consumed genistein-rich foods was developed from these recalls, and a database of the genistein content of foods found in Malaysia was set up. The FFQ was validated against 7-d food diary (FD) kept by 46 pregnant women and against non-fasting serum samples obtained from 64 pregnant women. Reproducibility was assessed by comparing the responses on two FFQs administered approximately 1 month apart. RESULTS: The Pearson correlation coefficient between FFQ1 and FD was 0.724 and that between FFQ2 and FD was 0.807. Classification into the same or adjacent quintiles was 78% for FFQ1 versus FD and 88% for FFQ2 versus FD. A significant dose -- response relation was found between FFQ-estimated genistein intake and serum levels. CONCLUSION: The FFQ developed is a reliable, valid tool for categorising people by level of genistein intake.

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

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

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

BACKGROUND: Planned 6- vs 12-hour placement of the double-balloon catheter for cervical ripening in labor induction hastens delivery. The Foley catheter is low-priced and typically performs at least as well as the proprietary double-balloon devices in labor induction. Maternal satisfaction with labor induction is usually inversely related to the speed of the process. OBJECTIVE: This study aimed to compare Foley balloon placement for 6 vs 12 hours in the labor induction of multiparas with unfavorable cervixes. STUDY DESIGN: A randomized controlled trial was conducted in a university hospital in Malaysia from January to October of 2022. Eligible multiparous women admitted for induction of labor for various indications were enrolled. Participant inclusion criteria were multiparity (at least 1 previous vaginal delivery of ≥24 weeks' gestation), age ≥18 years, term pregnancy >37 weeks' gestation, singleton pregnancy, cephalic presentation, intact membranes, normal fetal heart rate tracing, no significant contractions (< 2 in 10 minutes), and unfavorable cervix (Bishop score < 6). Participants were randomized after successful Foley balloon insertion for the balloon to be left in place for 6 or 12 hours of passive ripening before removal to check cervical suitability for amniotomy. The primary outcomes were the induction-to-delivery interval and maternal satisfaction with the allocated intervention assessed using a visual numerical rating scale (0-10). Secondary outcomes were derived in part from the core outcome set for trials on induction of labor (Core Outcomes in Women's and Newborn Health [CROWN]). Maternal outcomes were change in first Bishop score after intervention, use of additional method for cervical ripening, time to delivery after balloon removal, mode of delivery, indication for cesarean delivery, duration of oxytocin infusion, blood loss during delivery, presence of third- or fourth-degree perineal tear, maternal infection, use of regional analgesia in labor, length of hospital stay, intensive care unit (ICU) admission, cardiorespiratory arrest, and need for hysterectomy. The secondary neonatal outcomes were Apgar score at 1 and 5 minutes, neonatal intensive care unit (NICU) admission, cord blood pH, neonatal sepsis, birthweight, birth trauma, hypoxic-ischemic encephalopathy, or need for therapeutic hypothermia. Analyses were conducted with the t-test, Mann-Whitney U test, chi-square test, and Fisher exact test, as appropriate. RESULTS: A total of 220 women were randomized (110 to each intervention). Regarding the 2 primary outcomes, the induction-to-delivery intervals were a median (interquartile range) of 15.9 (12.0-24.0) and 21.6 (17.3-26.0) hours (P<.001), and maternal satisfaction scores were 7 (6-8) and 7 (6-8) (P=.734) for 6- and 12-hour placement, respectively. The following rates were observed for 6- and 12-hour placement, respectively: sequential use of additional cervical ripening agent (Foley reinsertion)-29 per 110 (26.4%) and 13 per 110 (11.8%) (relative risk, 2.23; 95% confidence interval, 1.23-4.10; P=.006); spontaneous balloon expulsion-22 per 110 (20.0%) and 37 per 110 (33.6%) (relative risk, 0.60; 95% confidence interval, 0.38-0.94; P=.022); and recommendation of the allocated intervention to a friend-61 per 110 (73.6%) and 87 per 110 (79.1%) (relative risk, 0.90; 95% confidence interval, 0.80-1.08; P=.341). Other secondary outcomes, including cesarean delivery, were not significantly different. CONCLUSION: Foley balloon placement for 6 hours for cervical ripening in parous women hastens birth but does not increase maternal satisfaction relative to 12-hour placement. Foley reinsertion for additional ripening was more frequent in the 6-hour group.

Screening for urinary tract infection in women with hyperemesis gravidarum.

AIM: The aim of this study was to evaluate urine microscopy, dipstick analysis and urinary symptoms in screening for urinary tract infection (UTI) in hyperemesis gravidarum (HG). MATERIALS AND METHODS: A prospective cross-sectional study was performed on women at first hospitalization for HG. A clean-catch mid-stream urine sample from each recruit was sent for microscopy (for bacteria, leucocytes and erythrocytes), dipstick analysis (for leukocyte esterase, nitrites, protein and hemoglobin) and microbiological culture. The presence of current urinary symptoms was elicited by questionnaire. UTI is defined as at least 10(5) colony-forming units/mL of a single uropathogen on culture. Screening test parameters were analyzed against UTI. RESULTS: UTI was diagnosed in 15/292 subjects (5.1%). Receiver-operator characteristic curve analysis of microscopic urine leucocytes revealed area under the curve=0.64, 95% confidence interval (CI) 0.5-0.79, P=0.063 and erythrocytes area under the curve=0.53, 95%CI 0.39-0.67, P=0.67 for UTI indicating the limited screening utility of these parameters. Microscopic bacteriuria (likelihood ratio [LR] 1.1, 95%CI 0.7-1.5) and urine dipstick leukocyte esterase (LR 1.4, 95%CI 1.1-1.8), nitrites (LR 2.3, 95%CI 0.3-17.2), protein (LR 1.0, 95%CI 0.7-1.6) and hemoglobin (LR 0.8, 95%CI 0.4-1.5) were not useful screening tests for UTI in HG. Elicited symptoms were also not predictive of UTI. CONCLUSION: Urine microscopy, dipstick analysis and urinary symptoms were not useful in screening for UTI in HG. UTI should be established by urine culture in HG before starting antibiotic treatment.

Single dose 17 alpha-hydroxyprogesterone caproate in preterm labor: a randomized trial.

OBJECTIVE: To evaluate the effect of a single 250-mg dose of 17 alpha-hydroxyprogesterone caproate (17-OHPC) intramuscularly as adjunct to nifedipine tocolysis in preterm labor. METHOD: Women diagnosed with threatened preterm labor between 22 and 35 weeks' gestation scheduled to receive nifedipine tocolysis and prophylactic antenatal corticosteroid were randomized to a single intramuscular injection of 250 mg of 17-OHPC or placebo saline in a double-blind fashion. Nifedipine tocolysis and corticosteroids were administered to all participants. Further management was otherwise carried out according to providers' discretion. Main outcome measures are delivery within 48 h and 7 days. RESULTS: Data were analyzed for the 56 participants randomized to 17-OHPC and 56 randomized to placebo. Delivery rates within 48 h were 11/54 (20.4%) versus 15/56 (26.8%) RR 0.76 (95% CI 0.38-1.51) and within 7 days were 13/52 (25.0%) versus 19/54 (35.2%) RR 0.71 (95% CI 0.39-1.29) for 17-OHPC and placebo groups, respectively, and were similar. Recruitment to delivery interval, gestation at delivery, delivery rate before 34 weeks' and 37 weeks' gestation, and neonatal outcomes were also similar. CONCLUSION: The results indicated that adjunctive single-dose 17-OHPC in combination with nifedipine tocolysis for threatened preterm labor did not delay delivery.