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  1. Hong JGS, Tan PC, Kamarudin M, Omar SZ
    BMC Pregnancy Childbirth, 2021 Feb 15;21(1):138.
    PMID: 33588801 DOI: 10.1186/s12884-021-03628-5
    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 .

  2. Tan GN, Tan PC, Hong JGS, Kartik B, Omar SZ
    BMJ Open, 2021 05 13;11(5):e046528.
    PMID: 33986063 DOI: 10.1136/bmjopen-2020-046528
    OBJECTIVE: To evaluate four foods in women with hyperemesis gravidarum (HG) on their agreeability and tolerability.

    DESIGN: Prospective, randomised, within-subject cross-over trial.

    SETTING: Single-centre, tertiary, university hospital in Malaysia.

    PARTICIPANTS: 72 women within 24-hour of first admission for HG who were 18 years or above, with confirmed clinical pregnancy of less than 16 weeks' gestation were recruited and analysed. Women unable to consume food due to extreme symptoms, known taste or swallowing disorder were excluded.

    INTERVENTIONS: Each participant chewed and swallowed a small piece of apple, watermelon, cream cracker and white bread in random order and was observed for 10 min after each tasting followed by a 2 min washout for mouth rinsing and data collection.

    OUTCOME MEASURES: Primary outcome was food agreeability scored after 10 min using an 11-point 0-10 Visual Numerical Rating Scale (VNRS). Nausea was scored at baseline (prior to tasting) and 2 and 10 min using an 11-point VNRS. Intolerant responses of gagging, heaving and vomiting were recorded.

    RESULTS: On agreeability scoring, apple (mean±SD 7.2±2.4) ranked highest followed by watermelon (7.0±2.7) and crackers (6.5±2.6), with white bread ranked lowest (6.0±2.7); Kruskal-Wallis H test, p=0.019. Apple had the lowest mean nausea score and mean rank score, while white bread had the highest at both 2 and 10 min; the Kruskal-Wallis H test showed a significant difference only at 10 min (p=0.019) but not at 2 min (p=0.29) in the ranking analyses. The intolerant (gagged, heaved or vomited) response rates within the 10 min study period were apple 3/72 (4%), watermelon 7/72 (10%), crackers 8/72 (11%) and white bread 12/72 (17%): χ2 test for trend p=0.02.

    CONCLUSION: Sweet apple had the highest agreeability score, the lowest nausea severity and intolerance-emesis response rate when tasted by women with HG. White bread consistently performed worst.

  3. Tan PC, Othman A, Win ST, Hong JGS, Elias N, Omar SZ
    PMID: 34089525 DOI: 10.1111/ajo.13377
    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 

  4. Sukarna N, Tan PC, Hong JGS, Sulaiman S, Omar SZ
    Arch Gynecol Obstet, 2021 08;304(2):345-353.
    PMID: 33452923 DOI: 10.1007/s00404-020-05950-3
    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 

  5. Goh YP, Tan PC, Hong JGS, Sulaiman S, Omar SZ
    Int J Gynaecol Obstet, 2021 Dec;155(3):532-538.
    PMID: 33484158 DOI: 10.1002/ijgo.13613
    OBJECTIVE: To evaluate the combined effect of massage and warm compress to the perineum (MassComp) compared with standard "hands-off" in the second stage of labor.

    METHODS: A randomized trial was conducted in a University hospital in Malaysia. Nulliparous women at term who were about to start pushing were randomized to massage during pushing and warm compress to the perineum in between pushes or to standard "hands-off" care. Primary outcome was suturing for perineal injury (episiotomy or tear).

    RESULTS: A total of 156 participants were analyzed based on intention to treat. Perineal repair rates were 53/79 (67%) for MassComp versus 70/77 (91%) for control (relative risk [RR] 0.72, 95% confidence interval [CI] 0.61-0.98, number needed to treat for an additional beneficial outcome [NNTb ] 5, 95% CI 2.83-8.62, P 

  6. Hasan NA, Hong JGS, Teo IH, Zaidi SN, Hamdan M, Tan PC
    Int J Gynaecol Obstet, 2022 Dec;159(3):951-960.
    PMID: 35726368 DOI: 10.1002/ijgo.14313
    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.

  7. Hamdan M, Shuhaina S, Hong JGS, Vallikkannu N, Zaidi SN, Tan YP, et al.
    Acta Obstet Gynecol Scand, 2021 Nov;100(11):1977-1985.
    PMID: 34462906 DOI: 10.1111/aogs.14247
    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.

  8. Vallikkannu N, Laboh N, Tan PC, Hong JGS, Hamdan M, Lim BK
    Arch Gynecol Obstet, 2022 Jan 09.
    PMID: 34999923 DOI: 10.1007/s00404-021-06383-2
    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 =  

  9. Lim BK, Zakaria R, Hong JGS, Omar SZ, Sulaiman S, Tan PC
    J Obstet Gynaecol Res, 2022 Jan 23.
    PMID: 35068018 DOI: 10.1111/jog.15157
    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.

  10. Hong JGS, Abdullah N, Rajaratnam RK, Ahmad Shukri S, Tan SP, Hamdan M, et al.
    Eur J Obstet Gynecol Reprod Biol, 2022 Jan 12;270:144-150.
    PMID: 35063897 DOI: 10.1016/j.ejogrb.2022.01.011
    OBJECTIVE: To evaluate the effect of combined perineal massage and warm compress to the perineum (MassComp) compared to perineal massage alone during pushing in the second stage of labour in reducing perineal trauma requiring suturing in nulliparas.

    STUDY DESIGN: A randomised trial was performed in a University hospital, Malaysia from June 2020 to May 2021. 281 term nulliparas who were about to start pushing in the second stage of labour were randomised to combined perineal massage and warm compress or perineal massage alone to the perineum. Primary outcome was suturing for perineal injury (episiotomy or tear). The Chi-square test was used to analyse categorical data, Student t test to compare means and distributions for normally distributed continuous data and Mann Whitney U test for appropriate ordinal data.

    RESULTS: Data from 277 participants (140 MassComp arm, 137 perineal massage alone arm) were analysed based on modified intention to treat basis. Perineal suturing rates were 133/140(95.0%) [MassComp] vs. 128/137(93.4%) [perineal massage alone] RR 1.02(95%CI 0.96-1.08), P = 0.615. Of the secondary outcomes, Likert scale response to recommend allocated treatment to a friend was 103/140(73.6%) vs. 84/137(61.3%) RR 1.20(95%CI 1.02-1.42)NNTb 9(95%CI 4.3-76.4) P = 0.029, participants' satisfaction with care (visual numerical rating scale 0-10) median [interquartile range] 6[6-8] vs. 6[5-8] P = 0.392, intervention to delivery intervals were 25[15-35] vs. 19[14-30] minutes P = 0.012, major perineal injury (episiotomy, second degree or higher tears) rates 116/140(82.9%) vs. 119/137(86.9%) RR 0.95(95%CI 0.86-1.05), P = 0.404, episiotomy rates 97/140(69.3%) vs. 97/140(70.8%) RR 0.98(95%CI 0.84-1.14), P = 0.795, and spontaneous vaginal delivery rates 103/140(73.6%) vs. 106/137(77.4%) RR 0.95(95%CI 0.83-1.09), P = 0.488 for MassComp vs. perineal massage alone respectively. Other maternal and neonatal outcomes were not significantly different.

    CONCLUSION: Massage and warm compress during pushing did not decrease the likelihood of perineal injury requiring suturing in nulliparas when compared to perineal massage alone. Women were more likely to recommend massage and warm compress during pushing to a friend.

  11. Tew MP, Tan PC, Saaid R, Hong JGS, Omar SZ
    Int J Gynaecol Obstet, 2022 Mar;156(3):508-515.
    PMID: 33890319 DOI: 10.1002/ijgo.13718
    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 

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