Displaying publications 1 - 20 of 121 in total

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  1. Hong J, Raghavan S, Siti Nordiana A, Saaid R, Vallikkannu N, Tan PC
    Int J Gynaecol Obstet, 2024 Apr;165(1):265-274.
    PMID: 37846154 DOI: 10.1002/ijgo.15199
    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.

  2. Ng YL, Segaran S, Yim CCW, Lim BK, Hamdan M, Gan F, et al.
    Am J Obstet Gynecol, 2024 Mar 21.
    PMID: 38521233 DOI: 10.1016/j.ajog.2024.03.018
    BACKGROUND: Contemporary guidance for preoperative feeding allows solids up to six hours and clear fluid up to two hours before anesthesia. Clinical trial evidence to support this approach for cesarean section is lacking. Many medical practitioners continue to follow conservative policies of no intake from midnight to the time of surgery, especially in pregnant women.

    OBJECTIVE: To evaluate the pragmatic approach of permitting free access to water to the point when the operating theater call to dispatch the woman compared to fasting from midnight in preoperative oral intake restriction for planned cesarean under spinal anesthesia on perioperative vomiting and maternal satisfaction.

    STUDY DESIGN: A randomized controlled trial was conducted in the Obstetric Unit, Universiti Malaya Medical Center from October 2020 to May 2022. 504 participants scheduled for planned cesarean delivery were randomized: 252 each to preoperative free water access until the call to dispatch to the operating theater or fasting from midnight. The primary outcomes were perioperative vomiting and maternal satisfaction. Analyses were performed using t-test, Mann-Whitney U and Chi-Square test as appropriate.

    RESULTS: Vomiting at up to six hours after completion of cesarean delivery were 9/252 (3.6%) vs. 24/252 (9.5%) RR 0.38 95% CI 0.18-0.79 p=0.007 and maternal satisfaction score (0-10 VNRS) median [interquartile range] 9 [8-10] vs. 5 [3-7] p<0.001 for preoperative free access to water and fasting respectively. Assessed before dispatch to the operating theater, thirst was reported by 69/252 (27.4%) vs. 134/252 (53.2%) RR 0.52 95% 0.41-0.65 p<0.001, capillary glucose level (mmol/l) mean ± standard deviation 4.8 ± 0.7 vs. 4.9 ± 0.8 p=0.048, and preoperative intravenous fluid hydration commenced in 49/252 (19.4%) vs. 76/252 (30.2%) RR 0.65 95% 0.47-0.88 p=0.005 for free access to water and fasting respectively. In the operating theater, ketone was detected in the catheterized urine in 38/252 (15.1%) vs. 78/252 (31.0%) RR 0.49 (5% CI 0.25-0.59 p<0.001 and the number of doses of vasopressors needed to correct hypotension were 2.3 ± 1.7 vs. 2.7 ± 2.2 p=0.009 for free access to water and fasting respectively. Recommendation of allocated preoperative oral intake regimen rates to a friend were 240/252 (95.2%) vs. 100/252 (39.7%) RR 2.40 95% CI 2.06-2.80 p<0.001 in favor of free access to water. Other assessed maternal and neonatal outcomes were not different.

    CONCLUSION: Free access to water compared to fasting in planned cesarean delivery reduced perioperative vomiting and was strongly favored by women. A number of pre and intraoperative secondary outcomes were also improved. However, post cesarean recovery and neonatal outcomes were not different.

  3. Aishah M, Kamarudin M, Hong J, Sethi N, Hamdan M, Tan PC
    Am J Obstet Gynecol MFM, 2024 Mar 04;6(4):101325.
    PMID: 38447677 DOI: 10.1016/j.ajogmf.2024.101325
    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

  4. Khairudin MN, Vallikkannu N, Gan F, Hamdan M, Tan PC
    PMID: 38447674 DOI: 10.1016/j.ajogmf.2024.101324
    BACKGROUND: Labor pain varies significantly among pregnant women, ranging from mild to extremely distressing. Non-pharmacologic pain relief methods during vaginal birth are increasingly popular, either as a complement to pharmacologic agents or at times as the primary method of pain relief. Multiple trials have reported that manual or by-hand massage reduces labor pain. The effectiveness of full-body mechanical massage using electric massage chairs on labor pain remains unexplored.

    OBJECTIVE: To evaluate mechanical massage using electric massage chair on labor pain in nulliparous women.

    STUDY DESIGN: A randomized counterbalanced crossover trial was conducted in a university hospital in Malaysia from August 2022 to February 2023. Eligible nulliparas in labor with a minimum labor pain score of 5 (0-10 numerical rating scale) were enrolled. Participants were randomized to 30 minutes on the massage chair with mechanical massage followed by 30 minutes on the massage chair without mechanical massage, or the other way around in massage sequence. The primary outcome was change in pain score comparing pain with and without mechanical massage as a paired comparison for the entire trial participants. Secondary outcomes were across arms analyses of maternal and neonatal outcomes. The paired t-test, t test, Mann- Whitney U test, Chi square test and Fisher exact test were used as appropriate for the data.

    RESULTS: 208 women were randomized; 104 to each intervention. Data was available from 204 participants (103 randomized to massage first and 101 to no massage first). The primary outcome of change in labor pain score (0-10 Numerical Rating Scale, NRS) after massage and no massage (all participants included after crossover, paired t-test analysis) was mean±standard deviation 4.51±2.3 vs 5.38±2.1 mean difference - 0.87 (95% CI -1.14 to -0.59), p<0.001, a significant reduction in pain score after electric chair mechanical massage compared to no massage. On the across randomized arms secondary analyses, labor pain score after their first massage chair session was 4.35±2.52 (randomized to massage first, received massage as initial intervention) vs 5.66±1.73 p<0.001 (randomized to no massage first, received no massage as initial intervention) mean difference -1.31 (95% CI -1.91 to -0.748), a significant reduction after mechanical massage. Other distal maternal outcomes (mode of delivery, labor analgesia, duration of labor and maternal agreement that mechanical massage is effective for labor pain) and neonatal outcomes (Apgar score at 1 and 5 minutes, cord artery blood pH and base excess, and neonatal admission) were not different across randomized arms.

    CONCLUSION: Mechanical massage using an electric massage chair significantly reduces labor pain, offering a potential non-pharmacologic pain management option during labor.

  5. Raj VI, Hassan A, Hanafiah N, Azhary JMK, Lim BK, Saaid R, et al.
    Int J Gynaecol Obstet, 2024 Feb 23.
    PMID: 38391250 DOI: 10.1002/ijgo.15431
    OBJECTIVE: To compare polyethylene glycol 4000 versus lactulose in chronic constipation during pregnancy.

    METHODS: Women at 28-32 weeks' gestation attending antenatal clinic for routine care were screened using the Rome IV chronic constipation criterion. Eligible women were approached and consented. Participants were randomized to oral polyethylene glycol (10 g/day) or lactulose (10 g/day) for 4 weeks. A bowel movement diary was kept and outcomes using the Patient Assessment of Constipation Symptoms questionnaire (PAC-SYM), Patient Assessment of Constipation Quality of Life questionnaire (PAC-QoL) and Bristol Stool Form Scale (BSFS), which were evaluated at the start and end of the four-week period. Relative risks (RR) were determined for the coprimary outcomes of complete spontaneous bowel movement (CSBM) and PAC-SYM mean score improvement (decrease in score of >1 from the baseline).

    RESULTS: A total of 4323 women underwent screening, of which 780 fulfilled the Rome IV criterion, and 360 consented to participate (180 randomized to PEG and lactulose, respectively). Data from 247 women who completed the study were analyzed. CSBM was achieved in 107/124 (86.3%) versus 102/123 (82.9%) (RR 1.04, 95% CI: 0.93-1.16, P = 0.464) for PEG and lactulose trial arms, respectively. PAC-SYM mean score improvement was 62/118 (52.5%) in the PEG arm versus 44/118 (37.3%) in the lactulose arm (RR 1.40, 95% CI: 1.05-1.88). Of secondary outcomes, a significant difference was found in favor of PEG, with respect to PAC-SYM abdominal symptoms subscale, normal stool versus loose stool consistency and side effects of vomiting and diarrhea. After controlling for parity, baseline PAC-SYM, PAC-QoL scores, characteristics different at baseline, only diarrhea and loose stools remained significant.

    CONCLUSION: Both PEG 4000 and lactulose are effective laxatives in pregnancy with similar performance after adjusted analysis. Diarrhea and loose stools are less frequently reported with PEG.

  6. Wan Jabarudin WNE, Narayanan V, Hamdan M, Gunasagran Y, Thavarajan RD, Kamarudin M, et al.
    Int J Gynaecol Obstet, 2024 Feb 15.
    PMID: 38358264 DOI: 10.1002/ijgo.15429
    OBJECTIVE: To evaluate oral rehydration therapy (ORT) compared with intravenous rehydration therapy (IVT) in the early inpatient management of hyperemesis gravidarum (HG).

    METHODS: A total of 124 women hospitalized for HG from February 10, 2021 till January 6, 2023 were randomized to ORT (n = 61) or IVT (n = 63) for an initial 12 h. Inclusion criteria includes women older than 18 years, with a viable intrauterine pregnancy less than 14 weeks at their first hospitalization for HG with ketonuria of at least 2+. Primary outcomes were (1) satisfaction score with allocated intervention, (2) weight change, and (3) ketonuria change at 12 h. Secondary outcomes included vomiting frequency, nausea score, serial vital signs, hematocrit and electrolyte levels at 12 h, deviation from treatment protocol (cross-over therapy), participant recommendation of allocated treatment to a friend, and length of hospital stay.

    RESULTS: Primary outcomes of (1) participant satisfaction score (on a 0-10 visual numerical rating scale) was 7 (interquartile range [IQR] 5-8) versus 9 (IQR 8-10), P 

  7. Karim KK, Gan F, Hong J, Hamdan M, Razali N, Tan PC
    Am J Obstet Gynecol MFM, 2024 Feb;6(2):101271.
    PMID: 38147896 DOI: 10.1016/j.ajogmf.2023.101271
    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.

  8. Gan F, Sooriappragasarao M, Sulaiman S, Razali N, Hong JGS, Tan PC
    Sleep, 2023 Dec 11;46(12).
    PMID: 37478474 DOI: 10.1093/sleep/zsad196
    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 

  9. Bashirudin SB, Omar SZ, Gan F, Hamdan M, Tan PC
    PMID: 37860619 DOI: 10.1016/j.eurox.2023.100249
    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 

  10. Yogamoorthy U, Saaid R, Gan F, Hong J, Hamdan M, Tan PC
    Am J Obstet Gynecol MFM, 2023 Nov;5(11):101158.
    PMID: 37734661 DOI: 10.1016/j.ajogmf.2023.101158
    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

  11. Thye CT, Hamdan M, Sethi N, Rajaratnam RK, Hong J, Tan PC
    Int J Gynaecol Obstet, 2023 Nov;163(2):601-609.
    PMID: 37199331 DOI: 10.1002/ijgo.14861
    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 

  12. Ramlee N, Azhary JMK, Hamdan M, Saaid R, Gan F, Tan PC
    Int J Gynaecol Obstet, 2023 Nov;163(2):547-554.
    PMID: 37177795 DOI: 10.1002/ijgo.14848
    OBJECTIVE: To identify independent predictors of maternal satisfaction with labor induction.

    METHOD: In this prospective observational cohort study, 769 women prior to their labor induction had sleep and psychological well-being assessed using Pittsburgh Sleep Quality Index and Depression, Anxiety and Stress Scales. Women were asked about the adequacy of labor induction information provided and their involvement and time pressure felt in the decision-making for their labor induction. Maternal characteristics, induction and intrapartum care measures, and labor and neonatal outcomes were also assessed. Prior to discharge, women rated their satisfaction with their birth experience.

    RESULTS: A total of 34 variables were considered for bivariate analysis, with 15 found to have P 

  13. Appadurai U, Gan F, Hong J, Hamdan M, Tan PC
    Am J Obstet Gynecol MFM, 2023 Nov;5(11):101157.
    PMID: 37722505 DOI: 10.1016/j.ajogmf.2023.101157
    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

  14. Kamarudzman N, Omar SZ, Gan F, Hong J, Hamdan M, Tan PC
    Am J Obstet Gynecol MFM, 2023 Nov;5(11):101142.
    PMID: 37643690 DOI: 10.1016/j.ajogmf.2023.101142
    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

  15. Hamid NA, Hong JGS, Hamdan M, Vallikkannu N, Adlan AS, Tan PC
    Am J Obstet Gynecol, 2023 Oct;229(4):443.e1-443.e9.
    PMID: 37207931 DOI: 10.1016/j.ajog.2023.04.049
    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

  16. Asmary A, Nurulhuda AS, Hong JGS, Gan F, Adlan AS, Hamdan M, et al.
    Am J Obstet Gynecol MFM, 2023 Aug;5(8):101031.
    PMID: 37244640 DOI: 10.1016/j.ajogmf.2023.101031
    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

  17. Tan PC, Ramasandran G, Sethi N, Razali N, Hamdan M, Kamarudin M
    BMC Pregnancy Childbirth, 2023 Jun 17;23(1):450.
    PMID: 37330467 DOI: 10.1186/s12884-023-05771-7
    BACKGROUND: Hyperemesis gravidarum (HG) affects about 2% of pregnancies and is at the severe end of the spectrum of nausea and vomiting of pregnancy. HG causes severe maternal distress and results in adverse pregnancy outcomes long after the condition may have dissipated. Although dietary advice is a common tool in management, trial evidence to base the advice on is lacking.

    METHODS: A randomized trial was conducted in a university hospital from May 2019 to December 2020. 128 women at their discharge following hospitalization for HG were randomized: 64 to watermelon and 64 to control arm. Women were randomized to consume watermelon and to heed the advice leaflet or to heed the dietary advice leaflet alone. A personal weighing scale and a weighing protocol were provided to all participants to take home. Primary outcomes were bodyweight change at the end of week 1 and week 2 compared to hospital discharge.

    RESULTS: Weight change (kg) at end of week 1, median[interquartile range] -0.05[-0.775 to + 0.50] vs. -0.5[-1.4 to + 0.1] P = 0.014 and to the end of week 2, + 0.25[-0.65 to + 0.975] vs. -0.5[-1.3 to + 0.2] P = 0.001 for watermelon and control arms respectively. After two weeks, HG symptoms assessed by PUQE-24 (Pregnancy-Unique Quantification of Emesis and Nausea over 24 h), appetite assessed by SNAQ (Simplified Nutritional Appetite Questionnaire), wellbeing and satisfaction with allocated intervention NRS (0-10 numerical rating scale) scores, and recommendation of allocated intervention to a friend rate were all significantly better in the watermelon arm. However, rehospitalization for HG and antiemetic usage were not significantly different.

    CONCLUSION: Adding watermelon to the diet after hospital discharge for HG improves bodyweight, HG symptoms, appetite, wellbeing and satisfaction.

    TRIAL REGISTRATION: This study was registered with the center's Medical Ethics Committee (on 21/05/2019; reference number 2019327-7262) and the ISRCTN on 24/05/2019 with trial identification number: ISRCTN96125404 . First participant was recruited on 31/05/ 2019.

  18. Hong JGS, Vimaladevi A, Razif NA, Omar SZ, Tan PC
    BMC Pregnancy Childbirth, 2023 May 24;23(1):378.
    PMID: 37226087 DOI: 10.1186/s12884-023-05685-4
    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 

  19. Sulaiman S, Sivaranjani S, Razali N, Lim BK, Hamdan M, Tan PC
    Int J Gynaecol Obstet, 2023 Mar;160(3):814-822.
    PMID: 35869955 DOI: 10.1002/ijgo.14364
    OBJECTIVE: To compare Foley catheter and controlled-release dinoprostone vaginal insert on induction-to-delivery interval and maternal satisfaction in women with one previous cesarean delivery.

    METHODS: This randomized controlled trial was conducted at the University Malaya Medical Center, Kuala Lumpur, Malaysia, from December 12, 2018, to May 28, 2019. A total of 78 term women scheduled for labor induction with one previous cesarean delivery who had ripe cervixes, singleton gestation, cephalic presentation, intact membranes, and reassuring cardiotocogram were randomized to Foley catheter or dinoprostone insert. The primary outcome was induction-to-delivery interval (in hours) and the secondary outcomes included maternal satisfaction on birth experience (assessed by 100-mm visual analog scale).

    RESULTS: Induction-to-delivery intervals were as follows: median 33.5 h (interquartile range [IQR], 26.1-36.2 h) versus 23.5 h (IQR, 12.7-34.5 h) (P = 0.004), and maternal satisfaction on birth process 100-mm visual analog scale was 80 mm (IQR, 64-88 mm) versus 82 mm (IQR, 67-88 mm) (P = 0.919) for the Foley and controlled-release dinoprostone arms, respectively. Cesarean delivery rates were 23 of 39 (59%) versus 20 of 39 (51%) (relative risk, 1.15 [95% confidence interval, 0.77-1.72]) (P = 0.496) and trial device insertion to removal time mean ± standard deviation was 20.1 ± 7.1 h versus 14.2 ± 7.3 h (P = 0.001) for Foley versus controlled-release dinoprostone, respectively.

    CONCLUSION: In term women after one previous cesarean delivery with unripe cervixes, controlled-release dinoprostone vaginal insert compared with Foley catheter shortens the induction-to-delivery interval but maternal satisfaction was not significantly increased.

    CLINICAL TRIAL REGISTRATION: This study was registered with ISRCTN on November 30, 2018, with trial identification number: ISRCTN16957529 (https://doi.org/10.1186/ISRCTN16957529). The first participant was recruited on December 12, 2018.

  20. Jamaluddin A, Azhary JMK, Hong JGS, Hamdan M, Tan PC
    Int J Gynaecol Obstet, 2023 Feb;160(2):661-669.
    PMID: 35869943 DOI: 10.1002/ijgo.14361
    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 

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