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  1. 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

  2. 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

  3. 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

  4. 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

  5. Crawford K, Hong J, Kumar S
    Am J Obstet Gynecol MFM, 2023 Dec;5(12):101187.
    PMID: 37832646 DOI: 10.1016/j.ajogmf.2023.101187
    BACKGROUND: Many risk factors for stillbirth are linked to placental dysfunction, which leads to suboptimal intrauterine growth and small for gestational age infants. Such infants also have an increased risk for stillbirth.

    OBJECTIVE: This study aimed to investigate the effect of known causal risk factors for stillbirth, and to identify those that have a large proportion of their risk mediated through small for gestational age birth.

    STUDY DESIGN: This retrospective cohort study used data from all births in the state of Queensland, Australia between 2000 and 2018. The total effects of exposures on the odds of stillbirth were determined using multivariable, clustered logistic regression models. Mediation analysis was performed using a counterfactual approach to determine the indirect effect and percentage of effect mediated through small for gestational age. For risk factors significantly mediated through small for gestational age, the relative risks of stillbirth were compared between small for gestational age and appropriate for gestational age infants. We also investigated the proportion of risk mediated via small for gestational age for late stillbirths (≥28 weeks).

    RESULTS: The initial data set consisted of 1,105,612 births. After exclusions, the final study cohort constituted 925,053 births. Small for gestational age births occurred in 9.9% (91,859/925,053) of the study cohort. Stillbirths occurred in 0.5% of all births (4234/925,053) and 1.5% of small for gestational age births (1414/91,859). Births at ≥28 weeks occurred in 99.4% (919,650/925,053) of the study cohort and in 98.9% (90,804/91,859) of all small for gestational age births. Of the ≥28-week births, stillbirths occurred in 0.2% (2156/919,650) of all births and 0.8% (677/90,804) of the small for gestational age births. Overall, increased odds of stillbirth were significantly mediated through small for gestational age for age <20 years, low socioeconomic status, Indigenous ethnicity, birth in sub-Saharan and North Africa or the Middle East, smoking, nulliparity, multiple pregnancy, assisted conception, previous stillbirth, preeclampsia, and renal disease. Preeclampsia had the largest proportion mediated through small for gestational age (66.7%), followed by nulliparity (61.6%), smoking (29.4%), North-African or Middle Eastern ethnicity (27.6%), multiple pregnancy (26.3%), low socioeconomic status (25.8%), and Indigenous status (18.7%). Sensitivity analysis showed that for late stillbirths, the portions mediated through small for gestational age remained very similar for many of the risk factors.

    CONCLUSION: Although small for gestational age is an important mediator between many pregnancy risk factors and stillbirth, mitigating the risk of small for gestational age is likely to be of value only when it is a major contributor in the pathway to fetal demise.

  6. 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.

  7. Khairudin MN, Vallikkannu N, Gan F, Hamdan M, Tan PC
    Am J Obstet Gynecol MFM, 2024 Apr;6(4):101324.
    PMID: 38447674 DOI: 10.1016/j.ajogmf.2024.101324
    BACKGROUND: Labor pain varies significantly among pregnant women, ranging from mild to extremely distressing. Nonpharmacologic 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: This study aimed to evaluate mechanical massage using an 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 the massage sequence. The primary outcome was a change in pain score comparing pain with and without mechanical massage as a paired comparison for the entire trial participants. The 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: Overall, 208 women were randomized: 104 to each intervention. Data were available from 204 participants (103 randomized to massage first and 101 to no massage first). The primary outcomes of change in labor pain scores (0-10 numerical rating scale) after massage and no massage (all participants included after crossover, paired t test analysis) were 4.51±2.30 and 5.38±2.10, respectively (mean difference, -0.87; 95% confidence interval, -1.14 to -0.59; P

  8. Mohd Yassin NA, Kamarudin M, Hamdan M, Tan PC
    Am J Obstet Gynecol MFM, 2024 May;6(5):101308.
    PMID: 38336174 DOI: 10.1016/j.ajogmf.2024.101308
    BACKGROUND: The global cesarean delivery rate is high and continues to increase. A bladder catheter is usually placed for the cesarean delivery because a distended bladder is assumed to be at higher risk of injury during surgery and to compromise surgical field exposure. Preliminary data suggest that self bladder emptying (no catheter) at cesarean delivery may have advantages and be safe.

    OBJECTIVE: This study aimed to compare the effects of self bladder emptying and indwelling Foley bladder catheterization for planned cesarean delivery on the rate of postpartum urinary retention and maternal satisfaction.

    STUDY DESIGN: A randomized controlled trial was conducted in a tertiary university hospital from January 10, 2022 to March 22, 2023. A total of 400 participants scheduled for planned cesarean delivery were randomized: 200 each to self bladder emptying or indwelling Foley catheter. The primary outcomes were postpartum urinary retention (overt and covert) and maternal satisfaction with allocated bladder care. Analyses were performed using t test, Mann-Whitney U test, chi-square test, or Fisher exact test, as appropriate. Logistic regression was used to adjust for differences in characteristics.

    RESULTS: Postpartum urinary retention rates were 1 per 200 (0.6%) and 0 per 200 (P>.99) (a solitary case of covert retention) and maternal satisfaction scores (0-10 visual numerical rating scale), expressed as median (interquartile range) were 9 (8-9.75) and 8 (8-9) (P=.003) in the self bladder emptying and indwelling Foley catheter arms, respectively. Regarding secondary outcomes, time to flatus passage, satisfactory ambulation, urination, satisfactory urination, satisfactory breastfeeding, and postcesarean hospital discharge was quickened in the self bladder emptying group. Pain scores at first urination were decreased and no lower urinary tract symptom was more likely to be reported with self bladder emptying. Surgical field view, operative blood loss, duration of surgery, culture-derived urinary tract infection, postvoid residual volume, and pain score at movement were not different. There was no bladder injury.

    CONCLUSION: Self bladder emptying increased maternal satisfaction without adversely affecting postpartum urinary retention. Recovery was enhanced and urinary symptoms were improved. The surgeon was not impeded at operation. No safety concern was found.

  9. Aishah M, Kamarudin M, Hong J, Sethi N, Hamdan M, Tan PC
    Am J Obstet Gynecol MFM, 2024 Apr;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

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