Displaying publications 1 - 20 of 52 in total

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  1. Norliyana, M., Nor Hamdan, M. Y., Rizal, A. R.
    MyJurnal
    Mycobacterium tuberculosis (MTB) is a rare cause of prosthetic joint infection. The diagnosis is challenging
    especially in cases of latent tuberculosis. QuantiFERON-TB Gold (QFT®) is an interferon-gamma relative assay
    (IGRA) which is highly specific and sensitive for detection of MTB infection. We report a case of 76-year-old lady
    diagnosed with tuberculous prosthetic joint infection following total knee replacement. Histological examination of
    abnormal synovial tissue taken intraoperatively reveals chronic granulomatous lesion and raised suspicion of
    tuberculous infection in otherwise asymptomatic patient. The tuberculin skin test, MTB acid-fast stain and
    tuberculosis polymerase chain reaction were negative. The diagnosis dilemma was solved with positive result of
    QuantiFERON TB Gold Test. The patient was treated with anti-tuberculous drug without any surgical intervention.
    At five months follow-up, patient was clinically well with no symptoms and signs of infection.
  2. Hamdan M, Cheong Y
    Obstet Gynecol, 2015 Jun;125(6):1499.
    PMID: 26000533 DOI: 10.1097/AOG.0000000000000892
  3. Hamdan M, Dunselman G, Li TC, Cheong Y
    Hum. Reprod. Update, 2015 Nov-Dec;21(6):809-25.
    PMID: 26168799 DOI: 10.1093/humupd/dmv035
    Endometriosis is a disease known to be detrimental to fertility. Women with endometriosis, and the presence of endometrioma, may require artificial reproductive techniques (ART) to achieve a pregnancy. The specific impact of endometrioma alone and the impact of surgical intervention for endometrioma on the reproductive outcome of women undergoing IVF/ICSI are areas that require further clarification. The objectives of this review were as follows: (i) to determine the impact of endometrioma on IVF/ICSI outcomes, (ii) to determine the impact of surgery for endometrioma on IVF/ICSI outcome and (iii) to determine the effect of different surgical techniques on IVF/ICSI outcomes.
  4. Hamdan M, Jaaffar AH, Khraisat O
    Data Brief, 2024 Aug;55:110572.
    PMID: 38966664 DOI: 10.1016/j.dib.2024.110572
    Shared governance is a concept that has been gaining popularity in the nursing field. It is a framework that allows nurses to have a greater role in clinical decision-making. This approach recognizes the expertise and knowledge that nurses possess and allows them to be active participants in the decision-making process. It is a way to empower nurses and to ensure that the best possible care is being provided to patients. By promoting shared governance, nurses are able to work collaboratively with other healthcare professionals and provide high-quality care that is evidence-based and patient-centered. This article presents data that was collected in an empirical study to investigate the impact of implementing a shared governance model on the perceptions of professional governance among nurses working in a tertiary hospital in Saudi Arabia by measuring the level of shared governance from the lowest level, the traditional governance level (management and administration only), to the highest level, the self-governance level (staff only), through six dimensions of nursing professional governance, including personnel, information, resources, participation, practice, and goals. The study was conducted over 8 months between July 2022 to February 2023 with the involvement of a random sample of 200 clinical nurses who completed a structured questionnaire before and after the study interventions as part of quasi-research. The interventions included designing and implementing a shared governance model, and providing a shared governance training to clinical to nurse participants. The pretest-posttest experimental group showed that there were improvements in the level of shared governance (shared governance level - primarily management/administration with some staff input), which denotes the effectiveness of nursing professionals governance training among nurses working in a tertiary hospital in Saudi Arabia. The data used in this study can be utilized by future studies for benchmarking purposes.
  5. Alhelou Y, Hamdan M, Razali N, Adenan N, Ali J
    BMC Pregnancy Childbirth, 2023 Sep 28;23(1):698.
    PMID: 37770819 DOI: 10.1186/s12884-023-06025-2
    BACKGROUND: Previous studies looked into the connections between pregnancy and the Zona Pellucida (ZP) thickness and Zona Pellucida Thickness Variation (ZPTV), as well as the embryo's radius, circumference, perimeter and global symmetry. However, no research has linked embryo implantation and pregnancy to the percentage of ZP thinning, the reduction in ooplasm volume, and the increase in perivitelline space (PVS) volume. Our objective is to correlate the percentage of ZP thinning, the percentage of ooplasm volume shrinkage and the percentage of PVS increase to the implantation. These data will be used for embryo selection as well as it can be put into a software that will assist embryo selection.

    MATERIALS AND METHODS: Retrospective study included 281 patients, all of them had 2 embryos transferred, 149 patients got pregnant with two gestation sacs and 132 patients did not get pregnant. All of the transferred embryos had the ZP thickness measured several times from time of ICSI till Embryo Transfer (ET), the ooplasm volume was calculated from time of ICSI till two Pronuclei (2PN) fading and the PVS was calculated from the ICSI time till the 2PN fading.

    RESULTS: The first characteristic is the change in the average ZP thickness that decreased by 32.7% + 5.3% at 70 h for the implanted embryos (Group 1) versus 23.6% + 4.8% for non-implanted embryos (Group 2) p = 0.000. The second characteristic is the average reduction in the volume of the ooplasm which is 20.5% + 4.3% in Group 1 versus 15.1% + 5.2% in Group 2, p = 0.000. The third characteristic is the increase in the volume of the PVS which was 38.1% + 7.6% in Group 1 versus 31.6% + 9.7% in Group 2 p = 0.000.

    CONCLUSION: The implanted embryos showed higher percent of ZP thinning, higher percent of ooplasm reduction and higher percent of PVS increase.

  6. Praveena SM, Pauzi NM, Hamdan M, Sham SM
    Mar Pollut Bull, 2015 Mar 15;92(1-2):222-6.
    PMID: 25597267 DOI: 10.1016/j.marpolbul.2015.01.003
    A survey among beachgoers was conducted to determine the swimming associated health effects experienced and its relationship with beach water exposure behaviour in Morib beach. For beach water exposure behaviour, the highest frequency of visit among the respondents was once a year (41.9%). For ways of water exposure, whole body exposure including head was the highest (38.5%). For duration of water exposure, 30.8% respondents prefer to be in water for about 30 min with low possibilities of accidental ingestion of beach water. A total of 30.8% of beachgoers in Morib beach were reported of having dermal symptoms. Bivariate analysis showed only water activity, water contact and accidental ingestion of beach water showed significant association with swimming associated health effects experienced by swimmers. This study output showed that epidemiological study can be used to identify swimming associated health effects in beach water exposed to faecal contamination.
  7. Hamdan M, Jones KT, Cheong Y, Lane SI
    Sci Rep, 2016 11 14;6:36994.
    PMID: 27841311 DOI: 10.1038/srep36994
    Mouse oocytes respond to DNA damage by arresting in meiosis I through activity of the Spindle Assembly Checkpoint (SAC) and DNA Damage Response (DDR) pathways. It is currently not known if DNA damage is the primary trigger for arrest, or if the pathway is sensitive to levels of DNA damage experienced physiologically. Here, using follicular fluid from patients with the disease endometriosis, which affects 10% of women and is associated with reduced fertility, we find raised levels of Reactive Oxygen Species (ROS), which generate DNA damage and turn on the DDR-SAC pathway. Only follicular fluid from patients with endometriosis, and not controls, produced ROS and damaged DNA in the oocyte. This activated ATM kinase, leading to SAC mediated metaphase I arrest. Completion of meiosis I could be restored by ROS scavengers, showing this is the primary trigger for arrest and offering a novel clinical therapeutic treatment. This study establishes a clinical relevance to the DDR induced SAC in oocytes. It helps explain how oocytes respond to a highly prevalent human disease and the reduced fertility associated with endometriosis.
  8. Hamdan M, Jaaffar AH, Khraisat O, Issa MR, Jarrar M
    Risk Manag Healthc Policy, 2024;17:1687-1700.
    PMID: 38946841 DOI: 10.2147/RMHP.S458505
    BACKGROUND: To ensure best possible patient outcomes, patient safety is a major component of healthcare delivery system that needs to be prioritized. Safety practices among nurses are essential to maintain patient safety, especially the practices of medication administration, handover, patient falls and unplanned extubations prevention.

    PURPOSE: To investigate the mediating effect of patient safety culture between the relationship of transformational leadership and safety practices among nurses.

    METHODS: The data in this cross-sectional study were gathered from a survey targeted clinical nurses using a random sampling technique. The study was conducted in a medical city in Saudi Arabia, and two hundred nurses were surveyed. The Multifactor Leadership, Hospital Survey on Patient Safety Culture, and Nursing Safety Practice questionnaires were used in the study.

    RESULTS: The results revealed significant positive associations between transformational leadership, patient safety culture, and nursing safety practices. Moreover, patient safety culture mediates the association between transformational leadership and safety practices among nurses.

    CONCLUSION: Enhancing transformational leadership capabilities among nurse managers should be considered in order to improve nursing safety practices. Additionally, patient safety culture should be measured and improved periodically to ensure better nursing safety practices.

  9. Esmaon R, Lim BK, Gan F, Hamdan M, Tan PC
    BMC Pregnancy Childbirth, 2024 Jul 04;24(1):461.
    PMID: 38965486 DOI: 10.1186/s12884-024-06616-7
    BACKGROUND: Maternal Group B Streptococcus (GBS) colonization is influenced by many factors but results are inconsistent. Consideration of antenatal risk factors may help inform decision making on GBS microbiological culture screening where universal screening is not standard of care. We sought to identify independent predictors of GBS colonization at 34-37 weeks gestation incorporating vaginal symptoms, perineal hygiene measures, sexual activity, and a potential novel factor, constipation.

    METHODS: In this prospective cross-sectional study, 573 women at 34-37 weeks gestation had an ano-vaginal swab taken and sent for selective culture for GBS. Women were asked about vaginal bleeding, discharge, irritation and candidiasis, antibiotic use during pregnancy, ano-vaginal hygiene practices such as douching and perineal cleansing after toileting, sexual intercourse related activities, and a potential novel factor for GBS carriage, constipation. Maternal basic demographics and obstetric-related characteristics were also collected. Bivariate analyses were performed to identify associates of GBS colonization. All variables with p 

  10. Shamsul BS, Chowdhury SR, Hamdan MY, Ruszymah BHI
    Indian J Med Res, 2019 05;149(5):641-649.
    PMID: 31417032 DOI: 10.4103/ijmr.IJMR_45_17
    Background & objectives: Seeding density is one of the major parameters affecting the quality of tissue-engineered cartilage. The objective of this study was to evaluate different seeding densities of osteoarthritis chondrocytes (OACs) to obtain the highest quality cartilage.

    Methods: The OACs were expanded from passage 0 (P0) to P3, and cells in each passage were analyzed for gross morphology, growth rate, RNA expression and immunochemistry (IHC). The harvested OACs were assigned into two groups: low (1×10[7] cells/ml) and high (3×10[7] cells/ml) cell density. Three-dimensional (3D) constructs for each group were created using polymerised fibrin and cultured for 7, 14 and 21 days in vitro using chondrocyte growth medium. OAC constructs were analyzed with gross assessments and microscopic evaluation using standard histology, IHC and immunofluorescence staining, in addition to gene expression and biochemical analyses to evaluate tissue development.

    Results: Constructs with a high seeding density of 3×10[7] cells/ml were associated with better quality cartilage-like tissue than those seeded with 1×10[7] cells/ml based on overall tissue formation, cell association and extracellular matrix distribution. The chondrogenic properties of the constructs were further confirmed by the expression of genes encoding aggrecan core protein and collagen type II.

    Interpretation & conclusions: Our results confirmed that cell density was a significant factor affecting cell behaviour and aggregate production, and this was important for establishing good quality cartilage.

  11. Liu Y, Che CC, Hamdan M, Chong MC
    Midwifery, 2024 Apr 22;134:104002.
    PMID: 38669756 DOI: 10.1016/j.midw.2024.104002
    BACKGROUND: The empowerment of pregnant women is a meaningful strategy that profoundly impacts the health of women and their children. Despite a significant increase in the empowerment of pregnant women and its measurement, little attention was given to a consensus on the selection and application of assessment instruments used for pregnant women.

    OBJECTIVE: To identify the available assessment instruments for measuring the empowerment of pregnant women and to describe the appraisal content and their psychometric properties.

    METHODS: We searched nine bibliographic databases for original studies that focus on the measurement of empowerment in pregnant women. Arksey and O'Malley's methodology and PRISMA-ScR were selected to guide the implementation of this scoping review. The COSMIN criteria was employed to assess the methodological quality and the quality of psychometric properties.

    RESULTS: A total of 23 studies were included and 13 instruments were extracted. Given comprehensive considerations, Kameda's prenatal empowerment scale may be deemed suitable. The included instruments comprehensively measured the attributes of empowerment, with a particular focus on facilitating women's choice and decision-making. Except for the four most recent self-designed questionnaires, the remaining instruments had been tested for reliability and/or validity.

    CONCLUSION: There were heterogeneous results regarding the included instruments' appraisal content and psychometric properties. Future studies focusing on the development or validation of measurement instruments should be guided by influential and identical standards.

  12. Hamdan M, Sidhu K, Sabir N, Omar SZ, Tan PC
    Obstet Gynecol, 2009 Oct;114(4):745-751.
    PMID: 19888030 DOI: 10.1097/AOG.0b013e3181b8fa00
    OBJECTIVE: To estimate the effect of serial membrane sweeping on the onset of labor in women who planned vaginal birth after cesarean (VBAC).

    METHODS: Women at term with one transverse lower segment cesarean delivery who were suitable for and who planned VBAC were approached to participate. Participants were randomly assigned to weekly membrane sweeping or weekly vaginal assessment for Bishop score until delivery. Participants and delivery providers were blinded to the allocated treatment. Standard obstetric care was given to all participants. The primary outcome was onset of labor which was defined as the presence of spontaneous regular and painful contractions that cause cervical dilation to at least 3 cm or prelabor rupture of membranes. Secondary outcomes included induction of labor and repeat cesarean delivery.

    RESULTS: One hundred eight women were randomly assigned to membrane sweeping and 105 to control. The spontaneous labor rate was 78.5% compared with 72.1% (relative risk [RR] 1.1, 95% confidence interval [CI] 0.9-1.3; P=.34), the induction of labor rate was 12.1% compared with 9.6% (RR 1.3, 95% CI 0.6-2.8; P=.66), and the all-cause cesarean delivery rate was 40.2% compared with 44.2% (RR 0.9, 95% CI 0.7-1.2; P=.58) for the membrane sweeping and control groups, respectively. Gestational age at delivery (mean+/-standard deviation) of 39.6+/-1.0 weeks for the membrane sweeping group compared with 39.6+/-0.9 weeks for the control group (P=.84) was no different.

    CONCLUSION: Serial membrane sweeping at term in women who planned VBAC has no significant effect on the onset of labor, pregnancy duration, induction of labor, or repeat cesarean delivery.

    CLINICAL TRIAL REGISTRATION: ISRCTN, isrctn.org, ISRCTN55163179.

    LEVEL OF EVIDENCE: I.

  13. Hamdan M, Omar SZ, Dunselman G, Cheong Y
    Obstet Gynecol, 2015 Jan;125(1):79-88.
    PMID: 25560108 DOI: 10.1097/AOG.0000000000000592
    OBJECTIVE: To investigate the association of endometriosis on assisted reproductive technology (ART) outcomes and to review if surgical treatment of endometriosis before ART affects the outcomes.

    DATA SOURCES: We searched studies published between 1980 and 2014 on endometriosis and ART outcome. We searched MEDLINE, PubMed, ClinicalTrials.gov, and Cochrane databases and performed a manual search.

    METHODS OF STUDY SELECTION: A total of 1,346 articles were identified, and 36 studies were eligible to be included for data synthesis. We included published cohort studies and randomized controlled trials.

    TABULATION, INTEGRATION, AND RESULTS: Compared with women without endometriosis, women with endometriosis undertaking in vitro fertilization and intracytoplasmic sperm injection have a similar live birth rate per woman (odds ratio [OR] 0.94, 95% confidence interval [CI] 0.84-1.06, 13 studies, 12,682 patients, I=35%), a lower clinical pregnancy rate per woman (OR 0.78, 95% CI 0.65-0.94), 24 studies, 20,757 patients, I=66%), a lower mean number of oocyte retrieved per cycle (mean difference -1.98, 95% CI -2.87 to -1.09, 17 studies, 17,593 cycles, I=97%), and a similar miscarriage rate per woman (OR 1.26, 95% CI (0.92-1.70, nine studies, 1,259 patients, I=0%). Women with more severe disease (American Society for Reproductive Medicine III-IV) have a lower live birth rate, clinical pregnancy rate, and mean number of oocytes retrieved when compared with women with no endometriosis.

    CONCLUSION: Women with and without endometriosis have comparable ART outcomes in terms of live births, whereas those with severe endometriosis have inferior outcomes. There is insufficient evidence to recommend surgery routinely before undergoing ART.

  14. Mansor M, Chong MC, Chui PL, Hamdan M, Lim CC
    Psychol Health Med, 2023 Jul;28(6):1549-1561.
    PMID: 36120729 DOI: 10.1080/13548506.2022.2124288
    This scoping review describes the research-based mindfulness intervention on anxiety, distress, and depression. The search strategy retrieved articles published in English from 2014 to 2019 and were retrieved across Scopus, Web of Science, Science Direct, CINAHL, and Google Scholar. The PRISMA-Scr checklist is a tool to evaluate the quality of the articles. The selection criteria initially included all original articles in English, with 1,527 that were related to mindfulness intervention for anxiety, distress, and depression. A total of 490 full texts were retrieved, and after the abstracts were reviewed, 124 full-text articles were included for eligibility, and the final eight studies were determined. The articles were reviewed and screened for relevance to mindfulness intervention in reducing anxiety, distress, and depression among those with chronic diseases. The results have shown that mindfulness intervention reduces anxiety, distress, and depression among patients with chronic diseases. The review contributes further insight into the fact that mindfulness intervention is also appropriate for other conditions to facilitate reducing psychological symptoms.
  15. Liu Y, Che CC, Hamdan M, Chong MC
    Res Nurs Health, 2024 Dec;47(6):659-668.
    PMID: 39177122 DOI: 10.1002/nur.22419
    Empowering pregnant women is a crucial process that healthcare providers should evaluate, as empowerment is a meaningful indicator that can reflect the impact of health promotion and education in antenatal care. The Empowerment Scale for Pregnant Women (ESPW) is a reliable and valid instrument for measuring empowerment. The cross-sectional study was conducted to translate and validate the psychometric properties of the ESPW among 526 pregnant women in China. The forward-backward method was used to translate the English version of the ESPW into the Chinese version. Reliability was examined with the internal consistency and test-retest coefficients. Validity was analyzed with structural, dimensionality, convergent, discriminant, and concurrent validity. The Cronbach's α value of 0.97 and the intraclass correlation coefficient of 0.98 (95% confidence interval [CI], [0.96, 0.99]) demonstrated excellent internal consistency and test-retest reliability. Exploratory factor analysis revealed that five factors with eigenvalues > 1 explained 68.41% of the total variance. Confirmatory factor analysis verified an acceptable model that fit the data exceptionally. The Chinese-translated version of the ESPW (CV-ESPW) had acceptable convergent and discriminant validity. Concurrent validity was supported by the correlation between the total scores of the CV-ESPW and the Chinese version of the Patient Perceptions of the Empowerment Scale (r = 0.64, p 
  16. 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

  17. 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.

  18. 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

  19. Hashim E, Hong J, Woo YL, Hamdan M, Tan PC
    Obstet Gynecol, 2024 Jul 01;144(1):53-59.
    PMID: 38703361 DOI: 10.1097/AOG.0000000000005597
    OBJECTIVE: To compare insertion failure rates for Pipelle endometrial sampling with a full bladder compared with the standard process (not taking into account bladder status) without cervical manipulation.

    METHODS: A single-masked randomized trial was conducted in a single tertiary care center from July 2021 to January 2022. Two hundred fourteen participants aged 18 years or older who were scheduled for outpatient Pipelle endometrial sampling were randomized: 107 each to having a full bladder (by oral water intake) or standard process (without delayed sampling and bladder status not taken into account). Women with known cervical stenosis, gynecologic malignancy, uterine anomalies, leiomyoma distorting the uterine cavity, acute cervicitis, urge bladder dysfunction, intense anxiety, need for anesthesia or analgesic before the procedure, positive pregnancy test, or previous failed office endometrial sampling were excluded. The primary outcome was the insertion failure rate of endometrial sampling at first attempt. Secondary outcomes were pain during procedure, satisfaction score, analgesia use, procedure duration, and need for cervical manipulation. Factoring in a baseline insertion failure rate of 30.0%, relative risk of 0.45, α of 0.05, 80.0% power, and a dropout rate of 10.0%, we needed 107 participants in each arm.

    RESULTS: The insertion failure rate was significantly lower in the full bladder group compared with standard process: 25 of 107 (23.4%) compared with 45 of 107 (42.1%) (relative risk 0.56, 95% CI, 0.37-0.84; number needed to treat to benefit 6.0, 95% CI, 3.20-15.70). Pain score (median) during the procedure (interquartile range) was 4 (3-6) compared with 5 (3-8) ( P =.004); patient satisfaction score was 8 (7-9) compared with 7 (4-8) ( P

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