Displaying publications 1 - 20 of 60 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. 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.

  3. 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 

  4. Hassanein MM, Huri HZ, Baig K, Abduelkarem AR, Al-Momani M
    Int J Gynaecol Obstet, 2024 Feb;164(2):613-623.
    PMID: 37702968 DOI: 10.1002/ijgo.15106
    OBJECTIVES: To develop and validate an electronic, patient-reported outcomes measure (PROM) specific for genitourinary syndrome of menopause (GSM) patients. The PROM aimed to accurately assess the burden of GSM symptoms, their impact on health-related and sexual quality of life, and the acceptability of vaginal treatments.

    METHODS: The study encompassed a comprehensive three-stage approach to the development and validation of the PROM. Initially, during the preliminary design stage, the necessity for a new PROM was recognized, an expert panel was formed, and semi-structured qualitative interviews were carried out with GSM patients. In the second stage, the study used the five-step pre-validation methodology established by Prior et al. to generate and refine the PROM items. The third and final stage encompassed the determination of scale and item content validity indexes to ensure validity. Additionally, the reliability of each construct was evaluated using Cronbach's α.

    RESULTS: The resulting PROM was named GSM-SVTAQ (GSM-symptoms and vaginal treatments acceptability questionnaire). It demonstrated excellent validity in assessing symptoms burden, health-related and sexual quality of life, and vaginal treatment acceptability, with high content validity indices and strong internal consistency. The scale content validity indices and Cronbach's α coefficients for the three domains were (0.926, 0.939), (0.875, 0.947), and (0.824, 0.855), respectively.

    CONCLUSION: The GSM-SVTAQ stands as the first GSM-specific, valid, and reliable PROM capable of comprehensively measuring the three components of GSM and the acceptability of vaginal treatments. Its implementation has the potential to significantly enhance patient care and outcomes in GSM management.

  5. Yen CF, Hamdan M, Hengrasmee P, Huang Z, Jeong K, Dao LA, et al.
    Int J Gynaecol Obstet, 2023 Dec;163(3):720-732.
    PMID: 37837343 DOI: 10.1002/ijgo.15142
    Endometriosis should be diagnosed as early as possible in the continuum of care; but substantial delays of approximately 6-8 years between symptom onset and endometriosis diagnosis have been widely reported. With the purpose of improving the prompt diagnosis of endometriosis, the Asia-Pacific Endometriosis Expert Panel (APEX) sought to address the reasons for diagnostic delays across the region, and formulate a multi-pronged approach to overcoming these challenges. In the first instance, clinical diagnosis is preferable to surgical diagnosis, in order to facilitate earlier empirical treatment and minimize the negative sequelae of undiagnosed/untreated disease. There should be a high clinical index of suspicion in women presenting with cyclical symptoms, including those involving extrapelvic organs. Diagnostic delays in Asia-Pacific countries are attributable to a variety of patient, physician, and healthcare factors, including poor awareness, normalization/trivialization of pain, individual/cultural attitudes toward menstruation, default use of symptom-suppressing treatments, misdiagnosis, and a lack of diagnostic resourcing or adequate referral pathways in some areas. Suggested initiatives to reduce diagnostic delays are geared toward improving public awareness, improving clinical diagnostic skills, streamlining multidisciplinary care pathways for timely referral, updating and implementing diagnostic guidelines, lobbying policymakers and insurance companies for endometriosis support, and increasing efforts to bridge data gaps and perform further research in this field. Formulating specific action plans and gathering traction are the responsibility of individual countries within local parameters. The APEX group advocates for any initiatives and policies that support the unmet needs of women with endometriosis, to improve patient experience and outcomes.
  6. Khan KS, Fawzy M, Chien PFW
    Int J Gynaecol Obstet, 2023 Dec;163(3):733-743.
    PMID: 37184087 DOI: 10.1002/ijgo.14837
    The integrity of randomized clinical trials (RCT) has become a concern owing to a recent rise in the number of retractions and the repercussions this has for evidence-based patient care. However, there is little research on the subject of RCT integrity assessment. Recent literature reviews have revealed that journals' authors' instructions concerning integrity and their investigation policies concerning allegations of misconduct are heterogeneous. The judicious use of integrity tests applied to RCT manuscripts is hampered by an absence of data concerning misconduct prevalence (pre-test probability), a failure to evaluate test performance (validity) and a lack of consensus over a gold standard (against which test accuracy can be evaluated). These deficiencies hinder the post-publication correction of RCT records, the integrity evaluations in systematic reviews of RCTs and the prospective application of preventive solutions in RCT peer-review and preprint assessment. Dealing with the current controversy about trustworthiness of RCT evidence requires a strong investment in research, reform and education concerning research integrity. The purpose of this review article is to highlight the current limitations in dealing with trial integrity-related concerns and to propose solutions to some of these issues.
  7. 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 

  8. 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 

  9. Leung TW, Damodaran P, Torres R, Chuncharunee S, Chu MY, Gamilla Z, et al.
    Int J Gynaecol Obstet, 2023 Nov;163(2):495-509.
    PMID: 37096333 DOI: 10.1002/ijgo.14804
    Iron deficiency anemia (IDA) is a major health burden among women in Asia. Key issues in IDA management in Asia are under-diagnosis and under-treatment. The lack of Asia-specific guidelines, and suboptimal utilization of treatment compounds the management of IDA. To address these gaps, a panel of 12 experts in obstetrics, gynecology, and hematology from six regions in Asia convened to review current practices and clinical evidence and provide practical guidance on IDA diagnosis and management in Asian women. The Delphi approach was used to obtain objective opinions and attain consensus on statements pertaining to awareness, diagnosis, and management of IDA. In total, 79 statements attained consensus and are summarized to provide guidance on raising awareness of IDA and approaches for improved diagnosis and treatment of IDA among women in various settings: pregnancy, postpartum, heavy menstrual bleeding, gynecologic cancers, and perioperative care. This clinician-led consensus integrates appropriate recommendations based on clinical evidence and best practices and is intended to guide decision making in the management of iron deficiency/IDA in women. The expert panel raises a call for timely diagnosis and utilization of appropriate treatment, including use of high-dose intravenous iron, stringent blood management, and interdisciplinary collaboration, for optimization of IDA management among women in Asia.
  10. Núñez-Núñez M, Maes-Carballo M, Mignini LE, Chien PFW, Khalaf Y, Fawzy M, et al.
    Int J Gynaecol Obstet, 2023 Sep;162(3):860-876.
    PMID: 37062861 DOI: 10.1002/ijgo.14762
    BACKGROUND: Randomized clinical trials (RCTs) are experiencing a crisis of confidence in their trustworthiness. Although a comprehensive literature search yielded several reviews on RCT integrity, an overarching overview is lacking.

    OBJECTIVES: The authors undertook a scoping umbrella review of the research integrity literature concerning RCTs.

    SEARCH STRATEGY AND SELECTION CRITERIA: Following prospective registration (https://osf.io/3ursn), two reviewers independently searched PubMed, Scopus, The Cochrane Library, and Google Scholar, without language or time restrictions, until November 2021. The authors included systematic reviews covering any aspect of research integrity throughout the RCT lifecycle.

    DATA COLLECTION AND ANALYSIS: The authors assessed methodological quality using a modified AMSTAR 2 (A Measurement Tool to Assess Systematic Reviews) tool and collated the main findings.

    MAIN RESULTS: A total of 55 relevant reviews, summarizing 6001 studies (median per review, 63; range, 8-1106) from 1964 to 2021, had an overall critically low quality of 96% (53 reviews). Topics covered included general aspects (15%), design and approval (22%), conduct and monitoring (11%), reporting (38%), postpublication concerns (2%), and future research (13%). The most common integrity issues covered were ethics (18%) and transparency (18%).

    CONCLUSIONS: Low-quality reviews identified various integrity issues across the RCT lifecycle, emphasizing the importance of high ethical standards and professionalism while highlighting gaps in the integrity landscape. Multistakeholder consensus is needed to develop specific RCT integrity standards.

  11. 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.

  12. 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 

  13. Ramly F, Mahamooth MIJ, Abidin HAZ, Sani H, Hassan J
    Int J Gynaecol Obstet, 2023 Feb;160(2):710-712.
    PMID: 36200647 DOI: 10.1002/ijgo.14493
  14. Kajdy A, Sys D, Pokropek A, Shaw SW, Chang TY, Calda P, et al.
    Int J Gynaecol Obstet, 2023 Jan;160(1):167-186.
    PMID: 35932096 DOI: 10.1002/ijgo.14388
    OBJECTIVE: To assess risk factors for anxiety and depression among pregnant women during the COVID-19 pandemic using Mind-COVID, a prospective cross-sectional study that compares outcomes in middle-income economies and high-income economies.

    METHODS: A total of 7102 pregnant women from 12 high-income economies and nine middle-income economies were included. The web-based survey used two standardized instruments, General Anxiety Disorder-7 (GAD-7) and Patient Health Questionnaire-9 (PHQ-9).

    RESULT: Pregnant women in high-income economies reported higher PHQ-9 (0.18 standard deviation [SD], P 

  15. Hasan NA, Hong JGS, Teo IH, Zaidi SN, Hamdan M, Tan PC
    Int J Gynaecol Obstet, 2022 Dec;159(3):951-960.
    PMID: 35726368 DOI: 10.1002/ijgo.14313
    OBJECTIVE: To evaluate immediate oxytocin and early amniotomy compared with delayed amniotomy after Foley catheter cervical ripening in nulliparous women on intervention-to-delivery interval.

    METHODS: A randomized trial was conducted from September 2020 to March 2021. A total of 140 term nulliparas (70 early amniotomy, 70 delayed amniotomy) with Foley catheter-ripened cervices (dilatation ≥3 cm achieved), singleton fetus, cephalic presentation with intact membranes, and reassuring fetal heart rate tracing were recruited. Women were randomized to immediate titrated intravenous oxytocin infusion and early amniotomy or delayed amniotomy (after 4 h of oxytocin). The primary outcome was intervention (oxytocin)-to-delivery interval (h).

    RESULTS: Intervention-to-delivery intervals (h) were mean ± standard deviation 9.0 ± 3.6 versus 10.6 ± 3.5 h (mean difference of 1.4 h) (P = 0.004) for the early versus delayed amniotomy arms, respectively. Birth rates at 6 h after oxytocin infusion were 19 of 70 (27.1%) versus 8 of 70 (11.4%) (relative risk, 2.38 [95% confidence interval (CI), 1.11-5.06]; number needed to treat: 7 [95% CI, 3.5-34.4]) (P = 0.03), cesarean delivery rates were 29 of 70 (41.4%) versus 33 of 70 (47.1%) (relative risk, 0.88; 95% CI, 0.61-1.28) (P = 0.50), and maternal satisfaction on birth process were a median of 7 (interquartile range, 7-8) versus 7 (interquartile range, 7-8) (P = 0.40) for the early versus delayed amniotomy arms, respectively.

    CONCLUSION: In term nulliparas with cervices ripened by Foley catheter, immediate oxytocin and early amniotomy compared with a planned 4-h delay to amniotomy shortened the intervention-to-delivery interval but did not significantly reduce the cesarean delivery rate.

  16. Tew MP, Tan PC, Saaid R, Hong JGS, Omar SZ
    Int J Gynaecol Obstet, 2022 Mar;156(3):508-515.
    PMID: 33890319 DOI: 10.1002/ijgo.13718
    OBJECTIVE: To evaluate the impact of preemptive metformin on the level of glycosylated hemoglobin (HbA1c) at 36 weeks of pregnancy in women with gestational diabetes mellitus controlled by diet change (GDMA1).

    METHODS: A randomized, double-blind, placebo-controlled trial was performed in a university hospital. Women with GDMA1 were recruited at 16-30 weeks of pregnancy and randomized to oral metformin 500 mg twice daily or identical placebo tablets to delivery. Level of HbA1c was taken at recruitment and at 36 weeks of pregnancy. The primary outcome was the change in level of HbA1c at recruitment and 36 weeks of pregnancy.

    RESULTS: Data from 106 participants were analyzed. The level of HbA1c during pregnancy increased significantly with a mean increase of 0.20% ± 0.31% (P 

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