Preoperative free access to water compared to fasting for planned cesarean under spinal anesthesia: a randomized controlled trial.

BACKGROUND: Contemporary guidance for preoperative feeding allows solids up to 6 hours and clear fluids up to 2 hours before anesthesia. Clinical trial evidence to support this approach for cesarean delivery 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: This study aimed to evaluate the pragmatic approach of permitting free access to water up to the call to dispatch to the operating theater vs fasting from midnight in preoperative oral intake restriction for planned cesarean delivery under spinal anesthesia on perioperative vomiting and maternal satisfaction. STUDY DESIGN: A randomized controlled trial was conducted in the obstetrical unit of the University of Malaya Medical Centre from October 2020 to May 2022. A total of 504 participants scheduled for planned cesarean delivery were randomized: 252 undergoing preoperative free access to water up to the call to dispatch to the operating theater (intervention group) and 252 undergoing fasting from midnight (fasting arm). The primary outcomes were perioperative vomiting and maternal satisfaction. Analyses were performed using t test, Mann-Whitney U test, and chi-square test, as appropriate. RESULTS: Of note, 9 of 252 patients (3.6%) in the intervention group and 24 of 252 patients (9.5%) in the control group had vomiting at up to 6 hours after completion of cesarean delivery (relative risk, 0.38; 95% confidence interval, 0.18-0.79; P=.007), and the maternal satisfaction scores (0-10 visual numerical rating scale) were 9 (interquartile range, 8-10) in the intervention group and 5 (interquartile range, 3-7) in the control group (P<.001). Assessed before dispatch to the operating theater, feeling of thirst was reported by 69 of 252 patients (27.4%) in the intervention group and 134 of 252 patients (53.2%) in the control group (relative risk, 0.52; 95% confidence interval, 0.41-0.65; P<.001), capillary glucose levels were 4.8±0.7 mmol/L in the intervention group and 4.9±0.8 mmol/L in the control group (P=.048), and preoperative intravenous fluid hydration was commenced in 49 of 252 patients (19.4%) in the intervention group and 76 of 252 patients (30.2%) in the control group (relative risk, 0.65; 95% confidence interval, 0.47-0.88; P=.005). In the operating theater, ketone was detected in the catheterized urine in 38 of 252 patients (15.1%) in the intervention group and 78 of 252 patients (31.0%) in the control group (relative risk, 0.49; 95% confidence interval, 0.25-0.59; P<.001), and the numbers of doses of vasopressors needed to correct hypotension were 2.3±1.7 in the intervention group and 2.7±2.2 in the control (P=.009). The recommendation rates for preoperative oral intake regimen to a friend were 95.2% (240/252) in the intervention group and 39.7% (100/252) in the control group (relative risk, 2.40; 95% confidence interval, 2.06-2.80; P<.001), in favor of free access to water. Other assessed maternal and neonatal outcomes were not different. CONCLUSION: Compared with fasting, free access to water in planned cesarean delivery reduced perioperative vomiting and was strongly favored by women. In addition, several pre- and intraoperative secondary outcomes were improved. However, postcesarean delivery recovery and neonatal outcomes were not different.

Sexual activity, vaginal symptoms, maternal perineal hygiene behavior, and constipation on ano-vaginal colonization of group B streptococcus in near term pregnancy.

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 < 0.05 found on bivariate analysis were then included into a model for multivariable binary logistic regression analysis to identify independent risk factors for GBS colonization. RESULTS: GBS colonization was found in 235/573 (41.0%) of participants. Twenty six independent variables were considered for bivariate analysis. Eight were found to have p < 0.05. Following adjusted analysis, six independent predictors of GBS colonization were identified: ethnicity, previous neonatal GBS prophylaxis, antenatal vaginal irritation, antibiotic use, recent panty liner use, and frequency of sexual intercourse. Vaginal discharge and perineal cleansing were not associated after adjustment. Recent douching and constipation were not associated on bivariate analysis. CONCLUSION: The identification of independent predictors of GBS colonization in late pregnancy may inform the woman and care provider in their shared decision making for microbiological screening at 35-38 weeks gestation in locations where universal GBS screening is not standard of care. ETHICS OVERSIGHT: This study was approved by the Medical Ethics Committee of University Malaya Medical Centre (UMMC) on August 9, 2022, reference number 2022328-11120.

Routine vaginal examination to assess labour progress at 8 compared to 4 h after early amniotomy following Foley balloon ripening in the labor induction of nulliparas: A randomized trial.

INTRODUCTION: Our objective was to compare the performance of the first vaginal examination at 8 versus 4 h after amniotomy following Foley ripening in nulliparous labor induction. MATERIAL AND METHODS: A randomized controlled trial was conducted from June 2021 to January 2022. 210 nulliparas at term for labor induction were randomized: 105 each to first vaginal examination at 8 or 4 h after Foley balloon ripening and amniotomy. Titrated oxytocin infusion was routinely commenced after amniotomy to expedite labor. Primary outcomes were the amniotomy-to-delivery interval (non-inferiority hypothesis) and maternal satisfaction with their allocated labor care (superiority hypothesis) within 24 h after delivery. Analyses performed using t-test, Mann-Whitney U test, and Chi-squared test as appropriate. RESULTS: The amniotomy-to-delivery interval was mean ± standard deviation 8.7 ± 3.4 versus 8.4 ± 3.7, mean difference 0.4 (97.5% CI: -0.7 to 1.5) hours, p = 0.442 within the pre-specified 2-hour non-inferiority margin, and maternal satisfaction score with allocated labor care was median [interquartile range] 8[7.5-10] versus 8[7.0-10], p = 0.248 for 8 versus 4 h arms, respectively. The amniotomy to first vaginal examination intervals was 5.9 ± 2.3 versus 3.6 ± 1.0 h, p < 0.001, and the number of vaginal examinations was 2[1-2.5] versus 3 [2, 3], p < 0.001 for 8 versus 4 h, respectively. The first vaginal examination was less likely to have been performed as scheduled, more likely to be indicated by the urge to bear down, and non-reassuring cardiotocography for the 8 h arm (p < 0.001). Spontaneous vaginal delivery was significantly more likely and instrumental vaginal delivery less likely, but cesarean rate was not significantly different for the 8 h arm (p = 0.017). CONCLUSIONS: A routine first vaginal examination at 8 h compared to 4 h is non-inferior for the time to birth but does not increase maternal satisfaction although the number of vaginal examinations is fewer. The increase in spontaneous vaginal delivery and reduction in instrumental vaginal delivery rates warrant further powered primary evaluation.

Psychometric validation of the Chinese version of the empowerment scale for pregnant women.

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 < 0.001). The CV-ESPW is a valid and reliable assessment tool for measuring pregnant women's empowerment in China and can potentially contribute to evaluating the effectiveness of programs that empower pregnant women.

Real-time imaging as visual biofeedback in active second stage of labor among nulliparas: a randomized controlled trial.

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<.001) for the intervention and control arm, respectively. Women randomized to the intervention arm were more likely to agree to recommend their management to a friend (88/115 [76.5%] vs 39/115 [33.9%]; relative risk, 2.26 [95% confidence interval, 1.72-2.97]; P<.001) and more likely to have less severe perineal injury (P=.018). CONCLUSION: Real-time viewing of the maternal introitus as visual biofeedback during pushing resulted in higher maternal satisfaction compared with the sham control of viewing the maternal face; however, the time to delivery was not significantly shortened.

Watermelon and dietary advice compared to dietary advice alone following hospitalization for hyperemesis gravidarum: a randomized controlled trial.

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.

Effect of mindfulness intervention on anxiety, distress, and depression for chronic diseases: a scoping review.

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.

Micturition in the toilet compared with bedpan in laboring Nulliparas: a randomized controlled trial.

BACKGROUND: Bladder overdistension in labor may lead to prolonged postpartum urinary retention. We hypothesized that nulliparas mobilizing to toilet is more likely to achieve satisfactory micturition. METHODS: One hundred sixteen (58 in each arm) term nulliparas in labor with filled bladders were randomized to mobilizing to the toilet or using bedpan to micturate. Primary outcome was satisfactory micturition defined as ultrasound derived post-void bladder volume < 150 ml. Following unsatisfactory micturition, participants crossover to the opposed intervention. Participants were catheterized if after crossover, residual bladder volume was ≥250 ml. RESULTS: Satisfactory micturition rates were 55/58 (95%) vs. 43/58 (74%) RR 1.28 95%CI 1.08-1.51 NNTb 4.8 95%CI 3.0-12.4 P = 0.008, failure to micturate 1/58 (2%) vs. 8/58 (14%) RR 0.13 95%CI 0.02-0.97 NNTb 8.3 95%CI 4.6-38.7 P = 0.047. After cross over following unsatisfactory bladder voiding, satisfactory micturition rates were 0/3 (0%) vs 13/15 (87%) P = 0.024, bladder catheterization rates were 3/58 (5%) vs. 2/58 (4%) RR 95%CI 1.5 (0.26-8.65) P = 0.648, maternal satisfaction with allocated intervention 55/58 (95%) vs. 9/58 (16%) RR 95%CI 6.1 (3.3-11.2) NNTb 95%CI 1.3 (1.1-1.5) P <  0.0001 and preference for mobilizing to the toilet if micturition was needed again during labor 55/58 (95%) vs. 53/58 (92%) for mobilizing to the toilet compared to bedpan use arms respectively. Labor and neonatal outcomes were similar. CONCLUSION: Satisfactory micturition was more frequently achieved with mobilization to the toilet than bedpan use. Women in both arms overwhelmingly prefer to mobilize to the toilet to urinate. TRIAL REGISTRATION: This study was registered with ISRCTN on 17/07/2019 with trial identification number: ISRCTN17787339 . First participant was recruited on 31/07/2019. The last patient was recruited on 18/12/2019.

Foley catheter and controlled release dinoprostone versus foley catheter labor induction in nulliparas: a randomized trial.

PURPOSE: To evaluate Foley catheter and controlled release dinoprostone insert compared to foley catheter alone on induction to delivery interval and maternal satisfaction. METHODS: A randomized trial was conducted in a university hospital in Malaysia from December 2018 to May 2019. Term nulliparas with unfavorable cervix (Bishop score ≤ 5) scheduled for labor induction were randomized to Foley catheter and controlled release dinoprostone insert simultaneously or Foley catheter alone. Primary outcomes were induction to delivery interval (hours) and maternal satisfaction on birth experience (assessed by 11-point Visual Numerical Rating Scale VNRS 0-10, higher score more satisfied). RESULTS: Induction to vaginal delivery intervals was mean ± standard deviation 22.5 ± 10.4 vs. 35.1 ± 14.9 h, P = < 0.001 but maternal satisfaction on birth experience was not significantly different median[interquartile range] VNRS 8[7-9] vs. 8[7-9], P = 0.12 for Foley catheter-controlled-release dinoprostone and Foley catheter alone arms, respectively. Cesarean delivery rates were 35/102(34.3%) vs. 50/101(49.5%), P = 0.02 RR 0.7 95% CI 0.5-0.9 NNTb 6.3 95% CI 3.5-39.4, pain score at 6 h after catheter insertion 5[2-8] vs. 1[1-3], P < 0.001, Bishop score at trial devices removal 9[9-10] vs. 8[7-9], P = 0.001, requirement for oxytocin induction or augmentation 39/102(38.2%) vs. 76/101(75.2%) NNTb 3 95% CI 2.0-4.1, P < 0.001 and amniotomy rates 73/99(73.7%) vs. 81/95(85.3%), P = 0.052 RR 0.9 85% CI 0.8-1.0 in Foley catheter-controlled-release dinoprostone and Foley catheter alone arms respectively. CONCLUSION: In nulliparas with unripe cervixes at term, combined Foley catheter and controlled release dinoprostone vaginal insert compared to Foley catheter alone reduces the induction to vaginal delivery interval and cesarean delivery rate but satisfaction was not significantly increased. CLINICAL TRIAL REGISTRATION: ISRCTN2282883, 03/12/2018, "prospectively registered" ( https://doi.org/10.1186/ISRCTN12282883 ).

Outpatient vs inpatient Foley catheter induction of labor in multiparas with unripe cervixes: A randomized trial.

INTRODUCTION: Multiparous labor inductions are typically successful, and the process can be rapid, starting from a ripened cervix with a predictable response to amniotomy and oxytocin infusion. Outpatient Foley catheter labor induction in multiparas with unripe cervixes is a feasible option as the mechanical process of ripening is usually without significant uterine contractions and well tolerated. Labor contractions can be initiated by amniotomy and titrated oxytocin infusion in the hospital for well-timed births during working hours as night birth are associated with adverse events. We sought to evaluate outpatient compared with inpatient Foley catheter induction of labor in multiparas for births during working hours and maternal satisfaction. MATERIAL AND METHODS: A randomized trial was conducted in the University of Malaya Medical Center. A total of 163 term multiparas (no dropouts) with unripe cervixes (Bishop score ≤5) scheduled for labor induction were randomized to outpatient or inpatient Foley catheter. Primary outcomes were delivery during "working hours" 08:00-18:00 h and maternal satisfaction on allocated care (assessed by 11-point visual numerical rating score 0-10, with higher score indicating more satisfied). CLINICAL TRIAL REGISTRATION: ISRCTN13534944. RESULTS: Comparing outpatient and inpatient arms, delivery during working hours were 54/82 (65.9%) vs. 48/81 (59.3%) (relative risk 1.1, 95% CI 0.9-1.4, p = 0.421) and median maternal satisfaction visual numerical rating score was 9 (interquartile range 9-9) vs. 9 (interquartile range 8-9, p = 0.134), repectively. Duration of hospital stay and membrane rupture to delivery interval were significantly shorter in the outpatient arm: 35.8 ± 20.2 vs. 45.2 ± 16.2 h (p = 0.001) and 4.1 ± 2.9 vs. 5.3 ± 3.6 h (p = 0.020), respectively. Other maternal and neonatal secondary outcomes were not significantly different. CONCLUSIONS: The trial failed to demonstrate the anticipated increase in births during working hours with outpatient compared with inpatient induction of labor with Foley catheter in parous women with an unripe cervix. Hospital stay and membrane rupture to delivery interval were significantly shortened in the outpatient group. The rate of maternal satisfaction was high in both groups and no significant differences were found.

Speculum versus digital insertion of Foley catheter for induction of labor in Nulliparas with unripe cervix: a randomized controlled trial.

BACKGROUND: Induction of labor (IoL) is an increasingly common obstetric procedure. Foley catheter IoL is recommended by WHO. It is associated with the lowest rate of uterine hyperstimulation syndrome and similar duration to delivery and vaginal delivery rate compared to other methods. Insertion is typically via speculum but digital insertion has been reported to be faster, better tolerated and with similar universal insertion success compared to speculum insertion in a mixed population of nulliparas and multiparas. Transcervical procedure is more challenging in nulliparas and when the cervix is unripe. We evaluated the ease and tolerability of digital compared to speculum insertion of Foley catheter for induction of labor in nulliparas with unripe cervixes. METHODS: A randomized trial was performed in a university hospital in Malaysia. Participants were nulliparas at term with unripe cervixes (Bishop Score ≤ 5) admitted for IoL who were randomized to digital or speculum-aided transcervical Foley catheter insertion in lithotomy position. Primary outcomes were insertion duration, pain score [11-point Visual Numerical Rating Scale (VNRS)], and failure. All primary outcomes were recorded after the first insertion. RESULTS: Data from 86 participants were analysed. Insertion duration (with standard deviation) was 2.72 ± 1.85 vs. 2.25 ± 0.55 min p = 0.12, pain score (VNRS) median [interquartile range] 3.5 [2-5] vs. 3 [2-5] p = 0.72 and failure 2/42 (5%) vs. 0/44 (0%) p = 0.24 for digital vs speculum respectively. There was no significant difference found between the two groups for all three primary outcomes. Induction to delivery 30.7 ± 9.4 vs 29.6 ± 11.5 h p = 0.64, Cesarean section 25/60 (64%) vs 28/64 (60%) RR 0.9 95% CI p = 0.7 and maternal satisfaction VNRS score with the birth process 7 [IQR 6-8] vs 7 [7-8] p = 0.97 for digital vs. speculum arms respectively. Other labor, delivery and neonatal secondary outcomes were not significantly different. CONCLUSION: Digital and speculum insertion in nulliparas with unripe cervixes had similar insertion performance. As digital insertion required less equipment and consumables, it could be the preferred insertion method for the equally adept and the insertion technique to train towards. TRIAL REGISTRATION: This trial was registered with ISRCTN registration number 13804902 on 15 November 2017.

Measuring empowerment in pregnant women: A scoping review of progress in instruments.

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.

Cross-cultural adaptation of the empowerment scale of pregnant women in China context: An integrative method of translation and linguistic validation.

AIM: To translate the Empowerment Scale for Pregnant Women (ESPW) into Chinese and to assess its linguistic validity. METHODS: The integrative method of the translation process, the Delphi technique, and cognitive interviews were used to implement cross-cultural adaptation and enhance comprehensibility and linguistic validation. This study recruited 14 experts in the expert review and cognitively reviewed 15 pregnant women. RESULTS: The two-round Delphi method created agreement on cultural applicability. The results of content validity achieved good levels: The item-level content validity index (CVI) ranged from 0.78 to 1.00, and the scale-level content validity index, calculated using two different formulas, were 0.97 and 0.81, respectively. Kappa values ranged from 0.74 to 1.00. Pregnant women could understand most of the items and response options in the cognitive interview. The revisions to the wording were made based on suggestions from experts and pregnant women. CONCLUSION: The prefinal simplified Chinese ESPW was semantically and conceptually equivalent to the English version, which was well prepared for further psychometric tests in the next stage of cross-cultural adaptation. PATIENT OR PUBLIC CONTRIBUTION: This comprehensive method successfully developed a Chinese tool to measure the empowerment of pregnant women, indicating the international applicability of this tool and the methodological scientific nature. The simplified Chinese ESPW has the potential to support the identification of empowerment levels of pregnant women and the evaluation of the effectiveness of health education and promotion programmes.

Self bladder emptying compared with Foley catheter placement for planned cesarean delivery: a randomized controlled trial.

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.

Electric massage chairs reduce labor pain in nulliparous patients: a randomized crossover trial.

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<.001), a significant reduction in pain score after electric chair mechanical massage compared with no massage. On the across randomized arms secondary analyses, labor pain scores after their first massage chair session were 4.35±2.52 (randomized to massage first, received massage as initial intervention) and 5.66±1.73 (randomized to no massage first, received no massage as initial intervention) (mean difference, -1.31; 95% confidence interval, -1.91 to -0.748; P<.001), 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 scores 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 reduced labor pain, offering a potential nonpharmacologic pain management option during labor.

Pipelle Endometrial Sampling With a Full Bladder Compared With Standard Care: A Randomized Controlled Trial.

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 <.001); and mean±SD procedure duration was 3.0±2.4 compared with 4.7±2.9 minutes ( P <.001) for the full bladder and standard process arm, respectively. Other secondary outcomes of cervical laceration, analgesia use, and adequacy of endometrial tissue for histopathologic assessment were not significantly different between groups. CONCLUSION: Pipelle endometrial sampling with a full bladder reduces the initial insertion failure rate, procedure-related pain, and duration of sampling and increases patient satisfaction compared with the standard process. CLINICAL TRIAL REGISTRATION: ISRCTN, ISRCTN33938192.

Routine vaginal examination to assess labor progress at 8 compared to 4 hours after early amniotomy following Foley balloon ripening in the labor induction of multiparas: a randomized trial.

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<.001). For the 8-hour arm, the first vaginal examination was less likely to be as scheduled and more likely to be indicated by sensation to bear down (P<.001), and the epidural analgesia rates were lower (13/102 participants [12.7%] in the 8-hour arm vs 28/102 participants [27.5%] in the 4-hour arm; relative risk, 0.46; 95% confidence interval, 0.26-0.84; P=.009). Other outcomes of the mode of delivery, indications for cesarean delivery, and delivery blood loss were not different. Neonatal outcomes were not different. CONCLUSION: Routine first vaginal examination at 8 hours compared with that at 4 hours was noninferior for the time to birth but did not improve maternal satisfaction.

Cold compared with room temperature compress on the repaired primiparous perineum following injury at normal vaginal delivery: a randomized controlled trial.

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.

Oral rehydration therapy versus intravenous rehydration therapy in the first 12 h following hospitalization for hyperemesis gravidarum: A randomized controlled trial.

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 < 0.001; (2) weight gain was 293 ± 780 g versus 948 ± 758 g, P < 0.001; and (3) ketonuria improvement was 50/61 (82.0%) versus 49/63 (77.8%) (relative risk [RR] 1.05, 95% confidence interval [CI] 0.88-1.26, P = 0.561) for ORT versus IVT, respectively. For secondary outcomes, vomiting frequency was 2.6 ± 2.7 versus 1.1 ± 1.4 episodes (P < 0.001), participant cross-over rate to opposing treatment 20/61 (32.8%) versus 0/63 (0%) (P < 0.001) (in the 12-h study period) and participant recommendation of allocated treatment to a friend rate 24/61 (39.3%) versus 61/63 (96.8%) (RR 0.41, 95% CI 0.30-0.56, P < 0.001) for ORT versus IVT, respectively. By hospital discharge, 31/61 (50.8%) of women allocated to ORT had required IVT. Other secondary outcomes of serial assessments of nausea score and vital signs, hematocrit and electrolyte levels, and length of hospital stay were not different. CONCLUSIONS: ORT was inferior to IVT in two primary outcomes and three secondary outcomes. Cross-over rate to intravenous therapy from oral therapy was 50.8% by hospital discharge. Intravenous rehydration therapy should remain as first-line rehydration therapy in the early inpatient treatment of HG. CLINICAL TRIAL REGISTRATION: The present study was registered in ISRCTN registry on December 6, 2020 with trial identification number: ISRCTN 40152556 (https://doi.org/10.1186/ISRCTN40152556). The first participant was recruited on February 10, 2021.