METHODS: Over a 3-year period a group of pregnant women with cardiac disease was followed until 6 weeks postpartum. Twenty women with pulmonary hypertension were compared with 20 controls without pulmonary hypertension with particular reference to maternal and fetal outcome. Analysis of data was carried out using Fisher's exact test and Student's t-test.
RESULTS: Except for Eisenmenger's syndrome, there were no differences in maternal morbidity and mortality between the two groups. There were more low birth weight babies but no significant differences in premature delivery rate, mode of delivery or perinatal mortality.
CONCLUSION: Except for Eisenmenger's syndrome, coexisting pulmonary hypertension complicating cardiac disease in pregnancy generally has a favorable outcome for both mother and fetus.
OBJECTIVE: To estimate the prevalence of postpartum dyspareunia.
SEARCH STRATEGY: Web of Science, Scopus, PubMed, and Embase databases were searched to July 2019 using keywords including 'perineal pain,' 'dyspareunia,' and 'sexual pain'.
SELECTION CRITERIA: Observational studies on the prevalence of postpartum dyspareunia were included.
DATA COLLECTION AND ANALYSIS: Two authors independently reviewed articles and extracted data. Study heterogeneity was evaluated by I2 index; publication bias by Egger and Begg tests.
MAIN RESULTS: Twenty-two studies enrolling 11 457 women were included. Based on meta-analysis, the overall estimated prevalence of dyspareunia was 35% (95% confidence interval [CI], 29%-41%). The prevalence was 42% (95% CI, 26%-60%) at 2 months, 43% (95% CI, 36%-50%) at 2-6 months, and 22% (95% CI, 15%-29%) at 6-12 months postpartum. Begg test showed no significant bias in data related to the prevalence of postpartum dyspareunia (p = 0.466).
CONCLUSION: The prevalence of postpartum dyspareunia was 35% and decreased with increasing postpartum duration. Given the high prevalence and its impact on a woman's quality of life, special attention should be paid to this common complaint during the postpartum period.
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
OBJECTIVES: We undertook a scoping systematic review to map the literature regarding post-publication integrity issues in RCTs.
SEARCH STRATEGY AND SELECTION CRITERIA: Following prospective registration (https://osf.io/pgxd8) we initially searched PubMed and Scopus but subsequently extended it to include the Cochrane Library, and Google Scholar databases without language, article type or publication time restriction until November 2022. Reviewers independently selected published articles covering any aspect of post-publication research integrity concerns in RCTs.
DATA COLLECTION AND ANALYSIS: The study findings grouped within domains relating to issues concerning post-publication integrity were extracted in duplicate, verified by a third reviewer, and then tabulated.
MAIN RESULTS: The initial search captured 3159 citations, of which 89 studies were included in the review. Cross-sectional studies constituted the majority of included studies (n = 34, 38.2%), followed by systematic reviews (n = 10, 11.2%), methodology reviews/studies (n = 9, 10.1%) and other types of descriptive studies (n = 8, 9.0%). A total of 21 articles (23.6%) covered the domain on general issues, 25 (28.1%) in the journal's instructions and policies domain, eight (9.0%) in the editorial and peer review domain, one (1.1%) in the correspondence and complaints (post-publication peer review) domain, 12 (13.5%) in the investigation for concerns domain, six (6.7%) in the post-investigation decisions and sanctions domain, none in the critical appraisal guidance domain, five (5.6%) in the integrity assessment in systematic reviews domain, and 26 (29.2%) in the recommendations for future research domain. A total of 12 of the selected articles (13.5%) covered two (n = 9) or three (n = 3) different domains.
CONCLUSIONS: Various research integrity domains and issues covering post-publication aspects of RCT integrity were captured and gaps were identified, mostly related with the necessary implications for all stakeholders to improve research transparency. There is an urgent need for a multistakeholder consensus towards creating specific statements for addressing post-publication integrity concerns in RCTs.
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.
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
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
METHODS: A cross-sectional study, incorporating 195 women involved in a longitudinal cohort study. Palpation for levator integrity was performed, followed by a four-dimensional translabial ultrasound. LAM avulsion defects were diagnosed in the presence of puborectalis muscle detachment from its insertion. Post-processing analysis of ultrasound volumes for LAM integrity on TUI was performed blinded against palpation findings. Agreement between methods was assessed using Cohen's κ.
RESULTS: In all, 388 paired assessments of LAM bilaterally, were available. Sixteen (8.2%) unilateral avulsion defects were detected on palpation. Sonographically, 31 (16%) were diagnosed with avulsions: 4.6% bilateral and 11.3% unilateral. An overall agreement of 91% was observed between digital palpation and TUI, yielding a Cohen's κ of 0.32 (95% confidence interval 0.15-0.48) demonstrating "fair agreement": and implying 25% sensitivity, 98% specificity, 63% positive predictive value, and 92% negative predictive value. Analysis of the first and last 20 palpations showed no change in performance during the 13-day study period.
CONCLUSION: Assessment of LAM avulsion defects by digital palpation is feasible but may require substantial training. Confirmation by imaging is crucial, especially if the diagnosis of avulsion may influence clinical management.
METHODS: Set in 9 centers across 4 Southeast Asian countries, a retrospective survey was performed for 12 recommended pregnancy/childbirth practices and 13 outcomes of women in each center before and after intervention. Qualitative interviews were conducted to assess staff awareness and experience in evidence-based practice.
RESULTS: There were significant decreases in the rate of episiotomy, from 64.1% to 60.1% (risk difference [RD] -4.0; 95% confidence interval [CI], -5.8 to -2.2) for all women and from 92.2% to 80.7% (RD -11.5; 95% CI, -13.4 to -9.6) for nulliparous women. Severe trauma decreased from 3.9% to 1.9% (RD -2.0; 95% CI, -2.7 to -1.4) for all women and from 6.7% to 3.0% (RD -3.7; 95% CI, -4.9 to -2.5) for nulliparous women. The frequency of intact perineum increased from 12.4% to 15.6% (RD 3.2; 95% CI, 1.9-4.6) for all women and from 1.7% to 8.0% (RD 6.3; 95% CI, 5.0-7.5) for nulliparous women.
CONCLUSION: An intervention based on understanding and using the best available evidence can result in significant improvements in care and health outcomes.