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OBJECTIVE: To compare the efficacy and safety of recombinant anti-D (R-anti-D) with conventional polyclonal anti-D (Poly anti-D) in preventing maternal-fetal rhesus D (RhD) alloimmunization and to investigate the immunogenicity of R-anti-D. METHODS: This was a randomized, open-label, multi-center clinical trial conducted in RhD-negative pregnant women who did not receive antenatal anti-D who delivered RhD-positive babies and showed negative indirect Coombs tests (ICTs) at baseline. The women were randomized in a 2:1 ratio to R-anti-D or Poly anti-D groups and were administered 300 mcg (IM) of the corresponding drug within 72 hours of delivery. ICT was performed 72 hours, 90 days, and 180 days after anti-D injection. Serum samples were collected to check for the development of antibodies against R-anti-D at days 90 and 180, using bridging enzyme-linked immunosorbent assay. The proportion of subjects who had positive ICT results at days 90 and 180 were compared between the groups using Fisher's exact test. RESULTS: A total of 144 women were randomized to the R-anti-D group and 71 to the Poly anti-D group. Three women in the R-anti-D and none in the Poly anti-D group had a positive ICT result at day 90. No woman in either group had positive ICT result at day 180. Both drugs were well tolerated with only 4 reports of adverse events in each group-all were mild, non-serious, and resolved without sequelae. No subject developed antibodies against R-anti-D. CONCLUSION: The studied R-anti-D is comparable in efficacy to conventional Poly anti-D and is safe and non-immunogenic.Trial Registration: Clinical Trials Registry of India Identifier: Trial Registration: Clinical Trials Registry of India Identifier: CTRI/2017/03/008101.
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INTRODUCTION: Monitoring labour by intermittent or continuous foetal heart rate monitoring has been discussed widely in literature. Robson's classification has categorized pregnant women in ten groups. The study proposes to examine in which patients one must recommend continuous or intermittent foetal heart rate monitoring. AIM: To study the effect of Continuous Electronic Foetal Monitoring (CEFM) on the overall rate of operative deliveries as well as the rate using Robson's classification and the neonatal outcome. MATERIALS AND METHODS: After Institutional Review Board approval, low risk parturients with a reactive foetal heart rate at arrival in labour were prospectively analysed. Women with a previous caesarean section, those requiring elective caesarean section and having high risk factors were excluded. Patient details, history, examination findings and the method of monitoring, whether continuous or intermittent was noted. 1803 women were monitored by CEFM and 2107 by intermittent auscultation. In both the groups of intrapartum monitoring, suspected foetal distress was followed by immediate intervention in the form of caesarean section or operative vaginal delivery without resorting to any other monitoring methods such as foetal scalp blood sampling, as per the institutional policy. Comparison was based on the need for operative deliveries in view of presumed foetal distress and the neonatal outcome between the two groups of monitoring and further in each Robson's class. Results were assessed using IBM® SPSS Version 22.0, Chi-square test, considering p<0.05 as significant. RESULTS: Operative deliveries in view of suspected foetal distress increased and the neonatal outcome was better with CEFM. Assessing in each Robson's class, only class 4A, 7A and 10A results were consistent with the overall outcome. In others (class 2A), women experienced reduced rate of operative deliveries and better neonatal outcome with CEFM. In yet others, there was no benefit with CEFM as there were increased operative deliveries without any difference in the neonatal outcome. CONCLUSION: Segregation of patients for intrapartum monitoring using Robson's classification would result in decreased operative deliveries and a better neonatal outcome.
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BACKGROUND: Stress urinary incontinence (SUI) is commonly encountered in gynecological practice. Nowadays, midurethral sling surgeries in the form of transobturator tape (TOT) surgery are recommended in its treatment. AIMS AND OBJECTIVES: To assess the outcome and patient satisfaction of TOT surgery in the treatment of SUI. MATERIALS AND METHODS: A prospective study was undertaken for patients of SUI who underwent TOT surgery by the outside in method and followed up for 5 years. The patients were assessed clinically and by the Patient Global Impression of Improvement (PGI-I) preoperatively and at postoperative day 3, discharge and 3 months follow-up. RESULTS: Successful surgical treatment with TOT was seen in all patients at the time of discharge. There was no recurrence of SUI seen up to 1 year, but at 5-year follow-up two patients had a recurrence of SUI on examination though they did not complain of SUI. Urinary retention, tape extrusion, and groin stitch infection were the commonly seen complications following surgery. On subjective assessment, 61 patients were completely satisfied at day 3, and all patients were completely satisfied at discharge and 3 months follow-up as per the PGI-I score. CONCLUSION: TOT gives an excellent outcome in the treatment of SUI.
