RESUMO
OBJECTIVES: To compare the efficacy and safety of monoclonal anti-Rhesus (anti-D) immunoglobulin (IgG) with polyclonal anti-D IgG in the prevention of maternal Rh-isoimmunization. METHODS: This was a randomized, multicenter, open-label, comparative clinical trial conducted in the obstetric in-patient departments of nine tertiary care hospitals in India. 206 Rhesus (D)-negative women, not sensitized to Rh antigen, and delivering Rh positive babies, received postpartum intramuscular administration of monoclonal or polyclonal anti-D IgG. The main outcome measures were the proportion of subjects protected from Rh-isoimmunization, identified by a negative indirect Coombs test (ICT) result, at day 180 after anti-D IgG administration, and incidence of adverse events. RESULTS: 105 subjects were randomized to the monoclonal group and 101 to the polyclonal group. 94 from the monoclonal group had a negative ICT result and none had a positive ICT result at day 180, whereas 87 from the polyclonal group had a negative ICT result and one had a positive ICT result; the rest (11 and 13 subjects respectively) were lost to follow-up. A total of 5 adverse events were reported (3 in the monoclonal group and 2 in the polyclonal group); only one of these was serious. All the adverse events were judged to be unrelated to the interventional drug. None of the subjects in the monoclonal group developed immunogenic reaction to the monoclonal anti-D. CONCLUSION: The efficacy and safety of the monoclonal preparation of anti-D was comparable to the polyclonal preparation of anti-D when used in the prevention of maternal Rh-isoimmunization.Trial registration Clinical Trial Registration Number: CTRI/2015/09/006172.
RESUMO
BACKGROUND: Epidural labor analgesia has not been fully accepted despite many advantages. Many times, the pregnant females reach hospital without antenatal checkup, and at that time, "episiotomy infiltration" becomes an ideal method for vaginal delivery. One of the most important problems after episiotomy is the severe perineal pain on the 1st day of postpartum period. OBJECTIVES: We compared the efficacy of clonidine 1 µg/kg as an adjuvant to 20 mg/ml lignocaine infiltration along the line of episiotomy incision for prolonging the duration and quality of analgesia with respect to various activities by single injection. METHODOLOGY: Majority of the patients, 94.2% in our study, had no idea about labor analgesia, and only 2.5% of all the patients expressed their interest to deliver without suffering from labor pains. One hundred and twenty pregnant female patients scheduled for full-term vaginal delivery were assigned into lignocaine and lignocaine-clonidine group according to infiltration they received. Pain scoring using visual analog scale and maternal satisfaction scale was monitored. At the end of the research project, the data were compiled and analyzed using appropriate statistical tests. RESULTS: Duration of analgesia after episiotomy during sitting, walking, and squatting was 22.7 ± 1.32, 21.73 ± 1.47, and 19.875 ± 1.48 h in clonidine + lignocaine group and 6.06 ± 1.26, 5.33 ± 1.18, and 4.01 ± 1.28 h in lignocaine only group, respectively, which was highly statistically significant P < 0001. CONCLUSIONS: Clonidine when added to 2% lignocaine infiltration in episiotomy improves the quality and significantly enhances the duration of analgesia.
