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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.
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
OBJECTIVE: To study maternal risk factors associated with full term low birth weight (LBW) neonates. DESIGN: Matched pair case control study. SETTING: Multicenter study including 2 medical colleges and 1 civil hospital, between July 2009 to December 2009. PATIENTS: Of 2382 neonates screened, 274 full term LBW babies (of 638) and 274 pair matched controls (of 1744) were included in the study. 364 LBW babies were excluded because of premature delivery/gestational age not known (314), unavailability of suitable matched controls (18), and insufficient data (32). METHODS: Maternal factors including birth spacing, height, pre-delivery weight and pregnancy weight gain, age, parity, educational and economic status, type of family, antenatal care (ANC), maternal exposure to tobacco, hypertension and anemia were studied. RESULTS: Birth spacing <36 months, maternal height ≤ 145 cm, pre-delivery weight ≤ 55 kg, pregnancy weight gain <6 kg, exposure to tobacco, inadequate antenatal care, maternal hypertension, low socio-economic status, maternal anemia and less maternal education were associated with delivery of a low birth weight infants. Conditional logistic regression analysis showed that significant risk factors associated with low birth weight were inadequate ANC (OR-4.98, 95% CI-2.64 to 9.39), maternal weight before delivery ≤ 55 kg (OR-4.81, 95% CI-2.53 to 9.15) and height ≤ 145 cm (OR-4.13, 95% CI-2.04 to 8.37). CONCLUSION: Maternal malnutrition, inadequate antenatal care and poor weight gain during pregnancy are significant predictors for delivery of a low birth weight neonate.
