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.
BACKGROUND To increase the incidence of safe and legalised abortions, it is important to know the clients. This study is a 6 years research of the records of MTP performed at the public hospital attached to a medical college, to know the trend, socio-demographic and obstetric status of the women undergoing MTP. The objectives of the study were to find trend, sociodemographic factors, obstetric status and complications of MTPs. MATERIALS AND METHODS A study of the records of all the MTP operations performed at the gynaecology department of the hospital from 2010 to 2016. Data analysis was done on MS excel. RESULTS Most women who underwent MTP were young, sexually active women and had completed 2 child family. Along with MTP, younger women preferred IUCD and elder women preferred Tubal Ligation as contraception. There is an overall gradual increase in the incidence of MTPs conducted which could be attributed to increase in population of the city and nearby areas. CONCLUSION In this study, most of the women preferred MTP after 2 nd Pregnancy and at the age of 21-35 years. Most women accepted permanent method of sterilization after MTP shows that women had completed family by the age of 30 years and had no access to effective contraceptive services. MTPs thus seems to be used as an emergency treatment for failed contraception. This trend should be discouraged but at the same time safe abortion should be legalised to safeguard the health of the women.
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.
INTRODUCTIONSpacing methods is one of the key strategies in the Family Planning Component of the RMNCH+A programme to bring about a decrease in the birth rates. 1 Intra Uterine Contraceptive Devices (IUCD) which are among the safest and most effective reversible contraceptives available, are affordable, convenient to use, do not require re-supply visits and are very costeffective.2 In order to popularize IUCDs, we have to understand the various factors which can influence the decision regarding its use. For this, it is imperative that related data over different time zones and different regions be regularly analysed and compared.The present study analyses the various sociodemographic factors of IUCD acceptors in the family planning OPD of a medical college. Also, service component like timing of insertion and wastage of Copper-T during insertion was studied. ABSTRACTBackground: Intra uterine contraceptive devices (IUCD) used as a spacing method is one of the main strategies of the family welfare programme, as they are among the safest and most effective, affordable and convenient reversible contraceptives available. The objectives of the study were to study the socio-demographic details of beneficiaries accepting Cu-T in the family planning OPD of the medical college, relation of IUCD insertion time with respect to menses or delivery and its outcome. Methods: After IEC approval, a descriptive, complete enumeration study of recorded data from IUD register from 2006 to 2015 (n=1141) was carried out from the IUCD registers of the family planning out-patient department (OPD) of a medical college. Results: Beneficiaries had a significantly lower literacy rate (p<0.05) and a lower employment rate (p<0.01) than their husbands. 447 (39.4%) women accepted IUCD before 1 year from their last delivery. In 20 women, IUCDs were expelled, while in 32 (2.8%), they were wasted. The difference between the couples having no male children and those having at least 1 male child opting for IUCD was statistically highly significant (p<0.01). Conclusions: Cu-T is being well utilised as a spacing method in the Family Welfare Component of the Reproductive and Child Health Programme. Evidence of Preference for a male child can be seen in this study.
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