Statistical Analysis χ 2 test was used to compare the outcome in different groups. The SPSS/ PCT statistical package for IBM PC was used to calculate logistic regression to calculate the logistic regression to consider the effect of serum titers other than 1: 16 for statistical validity. Results Immunotherapy Out of 105 RSA women with three or more than three abortions only 73 women were registered for non randomized trial and remaining 32 were registered under double blind randomized trial. Development of APCA was taken as immuno-potentiating factor. Once these antibodies developed women were advised to conceive. Non randomized trial Out of the 73 RSA women who were registered to receive paternal lymphocytes nine (9) were found to be positive for APCA at initial screening hence were excluded for immunotherapy. These were grouped as first group of control (group I). Remaining 64 women were offered immunotherapy to which 15 refused to receive immunotherapy these non-willing women were followed up for their next pregnancy results and were categorized into second group of controls (Group II). 6 women who entered into the immunotherapy trial dropped out during the course of immunization without developing APCA, and were labeled as third group of controls (Group III). Forty-three women went through the entire course of immunization, out of these 43 women. 13 did not develop APCA and were categorized into fourth control group (Group IV). Remaining 30 women who successfully converted from seronegative to seropositive status for APCA, following immunotherapy were labeled as study group i.e. Group V (Table 1). Table 1. Different groups under non randomized trial The status of APCA following each immunization in-group V women is shown in Table 2. None of the women developed adequate titer of cytotoxic antibodies after first injection of husband's lymphocytes. Whereas 2, 3, 4, 6 and 15 women converted to APCA positive status following 2 nd , 3 rd , 4 th , 5 th , and 6 th immunization respectively. Table 2. APCA status after immunization with husband's lymphocytes in the study group (group V) The pregnancy outcome in different control groups (I – IV) and in study group (group V) is shown in Table 3. It is evident from Table 3 that all the thirty women in the study group (group V) became pregnant in-between 1–6 months following immunotherapy. Twenty-six of them gave birth to full term healthy child (86.6%) while 4 (13.6%) aborted again. Table 3. Pregnancy outcome group following immunotherapy in non randomized trial While group I+III vs group V=P<0.01 * N = Number ** APCA = Antipaternal cytotoxic antibodies
Table 4. Pregnancy out come after immunotherapy in double blind randomized trial group * N = Number ** APCA = Antipaternal cytotoxic antibodies The difference in the outcome of pregnancy in the successfully immunized group (V) compared to those who were not immunized group (II) was statistically significant (P<0.001). Also in the immunized group, the success rate of pregnancy in women who either dropped out or did not
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- Spring '14
- Mole, APCA, Habitual abortion