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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.
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OBJECTIVE: Aim of study was to determine effect of epidural analgesia on progress of labour and mode of delivery, to find out its complications in labour and puerperium and to evaluate neonatal outcome in terms of APGAR score. METHOD: The present study was conducted in Department of Obstetrics and Gynaecology at Government Medical College Aurangabad over period of 2 years from June 2014 to June 2016 after taking approval from institutional ethical board. Hundred low-risk primigravidas were included in the study, 50 women received epidural analgesia for relief of labour pain at 3-4 cm and 50 women served as control. The important outcome FACTORS studied were the following : (1) duration of active phase of I stage, and II stage, (2) mode of delivery, (3) APGAR scores, (4) untoward reactions and intrapartum complications, (5) overall satisfaction of the mother. RESULTS: The operative delivery rates were not significantly different in both the groups (8% in the control group and 6% in the study group: p value NS, i.e. > 0.05). The duration of first stage (our study showed no significant difference in the duration of first stage in both the study and control groups p value > 0.05) and second stage of labour (p value NS > 0.05) and the need for oxytocin were comparable in the two groups. The side effects observed were minimal. It has given excellent pain relief and improved neonatal outcome (5 min). EA is associated with rates of vaginal delivery (88 v/s 84%) and LSCS rate (8 v/s 6%) which are comparable with control group. CONCLUSION: Epidural analgesia is a very promising, safe and effective method of pain relief. No major complications and a good APGAR score make it a good option of care in modern obstetrics.
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OBJECTIVES: To study the efficacy of fetal Doppler and non-stress test (NST) in predicting fetal compromise in preeclampsia and growth-restricted fetuses. METHODS: ln a prospective study, 189 pregnant women beyond 32 weeks of gestation with preeclampsia or growth-restricted fetuses confirmed by ultrasound were evaluated by Doppler velocimetry (umbilical and middle cerebral artery) and non-stress testing. The outcome of pregnancy was recorded according to Group I (n = 109, Doppler and NST normal), Group II (n = 48, Doppler abnormal and NST normal), Group III (n = 14, Doppler normal and NST abnormal), and Group IV (n = 18, Doppler and NST both abnormal). The evaluation was done by Chi square testing. RESULTS: Both Doppler and NST had a better specificity and negative predictive value, indicating that these tests were more predictive of a healthy fetus. The fetal compromise in terms of APGAR scores, NICU admissions, birth weight, etc., was greater when both Doppler and NST were abnormal. Doppler detected changes earlier in the disease cascade than NST as evidenced by the lead time of 5.86 days. CONCLUSION: The use of both the tests is necessary as it helps in detecting a spectrum of fetuses compromised at various stages of disease affection.
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Bacterial vaginosis (BV) is the most prevalent vaginal infection worldwide and is characterized by reduction of native lactobacilli. Antimicrobial therapy used to cure the disease is often found to be ineffective. We postulate that Bacillus coagulans Unique IS-2 (Unique Biotech Limited, India) might provide an appendage to antimicrobial treatment and improve curing rate. In the present study 40 Indian women diagnosed with BV by the presence of symptoms including white discharge, pH greater than 4.7, burning micturation, itching, soreness and redness at vulva. The subjects were divided in 2 groups probiotic (n = 20) and control (n = 20) based on age (control group, 33 ± 3 years and probiotic group, 32.5 ± 3 years), history of previous vaginosis (control group, 75% or 15/20 and probiotic group, 75% or 15/20) and severity of current vaginosis infection (burning micturation and itching, 35% in each group). Probiotic group subjects were assigned to receive a dose of antibiotic therapy [Ofloxacin-Ornidazole with strength of 200-500 mg per capsule/day for 5 days along with vaginal peccaries (co-kimaxazol) for 3 days] simultaneously with two probiotic capsules (10(9) CFUs of Bacillus coagulans Unique IS-2 per capsule). The control group received only antibiotic therapy. At the end of the treatment the 80% of probiotic group subjects showed significant positive response as revealed by reduction of vaginosis symptoms compared to the control group which exhibited reduction in 45% subjects only. Thus, the results of present study indicate that strain Bacillus coagulans Unique IS-2 can provide benefits to women being treated with antibiotics to cure an infectious condition.
