A Comparative, Randomized Control Trial in Patients of Per Vaginal Bleeding Comparing Efficacy of Oral Dydrogesterone Versus Vaginal Progesterone in Successful Pregnancy Outcome for Patients with Recurrent Pregnancy Loss.

BACKGROUND: Progesterone is essential for the maintenance of a healthy pregnancy. Any defect in the secretion of human chorionic gonadotropin or progesterone is associated with a significantly increased risk of first-trimester abortion. Progesterone is frequently prescribed to patients presenting with per vaginal (PV) bleeding in early pregnancy and a history of recurrent pregnancy loss. METHODS: Pregnant women up to 12 weeks of gestation with a history of more than two early pregnancy losses and presenting with vaginal bleeding were included in this study. All subjects were randomized to receive either vaginal progesterone 600 mg/day or oral dydrogesterone 30 mg/day. A detailed history-including menstrual history, previous pregnancies, previous miscarriages, and other risk factors-was obtained. The mean time required for the cessation of PV bleeding and continuation of pregnancy up to 24 weeks and till term was compared. RESULTS: A total of 200 patients were randomized to vaginal progesterone 600 mg/day (n = 100) or oral dydrogesterone 30 mg/day (n = 100). While 74 patients had two miscarriages in the progesterone group, 68 patients had two miscarriages in the dydrogesterone group. The time required for complete cessation of bleeding was significantly lesser among patients who received oral dydrogesterone compared to those who received intravaginal progesterone (53.90 ± 9.09 vs. 94.60 ± 7.29 h, p < 0.0001). Numerically higher number of patients receiving oral dydrogesterone had a successful continuation of pregnancy up to 24 weeks of gestation, as well as till full term compared to progesterone group (70 vs. 75). CONCLUSION: Oral dydrogesterone is preferred over vaginal progesterone in patients presenting with vaginal bleeding during early pregnancy and a history of recurrent early pregnancy loss.

A Multicenter, Randomized, Open-Label Trial Comparing the Efficacy and Safety of Monoclonal Anti-Rh (D) Immunoglobulin with Polyclonal Anti-Rh (D) Immunoglobulin for the Prevention of Maternal Rh-Isoimmunization.

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.

Effects of Epidural Labour Analgesia in Mother and Foetus.

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.

Impact of HIGH BMI on Pregnancy: Maternal and Foetal Outcome.

AIM AND OBJECTIVES: To review the effects of obesity (BMI > 30) on antepartum risk/intrapartum risk. To study neonatal outcome of pregnant women with raised BMI. MATERIAL METHOD: BMI of 500 pregnant women booked before 12 weeks calculated and categorised as normal, overweight, obese and morbidly obese at GMCH, Aurangabad. Pregnant women with systemic disease and previous LSCS were excluded. Antepartum, intrapartum and neonatal variables were studied, and statistical analysis was carried out. RESULTS: Antepartum variables: prolonged pregnancy (<0.05), severe PIH (<0.05), PPROM (<0.05), gestational DM (<0.05) and anaemia (<0.05) are strongly associated with raised BMI, whereas abortion (>0.05), oligohydramnios (>0.05), UTI (>0.05) and abruption (>0.05) are not associated with raised BMI. Postpartum variables: PPH (<0.05), pyrexia (<0.05), prolonged hospital stay (<0.05) and lactational dysfunction (<0.05) are strongly associated with raised BMI, whereas UTI (>0.05), thrombophlebitis (>0.05) and endometritis (>0.05) are not associated with raised BMI. BMI Neonatal outcome: IUGR (<0.05), preterm (<0.05), postterm (<0.05), LBW (<0.05) and macrosomia (>0.05) are strongly associated with raised BMI, whereas stillbirth (>0.05), intubation (>0.05), RDS (>0.05) and baby died within 24 (>0.05) are not associated with raised BMI. CONCLUSIONS: Overweight and obesity are risk factors for AP/IP/PP complication.

Safety and Efficacy of Oral Mifepristone in Pre-induction Cervical Ripening and Induction of Labour in Prolonged Pregnancy.

OBJECTIVES: To study the safety and efficacy of oral mifepristone in pre-induction cervical ripening and induction of labour in prolonged pregnancy. METHODS: This is a single blind randomized control trial. 100 women with prolonged pregnancy beyond 40 weeks and Bishop score <6 were recruited, and randomly allocated into two groups. Women who received Tab. Mifepristone 200 mg orally were assigned in Study Group (n = 50) and who received placebo orally were assigned in Control Group (n = 50) At the end of 24 h, change in the Bishop's score was assessed and Tab. Misoprostol 25 µg was administered intravaginally every 4 h, maximum 6 doses for induction/augmentation of labour. Analysis regarding safety and efficacy of the drug was done with regards to maternal and perinatal outcome. RESULTS: Among 100 subjects, 50 received mifepristone and 50 received placebo. Mean induction to delivery interval was 1,907 ± 368.4 min for Study Group versus 2,079 ± 231.6 min for Control Group. The improvement in mean Bishop score was 5.0408 ± 1.90 for Study Group compared with 3.26 ± 1.15 was for Control Group after 24 h. Mean dose of misoprostol in Study Group was 40 ± 27.2, while the same in Control Group was 52 ± 19.46. Eight (16 %) women in Study Group and two (4 %) women in Control Group delivered vaginally within 24 h without any need of augmentation. There were 6 (12 %) cesareans and 2 (4 %) instrumental deliveries in Study Group and 8 (16 %) cesareans and 5 (10 %) instrumental deliveries in the Control Group. There was no statistically significant difference in perinatal outcomes between two groups. CONCLUSIONS: Mifepristone had a modest effect on cervical ripening when given 24 h prior to labour induction and appearing to reduce need for misoprostol compared with placebo.

Role of fetal Doppler and non-stress test in preeclampsia and intrauterine growth restriction.

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.

Comparative study of efficacy and safety of oral versus vaginal misoprostol for induction or labour.

OBJECTIVE: To compare the efficacy of oral with vaginal misoprostol for induction of labour. DESIGN: A randomized trial. SETTING: Tertiary care hospital. PARTICIPANTS: Two hundred women requiring induction of labour. METHODS: Group A received oral misoprostol 50 mcg 6 hourly maximum 4 doses to 100 patients and Group B received vaginal misoprostol 50 mcg 6 hourly maximum 4 doses to 100 patients. When the patient entered active stage of labour i.e. clinically adequate constractions of 3/10 min of >40 s duration, and cervical dilatation of with 4 cm, further doses of misoprostol were not administered. Statistical analysis was done using chi-square test and t test. RESULT: Both groups were comparable with respect to maternal age, gestational age, indication of induction and initial modified Bishops score Mean number of dosage required for successful induction were significantly less in vaginal group than oral group (in oral groups A were 2.73 + 0.58, and in vaginal Group B 2.26 + 0.52, P value < 0.0001 highly significant). The induction delivery interval was significantly less in vaginal group than oral group (Group A 15.24 + 3.47 h Group B 12.74 + 2.60 h, P < 0.0001 highly significant). Oxytocin augmentation required was less in vaginal group. 26 caesarean sections were performed in oral group and 17 caesarean sections were done in vaginal group (P value 0.06 NS). APGAR score, birth weight, NICU admissions showed no difference between the two groups. CONCLUSION: This study shows that vaginal route of administration of misoprostol is preferable to oral route for induction of labour when used in equivalent dosage of 50 mcg 6 hourly.

Clinical Study of Bacillus coagulans Unique IS-2 (ATCC PTA-11748) in the Treatment of Patients with Bacterial Vaginosis.

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.