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INTRODUCTION The purpose was to compare two flexible regimens of intravitreal aflibercept (IVT-AFL) with fixed dosing every 8 weeks, beyond the first year of treatment, in patients with diabetic macular edema (DME). VIOLET was a 100-week, randomized, Phase IIIb, non-inferiority study in patients with center-involving DME previously treated with IVT-AFL for ≥ 1 year according to the European label. METHODS Patients received an initial dose of IVT-AFL at study baseline and were randomly assigned (1:1:1) to treat-and-extend (T&E), pro re nata (PRN), or fixed regimens. The primary endpoint was mean change in best-corrected visual acuity (BCVA) from baseline (randomization) to Week 52. RESULTS Full analysis set comprised 458 patients (baseline mean BCVA: 72.5, 71.0, and 72.7 letters in the T&E, PRN, and fixed-dose groups, respectively). Patients received a mean (min-max) of 10.0 (2-14; T&E), 11.5 (1-25; PRN), and 12.3 (3-13; fixed) injections over 100 weeks, with 13.3 (4-23), 25.0 (3-29), and 16.1 (5-25) clinic visits, respectively. At Week 52, mean (± standard deviation) BCVA changes from baseline were + 0.5 ± 6.7 (T&E), + 1.7 ± 6.8 (PRN), and + 0.4 ± 6.7 (fixed-dosing) letters (least squares mean difference [95% confidence interval]: T&E 0.01 [- 1.46, 1.47] and PRN 0.95 (- 0.52, 2.42) letters versus fixed dosing; p

Postpartum headache is a common complaint faced by most obstetricians, with over 39% of women having headache in the first postpartum week. With the increasing use of labour epidural analgesia, the incidence of postdural puncture headache (PDPH) due to inadvertent dural puncture is 0.5-1%. Most treatment modalities relieve the symptoms of PDPH by minimizing compensatory cerebral vasodilatation, or by sealing the dural puncture site. Treatment options include, conservative, pharmacological, and the gold standard, epidural blood patch (EBP). EBP is invasive and may result in rare however, severe complications. Sphenopalatine ganglion block (SPGB) has been proposed as a non-invasive intervention for PDPH, which has minimal adverse effects, which can be performed bedside. Here we are reporting a case of PDPH, following labour epidural analgesia which was effectively managed by a sphenopalatine block.

Background: In the dural puncture epidural technique (DPE), a dural hole is intentionally created, but no intrathecal drugs are administered. Our study's main objective was to compare the onset and duration of DPE analgesia with a conventional epidural (CE) when an intermittent epidural bolus dose was used. Materials and Methods: The double-blinded randomized control study was conducted on 60 parturient in active labor. Patients were randomly assigned into two groups using a computer-generated random sequence by closed envelope technique. Group CE received conventional labor epidural with 20 mL 0.1% ropivacaine and 30 μg fentanyl. In group DPE, dural puncture was performed, and 20 mL 0.1% ropivacaine and 30 μg fentanyl were given through an epidural catheter. The onset of analgesia, number of bolus doses required, and pain scores were monitored. Results: The onset of analgesia was faster in Group DPE than CE (4.40 ± 1.32 vs. 6.37 ± 2.04 min, P < 0.001). There was no significant difference in analgesia duration between the two groups (109.00 ± 26.63 vs. 104.17 ± 30.62 min, P = 0.517). The requirement of top-up doses was similar in both groups (2.47 ± 0.50 vs. 2.50 ± 0.50, P = 0.80). At 5 min, mean visual analog scores were less in DPE than CE group, and this difference was statistically significant (2.43 ± 1.25 vs. 3.97 ± 1.84, P = 0.002). Conclusion: Both techniques were effective in producing labor analgesia. However, the use of DPE technique with a 27G spinal needle produced faster onset of analgesia than CE technique when intermittent epidural boluses were used without affecting the maternal and fetal outcome.

Background and Aims: The patient's position during the insertion of the epidural catheter plays a major role in the success of labour analgesia. In our study, we compared the ease of insertion of the epidural catheter in either traditional sitting position (TSP) or crossed-legged sitting position (CLSP). The primary objective was to compare the number of successful first attempts at epidural placement between the groups. Secondary objective included patient comfort, ease of landmark palpation and the number of needle-bone contacts. Methods: The prospective non-blinded randomised control study was conducted on 50 parturient with uncomplicated pregnancy during active labour. Patients were randomly assigned into two groups using a computer-generated random sequence of numbers by closed envelope technique. Group TSP received epidural in a traditional sitting position and group CLSP received an epidural in a crossed-legged sitting position with knee and hip flexed. Results: The parturient in both groups were comparable with respect to the distribution of age, height, weight and parity. The baseline visual analogue score (VAS) and VAS scores at 15 min were comparable between groups. Percentage of a parturient with successful epidural placement in the first attempt was higher in CLSP group than in TSP group (88% versus 44%, P = 0.004). The landmark, needle-bone contact and comfort during positioning were comparable between the two groups. Conclusion: Cross-legged sitting position is a better position than the traditional sitting position for the ease of insertion of labour epidural catheter.

Background: Heavy menstrual bleeding (HMB) affects 10 to 35% of women. Studies indicate LNG-IUS which releases controlled amounts of levonorgestrel (LNG) is effective in non- surgical treatment for HMB and has fewer side effects when compared to the conventional pharmacological agents. It also improves the quality of life. Levonorgesterel releasing intra uterine system can be an alternative to hysterectomy in the control of HMB.Methods: Retrospective study of 2 years in a tertiary care centre, Kochi. 170 women with abnormal uterine bleeding were enrolled in the study. Clinical examination, routine investigations and imaging was done. Endometrial sampling done and followed with HPE reports in indicated cases.Results: Mean age was 41 years. 30.6% had menorrhagia. Adenomyosis in 44% and endometrial hyperplasia in 19. 4%. Lost follow up in 12.9% cases and expulsion in 3.6%. 4.1% were unsatisfied and had hysterectomy. The uterine width in adenomyosis was significantly reduced p

Background: Emergency LSCS can be categorized based on RCOG guidelines into category I and II which indicates maternal or fetal compromise. Here an urgent delivery and the DDI (decision to delivery interval) within 30 and 45 minutes respectively is needed.Methods: This is a retrospective cross-sectional analysis conducted on a sample of 630 patients who underwent caesarean section over a year, from June 2016 to June 2017. The DDI were further classified into ≤30 and >30 minutes for category I, ≤45 and >45 minutes for category II LSCS. The primary objective is to determine whether DDI in Category I and II emergency LSCS has an impact on fetal outcome and secondary objective is to ensure that DDI is within the standard criterion as per RCOG protocol.Results: Out of 630 samples of caesareans, it was found that 173 falls in Category I and 189 falls in Category II. Out of 87 (50.29%) patients delivered within 30 minutes in Category I, 29 babies required NICU admission. DDI was more than 30 minutes in 86 (49.71%) cases in Category I out of which 38 babies got admitted in NICU with low APGAR scores. Out of 176 (93.12%) patients who delivered within 45 minutes in Category II, 56 babies required NICU admission. DDI was more than 45 minutes in 13 (6.88%) cases in Category II and all these babies got admitted in NICU.Conclusions: Decision -delivery interval has a significant impact on fetal outcome.

Background: Placental location can be estimated easily using ultrasonogram by 16 weeks. It can be classified based on its location into central and lateral. Central can be anterior or posterior. Lateral can be left lateral or right lateral. Placental location has been attributed to both normal and abnormal pregnancy and neonatal outcomes.Methods: This is a prospective cohort study conducted in the department of Obstetrics and Gynecology which comprised of 450 singleton gestations between 18 and 24 weeks. The primary objective is to determine the association between placental location and pregnancy outcome and secondary objective is to find out the association between placental location and neonatal outcome. The study population was divided into two groups – central and lateral. Results were analyzed using SPSS version 20, Chi square test and independent two sample t-test.Results: The frequency of central placenta was 377 (83.8%) and lateral placenta in 73 (16.2%). Central placentation had an abnormal outcome in 182(48.3%), lateral placentas with abnormal outcome were 44(60.3%). Abnormal maternal outcomes like hypertensive disorders (33.3%), Intra Uterine Growth Restriction (10.2%), Antepartum haemorrhage (25%), Preterm birth (16.3%) were more in lateral placentation. The number of central placentas having NICU admissions were 62(16.4%) and lateral placenta with NICU admissions were 19(26%).Conclusions: There is a significant association between lateral placentation and abnormal pregnancy and neonatal outcomes. Second trimester ultrasound can be used as non-invasive predictor of adverse pregnancy and neonatal outcomes.

Background: Obstetric anal sphincter injury involves injury to the anal sphincter and rectal mucosa sustained at time of vaginal delivery and can result in significant long-term morbidity. These injuries have been defined as 3rd and 4th degree lacerations that involve disruption of the anal sphincter and rectal mucosa respectively. Objectives of this study were to find out the incidence of obstetrical anal sphincter injuries, to identify the risk factors for of OASIS and the outcome of primary repair in terms of anal incontinence and its associated complications.Methods: We did a descriptive study of OASIS by retrospective analysis of the labour case records. The study period was 1 year between August 2016 to July 2017. Inclusion criteria were singleton pregnancy, vertex presentation, instrumental and normal vaginal delivery. Exclusion criteria were multiple pregnancy, non-vertex presentation and caesarean section. Proforma was developed to capture the age, parity, gestational age in weeks, induction of labour, epidural analgesia, delivery duration, type of episiotomy, instrumentation, shoulder dystocia, occipito posterior position,manual support, weight of the baby, suturing method. Postnatal evaluation after 6 weeks and 6 months for perineal discomfort, pain, incontinence, wound infection, breakdown, fistula were noted. Results: The incidence of OASIS was 1.4%. 81.8% women had 3rd degree perineal and 18.1% had 4th degree perineal tear. The mean age of the patients were 27.9 years, gestational age of 39.45 weeks, 72.7% were primiparous. Induction of labour with prostaglandins was done in 36.36% and Pitocin augmentation for 81.81%. The duration of second 36.36% had 60-89 min and 27.27% had duration more than 90 min. 54.54% had epidural analgesia, 36.36% had shoulder dystocia, 36.36% had instrumental delivery. 72.72% babies had birth weight between 3-3.5 kg, 9% between 3.5-4 kg. Ano vaginal fistula developed in 9%.Conclusions: Appropriate training, anticipating and identifying major degrees of perineal tear helps in reducing the complications. Anovaginal fistula is distressing and disabling the patient and to her near ones.

Abdominal pregnancies constitute 1% of ectopic pregnancies, among which broad ligament pregnancy is a rare form. The maternal mortality rate has been reported to be as high as 20%. The diagnosis is seldom established before surgery. Laparoscopic management of broad ligament ectopic pregnancy is the ideal form of treatment in appropriately selected patients. We present the case report of successful laparoscopic treatment of a 3x3.5cm broad ligament pregnancy. A search of literature shows that ours is the 6(th) case report of such a rare ectopic pregnancy managed endoscopically successfully.

Background: Acute pancreatitis is rare in pregnancy, but it is associated with increased incidence of maternal and fetal mortality. It should be one of the differential diagnosis of upper abdominal pain with or without nausea or vomiting. S. amylase, lipase and ultrasound abdomen were the diagnostic methods. Conservative management is the main stay in mild cases. Severe cases have multiorgan involvement and needs multidisciplinary approach. The objectives of this study were to study the maternal and fetal outcome in pregnant women diagnosed with acute pancreatitis and to identify the risk factors for acute pancreatitis in pregnancy.Methods: Retrospective descriptive study of pregnant women diagnosed with acute pancreatitis in Amrita Institute of Medical Sciences, Kochi during the period of 5 years from January 2011 to December 2016. A proforma having patients age, parity index, gestational age, symptoms with duration, blood investigations, ultrasonography, interventions done, mode of delivery, supportive treatment, complications were developed. Fetal weight, Apgar score, fetal complications were also noted.Results: The mean gestational age of presentation was 30 weeks of pregnancy. Upper abdominal pain radiating to back, vomiting, fever was the commonest clinical presentation in majority of cases. The diagnostic methods were S.Amylase ,Lipase and Ultrasound abdomen. The mean age of the patients were 26 years and 66.7% were primigravidas in the present study. There were 4 patients in SAP and 5 in MAP groups. Complications in SAP group were ARF, ARDS, DIC, MODS, metabolic acidosis etc. SAP group had 3 maternal and 3 fetal loss.Conclusions: Severe acute pancreatitis has adverse maternal and fetal outcome due to multi organ failure and sepsis.

Aims and Objectives: Adnexal torsion is a rare gynaecological emergency that requires an early surgical intervention to save the adnexa from irreversible damage .Our study is about clinical presentation and management approach of adnexal torsion in a tertiary care centre. Study Design: Retrospective study. Materials and Methods: Review of case records during the five years of 2008 November -2013 November in Amrita Institute of Medical Sciences, Kochi, India. Results: Adnexal torsion was found mainly in the reproductive age. Ultrasound was the most commonly used imaging modality. Benign tumours predispose to torsion. Torsion occurred during postovulatory period in many cases. Polycystic ovaries were a risk factor for unexplained torsion in younger age groups. Diagnosis of adnexal torsion was mostly intra operative by direct visualisation of the rotated adnexa. Laparoscopy was the preferred method of surgical intervention. Ovarian conservation was tried in majority of the child bearing age groups. Conclusion: Adnexal torsion is a rare emergency which requires a high index of clinical suspicion for diagnosis as the symptoms are non specific. Imaging helps in diagnosis but most of them are diagnosed intra operatively. Laparoscopic conservative surgery is the preferred surgical approach especially in younger age groups. An early surgical intervention helps in salvaging the adnexa and prevents further complications.

Aim of the Study: To determine the impact of fetal presentation on pregnancy outcome in preterm premature rupture of membranes (PPROM). Study Design: Retrospective. Materials and Methods: Fifty eight PPROM patients (gestational age of 24-34 wk, complicated by PPROM and latency more than 24 h) between January 2008 to December 2012 were categorized into cephalic and non cephalic and pregnancy outcome were analyzed with standard statistical methods including the Chi-square test, t- test and Mann Whitney test. Results: The non cephalic (20.7%, 12/58) and cephalic group (79.3%, 46/58) among the 58 patients with PPROM were demographically homogenous. PPROM was significantly earlier in non cephalic group although latency was not much different in both groups. Maternal complications (abruption, chorioamnionitis and post operative wound infection) as a composite were more in non cephalic group. Neonatal death was also significantly more in non cephalic than cephalic. Conclusion: Non cephalic presentation at diagnosis of PPROM is likely to have an unfavorable effect on the maternal and fetal outcome.

Abiotic stress induced over-expression of superoxide dismutase (SOD), catalase and eroxidase enzymes were studied in the transgenic embryogenic calli of Hevea brasiliensis, clone RRII 105. Two month old calli were transformed using Agrobacterium tumefaciens harbouring the binary vector containing neomycin phosphotransferase (npt-II) for kanamycin resistance as the selectable marker gene, [bêta]-glucuronidase (GUS) as the reporter gene and the sequence coding for SOD enzyme under the control of 34S promoter. The transformed calli were proliferated in half strength Murashige & Skoog medium containing 2,4-D ( 0.1mg/l), BA.( 0.3mg/l) and KIN( 0.2 mg/l). SOD enzyme [EC1. 15.1.1] is a scavenger of free radical and is an antiageing enzyme. Over-expression of SOD, peroxidase and catalase enzymes in response to abiotic stresses like water, osmotic and different light regimes in transgenic embryogenic callus cultures was determined. Water stress was induced by the addition of different concentrations (0.2-1.0%) of phytagel and osmotic stress was induced using polyethylene glycol (PEG), mannitol and sorbitol (2-10%) in the culture medium. The activity of enzymes was estimated spectrophotometrically. Over-expression of SOD enzyme was 50% when 0.4% phytagel was added to the medium. 40% over-expression was obtained when the culture medium was supplemented with 4.0% PEG. This reveals that the free radical scavenging enzymes were overexpressed in transformed tissues when subjected to abiotic stress. Efforts are now being made to study the molecular mechanism of SOD gene expression in transgenic Hevea brasiliensis in response to abiotic stress under in vitro conditions.