Incidence & factors influencing maternal near miss events in tertiary hospitals of Maharashtra, India.

Background & objectives: Government of India (GoI) released operational guidelines for maternal near miss-review (MNM-R) in 2014 for use by programme managers of public health system to assist them for conducting MNM-R. The objective of the present study was to review the incidence and factors influencing MNM events in two tertiary hospitals of Maharashtra, India, as per the operational guidelines of the GoI released in 2014 and identify delays based on three-delay model to prevent such events in future. Methods: This prospective observational study was conducted in two tertiary hospitals of Maharashtra, from July 2018 to November 2020. All women during pregnancy, childbirth or postpartum upto 42 days meeting the eligibility criteria of MNM as per the 2014 GoI guidelines were included as cases (n=228), interviewed and discussed during the monthly MNM meetings at these hospitals. Results: The incidence of MNM was 11/1000 live births; the ratio of MNM to maternal deaths was 1.2:1. Leading causes of MNM were haemorrhage (36.4%) and hypertensive disorders of pregnancy (30.3%). Haemorrhage was maximum (70.6%) in abortion and ectopic pregnancies. Majority of the women (80.2%) were anaemic, of whom 32.4 per cent had severe anaemia. Eighty six per cent of women included in the study had MNM events at the time of admission and 81 per cent were referred from lower facilities. Level one and two delays were reported by 52.6 and 32.5 per cent of women, respectively. Level three delay at referral centres and at tertiary hospitals was reported by 69.7 and 48.2 per cent of women, respectively. Interpretation & conclusions: The findings of this study suggest that MNM-R should be undertaken at all tertiary hospitals in India as per GoI guidelines to identify gaps based on three-delay model. These hospitals should implement interventions as per the identified gaps with emphasis on strengthening the infrastructure, facilities and manpower at the first-referral units.

Impact of the Coronavirus Infection in Pregnancy: A Preliminary Study of 141 Patients.

BACKGROUND: The novel coronavirus disease (COVID-19) is the most challenging health crisis that we are facing today. Against the backdrop of this pandemic, it becomes imperative to study the effects of this infection on pregnancy and its outcome. Hence, the present study was undertaken to evaluate the effects of COVID-19 infection on the maternal morbidity and mortality, the course of labour as well as the neonatal outcome. MATERIALS AND METHODS: A total of 977 pregnant women were included in the study, from 1st April to 15th May 2020 at a tertiary care hospital. There were 141 women who tested COVID positive and remaining 836 patients were included in the COVID negative group. Findings were compared in both the groups. RESULTS: The incidence of COVID positive pregnant women was found to be 14.43%. More patients delivered by LSCS in the COVID positive and the COVID negative group (50%) as compared to COVID negative group (47%), (p > 0.05). Low APGAR score (0-3) was observed in 2(1.52%) neonates of COVID positive mothers and in 15 (1.91%) neonates of COVID negative mothers. Overall most of the babies were healthy. Out of all babies tested, 3 were detected positive initially which were retested on day 5 and were found to be negative. CONCLUSION: There is no significant effect of COVID infection on maternal and foetal outcome in pregnancy and there is no evidence of vertical transmission of the COVID-19 infection but long-term follow-up of these babies is recommended.

Recombinant anti-D for prevention of maternal-foetal Rh(D) alloimmunization: a randomized multi-centre clinical trial.

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.Trial Registration: Clinical Trials Registry of India Identifier: Trial Registration: Clinical Trials Registry of India Identifier: CTRI/2017/03/008101.

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.

A Multicenter, Randomized, Equivalence Trial of a New Recombinant Human Chorionic Gonadotropin Preparation versus Ovitrelle® for Ovulation in Women Undergoing Intrauterine Insemination Following Ovarian Stimulation.

CONTEXT: A new indigenous recombinant human chorionic gonadotropin (r-hCG) has been developed in India with a comparable pharmacological profile to that of Ovitrelle® (Merck Serono). AIMS: This study aims to compare the efficacy and safety of the new r-hCG with that of Ovitrelle for induction of ovulation in women undergoing intrauterine insemination (IUI). SETTINGS AND DESIGN: Randomized (2:1), multicenter, open-label, equivalence clinical trial conducted in India. SUBJECTS AND METHODS: A total of 217 women, aged 20-37 years, undergoing IUI were administered the new r-hCG (test) 250 mcg or Ovitrelle 250 mcg (comparator) after ovarian stimulation with gonadotropins. The ovulation rate was compared as the primary outcome. In addition, pregnancy rates, incidence of adverse events (AEs), and development of immunogenicity were assessed. Statistical Analysis Used: The ovulation and pregnancy rates were compared using Chi-squared test with statistical significance at P < 0.05. RESULTS: With 144 women in the test group and 73 in the comparator group, the ovulation rate (85.4% vs. 78.1%; P = 0.17) and pregnancy rate (serum ß hCG test) (11.8% vs. 12.3%; P = 0.91) were similar in both groups. A total of 15 AEs were reported (11 in the test r-hCG group and 4 in the comparator group) in 11 women; none of these were serious, and all were judged to be unrelated to the study drug. No subject developed immunogenic reaction to the test drug. CONCLUSIONS: The new preparation of r-hCG was equivalent to the conventional preparation of r-HCG in the induction of ovulation in patients undergoing IUI.

A Multicenter Phase IV Study to Investigate the Immunogenicity of Recombinant Human Follicle-Stimulating Hormone and Its Impact on Clinical Outcomes in Females Undergoing Controlled Ovarian Stimulation.

CONTEXT: Therapeutic proteins can cause immune responses, which may have clinical implications. AIMS: The aim of the study was to assess the immunogenicity of recombinant human follicle-stimulating hormone (r-hFSH), when used for controlled ovarian stimulation (COS). SETTINGS AND DESIGN: Prospective, multicenter study conducted at reproductive medicine clinics in India and Vietnam. MATERIALS AND METHODS: A total of 285 women, aged 20-40 years, undergoing 354 COS cycles for either intrauterine insemination (IUI) or in vitro fertilization (IVF) were studied. The primary outcome measure was the incidence of development of anti-drug antibodies (ADA) and their neutralization potential. Other outcome measures were follicle development, dose and duration of r-hFSH, positive serum pregnancy test, clinical pregnancy, cycle cancellation, and adverse events (AEs). STATISTICAL ANALYSIS USED: A sample size of 250 was planned. Descriptive statistics are presented. RESULTS: Four patients tested positive for ADA after r-hFSH administration at different time points; all of them tested negative, subsequently. None were found to have neutralization potential. The mean dose and duration of r-hFSH were 816 IU and 8.1 days in IUI and 2183 IU and 9.5 days in IVF, respectively. The serum and clinical pregnancy rates were 12.4% and 11.6% in IUI and 32.7% and 29.9% in IVF cycles, respectively. Seven AEs were reported, including two cases of ovarian hyperstimulation syndrome; two AEs were judged to be serious. CONCLUSIONS: The tested r-hFSH has very low immunogenic potential and did not lead to the development of neutralizing antibodies. The overall efficacy and safety of the drug were in-line with existing literature data, and no specific clinical impact of immunogenicity could be identified.

Segregation of Patients for Intrapartum Monitoring, using Robson's Classification.

INTRODUCTION: Monitoring labour by intermittent or continuous foetal heart rate monitoring has been discussed widely in literature. Robson's classification has categorized pregnant women in ten groups. The study proposes to examine in which patients one must recommend continuous or intermittent foetal heart rate monitoring. AIM: To study the effect of Continuous Electronic Foetal Monitoring (CEFM) on the overall rate of operative deliveries as well as the rate using Robson's classification and the neonatal outcome. MATERIALS AND METHODS: After Institutional Review Board approval, low risk parturients with a reactive foetal heart rate at arrival in labour were prospectively analysed. Women with a previous caesarean section, those requiring elective caesarean section and having high risk factors were excluded. Patient details, history, examination findings and the method of monitoring, whether continuous or intermittent was noted. 1803 women were monitored by CEFM and 2107 by intermittent auscultation. In both the groups of intrapartum monitoring, suspected foetal distress was followed by immediate intervention in the form of caesarean section or operative vaginal delivery without resorting to any other monitoring methods such as foetal scalp blood sampling, as per the institutional policy. Comparison was based on the need for operative deliveries in view of presumed foetal distress and the neonatal outcome between the two groups of monitoring and further in each Robson's class. Results were assessed using IBM® SPSS Version 22.0, Chi-square test, considering p<0.05 as significant. RESULTS: Operative deliveries in view of suspected foetal distress increased and the neonatal outcome was better with CEFM. Assessing in each Robson's class, only class 4A, 7A and 10A results were consistent with the overall outcome. In others (class 2A), women experienced reduced rate of operative deliveries and better neonatal outcome with CEFM. In yet others, there was no benefit with CEFM as there were increased operative deliveries without any difference in the neonatal outcome. CONCLUSION: Segregation of patients for intrapartum monitoring using Robson's classification would result in decreased operative deliveries and a better neonatal outcome.

A study of transobturator tape in stress urinary incontinence.

BACKGROUND: Stress urinary incontinence (SUI) is commonly encountered in gynecological practice. Nowadays, midurethral sling surgeries in the form of transobturator tape (TOT) surgery are recommended in its treatment. AIMS AND OBJECTIVES: To assess the outcome and patient satisfaction of TOT surgery in the treatment of SUI. MATERIALS AND METHODS: A prospective study was undertaken for patients of SUI who underwent TOT surgery by the outside in method and followed up for 5 years. The patients were assessed clinically and by the Patient Global Impression of Improvement (PGI-I) preoperatively and at postoperative day 3, discharge and 3 months follow-up. RESULTS: Successful surgical treatment with TOT was seen in all patients at the time of discharge. There was no recurrence of SUI seen up to 1 year, but at 5-year follow-up two patients had a recurrence of SUI on examination though they did not complain of SUI. Urinary retention, tape extrusion, and groin stitch infection were the commonly seen complications following surgery. On subjective assessment, 61 patients were completely satisfied at day 3, and all patients were completely satisfied at discharge and 3 months follow-up as per the PGI-I score. CONCLUSION: TOT gives an excellent outcome in the treatment of SUI.