The Journal of Obstetrics and Gynaecology of India
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SYSTEMATIC REVIEW META ANALYSIS

SYSTEMATIC REVIEW META ANALYSIS

Effect of Orlistat Versus Metformin in Various Aspects of Polycystic Ovarian Syndrome: A Systematic Review of Randomized Control Trials

Soumya Ranjan Panda1 • Madhu Jain1 • Shuchi Jain1 • Riden Saxena1 • Smrutismita Hota2

Abstract

Background: Polycystic ovarian syndrome (PCOS), a commonly prevalent endocrinopathy among reproductive age group women, is most often associated with obesity. Increased insulin resistance appears to be the central pathophysiologic mechanism responsible for various complications of PCOS. This makes ‘weight loss’ as the first-line treatment approach in PCOS. So various trials have tried to compare metformin (an insulin-sensitizing agent) and orlistat (an anti-obesity drug) aiming to achieve weight loss and hence higher ovulation rate for the group of obese PCOS patients. Keeping an eye on all these background facts, we designed this systematic review and metaanalysis to compare the effects of metformin andorlistat on various aspects of PCOS and to pick the better among the two drugs.

Materials and Methods: This is a systemic review of randomized control trials that studied the effectiveness of orlistat versus metformin in terms of improvement in ovulation rate, weight loss, lipid profile, etc. Systematic literature search over the period January 2000–December 2016 was performed in the following electronic databases: Medline, embase, google scholar, pubmed and The Cochrane Library and only randomized controlled clinical trials were included in our study. All authors carefully went through all sources of information independently.

Results: According to this study, weight loss, testosterone level after 4 weeks of treatment, total serum cholesterol and triglyceride level showed significant fall in orlistattreated group.

Conclusion: Our review shows that orlistat is a more effective drug than metformin and should be the preferred drug in obese PCOS in combination with weight loss.

Polycystic ovarian syndrome, Orlistat, Metformin, Obesity
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Parenteral Versus Oral Iron for Treatment of Iron Deficiency Anaemia During Pregnancy and post-partum: A Systematic Review

A. G. Radhika1,5 • Aparna Kandala Sharma2 • Vanamail Perumal2 • Anju Sinha3 • Vasumathi Sriganesh4 • Vidushi Kulshreshtha2 • Alka Kriplani2

Abstract

Introduction: The burden of iron deficiency anaemia during pregnancy and post-partum continues to remain high especially in India. Challenges to treatment include gastrointestinal side effects and non compliance to oral iron therapy. Newer parenteral formulations need to be explored as alternatives.

Methods: Meta-analysis of randomized controlled trials published between years 2011 and 2018 comparing anaemic pregnant and post-partum women treated with intravenous iron sucrose versus oral iron was performed. The primary outcomes were mean maternal haemoglobin,serum ferritin and haematocrit at the end of 1st, 2nd, 4th and 6th weeks and comparison of adverse effects.

Results: Eighteen studies including 1633 antenatal women were randomly assigned to intravenous iron sucrose (n = 821) or oral iron [ferrous sulphate, ferrous ascorbate or fumarate] group (n = 812) in ten trials . Another eight studies compared iron sucrose infusion with oral iron in 713 post-partum women who were randomly assigned to intravenous iron sucrose group (n = 351) or oral iron group (n = 362). Cumulative analysis of all the time points indicates that the estimated mean values of Hb in the intravenous iron sucrose and oral iron groups were 10.11 g/ dl and 9.33 g/dl, respectively, in antenatal group, while it was 10.57 g/dl and 9.74 g/dl in post-partum. The estimated mean ferritin level from first week to six weeks was 63.1 lg/l and 28.6 lg/l, respectively, in intravenous and oral iron groups. Cumulative estimate of haematocrit in the intravenous sucrose and oral iron over 6 weeks showed that the mean values in the respective groups were 30.5% and 29.5% in antenatal and 33.8% and 31.6%, respectively, in post-partum groups. Sensitivity analysis confirmed the reliability and consistency of the results. Oral iron was associated with significant gastrointestinal side effects. There was no significant difference in birthweight between the groups.

Conclusion: This meta-analysis demonstrates that intravenous iron sucrose is more effective than oral iron therapy for pregnant and post-partum women with iron deficiency anaemia. It is an effective and safe alternative to address the problem of iron deficiency especially in those who require rapid replacement of iron stores though medical personnel for intravenous administration of drug is required.

Trial registration CRD42015024343

Abbreviations:
IDA Iron deficiency anaemia
WHO World Health Organization
NFHS-4 National Family Health Survey-4
OR Odds ratio
IVS Intravenous iron sucrose
OIG Oral iron group
PCV Packed cell volume
MD Mean difference
CI Confidence interval
Hb Haemoglobin
ANC Antenatal clinic
QOL Quality of life
LMIC Low–middle-income countries

Iron deficiency anaemia, Intravenous iron, Oral iron, Pregnancy, post-partum
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Effectiveness and Safety of Camylofin in Augmentation of Labor: A Systematic Review and Meta‑Analysis

Nandita Palshetkar1 ● Ameya Purandare2,3 ● Hemant Mehta2 ● Rohan Palshetkar4

Abstract

This systematic review and meta-analysis assessed the effectiveness and safety of camylofin compared with other antispasmodics (drotaverine, hyoscine, valethamate, phloroglucinol, and meperidine) in labor augmentation. A systematic literature search until March 27, 2018, was performed, and data on the cervical dilatation rate (CDR) and duration of stages of labor reported in 39 eligible articles were analyzed using a random-effects model. CDR was significantly higher (0.38 cm/h, 95% confidence interval (CI) 0.10 to 0.67, p = 0.007), and the duration of the first stage of labor was significantly shorter (− 41.21 minutes, 95% CI, − 77.19 to − 5.22, p = 0.02) in women receiving camylofin than those receiving other antispasmodics for labor augmentation. CDR was significantly higher with camylofin compared with valethamate (0.6 cm/h, 95% CI 0.4 to 0.9, p < 0.0001) and hyoscine (20 mg) (0.5 cm/h, 95% CI 0.1 to 0.8, p = 0.02). The duration of the first stage of labor was significantly shorter with camylofin compared with hyoscine (20 mg) (− 59.9 min, 95% CI, − 117.9 to − 1.8, p = 0.04). However, CDR and the duration of first stage of labor were not statistically different between camylofin and drotaverine groups. The percentage of women having nausea and vomiting, cervical/vaginal tear, and postpartum hemorrhage were comparable with all antispasmodics, whereas tachycardia was least reported in women receiving camylofin (3, 2.07%) than those receiving other antispasmodics. This meta-analysis demonstrated the benefit of camylofin in labor augmentation with a faster CDR and reduction in the active first stage of labor in Indian women.

Augmentation , Camylofin , Cervical dilatation rate , Duration of first stage , Systematic review and metaanalysis
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Association of Leptin with Polycystic Ovary Syndrome: a Systematic Review and Meta‐Analysis

Mahesh Kumar Seth1,2 · Sarthak Gulati1,2 · Shreya Gulati2,3 · Amit Kumar2,4 · Dimple Rawat1,2 · Aradhana Kumari1,2 · Rohini Sehgal2,5 · Rinchen Zangmo2,5 · Vivek Dixit2,6 · Premlata1,2 · Arti Gulati1,2

Background Serum leptin has been considered as an important measurable diagnostic and prognostic biomarker for polycystic ovarian syndrome (PCOS), although its evidence for use in clinical practice is limited. We aim to synthesize the available evidence on the clinical use of serum leptin values in PCOS by doing a systematic review and meta-analysis of studies.

Objective To conduct a meta-analysis to determine the pooled effect size of the association of leptin levels in patients with PCOS.

Methods We searched electronic databases, i.e., PubMed, Google Scholar, Web of Science, ClinicalTrials.gov, and Medline from inception to September 2020, keeping filters for human studies and published in the English language. We used the random-effects model if heterogeneity between the studies was>50%; otherwise, a fixed-effect model was applied to determine the standardized mean difference with 95% CI for comparison of leptin level between cases and controls. All the statistical analyses were completed using software STATA version 13.

Results The meta-analysis included a total of 35 studies involving 2015 cases and 1767 controls that suggested statistically significantly higher leptin levels in the women with PCOS as compared to controls (SMD, 1.76, 95% CI 1.28 to 2.23, P<0.001). In the stratified analysis when only high methodological quality studies were included, we did not observe a statistically significant difference in the leptin level between PCOS and controls (SMD 0.68, 95% CI −0.09 to 1.46). Analysis restricted to low methodological quality studies observed statistically significant high leptin levels in PCOS women as compared to controls (SMD 2.24, 95% CI 1.65 to 2.83).

Conclusion The available evidence suggests that elevated leptin levels may be associated with risk of PCOS as compared to controls; however, failure to observe the similar association in high methodological quality studies demands further well designed adequately powered studies to validate the findings.

Leptin · PCOS · Polycystic ovary syndrome · Adipokine
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Association of Superoxide Dismutase Level in Women with Polycystic Ovary Syndrome

Arshi Talat1 · P. Satyanarayana2 · Pallavi Anand3

Several biomarkers involved in oxidative stress may influence polycystic ovary syndrome (PCOS). Superoxide dismutase (SOD) has been commonly identified as dismutase enzyme catalyzes the conversion of superoxide to hydrogen peroxide and elemental oxygen, and could serve as an important biomarker in this direction. The objective of the present study to determine the precise role of SOD levels in women with PCOS using a meta-analysis approach. The electronic databases like PubMed, Google Scholar, Web of Sciences, Clinical trial.gov, Cochrane Database of Systematic Review were searched for obtaining relevant studies on the association of SOD level in women with PCOS. Pooled standardized mean difference with 95% CI was computed using the DerSimonian and Liard method. A total of 267 articles were screened, out of which 12 articles fulfilled the inclusion criteria of the present meta-analysis involving 558 cases and 529 controls. Analysis including overall studies observed a higher SOD level (statistically non-significant) in women with PCOS compared to controls (SMD 0.35, 95% Cl −0.91 to 1.62, P = 0.58), however, statistically significant higher SOD levels were noted in studies using serum as a source of sample (SMD 1.53, 95% CI 0.25 to 2.81, P = 0.019). In conclusion, women with PCOS exhibited increased SOD levels compared to controls suggesting that the byproduct of oxidative damage is expected to be increased in women with PCOS.

PCOS · Polycystic ovary syndrome · Superoxide dismutase · SOD
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The Association between Maternal Birth Weight and Gestational Diabetes Mellitus: A Systematic Review and Meta-Analysis

Mehdi Shokri1 · Mahsa Rizebandi2 · Parviz Karimi1 · Gholamreza Badfar3 · Marzieh Parizad Nasirkandy4 · Gholamreza Kalvandi5 · Shoboo Rahmati6

Background and Aims Gestational diabetes mellitus is one of the most important issue related to health status of mothers and their children throughout life. This meta-analysis has been conducted to assess relationship between maternal birth weight and gestational diabetes.

Methods and Results This article is written using PRISMA guideline for systematic review and meta-analysis. We searched epidemiological studies without a time limit from following databases—Scopus, PubMed, Science Direct, Embase, Web of Science, CINAHL, Cochrane, EBSCO, and Google Scholar search engine using MESH keywords. Heterogeneity was determined using the Cochran Q test and I2 index. Data were analyzed using comprehensive meta-analysis, version 2. The significance level of the tests was considered as P < 0.05.

Results The result of combining ten studies with a sample size of 228,409 cases using a fixed-effect model showed that low maternal birth weight increased the risk of gestational diabetes mellitus (1.71 [95% CI 1.43–2.06, P < 0.001]). In addition, the result of combining nine studies with a sample size of 227,805 cases using a random-effects model showed that macrosomia did not increase the risk of gestational diabetes mellitus, and there was no significant relationship between them (1.04 [95% CI 0.79–1.38; p value: 0.730]).

Conclusion The results of this systematic review and meta-analysis showed that low maternal birth weight could be a risk factor for gestational diabetes in adulthood.

Gestational diabetes · Maternal birth weight · Systematic review · Meta-analysis
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A Systematic Review of Antenatal Risk Scoring Systems in India to Predict Adverse Neonatal Outcomes

Dinesh Raj Pallepogula1 · Adhisivam Bethou1 · Vishnu Bhat Ballambatu2 · Gowri Dorairajan3 · Ganesh Kumar Saya4 · Sureshkumar Kamalakannan5 · Sandhya Karra6

Background : The purpose of antenatal care (ANC) is to identify ‘at-risk’ pregnant women, to provide quality care for all, and maximize the allocation of resources for those who need them the most. To address the synergistic effect of risk factors, clinicians across the globe developed antenatal scoring systems. Objective This review aims to investigate various antenatal risk scoring systems developed and used in India to predict adverse neonatal outcome.

Methods : We reviewed articles published between January 2000 and April 2020, which have either developed a scoring system or used a scoring system, among the Indian population. This systematic review is reported based on Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines. Prediction model study Risk Of Bias Assessment Tool (PROBAST) was employed for the assessment of the quality of included studies. Data sources such as Embase, MEDLINE/Pubmed, APA PsycExtra, PsycINFO, CINHAL Plus, Cochrane Library, IndMED, LILACS, Scopus, WHO Reproductive Health Library and Web of science were searched.

Results : An initial search retrieved a total of 6246 articles. This systematic review identified six studies, of which one study developed an antenatal scoring system and the other five studies used two antenatal systems for predicting adverse neonatal outcome. The study which developed a risk scoring system had a high risk of bias (ROB) and concern for applicability. The overall sensitivity of the antenatal scoring system was high (77.4%), but the specificity was low (45%). Similarly, the positive predictive value is low (15.3%), and the negative predictive value is high (94.2%). A meta-analysis was not conducted due to the heterogeneity of the studies and insufficient data.

Conclusions : There is a need for a systematically developed antenatal scoring system for India. Such scoring systems can be promising in public health, proposing a paradigm shift in the implementation of effective mother and child health programmes locally as well as nationally.

Antenatal risk scoring · Risk score development · High-risk pregnancy · Systematic review · India
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Meta‑analysis to Assess the Association of Lateral Location of Placenta on Ultrasound with Preeclampsia

Saudamini A. Naik1 · Amit S. Naik1 · Shekhar B. Padhyegurjar2

Introduction Several studies have shown association between lateral placenta on ultrasound and preeclampsia (PE).This meta-analysis aims to review majority of the articles published between 1990 and 2020 and analyze the data extracted from them to find whether such an association really exists. Objective To conduct a meta-analysis to determine the degree of the association of lateral placenta on ultrasound with preeclampsia.

Methods We searched electronic databases keeping filters for human studies and published in the English language, between the year 1990 and 2020. Studies were reviewed by reviewers and studies which were analytical in nature, having focused research question and where odds ratio could be derived were identified, and included in the metanalysis.

Result Out of 16 included studies, 15 studies showed positive association (OR > 1) out of which 13 were statistically significant and only one study showed negative association. Eight studies showed extremely significant statistical positive association. The meta-analysis points toward positive association with OR 3.48 and Mantel–Haenszel Chi square 325.82 with relatively narrow 95% confidence interval around OR as 3.03–3.99 which clearly indicates a positive association between laterally placed placenta and preeclampsia. The findings of the individual studies in terms of OR and 95% confidence interval were plotted as individual line for each study, one aggregate estimate with summary OR and its 95% confidence interval was plotted on the Forest Plot.

Conclusion The Forest plot revealed association between lateral placenta on ultrasound and preeclampsia (PE).Hence it can be concluded that there is an association between lateral placenta on ultrasound and preeclampsia.

Lateral location of placenta · Lateral placenta on ultrasound · Pregnancy induced hypertension · Hypertensive disorders of pregnancy · Preeclampsia
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Non-Medical Determinants of Access and Quality of Maternal Health Services in India—Protocol for a Scoping Review

Yamini Priyanka Kuruba, Anju P. Sinha, Anoop Singh, Pranita Pradhan , A. G. Radhika

Introduction: The Maternal Mortality Rate (MMR) is one of the most important health indicators of a country. In India, MMR has decline from 130 to 113 per 100,000 live births between 2014 and 2018, however, there are wide disparities in utilization of maternal health services (MHS) among different states and across different socioeconomic groups within the states. Although the government is providing MHS through various health programs in India, there are several non-medical factors leading to the underutilization of MHS services.

Objective: To map and summarise the non-medical determinants of access and quality of MHS in India. Methods: We are conducting a scoping review of the published literature from 2000 till date in databases such as PubMed, Cochrane, Science Direct and CINAHL by including eligible qualitative as well as quantitative studies conducted in India. Data extraction and analysis will be conducted through a narrative integrative synthesis approach to summarize the non-medical determinants of access and quality of MHS in India and understand their mechanisms of influence. At the third SPINE20 summit 2022 which took place in Bali, Indonesia, in August 2022, 17 associations endorsed its recommendations.

Results: We will summarise the non-medical determinants that influence the access and quality of MHS.

Conclusion: This scoping review would help to understand and summarise the existing non-medical determinants of access and quality of MHS, highlight the research gaps and suggest potential modalities for improvement of access and quality of MHS.

Non-medical determinants · Maternal health services · India · Social determinants · Scoping review
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