Journal of Clinical and Diagnostic Research, ISSN - 0973 - 709X

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On Aug 2018




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Dr. Arundhathi. S
MBBS, MD (Pathology),
Sanjay Gandhi institute of trauma and orthopedics,
Bengaluru.
On Aug 2018




Dr. Mamta Gupta,
"It gives me great pleasure to be associated with JCDR, since last 2-3 years. Since then I have authored, co-authored and reviewed about 25 articles in JCDR. I thank JCDR for giving me an opportunity to improve my own skills as an author and a reviewer.
It 's a multispecialty journal, publishing high quality articles. It gives a platform to the authors to publish their research work which can be available for everyone across the globe to read. The best thing about JCDR is that the full articles of all medical specialties are available as pdf/html for reading free of cost or without institutional subscription, which is not there for other journals. For those who have problem in writing manuscript or do statistical work, JCDR comes for their rescue.
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Reviewing articles is no less a pain staking process and requires in depth perception, knowledge about the topic for review. It requires time and concentration, yet I enjoy doing it. The JCDR website especially for the reviewers is quite user friendly. My suggestions for improving the journal is, more strict review process, so that only high quality articles are published. I find a a good number of articles in Obst. Gynae, hence, a new journal for this specialty titled JCDR-OG can be started. May be a bimonthly or quarterly publication to begin with. Only selected articles should find a place in it.
An yearly reward for the best article authored can also incentivize the authors. Though the process of finding the best article will be not be very easy. I do not know how reviewing process can be improved. If an article is being reviewed by two reviewers, then opinion of one can be communicated to the other or the final opinion of the editor can be communicated to the reviewer if requested for. This will help one’s reviewing skills.
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Dr. Mamta Gupta
Consultant
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018




Dr. Rajendra Kumar Ghritlaharey

"I wish to thank Dr. Hemant Jain, Editor-in-Chief Journal of Clinical and Diagnostic Research (JCDR), for asking me to write up few words.
Writing is the representation of language in a textual medium i e; into the words and sentences on paper. Quality medical manuscript writing in particular, demands not only a high-quality research, but also requires accurate and concise communication of findings and conclusions, with adherence to particular journal guidelines. In medical field whether working in teaching, private, or in corporate institution, everyone wants to excel in his / her own field and get recognised by making manuscripts publication.


Authors are the souls of any journal, and deserve much respect. To publish a journal manuscripts are needed from authors. Authors have a great responsibility for producing facts of their work in terms of number and results truthfully and an individual honesty is expected from authors in this regards. Both ways its true "No authors-No manuscripts-No journals" and "No journals–No manuscripts–No authors". Reviewing a manuscript is also a very responsible and important task of any peer-reviewed journal and to be taken seriously. It needs knowledge on the subject, sincerity, honesty and determination. Although the process of reviewing a manuscript is a time consuming task butit is expected to give one's best remarks within the time frame of the journal.
Salient features of the JCDR: It is a biomedical, multidisciplinary (including all medical and dental specialities), e-journal, with wide scope and extensive author support. At the same time, a free text of manuscript is available in HTML and PDF format. There is fast growing authorship and readership with JCDR as this can be judged by the number of articles published in it i e; in Feb 2007 of its first issue, it contained 5 articles only, and now in its recent volume published in April 2011, it contained 67 manuscripts. This e-journal is fulfilling the commitments and objectives sincerely, (as stated by Editor-in-chief in his preface to first edition) i e; to encourage physicians through the internet, especially from the developing countries who witness a spectrum of disease and acquire a wealth of knowledge to publish their experiences to benefit the medical community in patients care. I also feel that many of us have work of substance, newer ideas, adequate clinical materials but poor in medical writing and hesitation to submit the work and need help. JCDR provides authors help in this regards.
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Every one of us: authors, reviewers, editors, and publisher are responsible for enhancing the stature of the journal. I wish for a great success for JCDR."



Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011




Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."



Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011
Anuradha

Dear team JCDR, I would like to thank you for the very professional and polite service provided by everyone at JCDR. While i have been in the field of writing and editing for sometime, this has been my first attempt in publishing a scientific paper.Thank you for hand-holding me through the process.


Dr. Anuradha
E-mail: anuradha2nittur@gmail.com
On Jan 2020

Important Notice

Original article / research
Year : 2023 | Month : January | Volume : 17 | Issue : 1 | Page : QC01 - QC04 Full Version

Detection of Creatinine in Vaginal Secretions of Women with Premature Rupture of Membranes in Third Trimester from Semiurban Population: A Cross-sectional Study


Published: January 1, 2023 | DOI: https://doi.org/10.7860/JCDR/2023/56744.17346
Hemant Gopalrao Deshpande, Monalisa Sarkar, Madhukar Jagannath Shinde, Chetan Gulati, Shubham Joon

1. Head, Department of Obstetrics and Gynaecology, Dr DY Patil Medical College, Hospital and Research Centre, Pune, Maharashtra, India. 2. Resident, Department of Obstetrics and Gynaecology, Dr DY Patil Medical College, hospital and Research Centre, Pune, Maharashtra, India. 3. Assistant Professor, Department of Obstetrics and Gynaecology, Dr DY Patil Medical College, Hospital and Research Centre, Pune, Maharashtra, India. 4. Resident, Department of Obstetrics and Gynaecology, Dr DY Patil Medical College, Hospital and Research Centre, Pune, Maharashtra, India. 5. Student, Department of Obstetrics and Gynaecology, Dr DY Patil Medical College, Hospital and Research Centre, Pune, Maharashtra, India.

Correspondence Address :
Dr. Chetan Gulati,
Resident, Obstetrics and Gynaecology, Dr DY Patil Medical College, Hospital and Research Centre, Pune, Maharashtra, India.
E-mail: chetan2189@gmail.com

Abstract

Introduction: Spontaneous rupture of the membranes any time beyond the 28th week of pregnancy but before the onset of labour is called Premature Rupture of Membranes (PROM). There are many techniques for diagnosing PROM that is based on both clinical assessments and biological studies. Each of these procedures has benefits and drawbacks. Since foetal urine is the major source of amniotic fluid, the presence of vagina and a high creatinine level may aid in the diagnosis of PROM.

Aim: To determine the cut-off levels of serum creatinine in predicting the PROM.

Materials and Methods: A cross-sectional study was conducted at Dr. DY Patil Medical College, Hospital and Research Centre in Pune, Maharashtra, India from June 1 2020 to June 5 2021. Two equal groups of 140 each pregnant women with gestational ages ranging from 28-42 weeks were created: one with a history of vaginal leaking (the study group, P), and the other with gestationally matched no leakage (the control group, C). Patient’s details such as age, gestational age, and obstetric history were noted. Each patient was examined and cervicovaginal secretions were collected. A 5 mL of saline was flushed in the posterior fornix of vagina. This fluid with vaginal wash was aspirated and creatinine concentration from vaginal fluid was determined by Jaffee synthetic chemical colorimetric method. The Student’s t-test and the Chi-square test were used to analyse the data.

Results: The study group’s vaginal fluid creatinine level was substantially higher (p-value<0.001). The cut-off value of 0.6 mg/dL had highest sensitivity 96.1% and specificity 100%. The area under the Receiver Operating Characteristics (ROC) curve was 0.917. The Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of serum creatinine at cut-off 0.6 mg/dL was 100% and 96.3% respectively.

Conclusion: Vaginal fluid creatinine is simple and easily available, which makes it acceptable to the candidate for a diagnosis of PROM.

Keywords

Amniotic membrane, Fetoprotein, Fibronectin, Gonadotropin, Prelabour, Prolactin

Rupture of the amniotic sac before the onset of labour is referred to as PROM. Risk factors include: low socio-economic status, underweight women, preterm labour history, urine infection, vaginal bleeding, cerclage, and amniocentesis (1). It complicates about 8-10% of term pregnancies and approximately 1% of preterm pregnancies (2). Gestational age and co-morbidities determine the course of treatment (3). One of the most frequent side-effects of preterm PROM is early delivery. The length of the latent period, which is the interval between membrane rupture and delivery, is inversely related to the gestational age at which PROM takes place (4). An analysis of a study evaluating patients with preterm PROM between 16 and 26 weeks’ gestation found that 57% of patients delivered within one week, and 22% had a latent period of four weeks (5). For instance, a large study of patients at term found that 95% of patients delivered within roughly one day of PROM (4). PROM is diagnosed by amniotic fluid at posterior fornix with a speculum examination. Nitrazine test observing a basic pH change on indicator paper. A fern test of dried amniotic fluid under the microscope (6). An ultrasound, but rarely done as one cannot differentiate PROM from other causes of oligohydramnios (7). Detection of alpha fetoprotein, insulin growth factor binding protein-1, foetal fibronectin, human chorionic gonadotropin, prolactin, urea, creatinine (8),(9),(10),(11),(12).

For gestational age-specific obstetric measures to improve perinatal outcome and reduce significant consequences, like cord prolapse and infectious morbidity, a primary and accurate diagnosis of preterm PROM would be necessary (chorioamnionitis, neonatal sepsis). On the other hand, a false-positive preterm PROM diagnosis may result in needless obstetric treatments, such as hospitalisation, the administration of antibiotics and corticosteroids, or even labour induction. Therefore, an early and precise PROM diagnosis is essential for maximising pregnancy outcomes; in fact, it is so important that an amnio-dye test (also known as a tampon test) may be advised if other tests for preterm PROM are inconclusive and if the pregnancy is far from the term. Amniocentesis is used during this test, and the amniotic cavity is injected with dye (13).

The PROM diagnosis is challenging and unreliable with conventional techniques. This study sought to establish the cut-off value and assess the validity of vaginal washing fluid creatinine for PROM diagnosis.

Material and Methods

A cross-sectional study was conducted at Dr DY Patil Medical College, Hospital and Research Centre in Pune, Maharashtra, India, from June 1 2020 to June 5 2021. Institutional Ethics Committee (IEC) approval was obtained (IESC/PGS/2019/137). Prior to the study, the patients provided written informed consent.

Inclusion criteria:

• Age group >18 years
• Confirmed PROM cases by positive nitrazine test and positive fern test
• Gestational age 24 to 36 weeks
• Cervical dilatation < 3 cm
• High-risk pregnancies include those in which the mother experienced preterm PROM during a previous pregnancy, preterm labour in the past, direct abdominal trauma, polyhydramnios, or numerous pregnancies.

Exclusion criteria:

• Active vaginal bleeding
• Preeclampsia
• Liver or kidney disease
• Vaginal bleeding or vaginal infection
• Foetal congenital anomalies or intrauterine foetal death
• Any circumstances that might affect the creatinine amounts in vaginal fluid.

Sample size calculation: The sample size included 280 women who complained of PROM, fitting the inclusion criteria. The prevalence of PROM was reported to be 10% (2), precision was set at 5% =0.05, Z value at 95% confidence= 1.96. Therefore, a total of 140 patients with confirmed PROM and 140 patients without PROM were enrolled in the study.

Patient’s details such as age, gestational age, obstetric history were noted. General and systemic examination was performed. Each patient was examined and cervicovaginal secretions were collected. These secretions were subject to:

• Fern test: A small drop of sample was spread evenly on a glass slide and air dried. It was observed under the light microscope (10x magnification) for an arborisation pattern. A single observer performed the test in all patients.
• Nitrazine test: In the deep vagina, a cotton tip applicator was used to deposit the substance onto nitrazine paper. Change in colour is suggested if pH <6.5 and test is considered positive (14).
• Measurement of creatinine levels: The posterior fornix of the vagina was flushed with 5 mL of saline. The same syringe was used to aspirate both fluids, which were then submitted right away to the central laboratory for creatinine measurement. Creatinine concentration from vaginal fluid was determined by Jaffee synthetic chemical colorimetric method (15).

Statistical Analysis

Mean and Standard Deviation (SD) were used to present quantitative data. According to the findings of the normalcy test, a comparison between the research groups was carried out using an unpaired t-test. The Fisher test, Student’s t-test, and Chi-square test were used to see whether there was any association between the research groups. A p-value <0.05 was considered significant. Analysis of Variance (ANOVA) test was used to find whether there was a significant association between serum creatinine levels with the gestational age of patients. For statistical analysis, appropriate statistical software was utilised, such as MS Excel and Statistical Package for the Social Sciences (SPSS) version 20.0.

Results

The majority of the patients in group P were in the age range of 21 to 30. The average age for group P was 26.49 ±5.03 years. Most of the patients in group C were between the ages of 21 and 30. In group C, the average age was 27.11± 4.80 years (Table/Fig 1).

It was observed that 48.6% and 51.4% patients in group P were primigravida and multigravida respectively while 42.1% and 57.9% patients in group C were primigravida and multigravida respectively (Table/Fig 2).

The mean gestational age of patients in group P and group C was 31.09±3.35 weeks and 31.53±3.37 weeks respectively (Table/Fig 3).

In group P, the cervix was 1 cm dilated in 47.9% patients while it was 2 cms and 3 cms dilated in 30% and 22.1% patients respectively. In group C, the cervix was 1 cm dilated in 49.3% patients while it was 2 cms and 3 cms dilated in 31.4% and 19.3% patients respectively (Table/Fig 4).

The mean vaginal fluid creatinine was considerably higher in group P than group C (Table/Fig 5).

There was no significant association of serum creatinine levels with gestational age of patients as per ANOVA test (p>0.05) in both the groups (Table/Fig 6). A cut-off value of 0.6 mg/dL for serum creatinine had the best sensitivity (96.1%) and specificity (100%). Serum creatinine’s positive and negative predictive values are 100% and 96.3%, respectively. The ROC curve’s area under it was 0.917 (Table/Fig 7),(Table/Fig 8).

Discussion

There is no non invasive method that can be used as the gold standard. Other non invasive diagnostic methods, which include pooling assessment, microscopic fern test, and pH examination of cervicovaginal discharge (nitrazine test) are not cost-effective, and diagnostic accuracy is not high if time has passed since membranes ruptured. The gold standard test currently used for diagnosis of PROM, the amnio-dye test, is invasive and there are risks of infection, abruption, and abortion (16). Recently, the focus of studies has been to detect various biochemical markers in cervicovaginal discharge when ROM occurs. These markers include alpha fetoprotein, foetal fibronectin, nsulin growth factor binding protein-1, prolactin, beta human chorionic gonadotropin, urea, lactate, placental alpha-microglobulin-1 and 2, and creatinine. Authors have speculated that analysis of vaginal creatinine and urea can be used as a foetal maturation test, in cases of preterm labour, as the creatinine level depends on gestational age (17),(18),(19). In the present study, the majority of the patients (63.6%) in group P were in the age group of 21-30 years. The mean age in group P was 26.49±5.03 years. The mean age in group C was 27.11±4.80 years. There was no significant difference between the groups as per Student’s t-test (p-value >0.05). In a study by Sharma A et al., mean ages were similar in all three groups (23.44, 23.40, and 23.30 in Group 1 (Confirmed PROM), group 2 (Unconfirmed PROM), and control group respectively) (18).

In the present study, 68 (48.6%) and 72 (51.4%) patients in Group P were primigravida and multigravida respectively while 59 (42.1%) and 81 (57.9%) patients in group C were primigravida and multigravida respectively. Sharma A et al., study, showed most of the patients were primiparous and were well matched in all the three groups (18). The mean gestational age of patients in group P and group C was 31.09±3.35 weeks and 31.53±3.37 weeks respectively. There was no significant difference between the groups. This was similar to the studies of Sharma A et al., and Begum J et al., (18),(19). Sharma A et al., found mean gestational age in weeks were 34.86, 34.98, 35.11 in group 1, group 2 and control group respectively (18). Begum J et al., study, evaluating cervicovaginal fluid for urea and creatinine for diagnosis of PROM had no particular difference between both groups with respect to maternal age, obstetric score and gestational age of the participants (19). A creatinine concentration of 1.75 mg/dL or more correlated significantly with a gestational age of 37 weeks or more (3). It was observed in present study that the mean vaginal fluid creatinine was strikingly higher in group P than in group C. The mean vaginal fluid creatinine in groups I, II, and III were 1.74±0.8 mg/dL, 0.45±0.2 mg/dL and 0.25±0.1 mg/dL, respectively. The creatinine level was significantly higher in the confirmed group (group I) than in the other two groups (p-value<0.0010) as reported in Zanjani MS and Haghighi L study (20). The mean urea levels were 26.35 mg/dL in the study group 1 and 3.12 mg/dL in the control group in Sharma A et al., study (18).

Malchi F et al., reported, the overall mean of creatinine in the case group was significantly higher than the control. It was noted that the sensitivity and specificity of creatinine was higher than urea in the diagnosis of PROM (21). Sharma A et al., cross-sectional study assessing creatinine levels in vaginal fluid as a marker of PROM found cervicovaginal fluid creatinine levels were more marked in women with confirmed leaking than the women in the control group (18). The findings of these studies were in agreement with the findings of the index study. Zanjani MS and Haghighi L study evaluating the reliability of vaginal fluid creatinine for the diagnosis of PROM showed mean vaginal fluid creatinine in groups I, II, and III were 1.74±0.8, 0.45±0.2 and 0.25±0.1 mg/dL, respectively. The creatinine level was significantly higher in the confirmed group (group I) than in the other two groups (p<0.0010) (20). In the present study, for serum creatinine a cut-off 0.6 mg/dL had highest sensitivity 96.1% and specificity of 96.3%. The area under the ROC curve was 0.917. Similar observations were noted in other studies (17),(18),(19),(22),(23),(24). The sensitivity, specificity, positive predictivity, and negative predictivity were all 100% in detecting PROM by evaluation of vaginal fluid urea and creatinine concentration with a cut-off value of 12 and 0.6 mg/dL, respectively (17).

Limitation(s)

Contamination of sample by blood, urine, or meconium. The estimation of vaginal fluid creatinine level is effective for patients not in labour and it is not accurate for patients with congenital foetal malformations.

Conclusion

Correct and prompt diagnosis of the condition is crucial to achieving the best pregnancy result. A proper diagnosis should serve as the foundation for management. This test is appealing in clinical practice due to its accessibility and simplicity. Vaginal fluid creatinine is therefore a potential contender to be accepted as a test for PROM diagnosis.

References

1.
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DOI and Others

DOI: 10.7860/JCDR/2023/56744.17346

Date of Submission: Mar 30, 2022
Date of Peer Review: Apr 27, 2022
Date of Acceptance: Aug 19, 2022
Date of Publishing: Jan 01, 2023

AUTHOR DECLARATION:
• Financial or Other Competing Interests: None
• Was Ethics Committee Approval obtained for this study? Yes
• Was informed consent obtained from the subjects involved in the study? Yes
• For any images presented appropriate consent has been obtained from the subjects. NA

PLAGIARISM CHECKING METHODS:
• Plagiarism X-checker: Apr 11, 2022
• Manual Googling: Aug 04, 2022
• iThenticate Software: Aug 18, 2022 (16%)

ETYMOLOGY: Author Origin

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