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Awareness regarding knowledge associated with polycystic ovarian syndrome (PCOS) among women in Wardha district- A cross-sectional study.

[version 1; peer review: 2 approved with reservations]
PUBLISHED 01 Sep 2023
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This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Women can develop PCOS (polycystic ovarian syndrome) at a young age. It is a reasonably common endocrine disorder that results in hormonal imbalances and mostly raises androgen hormone production. In India, one in eight women had PCOS, according to a study from the year 2020. More than half of the 10 million people with PCOS are unaware that they have it, hence there is a need for improved public awareness of the condition. For the general public to realize the necessity, it is necessary to have awareness of having symptoms like irregular periods and pelvic pain. Despite the way that there is no solution for PCOS, there are medicines that could facilitate the pressure and difficulties brought about by side effects. The likelihood of an early diagnosis will increase as PCOS becomes more well-known. The adoption of a standardized questionnaire, which will guarantee consistency in data collection and minimize bias, is the study's key strength. A big sample size will also increase the study's accuracy and the generalizability of its findings. The study's drawbacks include the possibility of recollection bias since respondents might not fully recall their familiarity with PCOS. Additionally, because the study will only be conducted in one Indian district, the generalizability may be limited of the outcomes. Analyzing the level of PCOS knowledge and awareness among women in India's Wardha area is the goal of this research proposal. The discoveries of this study will be useful for public health initiatives aiming at raising PCOS awareness and, ultimately, lowering the prevalence of PCOS among women.

Keywords

Polycystic ovarian syndrome, endocrine, androgen, anovulation

Introduction

Background/Rationale

The most well-known endocrine condition in ladies and a critical supporter of anovulatory fruitlessness is polycystic ovary syndrome (PCOS). Because of the variety of its aggregates, PCOS displays a great many clinical side effects and chance variables. Feminine cycle inconsistencies, ovarian pimples, and hirsutism are ordinary side effects. PCOS influences ladies of all races and nationalities who are of conceptive age. Patients with PCOS could display many signs and side effects, making it trying to definitively grade the sickness. The measures of the ESRHE/ASRM Rotterdam agreement meeting,1 which extended the earlier NIH (National Institute of Health) order of 1990, are as of now used to analyze PCOS. It was predicated on something like two of the accompanying qualities: polycystic ovaries by ultrasonography, hyperandrogenism, and oligo-anovulation. A board of trustees of experts was laid out by the Androgen Overabundance Society (AES) in 2006 to examine all PCOS-related material delivered fully intent on smoothing out determination. The AES standards are for oligo/anovulation, polycystic ovaries, and clinical and additionally biochemical hyperandrogenism simultaneously.2

There are four assortments of PCOS:

  • 1. Insulin-resistant PCOS: Around 70% of ladies have this sort of PCOS, making it the most pervasive. Generally, insulin obstruction happens when the body has higher-than-typical measures of insulin or hyperinsulinemia. This happens when our cells become somewhat “numb” to the impacts of insulin, making the pancreas emit expanding measures of the chemical until the cells get the message. You can experience difficulty getting thinner, convey additional load in your stomach or midsection, sugar cravings, and have side effects like exhaustion or mind haze assuming you have this sort of PCOS. Expanded androgen levels, which bring about issues like additional hair, males experiences include going bald, and skin breaking out, are brought about by high insulin levels.

  • 2. Post-pill PCOS: Certain individuals who quit utilizing the oral preventative pill foster post-pill PCOS. In this kind, no side effects like skin break out, sporadic periods or extreme hair development existed before the pill was at any point begun. Because of the kind of engineered progestins that are available in oral contraceptives like Ginet, Yasmin, and Yaz, are engaged with this sort of PCOS. The ovary hosts a get-together when you quit utilizing the pill, and there is a characteristic expansion in androgens, which could make the exemplary side effects of PCOS; be that as it may, there is no insulin opposition in this assortment. This generally happens three to a half years subsequent to suspending the medication. With legitimate sustenance, way-of-life changes, and enhancements or home-grown prescription help, this sort can be dealt with all the more quickly despite the fact that it can require an investment to mend all alone.3

  • 3. Adrenal PCOS: Around 10% of people with the determination have this sort of PCOS, which is welcomed by an abnormal pressure response.3 Elevated degrees of testosterone and androstenedione are frequently not noticed; all things being equal, DHEA-S, one more sort of androgen delivered by the adrenal organs, will regularly be raised alone.

  • 4. Inflammatory PCOS: Persistent irritation in provocative PCOS makes the ovaries produce an excess of testosterone, which prompts actual uneasiness and trouble in ovulating. Migraines, joint distress, unexplained depletion, dermatitis, and IBS indicate irritation here of PCOS. Regularly, blood tests will uncover raised incendiary markers, like high CRP (C-responsive protein). Different tests, like fasting glucose and insulin, are inside the typical reach, however, they may periodically be influenced by aggravation.3

50-70% of females with PCOS have insulin opposition, which expands their gamble of creating diabetes, metabolic condition, hypertension, dyslipidemia, and other comorbidities like hypertension and dyslipidemia.4 As per studies, ladies who have PCOS are bound to have higher carotid intima-media thickness and higher coronary vein calcium scores, also Ladies with PCOS are likewise bound to encounter psychological well-being sicknesses such as depression, uneasiness, bipolar, confusion, and voraciously consuming food problems. Indian ladies have a high PCOS commonness rate. Utilizing Public Establishments of Wellbeing (NIH) rules, the pooled predominance of PCOS was 5.8%.4 45% of females with PCOS express that they have never gotten direction on the most proficient method to deal with their way of life.5 As studies on PCOS have not been concluded previously in our Wardha District. So here is our aim to appraise the awareness of PCOS among the rural and semi-urban female population in District Wardha. With the help of its outcome, the campaign or health professional will try to educate and inform people about PCOS which will help in reducing the rate in Wardha district (India).

Objectives

  • To collect the question-based data on women in the Wardha district.

  • To assess the knowledge of awareness regarding polycystic ovarian syndrome (PCOS).

Protocol

Methodology

Type of Study – Cross-Sectional study (observational study)

Duration of study – 4 months

  • Conceptual research on polycystic ovarian syndrome will be done.

  • Prior to the initiation of the study, approval will be obtained from the ethics committee.

  • By using the random sampling method, the subject will be assigned.

  • The awareness research will be done through face-to-face interviews using a standardized questionnaire form.

  • Subjects will be provided informed consent, which will be filled out after explaining the purpose of the study.

  • Standardized Questionnaires will be given to the subject and will be filled by them.

  • The data collected will be tabulated and analyzed.

Study design

The study is conducted among the female general population of the Wardha district. The study is about the awareness of polycystic ovarian syndrome among women. The recruitment of the subject will be done independently and the awareness will be observed through a standardized questionnaire tool.

Setting

Method of data collection

  • Techniques of Sampling: Simple Random Sampling will be used.

  • Instrument: Researcher prepared a structured questionnaire consisting of MCQs.

Steps of data collection

  • Step 1: Permission will be obtained prior from the ethics committee for the data collection.

  • Step 2: Introduction between the participants and the researcher.

  • Step 3: The participants will be assigned by using a random sampling method.

  • Step 4: ICF will be taken from the participants who are willing to participate, after explaining the study purpose.

  • Step 5: Standardized questionary will be filled out by the subjects with the help of face-to-face interviews.

Expected dates of data collection

The data will be collected from March 2024 to July 2024.

Expected dates of recruitment

The First subject is to be recruited on 1st March 2024 and 375 participants will be recruited by the end of July 2024.

Participants

Cross-sectional study

Selection of subjects

Inclusion criteria

  • Age Range

  • Subjects aged above 15 to 45

  • Gender

  • Subjects only female will be included randomly.

  • Participants who are willing to participate after explaining the protocol.

Exclusion criteria

  • 1. Age below 15 and above 45 years

  • 2. The subject is under the category of vulnerable personnel patients in an emergency, ethnic minority group, homeless persons, minors, or others

  • 3. Participants not willing to participate

Sources of participants

Participants will be randomly assigned from the rural, semi-urban, and urban residential areas of Wardha district. Subjects will be recruited from various locations like hospitals, local institutions, homes, and from the campaigns in public spaces.

Variables

As studies on PCOS have not been concluded previously in our Wardha District. So here is our aim to appraise the awareness of PCOS among the rural and semi-urban female population in District Wardha. With the help of its outcome, the campaign or health professional will try to educate and inform people about PCOS which will help in reducing the rate in Wardha district (India).

Data source and management

The recruitment of the subject will be done independently and the awareness will be observed through a standardized questionnaire tool. Participants will be randomly assigned from the rural, semi-urban, and urban residential areas of Wardha district. Subjects will be recruited from various locations like hospitals, local institutions, homes, and from the campaigns in public spaces.

Bias

As the patient will be recruited randomly selection bias will be avoided.

Sample size6:

Daniel’s formula for sample size:

n=Zα/22P1Pd2
where;

Zα/2 is the level of significance at 5% i.e., 95%

Confidence interval = 1.96

P = Aware of polycystic ovarian syndrome = 57.8% = 0.578

d = Desired error of margin = 5% = 0.05

n=1.9620.57810.5780.052=374.81

n=375

Hence, 375 subjects were needed in the study.

Quantitative variables

In this study quantitative variables will be a percentage of female population such as who are aware of PCOS, who are aware about which organ system will be affected due to PCOS, aware about symptoms and indicators of PCOS and many more.

Method of data analysis

Measurable investigation including mean, standard deviation, recurrence, extent, and rate, and inferential measurements containing χ2 test, factor examination, and discriminant examination was utilized to dissect the information utilizing SPSS (factual bundle for sociologies) and Excel.

Dissemination

It will be published in an Index Journal.

Study status

The study yet to be started.

Result

As the study is yet to be started, the result will be concluded after the data collection at the end the study.

Discussion

Polycystic ovaries with high antral (2-8 mm) follicle numbers are the main attribute of PCOS. The average ovarian morphology is the result of the debilitated follicular turn of events and untimely discontinuance of follicular development after the aggravation of endocrine which includes hyperandrogenaemia, hyperinsulinemia, and Luteinizing hormone hypersecretion. Accordingly, more than 50% of patients have unpredictable periods, which is joined with anovulatory barrenness.7

The clinical show of PCOS changes broadly. Ladies with PCOS frequently look for care for feminine unsettling influences, clinical appearances of hyperandrogenism, and fruitlessness. Feminine aggravations usually seen in PCOS incorporate oligomenorrhea, amenorrhea, and delayed unpredictable feminine dying. Notwithstanding, 30% of ladies with PCOS will have ordinary menses. Around 85%-90% of ladies with oligomenorrhea have PCOS while between 30% to 40% of ladies suffering from amenorrhea can be a patient of PCOS.8

Barrenness influences 40% of ladies with PCOS. PCOS is the most well-known reason for anovulatory barrenness. Ladies suffering from PCOS have an ordinary no. of early-stage follicles which fundamentally expand. Nonetheless, because of confusion in factors engaged with the typical follicular turn of events, follicular development becomes captured as follicles arrive at a width of 4 to 8 mm. However, a predominant follicle doesn’t create, ovulation doesn’t result. Likewise, unconstrained early termination happens all the more regularly in PCOS with frequencies going from 42% to 73%.8 PCOS may be a genetic disorder. PCOS can be considered a heritable problem.

Insulin compensatory and opposition hyperinsulinemia are the main components of PCOS. The patients suffering from PCOS both with and without corpulence may contain higher commonness of insulin obstruction contrasted with solid controls, despite the fact that insulin opposition is more serious in fat subjects.8

Hyperandrogenism is a critical indicative component of polycystic ovarian syndrome influencing 60 to 100 percent of patients with both clinical (alopecia, hirsutism, and skin inflammation) and biochemical hyperandrogenism.8 Hyperandrogenism prompts constant anovulation and feminine aggravations in patients suffering from PCOS. More than 80% of ladies suffering from androgen abundance have PCOS.9 Hirsutism is a typical clinical show of hyperandrogenism happening in up to 70% of ladies with polycystic ovarian syndrome. Hirsutism is assessed with the help of a changed Ferriman-Gallwey scoring framework. This instrument is utilized to assess hair development at seven locales: upper lip, jawline/face, chest, back, midsection, arms, and thighs. More than 90% of typically bleeding ladies with hirsutism are distinguished through ultrasound to have polycystic ovaries. Also, PCOS happens in half of the ladies with less serious conveyance of undesirable hair development. Skin breaks out can be a marker of hyperandrogenism but less common in PCOS and also less unambiguous than hirsutism.

Weight gain can be a clinical element of PCOS, and following a proper lifestyle has been effective in diminishing stomach fat, and body weight, lessening testosterone, further developing insulin opposition, and declining hirsutism in women with PCOS.8

Weight reduction works on feminine abnormalities, side effects of androgen overabundance, and barrenness. The board of clinical signs of PCOS incorporates oral contraceptives for feminine anomalies and hirsutism. Spironolactone and finasteride are utilized to treat the side effects of androgen overabundance. Treatment choices for fruitlessness incorporate clomiphene, laparoscopic ovarian penetrating, and gonadotropins, and helped conceptive innovation. Letrozole and metformin might assume a significant part in ovulation enlistment. Appropriate conclusions and the executives of PCOS are vital for addressing patient worries yet additionally to forestall future metabolic, endocrine, mental, and cardiovascular inconveniences. Insulin-sharpening specialists are shown for most ladies with polycystic ovary disorder since they decidedly affect insulin opposition, feminine abnormalities, anovulation, hirsutism, and stoutness. Metformin has the most information supporting its adequacy. Rosiglitazone and pioglitazone are likewise successful in enhancing hirsutism and insulin opposition. Metformin and clomiphene, alone or in blend, are first-line specialists for ovulation acceptance. Insulin-sharpening specialists, oral contraceptives, spironolactone, and effective eflornithine can be utilized in patients with hirsutism.

Eflornithine hydrochloride in human skin has been endorsed as effective for treating facial hirsutism. It tends to be joined with laser treatment for further impact.

Oral preventative pills (OCPs) can be used for treatment. OCPs lessen hyperandrogenism by advancing direct regrettable criticism of luteinizing hormone (LH) emission, which brings about a diminished ovarian blend of androgens. One of the most up-to-date OCPs that may be more successful in lessening the development of new terminal hair and skin break out development is a recipe that contains a mix of nonandrogenic progestin, drospirenone, and ethinyl estradiol; subsequently, it is possibly great for the treatment of ladies with PCOS.10 Estrogen-progestin mix treatment (with the utilization of a mix OCP) stays the transcendent treatment for hirsutism and skin breakout in PCOS.11 Myoinositol is an over-the-counter food supplement that increments insulin awareness.12

Way of life changes, including a weight-lessening diet and exercise, are suggested as the first-line treatment for all hefty ladies with PCOS. In any case, numerous stout ladies with PCOS find weight reduction hard to accomplish and keep up with. Additionally, around 10-30% of ladies with PCOS are lean, and weight reduction isn’t a possibility for them. Consequently, insulin-sharpening drugs are being utilized all the more habitually and have come to assume a significant part in the persistent treatment of PCOS.13

Polycystic ovary condition (PCOS) and obesity are related with a more serious gamble of ovarian growths, where PCOS could be either the reason or as a result of an ovarian cancer.14 An instance of a 53-year-old postmenopausal lady introducing a monster ovarian cystic mucinous growth was accounted to weigh 24 kg. At the point when she was seen first at facility, she had gross stomach distension for 2 years, and she griped of excruciating forceful agony. Her figured tomography (CT) examine was done which came reminiscent of ovarian serous cystadenoma of enormous gigantic size 35 × 40 × 32 cm with moderate ascites.15 Obesity can be separated into metabolic syndrome (MetS) or metabolically unhealthy obesity (MUO) and metabolically healthy obesity (MHO). The clinical and metabolic aspects of women with MHO will be different in PCOS women with or without MetS/MUO and may contain high chances of having cardiovascular disease.16 In view of different clinical show, ladies with PCOS might introduce in gynecology, dermatology, or endocrinology OPD. The sequalae of PCOS arrives at past regenerative wellbeing, with an expanded gamble of cardiovascular illness and type 2 DM, mindfulness in regards to PCOS is significant for early finding and to forestall its sequalae.17 As per current science, the physiology connected with ovulation is constrained by chemicals of hypothalamo – pituitary – ovarian pivot. This pivot is upset in pcos. Different methodologies in ayurveda for patho-physiology in polycystic ovarian disorder reason that pcos is a puzzle. There is no finished comprehension of its essential pathophysiology according to present day science. No treatment is a panacea, as treatments have so far been designated at the side effects however not at the actual disorder.18 Uncontrolled steroidogenesis, insulin opposition, oxidative pressure, and genetic factors all assume a part in PCOS pathogenesis, which might start as soon as pre-birth life. Extra examination is expected to overcome any barrier between the numerous vulnerability factors that might assume a part in PCOS.19

This study is limited to only female population of age group 15 to 45 years of Wardha district. As in this study patient will be recruited randomly selection bias will be avoided.

A cross-sectional study of 400 women between the ages of 18 and 30 who were either working or attending college in the city of Indore was conducted. Only 41% of the 400 women who took part in the study were familiar with the term PCOS. 46% of the participants knew which organ system this condition affected. The majority of people learn about this condition via friends or family. The majority of the women, 49%, were aware of the numerous PCOS symptoms and indicators.20 So here is our aim to appraise the awareness of PCOS among the rural and semi-urban female population in District Wardha. With the help of its outcome, the campaign or health professional will try to educate and inform people about PCOS which will help in reducing the rate in Wardha district (India).

Ethical considerations

Approved by the Institutional Ethics Committee Ref. No. DMIHER (DU)/IEC/2023/597.

Datta Meghe Institute of Higher Education And Research Sawangi (M) Wardha- 442107 Maharashtra, India.

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Patil S and Mude G. Awareness regarding knowledge associated with polycystic ovarian syndrome (PCOS) among women in Wardha district- A cross-sectional study. [version 1; peer review: 2 approved with reservations]. F1000Research 2023, 12:1085 (https://doi.org/10.12688/f1000research.135193.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
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Reviewer Report 27 Aug 2024
Deepa Shanmugam, Aarupadai Veedu Medical College and Hospital, Vinayaka Mission’s Research Foundation (Deemed to be University), Puducherry, India 
Approved with Reservations
VIEWS 2
The title is complete with the aim of the research and study design clearly mentioned..

*Introduction tells about the problem statement,  background of the study,  novelty, need for the study and rationale...
*The objectives are clearly ... Continue reading
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HOW TO CITE THIS REPORT
Shanmugam D. Reviewer Report For: Awareness regarding knowledge associated with polycystic ovarian syndrome (PCOS) among women in Wardha district- A cross-sectional study. [version 1; peer review: 2 approved with reservations]. F1000Research 2023, 12:1085 (https://doi.org/10.5256/f1000research.148297.r307816)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Reviewer Report 23 Dec 2023
Milan Perovic, University of Belgrade, Belgrade, Serbia 
Approved with Reservations
VIEWS 2
Sejal Patil and Gaurav Mude have submitted a SPIRIT compliant Study Protocol entitled "Awareness regarding knowledge associated with polycystic ovarian syndrome (PCOS) among women in Wardha district- A cross-sectional study.". In general, this is a well written study protocol, but ... Continue reading
CITE
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HOW TO CITE THIS REPORT
Perovic M. Reviewer Report For: Awareness regarding knowledge associated with polycystic ovarian syndrome (PCOS) among women in Wardha district- A cross-sectional study. [version 1; peer review: 2 approved with reservations]. F1000Research 2023, 12:1085 (https://doi.org/10.5256/f1000research.148297.r218211)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.

Comments on this article Comments (0)

Version 1
VERSION 1 PUBLISHED 01 Sep 2023
Comment
Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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