EC-2 Form

Project Proposal
“This project will be conducted after receiving the approval from ethical review
committee for human research.”

1. Title of Project:
Unmet need for modern contraceptive methods among married reproductive aged
women in a rural area of Rolpa, Nepal.

2. Investigators:
2.1 Student: Dr. Samyukta Chand
Contact address: Mahidol University, Bangkok, Thailand
Tel: 0649827178 Fax:……...E-mail: samyuktachandshahi@gmail.com
2.2 Major Advisor: Asst. Prof. Dr. Kanittha Chamroonsawasdi
Contact address: Department of Family Health, Faculty of Public Health
Mahidol University , Thailand
Tel: ….0816511353……... Fax:……… E-mail: kanittha.cha@mahidol.ac.th
2.3 Co- Advisor 1: Asst. Prof. Dr. Paranee Vatanasomboon
Contact address: Department of Health Promotion, Faculty of Public Health
Mahidol University , Thailand
Tel: ……0815833321… Fax:...……E-mail: paranee.vat@mahidol.ac.th
2.4 Co-Advisor 2: Asst. Prof. Dr. Natkamol Chansatitporn
Contact address: Department of Biostatistics
Tel: ……0894908554…. Fax:..… E-mail: nutkamol.cha@mahidol.ac.th

3. Funding source: Self Budget: Self-funded, approximately 65000 Baht

4. Research category:
[ ] Biomedical Research
[] Social Science Research

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5. Research area:
[ ] Infectious Disease
[ ] Non-infectious Disease
[ ] Health Promotion
[✓] Others (please indicate): Reproductive health

6. Rationale and background (clear, comprehensive and concise):

According to United Nations Population Fund (UNFPA), the total fertility rate
(TFR) for world population in 2018 is 2.5 per woman with TFR 1.7 per woman for more
(1)
developed region and TFR 4 per woman in least developed region . The target of
Sustainable Development Goal(SDG) is to limit the world population to 8 billion and TFR
to 2 children per woman by 2030(2).
Family Planning (FP) refers to “a conscious effort by a couple to limit or space the
number of children they have through the use of contraceptive methods” (3)
. In 2018,
globally, contraceptive prevalence rate (CPR) among women aged 15-49 using modern
contraceptives (MC) is 57%. More developed region has 61% CPR using MC whereas less
developed region has 57% CPR using MC and least developed region has 36% CPR using
MC(1). Focusing on MC use, it can prevent pregnancy related health risks in women(4), curb
infant and maternal mortality rate(3), helps to prevent transmission of Human
Immunodeficiency Virus/Acquired Immuno Deficiency Syndrome(HIV/AIDS) and other
sexually transmitted diseases(5), empowering women and enhancing their knowledge(6),
reducing adolescent pregnancies and abortion(7), helping couple determine the number and
spacing of their children(8), elimination of poverty(9) and ultimately slows the population
growth(5).
World Health Organization (WHO) defines unmet need for FP as “Women who are
fecund and sexually active but are not using any method of contraception, and report not
wanting any more children or wanting to delay the next child”(10). Worldwide, more than
one in ten married or in-union women have an unmet need for family planning so as to say
they want to stop or delay childbearing but are not using any method of contraception to
prevent pregnancy(8).
In Nepal, even though TFR is 2.3 per woman in 2017, the TFR in urban area being
2.0 whereas TFR of rural area is 2.9 per woman. There is a huge variation in TFR of urban
and rural area so it is important to find the gap. CPR of Nepal is 54% with CPR of urban

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area being 55% whereas CPR of rural area is 49%. CPR for MC is 44% with 24% of unmet
need indicating that the CPR is stagnated since last few years so to maintain the current
TFR we need to take proper action in time to increase CPR which in turn will reduce the
unmet need for MC(3). From previous findings, factors related to unmet need for MC use
comprised of fear of side effect(11-13), inaccessibility, objection from husband(11, 12)
,
objection from family members(14), son preference(12),lack of information about method,
lack of counselling from health worker, limited choice of methods(5),inconvenient to use,
lack of time, breastfeeding (postpartum amenorrhea)(15), husband not at home, limited
access to contraception particularly among young people(16), poorer segments of
populations(16), unmarried people and cultural or religious opposition(14).
Rolpa is a remote district in hilly region with many rural villages which falls under
state number 5 of Nepal. Thawang is one of the rural municipality of Rolpa. The CPR of
Rolpa was 38.53% in 2015 , 37.37% in 2016 and 38.93% in 2017 which should be
increasing but is stalled(17). Although the resource allocation is equitable, there is scarcity
of trained human resource, poor FP service utilization pattern and problem in utilization of
the allocated budget resulting in poor indicators(3). Many studies related to FP have already
been done in Nepal but there are only few study which concerned on unmet need for MC
among married reproductive aged women in rural areas. This study tries to find out the
magnitude and associated factors of unmet need for MC among married reproductive aged
women in rural areas of Rolpa based on the PRECEDE-PROCEED model phase III(18).
The 3rd phase of the model focuses on behavioral factors including predisposing,
reinforcing and enabling factors that affect in MC use. This study will provide baseline
information for policy makers to effectively manage and plan FP programs in Nepal.

7. Objective(s):
7.1 General objective
To identify the proportion of unmet need for MC and analyze the relationship between
socio-demographic factors, predisposing factors, enabling factors, reinforcing factors and
unmet need for modern contraceptive methods among married reproductive aged women
in a rural area of Rolpa, Nepal.
7.2 Specific objectives

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 7.2.1 To explore the proportion of unmet need for MC among married reproductive
aged women in a rural area of Rolpa, Nepal
7.2.2 To describe the socio-demographic factors comprised of age, education, occupation
of respondent and her husband, family type, number of living children and family income
among married reproductive aged women in a rural area of Rolpa, Nepal.
7.2.3 To describe the predisposing factors comprised of son preference, knowledge on MC,
attitude towards MC, previous experience of MC use and women autonomy in fertility
control among married reproductive aged women in a rural area of Rolpa, Nepal
7.2.4 To describe the enabling factors comprised of respondent’s geographical accessibility
to MC services, respondent’s affordability on MC services, respondent’s acceptability on
MC services, availability of MC services and accommodation of MC services among
married reproductive aged women in a rural area of Rolpa, Nepal
7.2.5 To describe the reinforcing factors comprised of social support and mass media
among married reproductive aged women in a rural area of Rolpa, Nepal
7.2.6 To identify the association between socio-demographic factors, predisposing
factors, enabling factors and reinforcing factors with unmet need for contraception
among married reproductive aged women in a rural area of Rolpa, Nepal

8. Reasons for conducting this study in human subjects:

High TFR and low CPR are the major problems in rural area of Nepal where women
are not empowered to take contraceptive decision for proper use as well as adequate
MC knowledge and social support. This study will focus on factors associated to unmet
need of rural women. These factors need to be answered by each individual personally
and currently. No other secondary source of data can be substituted, then the study need
to be conducted in human subjects.

9. Benefits/usefulness to the subjects and society in general:

There is no direct benefit to the study subjects. But their contribution will help to find
out the factors related to the research questions and following benefits might be
rewarded:
1. It will help to gain a better understanding of current status of unmet need of
women in rural Nepal through contraceptive use.

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 2. It will be helpful for policy makers to establish an effective plan to enhance
Family planning programs in rural area by identifying key points of unmet
need.

10. Methodology:
10.1 Research design and Data collection method
10.1.1 Research design
A cross-sectional study will be conducted to find out the influencing factors on
unmet need for modern contraceptive methods among married reproductive aged
women in a rural area of Rolpa, Nepal.
10.1.2 Data collection method
 Self-administered questionnaire
 Interviews
 Physical examination
 Others (please indicate)

10.2 Reference population, Samples, Sample size and Sampling technique

10.2.1 Reference population: Married women of rural Rolpa, Nepal age
between 18 and 49 years old using following formula for finite population (19):
2
(N − 1) 𝑍∝/2 P(1 − P)
𝑛= 2
𝑍∝/2 P(1 − P) + (N − 1)𝑑 2

 n=desired sample size

 α=level of significance
 Z= standard normal deviation which correspond to 95% confidence level=1.96
 P=proportion of unmet need=0.28 (28% unmet need, District Health Report, Rolpa,
2016/17)(18)
 d=degree of accuracy required=.05
(2577 − 1) (1.96)2 (0.28) (1 − 0.28)
𝑛=
(1.96)2 (0.28)(1 − 0.28) + (2577 − 1)(0.05)2
 Total sample size n=278
 To avoid incomplete data due to various reasons, 10% will be added to the total
sample size so 278 +10% of 278=306.

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  Therefore, total 306 respondents will be selected for data collection.

10.2.2 Samples: Respondents will be selected by random sampling technique as the

samples.
Sampling: In Thawang rural municipality there are 5 wards with 2,577 total married
women of reproductive age (MWRA).
Step I: Total 3 wards will be selected out of 5 wards of Thawang rural municipality
by simple random sampling using lottery method. Total number of MWRA 1,544 in each
selected ward are as follows: 462 in ward 1, 626 in ward 3 and 456 in ward 5 respectively.
Step II: According to the data obtained from sample size calculation, 306
respondents will be proportionately allocated in each selected ward according to the
number of individual. Samples to be drawn from each ward are as follows: ward 1=92,
ward 3= 124 and ward 5= 90.
Step III: In each selected ward, the respondents will be selected based on inclusion
criteria.
Thawang rural municipality
Total MWRA=2577

Ward 1 Ward 2 Ward 3 Ward 4 Ward 5

N1=462 N2=597 N3=626 N4=436 N5=456

Samples Samples Samples

n1= 92 n3= 124 n5=90

Figure 1: SAMPLING FRAME

10.3 Inclusion criteria:

 Married reproductive aged women between 18-49 years living in Thawang, a rural
area of Rolpa, Nepal

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  Willing to participate and are living with their husband consecutively for at least 3
months
 Pregnant or no child or having at least 1 child with age of the child ≥6months.

10.4 Exclusion criteria:

 Married reproductive aged women but infertile or sterilized or early menopause.
 Divorced or widow reproductive aged women
 severely ill or with chronic conditions.
 Husband infertile

10.5 Discontinuation criteria:

1. Denial to participate or withdraw after signing informed consent form
2. Feeling sick or embarrassed during data collection

10.6 Duration of data collection:

The data will be collected after receiving the ethical approval from Ethic Review
Committee for Human research, Mahidol University and Nepal Health Research
Council. The duration for data collection will be approximately 3 months.

10.7 Data Collection (describe in detail, particularly the activities dealing with
human subjects)
After the ethical approval from Ethic Review Committee, Faculty of Public
Health and Nepal Health Research Council, introductory meeting will be conducted
with District Health Office(DHO) personnel and rural municipality officials to inform
about purpose and objective of the study and to inform about the content of
questionnaire, data collection process and context of local condition.
The data will be collected by face-to-face interview using questionnaire by the
researcher and three research assistants having experience in data collection in several
survey conducted in Nepal. They will be recruited and trained by the researcher with
one-day orientation.
Research assistants will be taught to understand the questions well and how to
ask questions effectively and clearly. They will introduce themselves, brief about the

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 purpose of the study and explain the respondents about the required time to answer the
questions which will take approximately within 30 minutes.
Collected data will be verified at the end of each day. Any inaccuracy and
inconsistency will be corrected in the next working day. To control the data quality,
researchers will regularly verify the data during the data collection time.
After decision to participate in this study, respondent will be interviewed by a
structured questionnaire to assess the unmet need for modern contraceptive methods. It
has 5 parts with total 81 questions. The details are as follows:
Part 1: comprised of 11 items on socio-demographic characteristics like age,
income, no. of children etc.
Part 2: comprised of 30 items on predisposing factors like knowledge, attitude,
previous experience, women’s autonomy, etc.
Part 3: comprised of 20 items on enabling factors like client’s affordability,
availability of health services etc.
Part 4: comprised of 11 items on reinforcing factors like social support, mass media.
Part 5: comprised of 9 items on modern contraceptive needs.

11 Risks and/or undesirable consequences that may happen to subjects and actions
to be taken to prevent or reduce them:
There will be no foreseeable physical or mental risks to the respondents
participate in this study. However, they might experience uncomfortable feeling from
recalling information about the past and thinking about current situation when
answering the questions. Some questions may be explicit and unexpected.
Respondents can stop any time or skip the questions if they feel discomfort to
answer. They will have access to discuss for any problems that they have encountered.
Their confidentiality and vulnerability will be the top priority.

12 Ethical considerations
The ethical clearance will be submitted to the Human Research Committee,
Faculty of Public Health, Mahidol University. The title and objectives of the research
will be explained. Full proposal of the research, curriculum vitae of the researcher,
advisor and co-advisor will be submitted to the committee. On approval of the research,

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 the researcher will obtain the Documentary Ethical Clearance. Permission to conduct
the study in Nepal will be obtained from National Health Research Council Kathmandu,
Nepal.
While collecting the data, each respondent will be well explained about the study
and will be requested to give an informed consent. Even if they agree to give the answers,
during answering, if they feel awkward or embarrassed, they will have the right to stop
answering the questions. Response from the respondents will be anonymous. However,
identification code will be used to identify data collection form.
The data collection form will be handled by primary investigators. The
respondent will have full right either to participate or not or withdraw the study at any
time of study period. All of the answers will be kept confidential. All the questionnaires
will be kept in a lock filing cabinet. Only the researcher can access to the data. In any
sort of report publication, any information that will make it possible to identify the
respondents will not be included. After entering and analyzing the data set, all the dataset
will be destroyed after 1 year by using paper shredder machine.

12.1Incentive present
[] No
[ ] Yes (please indicate):

13 Are there any negative impacts that may happen to institutions, society, culture
or environment?
[] No
[ ] Yes (please indicate the impacts): ………….………….....……...
Measures to prevent or confront such impact :………….………….....……...

14 Consent approval requirements:

[] Subject or representative
[] Head or authorized person of the designated institute

15 Research presentation:

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 [] Without declaring names, but with disclosing occupation of subjects and/or
site of study
[ ] Without declaring names, and site of study, but with disclosing occupation
of subjects
[ ] Without declaring names, site of study, and occupation of subjects

16. References (Vancouver style):

1. United Nations Population Fund (UNFPA). World Population Dashboard 2018 [cited
2018 27 November]. Available from: https://www.unfpa.org/data/world-population-
dashboard.

2. United Nations (UN). Transforming our World: The 2030 agenda for Sustainable
Development 2015 [cited 2018 18 October]. Available from:
https://sustainabledevelopment.un.org/post2015/transformingourworld.

3. Ministry of Health. Nepal Demographic Health Survey 2016 full reports Nepal2017
[cited 2018 20 November]. Available from:
https://dhsprogram.com/publications/publication-fr336-dhs-final-reports.cfm.

4. Bongaarts J. The Evolution of Family Planning Programs [cited 2019 5 January].

Population Council. Available from:
https://onlinelibrary.wiley.com/page/journal/17284465/homepage/specialonlineissueapril
2018.

5. World Health Organization (WHO). Benefits of Family planning/Contraception 2018

[cited 2018 20 November]. Available from: https://www.who.int/en/news-room/fact-
sheets/detail/family-planning-contraception.

6. United State Agency for International Development (USAID). Barriers to Family

Planning use in Eastern Nepal: Results from a mixed methods study 2018 [cited 2018 29
December]. Available from: https://dhsprogram.com/pubs/pdf/QRS21/QRS21.pdf.

7. World Health Organization (WHO). Safe abortion: technical and policy guidance for
health systems 2012 [cited 2018 29 December]. Available from:
https://www.who.int/reproductivehealth/publications/unsafe_abortion/9789241548434/en
/.

8. United Nations (UN). World Family Planning Highlights New York2017 [cited 2018
27 December]. Available from:
http://www.un.org/en/development/desa/population/publications/pdf/family/WFP2017_H
ighlights.pdf.

9. United Nations (UN). The Millennium Development Goals Report 2015 [cited 2018 19
December]. Available from:

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http://www.un.org/millenniumgoals/2015_MDG_Report/pdf/MDG%202015%20rev%20
(July%201).pdf.

10. World Health Organization (WHO). Sexual and reproductive health, Unmet need for
family planning 2018 [cited 2018 25 November]. Available from:
http://www.who.int/reproductivehealth/topics/family_planning/unmet_need_fp/en/.

11. Rai MK, Rai L, Dangol BK, Chaudhary TK. Predictors of use of contraception
among married women of reproductive age in a rural area of Nepal. JAAR. 2016;3(3):88-
99.

12. Bhusal CK, Bhattarai S. Factors affecting unmet need of family planning among
married Tharu women of Dang District, Nepal. Int J Reprod Med. 2018;2018:9312687.

13. Myint AH, Tiraphat S, Chompikul J. Determinants of the unmet need for family
planning among married fecund women in Natmauk Township, Magway Region of
Myanmar. J Pub Health Dev. 2018;16(2):41-57.

14. George N, Sulekha T, Ramachandran A, Peters A, PR K. The unmet needs for family
planning and its associated factors among ever married women in selected villages of
Anekal taluk, Karnataka: a community based cross sectional study. Int J Community Med
Public Health. 2018;5(5):2048-52.

15. Tegegn M, Arefaynie M, Tiruye TY. Unmet need for modern contraceptives and
associated factors among women in the extended postpartum period in Dessie town,
Ethiopia. Contracept Reprod Med. 2017;2:21.

16. Mehata S, Paudel YR, Mehta R, Dariang M, Poudel P, Barnett S. Unmet need for
family planning in Nepal during the first two years postpartum. Biomed Res Int.
2014:649567.

17. District Health Office. District Health Report, Rolpa 2016/17 [cited 2018 20
October]. Available from: https://dohs.gov.np/wp-
content/uploads/2017/06/DoHS_Annual_Report_2072_73.pdf.

18. Glanz K, Rimer BK, Viswanath K, Tracy Orleans C. Health behavior and health
education: Theory, Research, and Practice. 4th Ed. San Francisco: Jossey-Bass; 2008.

19. S. Lemeshow, DW. Hosmer Jr, J. Klar, SK. Lwanga, WHO. Adequacy of Sample
Size in Health Studies. John Wiley & Sons Ltd, West Sussex, England WHO.

This project will be performed in accordance with the Declaration of the

Helsinki Ethical Principles.

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 Signature …………..…………….…….…….…(Researcher)

(Dr. Samyukta Chand)

Date………………………

Signature …………..…………….…….……….(Major Advisor)

(Asst. Prof. Dr. Kanittha Chamroonsawasdi, Mahidol University)

Date………………………

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