Introduction
Introduction
Introduction
1.1 Background
Gestational age is the estimated age of gestation from a fetus during its development and this
is very important for the mother who wants to know when to expect the birth of her baby and
for the health care provider so they can choose the time at which to perform various
assessment(1).
GA is estimated using the first day of the last menstrual period (LMP), which assumes that
ovulation occurs on day 14 of the menstrual cycle. Irregular menses, unknown or uncertain
dates, oral contraceptive use or recent pregnancy or breastfeeding, issues that occur in a large
proportion of women, may all influence the accuracy of this method (2).
Normally, human gestation lasts for an average of 266 days from the date of conception or
280days from the first day of the last normal menstrual period (LNMP). Based on the
assumption that the typical menstrual cycle lasts for 28 days, with ovulation occurring on
approximately day 14(3).
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The 19 century obstetrician, Franz Karl Naegele developed a simple calculation to estimate
expected date of delivery that involves adding nine months and seven days to the first day of
the LNMP. This calculation, referred as Naegele`s rule, provides an indirect measurement of
the time of conception and remained the current standard for calculating the duration of
pregnancy based on the LNMP(3).
Ultrasound scanning is an imaging diagnostic procedure that mainly uses sound wave of
frequency greater than 20 Kilohertz (4). Ultrasound biometric measurements determine
gestational age based on the assumption that the size of the embryo or fetus is consistent with
its age(5). Ultrasound estimation of gestational age was done using a transabdominal
approach with a 3 to 6 MHz convex probe or a transvaginal approach using a 5 to 12 MHz
4D convex probe. Ultrasound dating includes mean gestational sac diameter and
crown-rump length (CRL) in the 1st trimester. Bi-parietal diameter, head circumference,
abdominal circumference, and femur length in the 2nd trimester and 3rd trimester. Fetal
biometric measures were considered if the CRL exceeded 84 mm in the 1st trimester.
Ultrasound dating can be performed even if the first visit of the pregnant woman was beyond
28 weeks, for documentation, and the EDD was assigned with variability of +/- 21 [days](6).
A major role of U/S is the accurate confirmation of gestational age which is critical in
settings where women often tend to not remember their exact conception dates. It also helps
to reduce the number of unnecessary interventions, reducing adverse maternal outcomes,
mainly “near miss” morbidity and mortality. Maternal conditions directly contribute to
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perinatal outcomes and up to 37% of patients are potentially misdiagnosed. This could be
corrected by incorporating U/S services in their care. U/S services may also result in the
recognition of conditions that could otherwise have been missed and resulted in adverse
outcomes such as placenta previa, adherent placenta, undiagnosed multiple pregnancies, and
mal- presentations leading to life-saving interventions in up to half of pregnant women .
All women have the right to have access to high quality care during pregnancy, childbirth,
and after childbirth(7).
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1.2 Statement of the problem
Globally, 15 million infants are born preterm and approximately one million children die each
year due to complications of preterm birth; of which 81% belong to low resource settings in Asia
and Africa. About 23.3 million infants (19.3% of live births) are estimated to be born small for
gestational age (SGA) in Low and Middle-Income Countries (LMIC) (8). Also every day about
830 women die from pregnancy or childbirth-related complications around the world. Most of
these deaths occur in low-resource settings and many of them are preventable (9).
Early pregnancy ultrasound measurements are considered to be the gold standard in determining
GA, as ultrasound measurements during mid and late pregnancy are unreliable (3). Obtaining an
early accurate GA in low resource settings is challenging due to the absence of ultrasound
equipment and the shortage of trained technicians. In these settings, the last menstrual period
(LMP) is often used for assessment of GA. Although LMP in high-income countries has an error
of only a few days, it has now been shown to be highly unreliable in low and middle income
countries. Low prevalence of early antenatal care and hence recall problems, high rates of
conception during lactation amenorrhea and conception immediately following long-duration
contraception patches contributes to this inaccuracy.
According to the International Fetal Growth standard the estimation of GA has the potential to
enhance the detection of growth disorder and, consequently, prenatal outcomes, by
standardization of diagnostic approach to IUGR and macrosomia(10).Accurate assignment of
gestational age may reduce post-dates labour induction and may improve obstetric care through
by allowing the optimal timing of necessary interventions and the avoidance of unnecessary
ones. More accurate dating allows for optimal performance of prenatal screening tests for
aneuploidy (6).
According to the 2017 Ethiopian Demographic health survey(EDHS) more than half (52%)of
pregnant women give birth outside of health facilities (7). It is obvious that if there is no correct
estimation of gestational age ,the mother and the fetus will not get right health care services at
the time of ANC follow up. However, to the best our knowledge there is no study that assessed
the correlation between self-reported and ultrasound determined age of the fetus in the study
setting.
Therefore, this research aims to determine the correlation between self-reported and ultrasound-
estimated gestational age among pregnant mothers attending ANC.
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1.3.Significance of the study
This research has significance in several ways .Initially, as per to our attempt of literature review,
we could not find published studies about the correlation between self-reported and ultrasound-
estimated gestational age. As a result, this research will serve as a foundation for further research
on this specific title.
Also, it will assess the accuracy of LNMP which is an easy method for resource-limited areas
and accurate parameters of ultrasound measurement are going to be used to determine gestational
age. The outcome of this research will help ANC providers to know the optimal timing for
necessary treatment or avoidance of unnecessary ones. This research has valuable significance
for pregnant women to know relatively accurate EDD.
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2. Literature Review
2.1Estimating gestational age of the fetus
There are different methods to determine gestational age (GA), clinicians use different methods
on various antenatal and postnatal indicators, such as the last menstrual period (LMP) and/or
birth weight and first-trimester ultrasound (US). Dating GA based on the LMP is a simple, low-
cost method. The LMP is a universally available piece of self-reported information and is the
method most used to estimate GA, particularly in developing countries as WHO states(11).
The accuracy of gestational age estimates derived from ultrasound or metabolomic models were
highest in term infants and lower in preterm and small for gestational age newborns. As the
researchers concluded that their findings support the accuracy of ultrasound as a gestational age
dating tool. It also supports the potential utility of metabolic gestational age dating algorithms in
settings where ultrasound or other accurate methods of estimating gestational age are not
available due to lack of infrastructure or specialized training (e.g. low income countries).,
However the accuracy of metabolomic model-based dating was generally less accurate than
compared to ultrasound(12).
On study that was conducted in urban Pakistan 942 (women) was included. On contrary, the
estimated gestational age using ultrasonography and LMP increased with greater gestational age
at presentation and among patients with no history of preterm delivery. As the author’s stated
taking ultrasonography as a standard, a bias was observed in LMP-based gestational age
estimates, which increased with advancing gestation at presentation. This resulted in the
misclassification of term deliveries as preterm(13).
In research that was conducted about sonographic dating formula based on fetal crown-rump
length (CRL) in a Hong Kong Chinese population. The researchers derived a formula suitable for
the dating of naturally conceived pregnancies between 6 and 15 weeks of gestation that has no
systematic prediction error (the 95% CI of mean difference between predicted and menstrual age
included zero), comparing favorably with established CRL dating formulae(14).
For prematurity, US at 21–28 weeks had the highest sensitivity (0.84) and the Capurro method
the highest specificity (0.97). For postmaturity, US at 21–28 weeks and the Capurro method had
a very high sensitivity (0.98). All methods of GA estimation had a very low specificity (≤0.50)
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for postmaturity. GA estimates at birth with the algorithm and the reference US produced very
similar results, with a preterm birth rate of 12.5%(12).
Out of 100(53) pregnant women, 44 (84.62%) pregnant woman have different gestational age
from US and last menstrual period (LMP). They concluded that the main method to follow fetus
growth in third trimester not biparietal diameter (BPD) measurement only. The BPD in third
trimester is not reliable and be useless when the patient pass 30 weeks and the BPD has to be
side with other measurements when we take it in later trimesters to emphasize the normal growth
of fetus and avoid wrong measurement of ultrasound (15).
Factors influencing the risk of discrepant GA between these two methods included household
income and interval of menstruation(16).
Estimation of fetal gestational age with ultrasound provides high accuracy and reliability, as
ultrasound is safe, easy operating and cheap. This result is consistent with the fact that, as the
gestational age increases; both femoral length and biparietal diameter will increase consequently.
The correlation analysis showed a strong positive correlation between BPD and FL (r= 0.981),
the correlation between FL and GA was 0.966 which is a strong and high. On the other hand, the
correlation between BPD and GA was 0.970 which is a strong and higher than that of FL(r
=0.966),As the researchers concluded that the estimation of gestational age with fetal biparietal
diameter and femoral length still remain the most common measurements to assess the fetal
growth. Evaluation of gestational age with biparietal diameter and femoral length joined together
is more accurate than biparietal diameter and femoral length when used separately(17).
The average time to complete ultrasound measurements was less than one minute in the
emergency set up. When physician-performed measurements were compared with TGA, the
correlation coefficients were 0.947 (0.926-0.968) for BPD, 0.957 (0.941-0.973) for femur length,
and 0.712 (0.615-0.809) for FH. When determining fetal viability, EP's overall accuracy was
96% using ultrasound and 80% using FH. The authors concluded that the EP’s should use
emergency ultrasound more often and with brief training, EPs can quickly and accurately
determine gestational age using ultrasound, these estimates that may be more accurate than
those obtained through physical examination (18).
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In study that was conducted in Maternity & Children’s Hospital in Jeddah, it was observed that
the TCD increases linearly with GA. The correlation between GA and the GA by TCD seems to
increase from 28 to 30 weeks. There is a good correlation between GA derived from TCD and
from established biometric indices like BPD, HC, AC, and femur length(14).
In the Anatomical Society of India the model derivation cohort included 202,300 spontaneous
conceptions, and the testing cohorts included 50,735 spontaneous conceptions and 1,924 assisted
conceptions. In the assisted conception cohort, first trimester dating ultrasound was accurate to
within about +/- 1.5 days compared to date of embryo transfer reference overall (mean absolute
error 0.21 (95% CI 0.20, 0.23). When compared to gestational age derived from date of embryo
transfer, the metabolomic estimation models were accurate to within about +/-5 days overall
(0.79 (0.76, 0.81) weeks). When ultrasound was used as the reference in validating the
metabolomic model, the mean absolute error was slightly higher overall (0.81 (0.78, 0.84)
weeks(12).
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2.1 Conceptual Frame Work
Various variables might influence the correlation between self-reported and ultrasound estimated
GA . These variables are categorized under four major categories. They are; Socio- demographic
status of the patient, obstetrics and Gynecology, Maternal knowledge , and Methods of
estimation. GA is considered as control variable for this study.
Gestational Age
Figure 1: Conceptual framework for the study of the correlation between self reported and US
estimated GA, Modjo, Oromia, Ethiopia,2022.
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3. Objective
3.1 General Objective
To assess the correlation between self-reported and ultrasound-estimated gestational age among
pregnant mothers attending antenatal care at Modjo Hospital , Modjo,Ethiopia 2022.
3.2.1 To determine self-reported gestational age by LNMP among mothers who will give birth
at Modjo Hospital in 2022.
3.2.2 To determine gestational age by ultrasound measurements among mothers who will give
birth at Modjo Hospital in 2022.
3.2.3 To identify the correlation between LNMP and ultrasound measurements among mothers
who will give birth at Modjo Hospital in 2022.
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4. METHODS AND MATERIAL
4.1. Study area and Period
This study will be conducted in Modjo Hospital. Modjo town is located in Oromia Regional
state, East Showa Zone at a distance of 70 km from Addis Ababa and 25 km from Adama town.
This town has 4kebeles. According to the projection of central statistical agency of Ethiopia
carried out in 2015, the estimated population of the town was 43,500. The town has two health
centers and one hospital. Modjo Hospital offers the following service with their respective
department : OPD, Emergency, Laboratory, Pharmacy and Radiology service. Approximately
7,260 pregnant women attending ANC and taking US during the last one year (2014). The study
will be conducted from September to January 2022.
4.3 Population
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4.4 Sample Size Determination and Sampling Procedure
4.4.1 Sample Size Determination
The sample size is determined by using a formula for a single population proportion by taking
50% for the proportion of LNMP and ultrasound estimated gestational age.
where :-
n= (1.96)20.5(1-0.5)
0.052
=
384
Since, the average number of pregnant women coming to the ANC department is 27.5 based on
the data conducted within one month on each day excluding weekends. So, the average number
of pregnant women coming to the department will be multiplied by the study conducted day.
Therefore the total population will be 605, so we will modify our sample size by using the
Correction Coefficient Formula.
n°
n=
(n° −1)
1+
N
Where:-
N - total population
384
n=
( 384−1 ) = 234.9 ≈ 235
1+
605
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We consider the non response rate (10%). So, the final sample size becomes 258.5≈ 259
4.4.2 Sampling Technique
The sampling frame will be prepared from lists of pregnant mothers attending ANC clinic in the
hospital and mothers for whom US ordered will be identified. Then mothers who are sent to the
Radiology department for an ultrasound scan will be selected by a computer generated simple
random sampling technique.
Data collection will be carried out by data collectors using an interview based questionnaire ,
chart review and using diagnostic ultrasound (US) imaging equipment (FF Sonic UF-4100) with
a 3.5 MHz transducer for transabdominal examination normally and 5 MHz transducer for very
thin women. Gestational age will be calculated by asking mothers for their LNMP and
Ultrasound indices (biparietal diameter, abdominal circumference, and femur length) according
to their pregnancy stages.
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be calculated considering Ultrasound as a reference. The level of significance will be defined as
p ≤ 0.05.
We agree up on operational terms to reduce differences and errors in data collection. Submission
of completed questionnaires to group leader by data collectors will be carried out daily. Each
questionnaire will be checked for completeness and consistency at the end of each data collection
day. Besides this, the data will be carefully cleaned before the commencement of the analysis.
Expected date of delivery - it is the expected date of delivery that was calculated either from
LNMP or Ultrasound estimated gestational age.
Symphysis fundal height - is the distance between the upper border of symphysis pubis (palpated
with the right index and middle fingers) and the uterine fundus ( palpated with the lateral aspect
of the assessor's left hand).
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4.11 Dissemination of the Result
The finding of this study will be disseminated to Modjo Hospital. As well for other governmental
and non- governmental concerned parties and will be published in reputable journal.
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4.12 Work Plan
MONTHS
1 2 3 4 1 2 3 4 1 2 3 4
2 Designing principal
questionnaire investigator
3 Submission of principal
1stdraft proposal investigator
4 Submission of principal
final proposal investigator
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Budget
Table 2: Budget for the study
Stationary
1 Pencil Each 12 5 60
2 Eraser Each 6 5 30
4 Marker Each 10 8 80
5 Sharpener Each 5 5 25
Total 1075
Cost of communication
Total 650
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Personal and transport cost
Budget summary
3 Stationary 1075
4 Total 8550
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Reference
1. Bisahnyui, P., Nkfusai, C. N., Bede, F., Kemjei, M., Atuhaire, C., Nchanji, K., ...& Cumber, S.
N. (2020). Comparative study of clinical methods versus ultrasound methods for accurate
gestational age determination in different trimesters of pregnancy, Ndop District Hospital, North
West region, Cameroon.The Pan African Medical Journal, 37.
2. Papageorghiou, A. T., Kemp, B., Stones, W., Ohuma, E. O., Kennedy, S. H., Purwar, M., ... &
International Fetal and Newborn Growth Consortium for the 21st Century (INTERGROWTH‐
21st). (2016). Ultrasound‐based gestational‐age estimation in late pregnancy. Ultrasound in
Obstetrics & Gynecology, 48(6), 719-726.
3. Gensa, T. (2016). Estimating Gestational Age by Symphysis Fundal Height, Last Normal
Menstrual Period and Parameters of Ultrasound in Third Trimester Pregnancy at Gandhi
Memorial Hospital, Addis Ababa, Ethiopia (Doctoral dissertation, Addis Ababa University).
4. Abduljabbar, H. S., Jabal, N. A. B., Hussain, F. A., Alqabbaa, R. M., Marwani, F. A.,
Alghamdi, S. A., ... &Alsulami, H. S. (2020). Knowledge, attitudes and practice about obstetric
ultrasonography among women attending a university hospital: a cross-sectional study. Open
Journal of Obstetrics and Gynecology, 10(12), 1763-1775.
5. Butt, K., Lim, K., Bly, S., Cargill, Y., Davies, G., Denis, N., ... & Salem, S. (2014).
Determination of gestational age by ultrasound. Journal of Obstetrics and Gynaecology Canada,
36(2), 171-181.
6. Sharma, L. K., Bindal, J., Shrivastava, V. A., Sharma, M., Choorakuttil, R. M., &Nirmalan, P.
K. (2020). Discordant dating of pregnancy by LMP and ultrasound and its implications in
perinatal statistics. Indian Journal of Radiology and Imaging, 30(01), 27-31.
7. Abawollo, H. S., Tsegaye, Z. T., Desta, B. F., Beshir, I. A., Mengesha, B. T., Guteta, A. A., ...
& Argaw, M. D. (2022). Contribution of portable obstetric ultrasound service innovation in
averting maternal and neonatal morbidities and mortalities at semi-urban health centers of
Ethiopia: a retrospective facility-based study. BMC pregnancy and childbirth, 22(1), 1-9.
8.Sazawal, S., Ryckman, K. K., Mittal, H., Khanam, R., Nisar, I., Jasper, E., ... & Bahl, R.
(2021). Using AMANHI-ACT cohorts for external validation of Iowa new-born metabolic
profiles based models for postnatal gestational age estimation. Journal of global health, 11.
9. Sarker, B. K., Rahman, M., Rahman, T., Rahman, T., Rahman, F., Khalil, J. J., ... & Rahman,
A. (2020). Factors associated with calendar literacy and last menstrual period (LMP) recall: a
prospective programmatic implication to maternal health in Bangladesh. BMJ open, 10(12),
e036994.
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10. Tiruneh, C. (2020). Estimation of gestational age using neonatal anatomical anthropometric
parameters in Dessie Referral Hospital, Northeast Ethiopia. Risk Management and Healthcare
Policy, 13, 3021.
11.Falatah, H. A., Awad, I. A., Abbas, H. Y., Khafaji, M. A., Alsafi, K. G., &Jastaniah, S. D.
(2014). Accuracy of ultrasound to determine gestational age in third trimester. Open Journal of
Medical Imaging, 4(03), 126.
12. Cinnusamy, M., Shastri, D., & Martina, J. A. (2021).Estimation of gestational age by
ultrasound measurement of fetal transcerebellar diameter. Journal of The Anatomical Society of
India, 70(1), 19.
13. Jehan I, Zaidi S, Rizvi S, Mobeen N, McClure EM, Munoz B, Pasha O, Wright LL,
Goldenberg RL. Dating gestational age by last menstrual period, symphysis-fundal height, and
ultrasound in urban Pakistan.Int J Gynaecol Obstet. 2010 Sep;110(3):231-4. doi:
10.1016/j.ijgo.2010.03.030. PMID: 20537328; PMCID: PMC2914118.
15. Gameraddin, M., Alhaj, B., &Alabdeen, M. Z. (2014).The reliability of biparietal diameter
and femoral length in estimation the gestational age using ultrasonography. J GynecolObstet,
2(6), 112e5.
16. Sahota DS, Leung TY, Leung TN, Chan OK, Lau TK. Fetal crown-rump length and
estimation of gestational age in an ethnic Chinese population. Ultrasound Obstet Gynecol. 2009
Feb;33(2):157-60. doi: 10.1002/uog.6252. PMID: 19115262.
17. Butt, K., & Lim, K. I. (2019).Guideline no. 388-determination of gestational age by
ultrasound. Journal of Obstetrics and Gynaecology Canada, 41(10), 1497-1507.
18. Sharma, L. K., Bindal, J., Shrivastava, V. A., Sharma, M., Choorakuttil, R. M., &Nirmalan,
P. K. (2020). Discordant dating of pregnancy by LMP and ultrasound and its implications in
perinatal statistics. Indian Journal of Radiology and Imaging, 30(01), 27-31.
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10. ANNEX
I had understood that the objective of this study was to assess the correlation between
gestational age by last normal menstrual period and ultrasound parameters such as head
circumference, femur length, biparietal diameter and abdominal circumference during
pregnancy. I clearly understood that all the research activities not hurt my health. It also
explained to me that I had the right to stop participation at any time.
It will take around —— minutes to complete the interview. Without your permission, no
information about you as an individual will be shared with any person or entity. Your
participation in the study is entirely optional, and you have the option of opting out entirely or
partially.
If you accept to engage in the study, I will begin by asking generic identifying questions. Only
truthful responses would aid in the improvement of the service. Adama General Hospital and
Medical college has given its consent to the investigation. “Do you mind if I continue?”
Date of interview
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Annex II- Questionnaire
Instruction - Please circle to the letter which contain the correct answer ( the most appropriate
answer)
Date
Questions Response
1. Questionnaire Code
2. Name of Hospital
3. Age
B. Can Write
B. Protestant Christian
C. Muslim
D. Other specify
B. Government Employed
C. Self Employed
D. Other specify
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Part II- Obstetric and Gynecological Questions Skip pattern
No Question Response
3. Number of pregnancy(gravidy)
B. No
8. EDD by LNMP
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Part III- Ultrasound parameters with its estimated gestational age and expected date of
delivery.
Femur length(FL)
Biparietal
diameter(BPD)
Head
circumference(HC)
Abdominal
circumference (AC)
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Kutaa I - Socio-demographic Questions
Guyyaa
Gaafilee Deebii
1. Koodii Gaafannoo
2. Maqaa Hospitaalichaa
3. Umrii
E. kolleejjii fi isaa ol
B.Amantaa Pirotestaatii
C. Amantaa Musliimaa
D. Kan biroo
B. Hojjattuu Mootummaa
C. Hojii dhuunfaa
D. kan biroo
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Kutaa II- Gaafilee ulfaa fi gadaamessaa Skip pattern
la Gaaffii Deebii
k
B. Miti
6. Gaaffii 5 ffaaf deebiin kee sirrii yoo ta'e , guyyaan ____/___/___ Guyyaa /ji'a / bara
laguu yeroo dhumaaf argite yoomi ture ?
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Kutaa III - Tilmaama umrii ulfaa fi guyyaa dahuumsaa eegamu safartuuwwan
Altiraasaawundiitiin
Femur length(FL)
Biparietal
diameter(BPD)
Head
circumference(HC)
Abdominal
circumference (AC)
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Annex III - Declarations
We, the under signed declare that , this proposal is our original work and its report has never
been presented in this college or any other university. That all the resources and materials used
here have been fully acknowledged .
Declared by :-
Betel Kifle
Fenet Aman
Kalkidan Belete
Lelise Girma
Meron Abush
Tselot Biru
Approved By :-
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