Chapter I

Introduction
1.1 Background

IDD is the world’s single most significant cause of preventable brain damage andmental retardation. Twenty nine percent of the population (1570 million people) is at
risk of iodine deficiency today in the world. The immense danger to health due to IDD
arises from the fact that these disorders can began even before the child is born.
Although iodine is needed in small amount on an average of 150mcg (100 to 300) perperson per day, 1, 2 lack of iodine is associated with wide range of clinical and subclinical conditions. The most obvious sign of IDD is goiter, which is a grossenlargement of the thyroid gland in the neck, with a global prevalence of 12%. In
addition to goiter, IDD leads to infant mortality, stillbirths, birth complications, mental
retardation and depressed psychomotor functions. Moderate IDD in early childhood has
been estimated to lower the intelligence quotient by about 10-15 points, while in adults
it causes lethargy. 3

IDD is an important major micronutrient deficiency problem in Nepal. In some isolated
mountainous area of Nepal, most of the adult woman had goiter and up to 10% of
population were cretins, the severest form of IDD. 4

First nation wide clinical prevalence survey for goiter conducted in 1956 -1967 showed
high prevalence of endemic goiter and cretinism. IDD prevalence survey conducted inhigh Trisuli and upper Langtang area during 1976-1977 revealed that the total goiterrate was 55.3%, while cretinism was 5.1%. 4 Similar survey conducted in 1979-1982 in
14 districts, the total goiter rate noted was 57.6% and cretinism prevalence was 2.8%.
National level survey conducted in 15 districts of Nepal from 1985 to 86 revealed therate of goiter and cretinism, 39.7 %, 0.4% respectively. 5 A national level survey, Nepal
Micro Nutrient Status Survey conducted in 1998 established the low median urinary
iodine excretion of 43.65 in women and 35.1 in children, which is less than WHO value1

of 100 mcg / L. Similarly NMSS showed a total goiter rate (TGR) of 50% and 40% in
women and school age children respectively. 6

Nepal IDD status survey 2005 provides the national estimates on the status in the
country, which are directly comparable to the NMSS 1998. This national level study
done in different eco-geographical region revealed that national median UIE increased
from 143.8 mcg /l to 188.0 mcg /L among school age children (SAC). The proportionof SAC with low urinary iodine excretion (UIE) values between WHO cut off value of
100 mcg /L decreased from 35.15 to 27.4 percent in 2005.The survey showed anincrease in the proportion of house hold using iodized salt with 2 children logo, which
is 37.7 percent compared to 9 percent in 1998. Iodine content in salt at household levelmeasured using rapid test kit (RTK) found that 94.9 percent of house hold consumed
salt with some iodine content which was an improvement over NMSS 1998 value of 83
percent. In addition 57.7 percent of all household in the country used adequately
iodized salt, which was slightly better than 1998 situation of 55.2 percent. 5

1.2 Statement of the problem
Iodine deficiency is the world’s single most significant cause of preventable brain
damage and mental retardation. Globally prevalence of goiter is 12 percent and 29
percent of the population is at risk of developing iodine deficiency. Nationwide
prevalence survey conducted in Nepal in 1985-1986 showed an overall total goiter rateof 44 percent in school children and adults. More recently, an assessment of IDD
problem by estimation of urinary iodine among Nepalese school children conducted in2005 in 190 urine samples showed 3.2 percent of children had urine iodine less than 20
micro grams per liter. In addition, 27.9 percent children had urine iodine level 100
mcg/L, the normal WHO recommended levels. Current IDD status assessment
conducted in 2004 in Nepal noted that 16.3 percent household salt samples were foundto have less than 15 ppm iodine, 35. 33 percent samples found to have 15 to 30 ppm, 40
percent samples were found to have 30-50ppm and 12.64 percent salt samples had
iodine greater than 50 ppm. The disease burden study (SLTHP, 1997-2017) has shownthat great 1st category that includes pre-transition disorders such as infectious diseases,
maternal and perinatal disorders and nutrition deficiency in Nepal are responsible for2more than two third of the disease burden i.e. 68%. Therefore, nutrition intervention
has been recommended as a priority element of EHCS. 7

Similarly, NHS strategy (2004) and NHS implementation plan have recognized thenutritional problem of mother and children and have recommended adopting a specificimplementation strategy with regards to nutrition. 7

1.3 Rationale

IDD will remain to be health problems unless human behavior is changed, which is aprocess requiring multi-sectoral approach. There is hardly any study of this type donein this country regarding iodine supplementation and pregnancy outcomes (mother andnewborn health).

The first nation-wide clinical prevalence survey for goiter was conducted in 1965-1967,
which showed a high level of endemic goiter and alarmingly high rate of cretinism. 4
Since than more than ten IDD prevalence surveys have been conducted through out thecountry, most of those are based on children and adult population (non pregnant). Someof the studies have tried to focus the status of IDD among the women of reproductive
age group but none have involved the pregnant women.

A nation-wide IDD prevalence survey was conducted in 1985-1986 in 15 districts by
Ministry of Health and noted an overall total rate of goiter was 44% in both school
children and adults. More recently a situation analysis of children conducted in 1992 by
the Ministry of Health and UNICEF showed goiter prevalence rate from 23-46%. 6 In
areas with severe iodine deficiency (< 50 mcg intake/day), goitrogenesis as well as
hypothyroidism were frequently observed in mother and newborn as a result of theinability of the thyroid gland to adjust to changes in thyroid economy associated withpregnancy. Hence, the pregnant woman and the newborn have been considered primarytargets for iodine supplementation in such areas.8

The world health report 2002 clearly describes how childhood and maternal underweight are the greatest risk factors among several main factors that affect people’s

3

health and diseases status in the world, particularly in Asia (WHO, 2002). In theMillennium Development Goals under weight has been adopted as a key indicator ofpoverty and hunger. 8

In addition, improvement in nutrition can help meeting the MDGs by contributing to
the achievement of universal primary education, reducing child mortality, improving
maternal health, as well as reducing poverty and hunger. From these points of view, it
is recognized that policies, program and process for nutrition improvement have a greatrole to play in promoting healthy lives and development across the globe.

Since the severe clinical findings of different studies conducted to know the IDD status
are only the tip of the iceberg, mild to moderate deficiencies which are difficult to
identify with commonly available tests remained to be the most important iodine
deficiency disorders in the community. Pregnancy and intrauterine life are the mostvulnerable period to be suffered from IDD 9.

Ministry of Health and Population has prioritized Iodine Deficiency Disorders as a highlevel activity in its Nutrition Policy and Strategy 2004. MOH has set an objective to
virtually eliminate iodine deficiency diseases and sustain the elimination. “By the year2017 iodine deficiency disorders will be eliminated virtually from Nepal” this is a set
goal of MOHP Nepal. 7

All these finding associated with pregnant women justifies the burning issue for the
research on iodine deficiency disorders among pregnant mother and newborn. With
these motivations, the present intervention study has been designed to assess the effectof iodine supplementation during second half pregnancy to its outcomes (maternal andneonatal health).

4

1.4 Hypothesis

Regular supplementation of iodine during second and third trimesters of pregnancy inaddition to appropriate MNH care interventions improves overall health status of
mother and newborn.

1.5 Research questions•

What was the effect of iodine supplementation during pregnancy in mother andnewborn health outcomes?

•

What was the prevalence of IDD among the pregnant women & newborn?

•

What was the knowledge, attitude and practice about the use and need of
iodized salt in their family?

•

What was the existing KAP about MNH care among the pregnant mothers?

1.6 Objectives

1.6.1 General Objectives

To find out the maternal and newborn health status in relation to the regular daily
iodine supplementation in addition to appropriate maternal and neonatal health careinterventions during pregnancy among pregnant women in Chautara hospital.
1.6.2•

Specific Objectives

To identify/assess the status of IDD among pregnant women and their newbornsof Sindhupalchowk district.

5

•To differentiate between the IDD status of pregnant women with and with out
regular supplementation of iodine using various indicators of IDD (serum
thyroid hormone level and maternal goiter rate).

•

To compare the status of newborns of pregnant women with and without iodine
supplementation.

•

To assess/understand KAP about use and need of iodized salt among thefamilies of pregnant women.

•

To assess KAP about care of pregnancy, delivery and newborn among the same
pregnant women.

6Chapter II

Literature Review
Iodine is a chemical element, which is found in trace amount in thyroid hormones.
Iodine is necessary for the synthesis of thyroid hormones. 10

2.1 Iodine deficiency disorders
In areas where there is little iodine in the diet typically remote inland areas where no
marine foods are eaten iodine deficiency (ICD 10, E00-E02) gives rise to goiter (socalled endemic goiter), as well as cretinism, which results in developmental delays andother health problems.1 Population effects of severe iodine deficiency termed IDD
include endemic goiter, hypothyroidism, cretinism, decreased fertility rate, increased
mortality and mental retardation. 11
For children aged 0-59 months: 90mcg, for children aged 6-9 years: 120 mcg, forindividuals older than 12 years, for adolescents and adults: 150 mcg, for pregnant andlactating women: 200 mcg. 1
Similarly US, Institute of Medicine recommended daily allowance of iodine is as given.
Normal daily iodine intake is 100- 150 mcg per day, 150 mcg for adults andadolescents, and 220 mcg per day for pregnant and 290 mcg per day for lactating
mother. For children aged 1 to 11 years recommended daily amount of iodine is 90 to
120 mcg, for infants 110 to 130 mcg is needed. Upper limit of safe daily iodine intake
is 1100 mcg per day for adult and it is lower for children. 3
Thyroid hormones (T3, T4 and TSH) are essential for neuronal development, sexual
development, growth and other important functions of thyroid hormones are regulationsof metabolic rate, body heat and energy production. 12

Prevalence of IDD in different group is worth mentioning. Regarding sex prevalence,
after 10 years goiter is high among girls in iodine deficiency prone areas. Most
devastating complication of IDD occurs when iodine is deficient during fetal andneonatal growth that is pregnant women and lactating mothers. The most common andsevere manifestations of IDD are goiter, hypothyroidism and cretinism which is7

classified in two different types. One is neurological, manifested with mental
retardation (deficiency during pregnancy) and the other is myxomatous type, which ischaracterized by mental as well as physical growth retardation (deficiency during
pregnancy and lactating period). Iodine deficiency is the worldwide leading cause of
preventable mental retardation and brain damage. 10

Internationally, 2.2 billion people are at risk for IDD, of these 30 to 70 % has goiter and
1 to 10 % has cretinism. Regarding morbidity and mortality, mild to moderate IDD are
manifested as thyroid functions abnormalities. Severe forms of IDD as endemic goiterand cretinism are related to increased miscarriages and infant mortality. 13 According to
the World Health Organization, the number of countries where iodine deficiency was apublic health problem was reduced to 54 in 2003, down from 110 in 1993 through its
program of salt iodization. The WHO says the drop is due mainly to the use of iodized
salt for human and animal consumption to prevent and control iodine deficiency. 14

In some isolated mountainous area of Nepal, most of the adult woman had goiter and
up to 10% of population were cretins, the severest form of IDD. 4

A national level survey Nepal Micro Nutrient Status Survey conducted in 1998
established the low median urinary iodine excretion of 43.65 in women and 35.1 inchildren, which is less than WHO value of 100 mcg / L. Similarly NMSS showed atotal goiter rate (TGR) of 50% and 40% in women and school age children respectively.
6

National level survey conducted in 15 districts of Nepal from 1985 to 86 revealed therate of goiter and cretinism 39.7 % and 0.4 respectively. Nepal IDD status survey 2005
provides the national estimates on the status in the country, which are directlycomparable to the NMSS 1998 respectively.

Iodine content in salt at household level measured using rapid test kit (RTK) found that
94.9 percent of house hold consumed salt with some iodine content which was an
improvement over NMSS 1998 value of 83 percent. In addition 57.7 percent of allhousehold in the country used adequately iodized salt, which was slightly better than1998 situation of 55.2 percent. 15
8Pregnancy in an area with a marginally low iodine intake is associated with significant
alterations in thyroid function and specifically pregnancy induced goitrogenesis andexcessive thyroid stimulation in a significant fraction of the women. Relative
hypothyroxinemia, evidenced by a less than adequate rise in total thyroxin levels andthe gradual lowering of free thyroxin levels during the first half of gestation with
gradual rise, within the limits of normality, of serum TSH after the first trimester; and amarked elevation in serum TBG levels, particularly near term are the effects of mild tomoderate iodine deficiency during pregnancy. 16

The rise in serum TG was highly correlated with changes in TV (thyroid volume),
thereby providing an interesting marker for goitrogenesis occurring during pregnancy.
Excessive thyroid stimulation was observed in both mothers and newborns. Pregnancy
constitutes a challenge for both the maternal and fetal thyroid glands, enhanced by the
reduced availability of iodine, and to recommend systematic addition of iodine during
pregnancy and lactation in the country. 8

There is potential risk of goitrogenic stimulation in both mother and newborn in thepresence of mild iodine deficiency. Iodine supplementation benefits pregnant womenwith excessive thyroid stimulation. In conditions of mild iodine deficiency, pregnancy
fully justifies the monitoring of thyroid function and volume and therapeuticintervention to avoid hypothyroxinemia and ontogenesis. 17

2.2 Prevalence of the IDD
The data required to estimate burden of IDD in community includes the following:•

The total population including the number of children under 15 years ofage (in which the effects of iodine deficiency are so important);•

The goiter rate, including the prevalence of palpable or visible goiterclassified according to accepted criteria;•

The rates of cretinism and 'cretinoidism' in the population;•

Urinary iodine excretion (UIE);•The level of iodine in the drinking water;

9•The level of serum thyroxin (T4) in various age groups. Particularattention is now focused on the levels in the neonate because of theimportance of the T4 level for early brain development.

2.3 Indicators of IDD
There are certain characteristics, which delineate the whole range of IDD in community.
10•

Laboratory indicators: Urinary iodine excretion (UIE), newborn with IDD showraised TSH, measurement of a dried whole blood spot level of thyroglobulin(TG) in children.

•

Imaging studies: Radioactive iodine uptake value and thyroid size scanning withultrasonography.

•

Other tests: TFT (Thyroid function test), mild iodine deficiency will fall with innormal reference but moderate to severe deficiency leads to raised TSH anddecreased T3, T4•

Histological findings: Diffuse hyperplasia of thyroid gland

2.4 Thyroid function during pregnancy
Iodide deficiency is probably the number one problem when it comes to thyroid disease
worldwide, in many of the countries both in Europe and in the developing world, said
Dr. Stagnaro-Green. And it is probably the number one reason why children are bornwith decreased I.Q. What really is needed in those countries is some form ofintervention that all mothers who are pregnant get iodide before pregnancy and during
pregnancy. 18
Dr. Alex Stagnaro-Green, a professor of Obstetrics and Gynecology at New Jersey
Medical School, says thyroid disease is, after diabetes, the most common endocrine
disease worldwide during pregnancy, due in large part to iodide deficiency. Iodide
deficiency usually happens when soil contains low levels of iodine, causing a low
concentration of iodine in food products and insufficient iodine intake in the population.
Dr. Stagnaro-Green says during pregnancy, a baby's development is dependent on the10mother's thyroid function. If thyroid abnormalities are not detected, he says it can leadto several complications for mother and baby. 19
One of the most exciting studies that have come out in the last 30 years was publishedthis year, about six month ago, from a group in Italy, he said. Half the women theygave thyroid hormone, the other half they didn't give thyroid hormone. They found thatthe half they gave thyroid hormone to, their miscarriage rate and their preterm delivery
rate was at the normal level. The half that had thyroid antibodies and not given the
thyroid hormone, their miscarriage rate was four to eight times higher. That was thefirst study to demonstrate that an intervention makes a difference. If another study
confirms that and expands upon it, then there will probably be a very strong call foruniversal screening for all women for thyroid disease in pregnancy. Assessment of TF
during pregnancy should be done with careful clinical evaluation of the patient’s
symptoms as well as measurement of TSH and free, not total thyroid hormones. 12
Regarding pregnancy and IDD more than a dozen national and more than three times ofnational, international publications were reviewed most of them are concerned withclinical endocrinology only few are relevant in public health. A couple of findings are
mentioned below.
There was no statistically significant difference in the frequency of PPTD in the threegroups (P = 0.56): +/+ group, 59% (95% confidence interval, 36–79%), +/- group, 60%(36–81%); and -/- group, 46% (26–67%), although a small trend was observed. One of
the six women leaving the study had evidence of PPTD (abnormal TSH 3 months
postpartum), and one had normal TSH 3 months postpartum (no further test available).
Neither these data nor intention to treat analysis including all six censored womenaltered the outcome. PPTD developed in 55% of the participants. In 67% of the cases,
abnormal TSH was accompanied by abnormalities in thyroid hormones (clinical PPTD),
whereas 33% had abnormal serum TSH only (sub clinical PPTD). 21, 22

2.5 Iodine supplementation and thyroid function in late pregnancy
Measurements of TSH, thyroid hormones, and thyroid antibodies in week 35 ofpregnancy in women receiving iodine (+/+ and +/- groups) and women not receiving
iodine (-/- group) are described. There were no statistically significant differences when11

comparing absolute values at 35 weeks gestation. Iodine supplementation modified
changes in TSH and TG during pregnancy. In the group without iodine there was asmall, but systematic, increase in TSH during pregnancy, whereas the TSH alterations
during pregnancy in the group with iodine showed a more diverse pattern, with nosignificant difference between early and late pregnancy. The small increase in TG
during pregnancy reverted to a considerable fall after iodine supplementation. Free T4
declined during pregnancy, and iodine supplementation made no significant difference.
Antibody levels were lower in late pregnancy, with no differences between groups. 22
Iodine requirements are increased during pregnancy and the postpartum period, andconsequently, the recommended iodine intake is higher. 23 A possible unintended effectof increasing the iodine intake in pregnant and lactating women with mild to moderate
iodine deficiency is an increase in postpartum autoimmune thyroid dysfunction.
However, in the current study we found no significant increase in the prevalence,
severity, or duration of PPTD when 150 µg iodine were given to TPO-Ab-positive
women during pregnancy only or during pregnancy and the postpartum period. Iodine
supplementation induced minor late pregnancy differences in thyroid function similar to
those found in previous studies of pregnant women in areas of mild to moderate iodine
deficiency. 22 These variations probably had little clinical significance.
Two randomized studies have previously focused on iodine supplementation and its
impact on the prevalence and severity of PPTD 16. Janssen et al. hypothesized, based on
their observation of low iodine excretion during the hypothyroid phase of PPTD 22 thatiodine deficiency might worsen this phase of PPTD. In a subsequent study performed in
Sweden, an iodine-sufficient area, they randomized 58 TPO-positive women to receive
no supplement, 0.1 mg L-T4, or 150µg iodine/day during the postpartum period. 23
Contrary to their hypothesis, they found an aggravation of the hypothyroid phase of
PPTD in the iodine group. The frequency of PPTD was not different from those in thecontrol and L-T4 groups. They recommended that iodine should not be given during the
postpartum period.
Reinhardt and colleagues addressed the efficacy and safety of iodine given during the
postpartum period in an area of mild iodine deficiency (Germany). 21 They randomized
70 women with no previous thyroid disease and no iodine supplementation during

12

pregnancy to receive either 50 or 250µg iodine/day in the postpartum period (8 months).
The study did not include a control group. Thyroid dysfunction developed in 6 womenin the group receiving 50µg iodine and in 5 women in the group receiving 250 µg.
Seven had sub clinical and 4 had manifest thyroid dysfunction, and 8 of these were
either TPO-Ab or Tg-Ab positive. They concluded, on the basis of a prevalence of
manifest thyroid dysfunction of 5.7% (4 of 70), that iodine supplementation, up to 250µg/day, in the postpartum period was safe. 21
The present study supports that iodine supplementation during pregnancy andpostpartum is safe, even in women with circulating TPO-Ab. We did not confirm thatwomen given iodine supplementation during the postpartum period had a more severe
hypothyroid phase of PPTD, as found by Kämpe et al. 17 On the contrary, we found thatthe hypothyroid phase tended to be less severe in women receiving iodine postpartum[significantly higher T4 (P = 0.03) and lower TSH (P = 0.04) in the +/+ group comparedto the -/- group, with no significant difference in free T4]. As our study environment ismore iodine deficient, the difference in findings could be a matter of substrateavailability for hormone synthesis during the period of thyroid regeneration. Several
studies have demonstrated high urinary losses of iodine during the previous phase of
thyroiditis. 24

2.6 Long-term consequences
Although abnormalities in thyroid function mostly were transient and tended tonormalize with in 9 months postpartum.14 women (21%) still had abnormal serum TSH
at the end of the randomized study (9 months postpartum). Twelve had hypothyroidism(9 sub clinical and 3 clinical), and 2 had hyperthyroidism (1 sub clinical and 1 clinical).
24

Follow-up 3 yr postpartum (median) of the initial cohort (n = 72) showed that four
women later had a registered diagnosis of thyroid disease. From the +/- group, thewoman with symptoms of PPTD during the study period had transient hypothyroidism
1.5 yr later, one woman developed euthyroid goiter, and one developed permanent
hyperthyroidism due to Graves’ disease (she left the study after pregnancy andtherefore was excluded). From the -/- group, one woman had hyperthyroidism due totoxic adenoma. 24
13

Of the remaining 68 women, 67 completed a questionnaire and had a test of thyroid
function. Four women had either sub clinical (n = 2) or clinical (n = 2) hypothyroidism.
These 4 women were all sub clinically hypothyroid at the end of the randomized study.
Thus, a total of 8 women (11%) had evidence of thyroid disease at follow-up.

2.7 Hypothyroidism during pregnancy
The incidence of hypothyroidism in pregnant women has been estimated to be 0.3–
0.7%. There is a known association between hypothyroidism and decreased fertility 25.
For this reason, the frequency of hypothyroidism in pregnancy is actually lower than the
0.6–1.4% frequency in the general population. Causes of hypothyroidism during
pregnancy are listed here. Autoimmune thyroid disease (Hashimoto thyroiditis) andpost thyroid ablation therapy are the most common causes of hypothyroidism 25.
Hypothyroidism during pregnancy has been associated with pregnancy-induced
hypertension, placenta abruptio, postpartum hemorrhage, and an increase in thefrequency of low birth-weight infants. 26
Recently, Haddow et al. 12 reported that untreated hypothyroidism during pregnancy
may cause a significant decrease in the IQ of children. In this study, the authors
measured thyroid hormone concentrations in 25 216 pregnant women. Thyroid
deficiency was undetected at the time of pregnancy in 48 of 62 women with low thyroid
hormone concentrations. The IQ scores of children born to these women were, on
average, seven points lower than those of children born to women with thyroid values
within the appropriate reference intervals. Approximately 20% of these children had IQ
levels of 85 or lower. This study suggests that TSH should be measured before or earlyin pregnancy to allow adequate treatment of the mother. Further research is required todetermine when screening should take place, and treatment guidelines. 20

2.8 Diagnosis of hypothyroidism
As with the assessment of hyperthyroidism, laboratory evaluation of hypothyroidism
should be made using TSH and an assessment of free hormone values, either directly or
via a calculated index. Total T4 and T3 measurements should be considered unreliablebecause of the increase in TBG concentrations. In addition, pregnant women who areon thyroid replacement therapy require larger doses compared with non-pregnant

14

patients because of increases in the TBG concentration and increased type III
deiodinases from the placenta. 24
When thyroid deficiency occurs simultaneously in a pregnant woman and her fetus, thechild's neuropsychological development is adversely affected. Whether developmental
problems occur when only the mother has hypothyroidism during pregnancy is notknown.
In 1996 and 1997, thyrotropin was measured in stored serum samples collected from
25,216 pregnant women between January 1987 and March 1990. We then located 47
women with serum thyrotropin concentrations at or above the 99.7th percentile of thevalues for all the pregnant women, 15 women with values between the 98th and 99.6th
percentiles, inclusive, in combination with low thyroxin levels, and 124 matched
women with normal values. Their seven-to-nine-year-old children, none of whom had
hypothyroidism as newborns, underwent 15 tests relating to intelligence, attention,
language, reading ability, school performance, and visual–motor performance. 27
The children of the 62 women with high serum thyrotropin concentrations performed
slightly less well on all 15 tests. Their full-scale IQ scores on the Wechsler Intelligence
Scale for Children, third edition, averaged 4 points lower than those of the children of
the 124 matched control women (P=0.06); 15 percent had scores of 85 or less, ascompared with 5 percent of the matched control children. Of the 62 women withthyroid deficiency, 48 were not treated for the condition during the pregnancy understudy. The full-scale IQ scores of their children averaged 7 points lower than those of
the 124 matched control children (P=0.005); 19 percent had scores of 85 or less. Elevenyears after the pregnancy under study, 64 percent of the untreated women and 4 percentof the matched control women had confirmed hypothyroidism. 27 Undiagnosed
hypothyroidism in pregnant women may adversely affect their fetuses; therefore,
screening for thyroid deficiency during pregnancy may be warranted. 28 The link
between hypothyroidism caused by iodine deficiency during pregnancy and mental
retardation in the offspring has been recognized for nearly 100 years. Iodine deficiency
is associated with thyroid deficiency in both mother and fetus 22 a situation that makes it
impossible to determine whether the mental retardation of the fetus is due to maternal
hypothyroidism or both maternal and fetal hypothyroidism. In developed countries,
chronic autoimmune thyroiditis is the most common cause of hypothyroidism among
15

women in their child bearing years. Antibodies responsible for compromising maternal
thyroid function can cross the placenta and, in some instances, compromise fetal andneonatal thyroid function. 12 One such antibody, the thyrotropin-receptor–blocking
antibody, has been implicated in cases of transient congenital hypothyroidism that wereidentified by screening programs for newborns. 27
In 1969, Man and Jones suggested that mild maternal hypothyroidism alone wasassociated with lower IQ levels in the offspring; their study involved a cohort of 1349
children, and measurements of serum butanol extractable iodine were used to
distinguish between euthyroidism and hypothyroidism in women.29 A study by
Matsuura and Konishi in 1990 documented that fetal brain development is adversely
affected when both the mother and fetus have hypothyroidism caused by chronic
autoimmune thyroiditis.30 In such cases, transient neonatal hypothyroidism is present.
In an earlier, population-based survey of 2000 pregnancies, serum thyrotropin
concentration was measured during the second trimester. 31 The concentrations werehigh (above 6 mU per liter) in 49 of the women, of whom 6 (3 per 1000) had low serum
free thyroxin concentrations. If a lowering of the IQ levels of the offspring were tooccur sufficiently often in association with this degree and frequency of maternal
thyroid deficiency, then systematically determining the thyroid status of all women
before or very early in pregnancy might be justified. The aim of the current study was
to determine whether undetected or inadequately treated maternal thyroid deficiency
during pregnancy is associated with lower IQ scores in the offspring in the absence of
neonatal hypothyroidism. 20

16

Chapter III

Methodology

3.1 Research design
This was a non-equivalent group (quasi experimental) type of study design because thestudy was lacking randomization in the selection of subjects in both the groups andcontrol group was not equivalent to the intervention group in all aspect. The subjects ofstudy, the pregnant women were not selected by randomization but were selected on thebasis of natural process of registration in ANC clinics and hospital wards.

3.2 Study site
The site of this study was Sindhupalchok district. All pregnant women of
Sindhupalchok were taken as the study population. Sindhupalchok is situated in hilly
ecological zone of Central Development Region of Nepal. This is bordered by
Kavrepalanchok, Katmandu, Nuwakot, Rasuwa, and Dolakha. It is also bordered by aninternational boundary with Tibet of China in the north.

Study was conducted in the same center to compare the maternal and newborn healthstatus (outcomes) between non-randomly selected pregnant women. The intervention
group was of 60 pregnant women of first and second trimester those who wereregistered in Chautara Hospital and district ANC centre. The control group was of 60
pregnant women of similar pregnancy status those who were admitted in the maternity
ward of same hospital.

3.3 Sample size and sampling
Optimum size of sample was calculated according to the formula. Since the study
design was interventional, subjects were compared and tested with appropriate
statistical tests.

17

Total population of Sindhupalchok: 293719, total female population of reproductive
age: 68740

No of expected pregnancy: 13550, no of pregnancy with 4 ANC visits: 2324

No delivery conducted by HW: 1220(9 percent), no of delivery in HI: 475 (3.5
percent)

ANC covered by district clinic: 800 (1 in 3), delivery conducted in Hospital / HW:
400

Study period 3 to 5 months, subjects enrolled: Mid trimester
Sample size (n): 100 to 120 32
Sample size was calculated according to: 4 PQ / L2

4 X 40 X 60 divided by 10 x 10 equals to 97.44 that is 98

Estimated size of sample would be approximately 100 to 120.

3.4 Selection of study pregnant womenInitially 60 pregnant women of different centers of Sindhupalchowk who hadcompleted first trimester of gestation were screened. Screening was done on the basisof inclusion criteria. All were interviewed with standard questionnaires along withdetail general physical and obstetrical examination. Basic blood tests, routine urine
tests and especial tests for iodine and thyroid hormones were performed according tostandard procedures. Salt iodine estimation of all samples from respective household
was performed. Findings were recorded in standard recording forms for further analysis.

3.5 Follow up
18

All the pregnant mothers in the study group were followed every month for regularconsumption (consumption) of iodine, iron and folic acid tablets & ANC care. Findings
were recorded in standard forms for further analysis. Special counseling procedures
were applied to minimize defaulter. Subjects were educated about MNH care and werereferred to appropriate centers for complications and abnormalities.

3.6 Midterm evaluation
All the enrolled subjects were evaluated in the middle of the study with standard study
tools. Subjects were followed up for their weight gain, development of fetus andappearance of any abnormal findings. They were counseled about care of pregnancy,
delivery and new born. Importance of regular consumption of iodine, iron and folicacid tablets was explained during their visits. Findings of the evaluation were recorded
accordingly.

3.7 Outcomes (final) evaluation including study of newborn
Subjects under study were subjected to final interview, general physical & obstetricalexaminations,laboratory

investigations

accordingtostandard

study

tools

(questionnaires, examination forms, iodine estimation forms & lab investigations
forms). Study of new born was carried out to find the status of newborn according tostandard neonatal examination forms. Information collected was subjected to different
stages of standard data management procedures. Finally, raw data was computed,
analyzed, compared and tested by appropriate statistical tests.

3.8 Outcome evaluation of control subjects
General physical and obstetrical examination of control subjects was performed when
they arrived to the maternity ward of Chautara Hospital. Study questionnaires andexamination forms were filled in detail for further analysis. Examination of newborn
was carried out in detail and recorded in newborn examination form. Study tools were19

similar to intervention group except intervention of oral iodine and regular monitoringof intervention subjects.

3.9 Intervention
Intervention group was provided with a mineral capsule (Komb) containing 150 mcg of
iodine to take orally every day from the day of enrolment till delivery along with ironplus folic acid tablets and maternal and neonatal health care package.

Control group was taken from regular attendants of maternity ward of Chautara hospitaland assessed for enrollment. Information about pregnancy outcomes was collected only
once from the control group. No any intervention was given to the control group.
Study group was followed up regularly till the pregnancy was completed with an
outcome. Findings were compared between both the groups to get intended outcomes.
For comparison, base line data collected from study group was also used as proxy forcontrol group.

3.10 Monitoring and follow up
All pregnant mothers in the study group were followed every month for the regularintake (consumption) of iodine, iron, tablets & ANC care. Findings were recorded
using standard tools (questionnaires and examination forms). Standard counselingprocedures were applied to minimize defaulters. Subjects were educated about MNHcare and were referred to the appropriate centers for any abnormalities.

3.11 Validity and reliability
Validity and reliability of the study was considered with high priority to minimize therespective errors.

1. Appropriate sample size was selected
2. Standard study design was applied
3. Pre testing was done in separate area than the study site20

4. Standard tools and techniques was developed for data collection
5. Training and orientation for enumerators was conducted as per need anddata was collected under strict supervision of researcher
6. Researcher himself supervised data collection through out the study
7. Confounding factors was controlled during design and analysis of the study

3.12 Schematic presentation of study designFirst of all pregnant mothers were selected for enrollment in the study. They werescreened and appropriate candidates were enrolled in the intervention study. Those who
did not meet the criteria were excluded according inclusion criteria. Intervention wasgiven to those selected 60 pregnant women and followed till they deliver. Similarly 60
pregnant mothers who were admitted in the maternity ward of same hospital were taken
as control for comparison.

21

Schematic Presentation of study design
Enrollment ofPregnant women

Screeningof Pregnant
women

Clinical assessmentof Pregnant
women
Enrollment of 120
pregnant womenfor study

60 cases

60 controls
Intervention with
Kombe iodine
One shotassessment

Comparison

22

Follow up

3.13 Exclusion criteria
Following subjects were not included in the study:
1. Pregnant women of more than second trimester of pregnancy
2. Pregnancy of less first trimester of pregnancy
3. Confirmed cases of multiple pregnancy
4. Pregnant cases of more than 3-4 hours far from study site
5. Pregnant women with bad obstetric history for example
6. Subjects with H/O complications who needs intensive obstetric care23

3.14 Conceptual frame work

Demographic
factors

Awareness about needand use of
Iodine ,Iron tab , Vit.A
Healthymother

MNH care
Intervention
package

Improved
Maternal
healthPregnancy
out comes

Healthy
Newborn

KAP about
MNH careIodine capsuleIntervention

24

3.15 Operational definitions
Iodine Supplementation- Comb mineral capsules (containing 150mcg of Iodine alongwith mineral), which was supplied to pregnant mothers for 3 to 5 months asintervention till she delivered.

Iodine- Comb mineral capsules (Iodine capsules):Specifications (a): Comb mineral has Light brown color, moisture 5.0% , Max pH
6.8+_0.5, Ash 64+_2.0%,NaCl 60.4+_2%,Bacteria count 10000/Gm max ,E.coli
Negative Specifications (b):mineral content consists of: I 149.5mcg, Na 25.1, K 5.7,Mg
235.3, Ca 144.3.P 250.9 mcg / capsulePregnancy outcome- Results of the pregnancy in consideration to mother & newborn
health including maternal and neonatal morbidity and mortality

Maternal- Normal full term delivery, premature delivery, post term delivery, abortions,maternal complications & maternal deaths

Fetal- Fetal death, late fetal deaths, still births, perinatal deaths, neonatal deaths,
premature and post term baby
 Normal birth weight: 2.5 Kg or more
 Low birth weight: less than 2.5 Kg
 Small for date baby: birth weight less than 2.5 Kg in a baby who has completed
37 to 42 weeks of gestation.

Maternal and neonatal health (MNH)- State of mother and newborn’s healthincluding morbidity and mortality

MNH care service package- Essential health care package especially focused onantenatal, delivery, perinatal and postnatal care developed and implemented by DOHS
/MOH Nepal.

25

Maternal Night blindness- Inability of pregnant women to see properly in dim lightafter 20 weeks of pregnancy because of deficiency of vitamin A.
Thyroid function tests (T3, T4, and TSH)- Biochemical criteria to measure the statusof iodine in the blood of the study subjects before and after intervention
Goiter -Globular swelling in front of neck which moves on swallowing grade I to 3. 33
AnemiaTable: Level of Hemoglobin percent (%) less than WHO cut off points 33
Hb% cut-off point (Gm/dl)
Physiological group

Moderate anemia

Severe anemia

Pregnant women

7.0 -10.9< 7.0

Non –pregnant women

7.0-11.9< 7.0(6- 7.0-10.9< 7.0

Pre-school

children59months)

3.16 Data collection
Tools for data collection:
1. Questionnaires
2. Clinical examination forms (mother & newborn)
3. Laboratory investigations forms (routine & TFT)
4. Observation checklists
Health workers at local health institution were hired for data collection, 2 nursing
staffs, 1 defaulter tracer, 2 laboratory technicians,1 health assistant , 1 supervisior,1supporting staff, and 5 FCHVs.

3.17 Data management and analysis
Collected data were edited, cleaned and subjected to statistical analysis with the help of
SPSS version 13. Data were analyzed and presented in the forms ofdescriptive

statistics like frequency, percent, mean and standard deviation. Significance ofdifference between control and intervention and also between pre and post intervention
groups was tested by T test and Chi square test. Fetal outcomes like birth weight, length,
respiratory rate, heart rate, maternal outcomes like thyroid function test (thyroid
hormones) and amount of blood loss during delivery were subjected to T test. Fetal

26

maturity status, maternal health during delivery and other categorical variables were
tested with Chi square test. Rest of the qualitative variables were dealt with Chi square
tests.

3.18 Ethical approval and informed consent
Ethical clearance was taken from Institutional Review Board (IRB) of the Institute ofMedicine. Formal permission was taken from DHO of Chautara hospital. Voluntary
participation requested from mothers and confidentiality and privacy about the
information of subjects was maintained. Prior written consent was taken from eachsubject.

27

Chapter IV

Results

This chapter deals with the findings of the study obtained from analysis andinterpretation of the data. The structural response, physical and biochemical findings of
120 pregnant mothers (60 interventions and 50 controls) have been analyzed according
to the objectives of the study. The study was conducted among the pregnant women
who were attending the ANC clinic and maternity ward of Chautara Hospital from firstweek of June to last week of November 2007.

4.1 Demographic profile of respondents
Demographic characteristics of subjects of both the study and control group was
described depending upon the findings presented in the table. Three fifth (59.2 percent)of the subjects fell under 20 to 35 years age group. Percentage of adolescent pregnancy
was still high (40 percent). But the Percentage of elderly pregnancy was less than 1(0.8)
percent. Mean age of pregnant mothers was 22.1 years (SD 3.69).
Table 1: Age distribution of pregnant women
Age category of
pregnant mothers

Intervention group(n = 60)

Control group (n =
60)

Total

Less than or equal
to 20 years

28(46.7)

20(33.3)

48(40.0)

20 to 35 years

32(53.3)

39(65.0)71(59.2)

01(1.7)

1(0.8)

21.7 (S.D. = 3.07)

22.5 (S.D. = 4.22)

22.1 (S.D. =3.69)

36 years and above

Mean age28

Ethnicity wise population of subjects was distributed diversely. Chhetri had highest
percentage (35 percent), others including Dalits had occupied less than two (1.7). The
percentage of under privileged group was insignificant. Other privileged casts occupied
more than 98 percent. Number of Dalits and other under privileged casts was very low.
Giri was a special caste, which comprised one fifth of total population (20 percent).

Table 2: Ethnic distribution of pregnant women
Ethnic distribution
Intervention group(n = 60)
Brahmin11 (18.3)

Control group(n = 60)
9 (15)Total
20 (16.7)

Chhetri20 (33.3)

22 (36.7)

42 (35.0)Newar

15 (25.0)

11 (18.3)

26 (21.7)Giri

8 (13.3)

16 (26.7)

24 (20.0)

Tamang ,Gurung

5 (8.3)

1 (1.7)6 (5.0)

Others1 (1.7)

1 (1.7)2 (1.7)

There were only two religions in the study. More than three quarter of population ofsubjects belonged to Hindu religion (79.2) while Buddhism occupied remaining one
quarter.

Number of Hindus was more predominant in intervention group than incontrol group while Buddhists were relatively more in control group than inintervention.

Table 3: Religion distribution of pregnant women
ReligionIntervention group(n = 60)

Control group(n = 60)

Total

Hindu

52(86.7)

43(71.7)

95(79.2)

Buddhist8(13.3)17(28.3)25(20.8)29

Occupation of most of study subjects was agriculture (90.8 percent). No of mother
having occupation of service, business and house wife was less than 10 percent (9.1
percent). Number of mothers with service was only one (1.7 percent). In total status ofservice holders was less than one (0.8), percentages of business and housewife was 5.0
and 3.3 respectively.

Table 4: Occupation distribution of pregnant women
Occupation ofpregnant women
Agriculture

Intervention group(n = 60)
54(90.0)

Control group(n = 60)
55(91.7)

Total
109(90.8)

Service1(1.7)

01(0.8)

Business3(5.0)

3(5.0)

6(5.0)

Housewife2(3.3)

2(3.3)

4(3.3)

4.2 Literacy and educational status of pregnant women
Educational status of study subject was much better than other general pregnant
mothers because they were aware of antenatal checkup and care of pregnancy. They
were self referred cases attending antenatal clinic of Chautara Hospital for antenatal
check up and care of pregnancy. Regarding literacy of study subjects, no of illiterates
was only 5 percent, rest of the subjects were literate (95 percent). Among the literates
less than four percent were higher secondary graduates (3.3 percent) remaining subjects
have completed either primary or secondary level of education both in equal
percentages (45.8 percent). There was no significance difference between intervention
and control subjects. There is no one in higher secondary level of education in thecontrol group.

Table 5: Literacy and educational status of pregnant women
Literacy Status
Intervention group
Control group(n = 60)
Literate

56(93.3)(n = 60)
58(96.7)

30

Total

114(95.0)

Illiterate4(6.7)

2(3.3)

6(5.0)

Illiterate4(6.7)

2(3.3)

6(5.6)

Primary (up to grade5)25(41.7)30(50.0)55(45.8)

Secondary (6 to 10

27(45.0)28(46.7)55(45.8)

04(3.3)

Educational Status

grade
Higher secondary (104(6.7)

plus 2)Type of the family was also similar to the other similar geographical regions. Morethan 3 families out of five (62.5 percent) were of joint in type, rest of the families wereof nuclear in type (37.5 percent). There was very much similarities between
intervention and control group. Regarding location of household almost all (100percent) households were located in rural setting because of sociogeographical situationof the district. Chautara the head quarter of Sindhupalchowk district itself was a ruralcommunity.

4.3 Knowledge about iodized salt (Aayonoon) and its use
There was a couple of studies done to find out the status of IDD in Sindhupalchok
district in the past. Studies have shown that still the no of house holds using salts otherthan iodized salt was still very high. This study has shown that the no of subjects who
knew about iodized salt (Aayonoon) and its use was very high than previous study. Noof study subjects who knew about iodized salt was nearly universal (98.3
percent).Those who didn’t know about Aayonoon were less than 2 percent. Considering
the percentages of use of iodized salt, four out of five (82.5 percent) study subjects
were using iodized salt in their family. Only less than one out of five (17.5 percent)were using salts other than Aayonoon. There was not much difference between subjectsof intervention and control group in the use of iodized salt.

31

Table 6: Knowledge about iodized salt and its use
Characteristics

Intervention

Control group

group(n=60)(n=60)

Total

Heard about
iodized saltYes

58 (96.7)

60 (100)

118 (98.3)

No

2 (3.3)0

2 (1.7)Yes

50 (83.3)

49 (81.7)

99 (82.5)No

10 (16.7)

11 (18.3)

21 (17.5)

Use of iodized salt

32Percentage wise distribution of duration of use of iodized salt among the families ofstudy subject is depicted in table. Which shows nearly half of the families were using
iodized salt for more than 3 years. Percentages of families using less than one year was
still one out of five (18.3 percent). Nearly one third of the families were using iodized
salt for 1 to 3 years duration.
Table 7: Duration of use of iodized salt by subjects
Duration of use

Intervention

Control groupof iodized salt

group(n=60)(n=60)

Total

Less than 1 year

11 (18.3)

11(18.3)

22 (18.3)

1 to 3 year

15 (25.0)

24 (40.0)39 (32.5)

More than 3

34 (56.7)

25 (41.7)

59 (49.2)

years
Similarly persons who advised to use iodized salt to the families of study subject arealso presented. Less than half of the families of study subject were advised to takeiodized salt by neighbors. Percentages of advice given by health workers and family
members to use iodized salt were nearly equal (7.6 and 8.4 percent). Less than 6 (5.9
percent) percent of families of subjects were advised to use iodized salt by the teachers.
One third (32.8 percent) of subjects were not advised by anyone to use iodized salt.
Neighbors were common source of advice to the families of pregnant women withpercentages of 33.9 and 56.7 respectively in both control and intervention group. There
was no significance difference between intervention and control group about advice
given to use iodized salt to their families.

Table 8: Persons who advised to use iodized salt to subjects
Who advised toIntervention
Control groupuse iodized salt

group(n=60)

Total(n=60)None

20 (33.9)

19 (31.7)

39 (32.8)

Health worker

7 (11.9)2 (3.3)9 (7.6)33

Neighbor20 (33.9)

34 (56.7)

54 (45.4)

Family members

5 (8.5)5 (8.5)10 (8.4)

Teacher

7 (11.9)07 (5.9)4.4 Pregnancy related characteristics of intervention and control
group
Different characteristics related to pregnancy were studied with the help of structured
questionnaires and physical examination forms in both the subjects of intervention andcontrol group. Both the subjects belonged to similar circumstances presenting similar
characteristics for comparison. Characteristics were compared between intervention
and control and also between pre and post intervention in the same study subjects.

Parity of intervention and control group is presented in the table. Three out of fivepregnant women (59.2percent) were primigravida. Two out of three pregnant women
were second gravida and less than 8 percent of pregnant women were

multigravida.

There was no significance difference between intervention and control group.

Table 9: Parity of subjects
Parity of subject
Intervention

Control group

Total

group(n=60)(n=60)

Gravida 1

36(60.0)35(58.3)

71(59.2)

Gravida 221(35.0)19(31.7)

46(33.3)

More than gravida 23(5.0)

6(10.0)9(7.5)

34

Status of antenatal check up of pregnant women of intervention and control group ispresented in the table, which has revealed that status of antenatal check up in both thegroups was universal (96.7 and 96.7 percent). Less than four (3.3 percent) percentage
of pregnant women did not have antenatal checkup.

Table 10: Status of antenatal check up of subjects
Ante natalIntervention
Control groupcheck up

Totalgroup(n=60)(n=60)

Yes

58(96.7)

58(96.7)

116(96.7)

No2(3.3)

2(3.3)

4(3.3)

More than two third (43.3percent) of subjects had completed second antenatal visit.
Nearly one third (30 percent) of the pregnant mothers had completed first visit.
Pregnant women those not attending ANC at all and those attending more than third
visit were 3.3 and 3.3 percent respectively. Number of subjects those attending at later
visits ie third and fourth visits in intervention group were nil while number of subjects
attending first and fourth visits were relatively less in control group.
Table 11: Status of antenatal visits
No. of ANC
Intervention
visitsgroup(n=60)

Control group(n=60)

Total

None

2 (3.3)2 (3.3)4 (3.3)First visit

35 (58.3)

1 (1.7)36 (30.0)

Second visit

23 (38.3)

29 (48.3)

52 (43.3)

Third visit0

24 (40.0)

24 (20.0)

Fourth visit

04 (6.7)4 (3.3)35

Pregnant women not vaccinated against tetanus even a single dose were less than six
percent only. Pregnant mothers having TT 1 vaccination were nearly three out five(55.8 percent). Numbers of mothers having TT 2 injection were less than two out of
three (38.3 percent) with a marked difference between subjects of intervention andcontrol group in TT1 and TT2 injection. Use of iron and folic acid tablets during
pregnancy is presented in following table which shows that only less than six (5.8 )percent of pregnant women were not taking iron and folic acid tablets at all. So the useof iron and folic acid tablet during pregnancy was universal.

Table 12: Status of TT injection and use of iron tablets
Characteristics

Intervention

Control groupof mothergroup(n=60)(n=60)

Total

No. of TT injectionNon5(8.3)

2(3.3)

7(5.8)TT 1

49(81.7)

18(30.0)67(55.8)

TT 2

6(10.0)40(66.7)

46(38.3)

Yes

55(91.7)

58(96.7)

113(94.2)

No

5(8.3)

2(3.3)

7(5.8)

Use of Iron tablets

36

Mean height among mothers of intervention group was 158.75 CM with a standard
deviation of 2.808. Mean weight of the same group was 56.12 Kg with a standard
deviation of 3.284. Similarly mean height of mothers of control group was 159.73 CM
with a standard deviation of 1.103 while weight of the same group was 57.87 Kg with astandard deviation of 2.960.

Table 13: Mean weight and height of subjects
Characteristics
Intervention
Control group

Total

group(n=60)(n=60)

Mean height in

158.75 ( SD

159.73 (SD 1.103)

159.24 (SD 2.181)

CM

2.808)

Mean weight in

56.12 (SD 3.284)

57.87(SD 2.960)

56.99 (3.235)

KG

4.5 Maternal outcomes among intervention and control group
Maternal out comes were described as types of delivery , duration of third stage ,amount of blood loss , any complications , status of referral and duration of pregnancy
at delivery. These were considered as the standard indicators of maternal out come.
Each component of maternal outcomes were analyzed and presented according to theobjectives. Less than half of the deliveries were normal (45 percent), one out of threedeliveries were combined with episiotomy followed by normal delivery with tear which
was 15.8 percent. Only five percent of deliveries were complicated needing assistance.
There was no significance difference between the deliveries of intervention and control
group.

Table 14: Type of delivery of intervention and control subjects
ControlType of delivery
Intervention
group (n=60) group(n=60)
Normal delivery
27(45.0)27(45.0)

Total
54(45.0)

Normal delivery withepisiotomy
Normal delivery with tear21(35.0)20(33.3)

41(34.2)

10(16.7)9(15.0)19(15.8)

Assisted delivery2(3.3)

4(6.7)

6(5.0)

37

Four out of five (80.8 percent) deliveries had third stage of less than 30 minutes while
one out of five (19.2 percent) had prolonged third stage (more than 30 minutes). The
difference between intervention and control group was not significant. Amount ofblood loss was measured in milliliter. Nearly 90(89.2) percent of deliveries had lost lessthan 200 and more than 50 ml of blood while less than eight (7.5) percent had lost morethan 200 ml of blood during delivery.
Table 15: Duration of third stage and amount of blood loss
Duration of third
Intervention
Control
Total
stage in minutes
group
group(n=60)(n=60)
10 to 30 minutes
50(83.3)
47(78.3)
97(80.8)

More than 30 minutes 10(16.7)

13(21.2)

23(19.2)

P-valueAmount of blood loss in mlLess than 50

2(3.3)

2 (3.3)4 (3.0)50 to 200

55(91.7)

52(86.7)

107(89.2)

More than 2003(5.0)

6(10.0)9(7.5)

0.582

More than ninety (92.5) percent of the mothers had delivered between 38 to 42 weeks
of pregnancy which is considered as normal. Only less than 7.5 five percent pregnant
women had delivered before 38 weeks of gestation. None had delivered before 29 andafter 42 weeks of gestation. The difference in duration of pregnancy is statisticallysignificant between intervention and control group. The difference in weight ofpregnant mother before and after intervention of at least three months duration is also
statistically significant.

38

Table 16: Period of gestation at delivery and mean weight of subjects
Period of gestation
Intervention
ControlTotal
in weeks

group (n=60)

P-valuegroup(n=60)

29 to 3709(15)9(7.5)

0.002

38 to 4260(100)51 ( 85.0)111(92.5)

More than 42

0

0

0

Mean weight in Kg

Pre intervention

Post intervention-

Mean weight in KG

56.12

59.62)-

Standard deviation

SD = 3.284

SD = 3.325

-

0.000

4.6 Perinatal outcomes
Perinatal outcomes comprises of fetal maturity, weight of newborn, general conditionof fetus, fetal length perinatal morbidity and mortality. These indicators were analyzed,
computed and compared to find out the difference between intervention and control
group. Mean weight of newborn in intervention group was 3.333 Kg with a standard
deviation of 0.2515; similarly weight of newborn in control group was 3.046 Kg with astandard deviation of 0.4408. Weight of newborn was highly significant between
intervention and control group. Similarly length of newborn was also statisticallysignificant.

Table 17: Mean weight and length of newborn
Weight ofIntervention

Control

newborngroup

group(n=60)(n=60)

39

Total

P-valueMean weight (SD)

3.333 (0.2515)

3.046 (0.4408)

-

0.000

Mean length (SD)51.00 (1.507)

50.18 (1.546)

-

0.004

More than half of newborn (55.8 percent) had fair general condition during birth. Morethan one third of new born (35.8) had good general condition and less than nine (8.3)
percent had poor general condition. Regarding cry of the new born , nearly four out offive babies ( 78.3 percent) had active cry while one out of five babies had moderate andless than three(2.5) babies had poor cry. There was no significant difference in generalcondition and cry of newborn between babies of intervention and control group.

Table 18: General condition and cry of newborn
Characteristics ofIntervention group Control
Total
newborn(n=60)
group(n=60)

P-value

General condition of newbornGood26(43.3)

17(28.3)

43(35.8)
0.221

Fair

30(50)

37(61.7)

67(55.8)

Poor4(6.7)

6(10)10(8.3)50(83.3)

44(73.3)

94(78.3)

Cry of newborn
Active0.152
Moderate

10(16.7)

13(21.7)

33(19.2)

Poor0

3(5.0)

3(2.5)

40

Almost three quarter (75.8 percent) of newborns were pink in color at birth. Less than
one quarter (23.3 percent) newborns were pale at birth and less than one (0.8) percentof newborns were blue at time of child birth. Similarly four out of five (78.3 percent)babies newly born were sucking well while less than six (5) percent newborn were
sucking poorly. Color of newborn and sucking were not statistical significant between
intervention and control group.
Table 19: Color and sucking of newborn
Characteristics Intervention group Control groupof newborn(n=60)(n=60)

Total

P-value

Color of newborn

Pink

44(73.3)

47(78.3)

91(75.8)
0.434

Pale

16(26.7)

12(20.2)

28(23.3)

Blue01(1.7)

1(0.8)

48(80.0)46(76.7)

94(78.3)

Sucking

Well

0.233
Moderate

11(18.3)9(15.0)20(16.7)

Poor

1(1.7)

5(8.3)

6(5.0)

Initiation of breast feeding to feed colostrums was studied in recently delivered motherduring their hospital stay to know the status of knowledge of importance of early breast
feeding. Three quarter (76.7 percent) of mothers had first breast fed their babies with in
10 to 30 minutes of delivery. Nearly one out of five (18.3 percent) babies was breast
fed with in 30 to 60 minutes of child birth. Percentage of newborn who were breast fed
before 10 minutes and after one hour of birth was less than five. The difference in41

initiation of breast feeding to their babies was statistically significant between
intervention and control group.

Table 20: Initiation of breast feeding of newborn
Breast feeding of Intervention group Control group
newborn(n=60)(n=60)

Total

Less than 105(8.3)

05(4.2)

10 to 30

50(83.3)

42(70.0)92(76.7)

30 to 605(8.3)

17(28.3)

22(18.3)

More than 60

01(1.7)

1(0.81)

P-value

0.004

4.7 Laboratory characteristics of study subjects
To know the status of thyroid hormones of study subject, biochemical indicators wereused. To know the difference in thyroid profile before and after intervention thyroid
function tests of intervention subjects were performed, data collected, analyzed andcompared. Among the three hormones thyroxin (T4) was significantly different
between pre intervention and post intervention. Rest of the hormones, triiodothyronin(T3) and thyroxin (T4) did not show significant difference between pre and postintervention.
Table 21: Laboratory characteristics of study subject
Thyroid function test

Pre intervention
mean value
2.660 (0.7019)

Post intervention
mean value
2.798 (0.6407)

P-value

Thyroxin(T4) ng

1.115(0.1777)

1.220 (0.1870)

0.000

Thyroid stimulating
hormone(TSH) IU

1.570 (1.1282)

1.655 (0.9143)

0.554

Triiodothyronin (T3) pg

42

0.097

Chapter V

Discussion
IDD is an important micronutrient deficiency disorder in Nepal. Long back in someisolated mountainous areas of Nepal, most of the adult women had goiter and 10
percent of were cretins (severest IDD) population. 4

Status of IDD has been improved a lot in last 3 decades. Since the introduction of
iodized salt prevalence of using of Aayonoon has been improving. A couple of studies
done in Sindhupalchok and neighboring district Kavre (Current IDD status assessment)
2004 has shown increasing trend in use of iodized salt and decreasing trend of iodine
deficiency disorders but not to the satisfactory level. Reports of those studies havepointed out Sindhupalchok as a district of iodine deficiency disorders with fairly highprevalence. Different national and sub national level studies done in past and some of
the recent studies have identified IDD is still prevalent in most of the mountainous
districts of Nepal. 35 Depending upon the reports of those studies we have selectedSindhupalchok as a study district. Our objectives of doing study in Sindhupalchok is tofind out the status of iodine deficiency disorders among pregnant women and impact of
iodine intervention during pregnancy to the perinatal outcomes in the same group.
Demographic characteristics of subjects were studied to know the relation of thosefactors with the pregnancy outcomes. Age distribution of pregnant mothers showed that59 .2 percent of mothers belonged to 20 to 35 year age group, 40 percent of the
respondents were below 20 years. This is greater than national figure. Pregnant women
having age of more than 35 year were less than 1(0.8) percent which is better thannational figure. There were similarities in age distribution between both groups.
Number of adolescent pregnancy was still high as compared to national context. Meanage of pregnant mother was 22.1 years. Ethnically, distribution of subjects is diverse.
Majority of study subjects belonged to Chhetri, followed by Newar (21.7 percent), Giri(20 percent) and Bramin (16.7 percent). Tamang and Gurung were 5 percent. Others
minorities were less than 2 (1.7) percent. Hindu was the most common religion (79.2
percent) followed by Buddhism (20.8 percent). Agriculture was most important
occupation of subjects (90.8 percent). Service, business and housewife altogether
comprised 9.2 percent. Almost (95 percent) of subjects were literate, among them43

completing primary and secondary level education were 45.8 percent each. Number
completing higher secondary level was less than 4 percent. Three out of five (62.5
percent) pregnant women lived in joint family while 37. 5 percent lived in nuclear
family. Being mountainous district almost all (100 percent) households were located inrural area. Knowledge about iodized salt was universal (98.3percent) which was better
than previous report. 35 Use of iodized salt (salt with two children logo) was fair (82.5
percent ) among the subjects which was fairly good than 2004 report. 35

Among those who were using iodized salt, 49.2 percent were using it for more than 3
years shows that awareness about iodized salt is not that old. Majority of advice to takeiodized salt was given by neighbors (45.4 percent). 32.8 percent of respondents did not
get advice from any means. Role of health workers in giving advice was minimal (7.6
percent).

Pregnancy characteristics of subjects were described in terms of parity of mother, status
and number of ANC visit, number of TT injection and use of iron plus folic acid tablets.
Three out of five (59.2 percent) pregnant were primigravida, one out of three (33.3
percent) were gravida 2 and less than 8 percent were multi gravida (more than 2gravida). Almost all (96.7 percent) subjects had attended ANC which was extremely
high than national figure (Annual report FY 2062 -63). Percent of completing second
visit was 43.3 percent. Percentages of subjects those who had completed fourth visit
was 3.3 percent which was significantly less than national figure. 36 Majority (55.8
percent) of pregnant women were vaccinated against tetanus for once only while thenumber vaccinated twice for tetanus was 38.3 percent. Most of the subjects had taken
iron and folic acid tablets (94.2 percent) for 1 to 5 months. Mean height of pregnant
mothers was 159.73 cm with a standard deviation of 2.181.

Maternal outcomes were described in terms of type of delivery, duration of third stage,amount of blood loss in milliliters, period of gestation at delivery in weeks and mean
weight in kg before and after implementation of iodine capsule. 45 percent of deliveries
were normal followed by normal delivery with episiotomy, normal delivery with tearand complicated assisted delivery. A percentage of complicated assisted delivery was
5.8.Eight percent of deliveries had normal third stage (10 to 30) minutes. Majority ofdeliveries had lost moderate amount of blood (50 to 200ml). More than 90 (92.5)
44percent deliveries had completed weeks of gestation (38 to 42 weeks), which wasstatistically significant. Mean weight of mothers before and after intervention was
56.12 Kg with a standard deviation of 3.284 and 59.62 Kg with a standard deviation of
3.325 respectively with great statistical significance. One of the most exciting studies
done in Italy has come out with a finding that the rate of preterm delivery andmiscarriage was four to eight times higher in the mothers whose thyroid deficiency
disorder was not corrected. That was first study to demonstrate that in intervention
makes difference. 12

Perinatal outcomes were described in terms of mean weight, mean length, generalcondition, cry, color and sucking of newborn. Those outcome indicators were comparedand tested statistically between intervention and control group. Mean weight ofnewborns of intervention and control group were 3.333 Kg (SD= 0.2515) and 3.046 Kg(SD=0.4408) respectively with a high statistical significance. Similarly mean length ofnewborns of intervention and control group were 51.00cm (SD=1.507) and 50.18cm(SD=1.546) respectively with a statistical significance. Majority of newborns(55.8
percent ) had fair degree of general condition, 35.8 percent had good and 8.3 percent
had poor degree of general condition. Four out five (78.3 percent) newborns had active
cry, 19.2 percent had moderate and 2.5 percent of the newborns had poor cry.
Regarding color of newborn at delivery, 75.8 percent had pink, 23.3 percent had paleand 0.8percent of newborn had blue color at birth. Four out of five (78.3 percent)newborns sucked well, 16.7 percent had sucked moderately and 5 percent of babies hadvery poor sucking. Three quarters (76.7 percent) of the babies were breast with in 10 to
30 minutes of birth while 18.3 percent of babies were breast with in 30 to 60 minutes ofchild birth. Percentage of newborns that were breast fed beyond 60 minutes was 0.81.

Laboratory investigations were also performed to find out the significant biochemicaldifference between pre and post intervention. TFT was performed as an indicator to
identify the difference in thyroid hormone level of study subjects. Mean value of three
hormones, Tri-iodothyronin (T3), thyroxin (T4) and thyroid stimulating hormone(TSH) were computed to compare and test statistically. Mean values of T3 during preand post intervention period were 2.660 pg (SD=0.7019) and 2.798(SD=0.6407). In thisstudy there was no statistical significance in the mean difference of T3 between pre andpost intervention study.
45

Mean values of T4 during pre and post intervention period were 1.115 (SD=0.1777)
and 1.220 (SD = 0.1870) respectively with high statistical significance (P-value=0.000).
Similarly values of TSH in study subjects during pre and post intervention period were1.570(SD=1.1282) and 1.655(SD=0.9143) respectively. This study did not show
significant difference in TSH level between pre and post intervention study thoughelevated serum TSH, unless exceptional pathological situations indicates the potential
risk of iodine deficiency on brain development. There was no logical and biochemical
co-relation among the changes in hormonal level between pre and post intervention
period. Immediate effects may not be detected even if there is significant decrease inthyroid hormone level. This was recently reported by Haddow et al. 12, 20 The effects
will be detected in the mental development of their children, which needs to be tested
by IO of school age children. A population-based survey of 2000 pregnancies forthyroid function test during second trimester was performed which showed highconcentration of TSH (above six mu per liter) in 49 of the women, of whom 6 (3 per1000) had low serum free thyroxin concentrations. 31

46

Chapter VI

Conclusion and Recommendations

6.1 Conclusion
We conclude that regular supplementation of iodine along with iron and folic acidtablets during pregnancy preferably in first and second trimester, following systematic
screening for iodine deficiency disorders (especially for hypothyroidism) may be worth
while even when the degree of deficiency is mild and does not cause immediate clinicalmanifestations in the women. If routine screening were to be introduced, the mostconservative policy would be to perform at the first prenatal visit preferably in the firsttrimester. Intervention with standard maternal and neonatal health care package, regularsupplementation of iron folic should also be incorporated to achieve desired perinatal
outcomes. 93 percent of deliveries were full term, less than 5 percent deliveries werecomplicated, significance difference in mean weight gain during third trimester ofpregnancy following intervention, significance difference in mean weight and length ofnewborn and significance difference in thyroxin hormone level all these findings
supported to conclude the study. Finally regular supplementation of iodine in oral form
for more than three months during pregnancy preferably during early stage along withregular intake of iron and folic acid and intervention of standard maternal and neonatal
health care package will bring significant positive changes in perinatal (maternal andneonatal) outcomes . Intervention in early pregnancy is the important factor to achieve
expected out comes in the development of nervous system of newborn.

47

6.2 Recommendations•

Program of regular supplementation of iodine in oral form in iodine deficientarea during early stage of pregnancy can be implemented to avoid birth ofiodine deficient new born.

•

Integrated intervention of standard maternal and neonatal health care package
and oral iodine supplementation can be implemented to bring better perinatal
outcomes.

•

Regular intake iron and folic acid tablets and iodine capsules can jointly be run
together to get intended maternal and neonatal outcomes.

•

Early systematic screening of women in early stage of pregnancy during
prenatal visits to find out iodine deficiency disorders is recommended.

•

Campaign to raise awareness about the use of iodized salt especially in iodine
deficient areas is also recommended.

•

Regular monitoring of salt iodization in those iodine deficient areas should be
strengthened.

•

Further research on iodine intervention and pregnancy outcomes in a large scalein early stages of gestation followed by assessment of IQ of school age children
in the same subjects is recommended.

48

References
1. ICCIDD, UNICEF. Progress towards the Elimination of Iodine Deficiency Disorder(IDD).
2. WHO, the world Health Report 2002, was reducing Risks, Promoting Healthy Life
Geneva 2002.
3. Dunn JT. Glinoer D. 1993 Specific recommendations on iodine nutrition formothers and infants in Europe. In: Delange F, Dunn JT, Glinoer D, eds. Iodine
deficiency in Europe: a continuing concern. New York: Plenum Press; 478.
4. HMG, Ministry of Health (1967). Endemic Goiter in Nepal, WHO/SEA/26, October
1967.
5. HMG/N, New ERA, Micronutrient Initiative, UNICEF Nepal, and WHO.
6. NMSS (1998). Nepal Micronutrient Status Survey 1998. Katmandu, Nepal:
Ministry of Health, Child Health Division,
7. MoHP Department of Health Services National Nutrition Policy and Strategy(NNPS), 2004.
8. Glinoer D. The regulation of thyroid function in pregnancy: pathways of endocrine
adaptationfromphysiology

topathology.

EndocrRev

1997;

18:404-433.[Free Full Text]
9. Glinoer D, De Nayer P, Delange F, et al. 1995 A randomized trial for the treatmentof mild iodine deficiency during pregnancy: maternal and neonatal effects. J Clin
Endocrinal Metab. 80:258–269.
10. Hetzel, B.S., and Pandav, C.S. 1996. S.O.S. for a billion. The conquest of Iodine
11. Gardner LI. Historical notes on cretinism. In: Gardner LI, ed. Endocrine and genetic
diseases of childhood and adolescence. 2nd ed. Philadelphia: W.B. Saunders,
1975:234-8.
12. Haddow JE, Palomaki GE, Allan WC, et al. Maternal thyroid deficiency during
pregnancy and subsequent neuropsychological development of the child. N Eng J
Med 1999; 341:549-555.
13. Karmakar, M.G. & C.S. Pandav (1885). Iodine Deficiency Disorders in Nepal:
Monitoring and Quality Control of Iodated Salt, A Report, All India Institute ofMedical Sciences, New Delhi, May-June 1985.

49

14. WHO, the world Health Report 2002, was reducing Risks, Promoting Healthy Life
Geneva 2002.
15. MOH, MI, New ERA, 2005, Nepal Iodine Deficiency Disorders Status Survey
16. Pharoah POD, Connolly KJ, Ekins RP, Harding AG. Maternal thyroid hormone
levels in pregnancy and the subsequent cognitive and motor performance of thechildren. Clin Endocrinol (Oxf) 1984; 21:265-270.[Medline]
17. Corinne R. Fantz, Samuel Dagogo-Jack, Jack H. Ladenson and Ann M. Gronowski
Thyroid Function during Pregnancy 45: 2250-2258, 1999 Maternal Thyroid
Deficiency during Pregnancy and Subsequent Neuropsychological Development of
the Child
18. VOA. com. 13 December 2006, Physician Urges Tests for Thyroid Disease during
Pregnancy, News; Voice of America, New York19. Matsuura N, Konishi J. Transient hypothyroidism in infants born to mothers withchronic thyroiditis -- a nationwide study of twenty-three cases. Endocrinol Jpn
1990; 37:369-379. [Erratum, Endocrinol Jpn 1990; 37:767a.][Medline]
20. Utiger RD. Maternal hypothyroidism and fetal development. N Engl J Med 1999;
341:601-602.
21. Reinhardt W, Kohl S, Hollmann D, et al. 1998 Efficacy and safety of iodine in the
postpartum period in an area of mild iodine deficiency. Eur J Med Res. 3:203–210
22. Nøhr SB, Laurberg P. 2000 opposite variations in maternal and neonatal thyroid
function induced by iodine supplementation during pregnancy. J Clin Endocrinal
Metab. 85:623–627
23. Pedersen KM, Laurberg P, Iversen E, et al. 1993 Amelioration of some pregnancyassociated variations in thyroid function by iodine supplementation. J Clin
Endocrinol Metab. 77:1078–1083.
24. Daniel G, Nayer PD, Delange F, Lemone M. A Randomized Trial for the Treatmentof Mild Iodine Deficiency during Pregnancy. Journal of Clinical Endocrinology
and Metabolism
25. Maternal and Neonatal Effects, 1995, by U.S.A
26. Mandel SJ, Larsen PR, Seely EW, Brent GA. Increased need for thyroxin during
pregnancy in women with primary hypothyroidism. N Engl J Med 1990; 323:91-96.
27. Dussault JH, Fisher DA. Thyroid function in mothers of hypothyroid newborns.
Obstet Gynecol 1999; 93:15-20.

50

28. WHO. A statement by the WHO. Safe use of iodized oil to prevent iodine
deficiency in pregnant women.
29. Delange, F., Dunn, J.T., and Glinoer, D. 1993. Iodine Deficiency in Europe. A
continuing concern. New York: Plenum Press publ. 1-491 pp.
30. Laurberg P, Pedersen KM, Hreidarsson A, Sigfusson N, Iversen E, Knudsen PR.
1998 Iodine intake and the pattern of thyroid disorders: a comparative
epidemiological study of thyroid abnormalities in the elderly in Iceland and in
Jutland, Denmark. J Clin Endocrinal Metab. 83:765–769.
31. Klein RZ, Haddow JE, Faix JD, et al. Prevalence of thyroid deficiency in pregnant
women. Clin Endocrinol (Oxf) 1991; 35:41-46.[Medline]
32. Department of Health Services, MoH, Nepal. Annual report (2061/62)
33. UNICEF /WHO. Website available at
34. WHO. Iodine Status Worldwide, WHO Global Database on Iodine Deficiency,
2004
35. Joshi AB, Banjara MR, Rikimaru T and Pandey S. Assessment of Current Status of
IDD for the Development of Future Control program JICA Nepal. 2004.
36. DOHS, UNFPA .Annual Report 2004 -2005. 2006, Nepal
37. ACC / SCN. Micronutrient update, 4th Report on the world Nutrition situation,
2000
38. DOHS, NPHA, WHO. National Health Prevention and Treatment protocols 2005,
Nepal
39. Deficiency Disorders. 2nd Ed. Delhi: Oxford University Press publ. 1-466 pp.
40. Hetzel, B.S. The Story of Iodine Deficiency: An International Challenge. New
York: Oxford University Press, 1989.
41. http://indorgs.virginia.edu/iccidd/www.thyroidmanager.org.

(Micronutrient

Initiative, Kiwanis International ).
42. MOH, UNICEF, WHO, MI, New ERA Ltd.1998, Nepal Micronutrient Status
Survey.
43. MOHP, New Era. Demographic Health Survey 2006, Nepal
44. MoH, WHO, UNICEF, New ERA. Nepal Micronutrient Status Survey, 1998.
45. Pop VJ, Kuijpens JL, van Baar AL, et al. Low maternal free thyroxin
concentrations during early pregnancy are associated with impaired psychomotor
developmentin

infancy.

Clin

Endocrinol

155.[CrossRef][Medline]
51

(Oxf)

1999;

50:149-

46. Susanne B. Nøhr A. Jørgensen K. Pedersen M. and Peter L.The Journal of Clinical
Endocrinology & Metabolism: Vol. 85, No. 9 3191-3198 Copyright © 2000 by the
Endocrine Society
47. UNICEF. State of the Worlds Children 2004
48. UNICEF. Indicators for assign iodine deficiency disorders & their control throughsalt iodization, New York, 1994.
49. Zulewski H, Muller B, Exer P, Miserez AR, Staub JJ. 1997 Estimation of tissue
hypothyroidism by a new clinical score: evaluation of patients with various gradesof hypothyroidism and controls. J Clin Endocrinol Metab. 82:771–776. Delange F,
Dunn.

52

Annexes
Survey Questionnaire for Pregnant women(Questions need to be asked to all pregnant women & general physical & obstetricalexamination of the same should be performed)

1. General information
Date (dd/mm/yy):// 2064

ID no.

Name of respondent:

Age: ………

Religion:

Caste/ Ethnicity:

District:

Village/Tole

VDC/ Municipality:

Ward number

Occupation (write clearly type in brief):

Education:

1) Can’t read write2) Can read and write
3) Primary level school (up to 5grade)
4) Secondary level school (6 to 10 grade)
5) Higher Secondary education (10 plus grade)6) University education

1. Type of family

1) Single (nuclear)

2) Joint

53(In completed years)

2. Location of the household

1) Rural2) Urban

2. Knowledge on iodized salt

3. Have you ever heard about iodized salt?

1) Yes2) No

If yes, what was the source?

1) Radio

2) T V3) News Papers

5) Don’t know

4. Do you use iodized salt?

1) Yes2) No

5. Since when are you using iodized salt?

…………………………………………. (Years/months)

6. Who suggested you to use iodized salt?

1) Health personnel
2) Neighbor3) Family members
4) Teachers5) Others (specify)

544) Others ……

3. Knowledge on IDD
7. Do you know any symptoms or disease caused by iodine deficiency?
1) Yes2) No

If yes, what are they?
a)
b)
c)

8. Is any member of your family has been suffering from goiter?

1) Yes

Q.N.

2) No

Questions and filters

Answers

Answeror Code9.
How many times did you

Number of conceptions

conceive?

10.
How many times did you

Number of live births

have live births

11.
What is the number of living

Number of living children

children?

12.
What is the period of

Period of amenorrhea (in months)

amenorrhea of last
pregnancy?

13.
What is the date of your last
menstruation?

LMP:(dd/mm/yy)// 206455

Skip

If yes mentions relation to the pregnant women ………………

Age (in years)……………

4. Knowledge about Maternal care:14.
Did you see anyone for ANC

1 Yes_______(antenatal care)?

0 No

Whom did you see?

1 Doctor

If
Skip

15.
_______

2 ANM
3 MCHW
Only one answer

4 Other

Do you have a maternal

1 Yes

health card?

0 No

Record from the card

Number of visits_______

Number of TT vaccines_______

Number of times_______

1.

Delivery preparation______

During your ANC were you

2.

Breast feeding______

counseled on the following?

3.

Child spacing______

4.

Immunization

16.
_______Skip

17.

A Number of ANC visits
B Number of TT vaccines

18.
How many times did you see
someone for care during the
Pregnancy?
For woman not having card

19.

Multiple answer possible
Read the options

5. Danger signs of pregnancy____________

6. No counseling_______

20.
For how long did you

If No,

Number of ---------days

consume iron pills/folic acid?

56

No,

21.
Do you know about danger
signs /symptoms during
pregnancy?

1 yes
0 no

What danger
signs/symptoms require
immediate medical
assistance during delivery?

O Do not know
A Fast and difficult breathing
B Bleeding from genital tract
C Swelling of legs, arms, face
D High fever
E High blood pressure
F Blurred vision
G Anemia
H Persistent vomiting
I Fainting/fitting
X Others-----------

If no skip

22.

Multiple responses
possible Record all
responses
Don't read the options

23.
Do you have any difficulty to
see in dim light during thispregnancy?
(Question regarding Nightblindness during
pregnancy)

1 Yes
0 No
Don’t know

24. Iodine content in the Salt sample
1. Sample I1)10 PPM

2)Below 15 PPM

3)Above 15 PPM

2. Sample II1) 0 PPM

2) Below 15 PPM

3) Above 15 PPM

Name of enumerator:

Designation:

Signature:

Name of the clinic:

Date:

57

Iodine Supplementation and Pregnancy Outcomes among Pregnant Women in
Sindhupalchok

Consent FormThank you for agreeing to participate in this study and being interviewed. The
examination results of the study will be shared with you. You have agreed to answer a
few questions, perform physical and laboratory examination. You have the right to stop
the interview and examinations at any time.

……..yes, I agree to be interviewed and examined……..No, I do not agree to be interviewed

Print Name: …………………………………..

Participant’s Signature:……………....................

58

Date: ……………………..

Respondents’ initial Physical Examination Form
ID No.
Name of the respondents
Address:
No of visits

Date of examination
Age in Yrs.
………………… VDC/Municipality …………..W.No…………………. District

1. VitalsBP
Pulse
Temperature (F)Height (CM)Weight (Kg)
BMI

5.

Other examination if any:

2 General
Skin color, Pallor, Jaundice
Edema

6.

Advice given to the mother
About care of pregnancy, delivery,

newborn
3 Neck:Thyroid swellingStage I
Stage II
Stage III
4 Abdominal
Height of the fundus (in weeks)

About Iodine supplementation

Diagnosis (along with POG)……………………………..

Fetal parts palpable or not
Presentation
Lie
Head of the fetus
FHS
Liquoradequate
not adequate
Lab. Investigation
Blood: HB
…gm%
Group
Rh typing
Sugar (R)VDRL
Serum:HBsAg
HIV
Serum thyroid profile:
T3,
T4,
TSH

Urine:
routine
Sugar
AlbuminUrine iodine estimation in mcg

Name of the enumerator:
Name of the clinic
Location:

Designation:
signature59

Respondents’ Follow up Physical Examination Form

ID No.

Date of examination:

Name of the respondents:

Age in Yrs…………

//

Address: …………….……………… VDC………….Ward No……………………District
No of Follow up visits (Following Iodine capsule introduction): 1

2

3

1. Vitals
BP
Pulse
Height (CM)Weight (Kg)
BMI

5.

Other examination if any:

2 General
Skin color, Pallor, Jaundice
Edema

6.

Advice given to the mother4

5

About care of pregnancy, delivery,
newborn

3 Neck:Thyroid swellingStage I
Stage II
Stage III
4 Abdominal
Height of the fundus (in weeks)

About Iodine supplementation

Diagnosis (along with POG)……………………………..

Fetal parts palpable or not
Presentation
Lie
Head of the fetus
FHS
Liquoradequate

Not adequate

Name of the enumerator:
Name of the clinic
Location:

Designation:
signature60

Respondents’ final Physical Examination Form (Post Intervention)
ID No.
Date
Age (Yrs).
Address:…………..W.No
No of visits ……………….

Name of the respondents
Dist: …………………
Name of the Hospital/ Institution:

History of medication (months): iodine capsule
1. Vitals
BP

VDC/Municipality

Iron folic acidothersmm of Hg

Pulse

per minuteTemperature

HeightCM

WeightKg

BMI

2. General
Skin color

PallorJaundice

Oedema3. Neck for thyroid swelling
Grade I

Grade II

Grade III

0F

4. Abdominal examination
Fundal heightweeks

Presentation

Position of fetus

Head of the fetus

engaged

fixed

free

FHS

regularirregular

absentPolyhydramnous

oligohydramnious

per minuteLiquoradequate

5. Other examination if any:
6. Obstetric findings (including PV findings):
Dilation of os

CM

Effacement

StationLiquorPresentation

Cephalicclear

Membranethin muconeum

frank muconeum stained

BreechCompound7. Complete Diagnosis (including Period of gestation):
8. Delivery findings:
Type of delivery
Sex of baby

Date of delivery
M/F

Weight of baby:

Condition of baby: Poor / Fair / Good
Amount of blood lossml

9. Condition at discharge

MotherTime of delivery
Kg

Length of baby

Delivery of placenta (3 rd stage):

Condition of Mother:

Poor

fair

Good

Baby

10. Lab investigation (Post intervention): T3
11. Delivery conducted by:

Gm

T4

Name

TSH
Designation

12. Name of the institution:

61cm

Respondents’ final Physical Examination Form (Control)
ID No.
Date
Age (Yrs).
Address:…………..W.No
No of visits ……………….

Name of the respondents
Dist: …………………

History of medication (months):

Iron folic acid

1. Vitals
BP

VDC/Municipality

Name of the Hospital/ Institution:othersmm of Hg

Pulse

per minuteTemperature

HeightCM

WeightKg

BMI

2. General
Skin color

PallorJaundice

Oedema3. Neck for thyroid swelling
Grade I

Grade II

Grade III

0F

4. Abdominal examination
Fundal heightweeks

Presentation

Position of fetus

Head of the fetus

engaged

fixed

free

FHS

regularirregular

absentPolyhydramnous

oligohydramnious

per minuteLiquoradequate

5. Other examination if any:
6. Obstetric findings (including PV findings):
Dilation of os

CM

Effacement

StationLiquorPresentation

Cephalicclear

Membranethin muconeum

frank muconeum stained

BreechCompound7. Complete Diagnosis (including Period of gestation):
8. Delivery findings:
Type of delivery
Sex of baby

Date of delivery
M/F

Weight of baby:

Condition of baby: Poor / Fair / Good
Amount of blood lossml

9. Condition at discharge

MotherTime of delivery
Kg

Length of baby

Delivery of placenta (3 rd stage):

Condition of Mother:

Poor

fair

Good

Baby

10. Lab investigation (Post intervention): T3
11. Delivery conducted by:

Gm

T4

Name

TSH
Designation

12. Name of the institution:

62cm

Respondents’ initial Blood Examination Form
ID No.

Date of examination:

Name of the respondents:

Age in Yrs…………

//

Address: …………….……………….VDC……….…… W.No……………………………..District
No of Follow up visits (Following Iodine capsule introduction):

1

2

3

4

5

Serum thyroid profile:
T3,
T4,
TSH
Name of the enumerator:
Name of the clinic
Location:

Designation:
signature

Respondents’ Final Blood Examination Form
ID No.

Date of examination:

Name of the respondents:

Age in Yrs…………

//

Address: …………….……………….VDC……….…… W.No……………………………..District
No of Follow up visits (Following Iodine capsule introduction): 1

Date of delivery ……………… Sex of baby

M

F

2

T3,
T4,
TSH
Designation:
signature

63

4

5

.weight of baby ……Kg…..Gm

Serum thyroid profile:

Name of the enumerator:
Name of the clinic
Location:

3

SINDHUPALCHOWK

MotangHelumbu

Gumba

BaruwaGlocheTatopani

Thanpalkot
Ichok

GunsakotThampalChhap
Banskharka

Mahankal

Listikot

KiwoolPalchok
Dubachour

BhoteNamlang
Lagarche

Pangtang

Fulpingkatti
Dhuyang

BaramchiSelangHagam
MarmingJyamireGati
SipalKavre
MelamchiSindhukot
JalbireSyauleBazar
SikharpurNawalpur
Haibung
Maneswor
BataseKarthali
Bhotechaur Bansbari
Bahrabise
KunchokFulpingkot
Ghorthali
Pipaldada
Kubhinde
Badegau
RamcheChoutara
MankhaFatakshila SipaPokhare
GhuskunFulpingdandagau
Choukati
Sanusiruwari
TekanpurPagretarPiskarIrkhu
Bhimtar Bhotasipa
ThumPakhar Petaku
Kadambas
ThuloSirubari
Yamunadanda
TauthaliThakani Talramarang

Sangachok

Sunkhani
KalikaThokarpa

ThuloPakhar Jethal
Atarpur

Lisankhu
ThuloDhading64