الفهرس 
INTRODUCTIONOnly 14 pages are availabe for public view
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Abstract
Essential trace elements are especially important for such critical population groups as children and pregnant women. An inadequate trace element supply of pregnant women and the children’s growing organism can trigger a cascade of metabolism disorders and result in severe health disorders. Zinc deficiency has long been considered a common but overlooked problem in developing countries. Zinc deficiency in the mother creates a double risk for the child’s health. On the one hand, it increases the rate of pregnancy and delivery complications in women; contributes to deteriorating fetus development and fetus conditions and to increase newborn morbidity. On the other hand, zinc deficiency in the mother results in the infant’s inadequate micronutrient supply that reduces the rate of age-specific development and predisposes the child to increased morbidity.
In spite of this knowledge, the biological importance of micronutrients is not always taken into account in clinical practice. Nowadays, there are prerequisites for implementing a wide spectrum of clinical research in this field. In the last decade, experimental and epidemiological data have been accumulated and new highly sensitive and specific methods of accurate diagnosis of deficiency conditions have been developed.
Studies have been conducted to determine whether zinc supplementation will improve birth weight, maternal and fetal mortality and morbidity, but the results have been mixed, as many were conducted in well-nourished populations.
The present research was designed to evaluate the effect of zinc supplementation on the pregnancy outcome parameters. It was a double blind randomized controlled trial, conducted on pregnant women attending the health centres in Smouha and Moharam Bec for antenatal care. These two centers serve low and middle income pregnant population. Most of the pregnant women in this study were in the category of read and write or illiterate and most of them were not working.
The sample size required to enable detection of a men difference of 150 grams in birth weight with 80% power, 0.5 SD for each group 5% level of significance was estimated to be 534 (178 per each group).
The participants of this study were totally 1055 healthy pregnant women aged 20-45 years assessed for eligibility. Of these cases only 675 were low serum zinc level below the estimated median for the gestational age and were suitable for enrollment to the study .In this three arm design study, participants were randomly assigned to one of three parallel groups in 1:1:1 ratio .Participants of this study received supplements from 16 weeks till delivery .group 1 received placebo, group 2 received zinc and group 3 received zinc plus multivitamins .These 675 cases were followed up till delivery . During the period of follow up some cases developed complications, others were lost to follow up, so, those who completed the study were 199 cases in the placebo group, 198 in the zinc group and 200 in the zinc plus multivitamins group.
A subsample of 100 women of the study cases were assessed for their dietary intake. Dietary data were collected using 24-hour recall method and food frequency questionnaire.
A predesigned questionnaire interview was administered to the selected mothers to collect the study data and a precoded schedule was used to collect information concerning the mothers and newborns. It included:
A-Baseline data :
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• Socioeconomic data regarding, level of education of the parents, income and family size.
• Data concerning current pregnancy and labor.
• Data concerning newborn condition including accurate measurement of weight, length and head circumference.
• Dietary data were collected using a semiquantitative food frequency questionnaire. The nutritive value of the daily diet was computed using the Egyptian food composition tables (1996).
• Ultrasound was used for verification of gestational age for all cases enrolled to the study.
• Biochemical data: determination of ;
a. Blood hemoglobin level using the cynamethemoglobin method.
b. Serum zinc level using atomic absorption spectrophotometric technique.
c. Fasting blood sugar and urine analysis.
B-Follow up data:
This included:
1- Routine data obtained during antenatal care such as blood pressure, weight gain, hemoglobin concentration, fasting blood sugar and urine analysis. They were used for detecting complications and thereby excluding non-eligible cases. Hemoglobin concentration was measured by cyanmethemoglobin method.
2- A second estimation of the plasma zinc concentration at the 28th -32nd weeks gestation.
3- At least one ultrasound examination to all women in the three groups at 24-34th weeks f gestation to assess:
• Gestational age.
• Anthropometric measurements of the fetus.
Data on delivery, postnatal complications, birth weight and neonatal complications were obtained by a trained nurse/midwife during the postpartum home visits. Also, during the routine 1st visit of the newborn to the health facility for immunization and thyroid blood sample testing (1st week after delivery)
C-Delivery data:
• Place of delivery.
• Mode of delivery.
• 2nd and 3rd stage complications.
• Stillbirth or preterm delivery.
D-Neonatal data:
• Birth weight measured within 72 hours of birth to the nearest 10 gm.
• Head, chest and arm circumferences to the nearest 0.1 cm.
• Clinically apparent congenital malformation.
• Early neonatal morbidity, mainly infections.
Description and analysis of data were made by SPSS version ”11.5”.
Findings of the present study can be summarized as follows:
It is worth mentioning that, the placebo group is considered as the reference group against which the other supplemented groups are compared. In fact this group routinely received iron and folic acid as per the ANC program in Egypt. So, the results of this research are in favor of adding zinc and /or zinc plus multivitamins to obtain better outcome of pregnancy regarding the mother and the baby .
• Zinc intake among cases of the study represented 59.36%, 59.36% and 62% of the RDA for groups zinc, zinc plus multivitamins and placebo group respectively.
• The iron intake among pregnant women in this study was below 50% of the RDA, the mean intake of iron was 10.43, 9.30 and 10.09 for zinc, zinc plus multivitamins group and for placebo group respectively.
• The second measurement of zinc level after supplementation was changed from 58.556.87 to 75.077.44 among cases received zinc supplementation, and from 59.176.46 to 70.357.95 for the group received zinc plus multivitamins, and this change was significant . Meanwhile,the change after supplementation inside the placebo group was minimum and not significant ,it was 60.236.49 and it became 60.689.48.
• There was a positive effect of zinc supplementation on iron status of the pregnant women of the supplemented groups. As the heamoglobin level of cases in zinc and zinc plus multivitamins group was 10.6057 and 10.5661 compared to 9.9572 in the placebo group and this difference was significant (P = 0.001).
• There was no significant change regarding mode of delivery among the cases of the three groups of the study. (P= 0.58).
• Zinc supplementation was effective in reducing 2nd and 3rd stage complications among cases of the study who received zinc and zinc plus multivitamins compared to the placebo group; the effect of supplementation was significant. (P=0.001 and RR =1.428 ,1.345) for groups zinc and zinc plus multivitamins respectively .
• Still birth and preterm delivery were significantly lowered among cases supplemented with zinc and zinc plus multivitamins groups than placebo group, (P= 0.001). There were 1.5% (R.R= 1.117) and 3.5% (R.R= 1.059) preterm and still birth in zinc and zinc plus multivitamins groups respectively compared with 13.1% in the placebo group.
Effect of supplementation on the neonates:
• No effect of supplementation was reported on birth weight and other anthromponetric measurements of the neonates of the cases of the study groups.
• Also, there were no effect on the neonatal clinically apparent congenital malformation among the supplemented groups compared to the group received placebo (P= 0.46).
• There were significant effect of supplementation on the reduction of early neonatal morbidity in zinc and zinc plus multivitamins groups compared with the placebo group (P= 0.001), RR (1.71, 1.69) for groups zinc and zinc plus multivitamins respectively .