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Detection & management of anaemia in pregnancy in an urban primary health care institution.

Background & objectives: In India, anaemia in pregnancy remains a major public health problem associated with increased risk of low birth weight deliveries. A study was carried out at an urban primary health institution in Delhi, to assess feasibility of screening all pregnant women attending antenatal clinic for anaemia, identifying those with moderate anaemia (haemoglobin between 5.0 - 7.9 g/dl), administering intramuscular (im) therapy to them in the out-patient department (OPD), and observing the impact on maternal haemoglobin (Hb) levels and birth weight of the infant.

Methods: In the antenatal clinic all pregnant women were screened for anaemia. Women with Hb between 5.0- 7.9 g/dl were counselled and those who were willing, were given six intramuscular injections each consisting of iron sorbitol citric acid complex containing 150 [micro]g elemental iron, 1500 [micro]g folic acid, 150 [micro]g hydroxocobalamine acetate (vitamin [B.sub.12]). They were followed up through pregnancy and till delivery. Birth weight of infants of women who received therapy were compared with birth weight of infants born in DCMC.

Results: Over 80 per cent of 3698 women who attended the antenatal clinic were anaemic; 745 (20.1%) had Hb between 5.0-7.9 g/dl. Of these, 419 women agreed to take im therapy as outpatients; 367 took all 6 injections. Metallic taste on the tongue, nausea, vomiting and pain at the injection site were the side effects reported. The mean Hb even 9 wk after completion of therapy was only 9.6 g/dl. Mean birth weight in 340 women who completed the treatment was 2.8 kg--significantly (P<0.001) higher than birth weight in women who had Hb <8.0 g/dl at the time of delivery, but lower than birth weight of infants born to non anaemic women.

Interpretation & conclusions: In urban primary health care institutions, it is possible to screen pregnant women for anaemia, identify those with Hb between 5.0 and 7.9 g/dl and give them im therapy as outpatients. Use of a preparation with fewer and milder side effects, counselling and support of women who develop side effect may result in high compliance rates: 900 mg of elemental iron as iron sorbitol citric acid was insufficient to raise mean Hb beyond 9.6 g/dl. The dosage has to be increased to achieve optimal results in relation to maternal haemoglobin levels and birth weight.

Key words Anaemia--intramuscular iron--low birth weight--pregnancy

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Anaemia in pregnancy has been globally recognized as a major public health problem. Studies carried out in India during the 1950s and 1960s, had shown that in women attending antenatal clinics in medical colleges, prevalence of anaemia in pregnancy was over 80 per cent; and that maternal anaemia was associated with increased risk of low birth weight deliveries, maternal morbidity and mortality (1). Screening all pregnant women by haemoglobin estimation for early detection of anaemia and effective management of anaemia with oral or parenteral iron therapy had been incorporated as an essential component of antenatal care globally and in India (2-7). India was the first developing country to conceptualise (8) and initiate National Nutritional Anaemia Prophylaxis Programme (NNAPP) to prevent anaemia among pregnant women in 1973. The programme was modified and renamed as National Anaemia Control Programme in the nineties, because majority of pregnant women were anaemic during pregnancy and, therefore, required treatment for anaemia. However, the outreach and coverage of these programmes have been very low. Data from surveys carried out by Nutrition Foundation of India (NFI) (9), Indian Council of Medical Research (10) (ICMR), National Nutrition Monitoring Bureau (11) (NNMB) and District Level Household Survey (12) (DLHS) showed that there has not been any decline in the prevalence of anaemia in pregnancy. The Tenth Five Year Plan (13) emphasized the need for operationalization of universal screening for anaemia in pregnant women, early detection and appropriate management of anaemia including intramuscular (im) therapy for those with haemoglobin (Hb) between 5.0-7.9g/dl as a part of Reproductive and Child Health Programme. These recommendations have been implemented as a part of antenatal care in some medical colleges and district hospitals. But unlike other components of antenatal care such as tetanus immunization, detection and treatment of anaemia has not been incorporated as a part of antenatal care in primary health care settings. Unless this gets operationalized as an essential component of antenatal care in primary health care settings where majority of pregnant women get antenatal care, reduction in the prevalence of anaemia or its adverse effects is unlikely. The present study was undertaken in an urban primary health care institution to assess feasibility of screening all pregnant women attending antenatal clinic for anaemia; identifying those with moderate anaemia (Hb between 5.0 - 7.9 g/dl); administering intramuscular (im) therapy to them in the out patient department (OPD); and observing the impact of im therapy on maternal Hb levels and birth weight of the infant.

Material & Methods

The study was undertaken in the Defence Colony Maternity Centre (DCMC), New Delhi, between April 1, 2005 and December 31, 2006. The study consisted of four components: (i) standardization and quality control of Hb estimation by cyanmethaemoglobin method (14) and reorganization of the antenatal OPD routine to include Hb estimation in all new cases; (ii) Hb estimation in all women coming to the antenatal OPD to assess feasibility of screening all pregnant women for anaemia; (iii) Hb estimation in all women delivering in the hospital to assess association between anaemia and birth weight; (iv) women with Hb level between 5.0-7.9 g/dl, who had come to the antenatal clinic during the second trimester of pregnancy, without any prior iron medication, who did not have any systemic or obstetric problems and were living near the hospital were counselled for intramuscular therapy as out patients. Those who were willing were given six injections (each containing iron sorbitol citric acid complex corresponding to iron 150 mg; folic acid ip 1500 gg and hydroxocobalamine acetate BP corresponding to hydroxocobalamine 150 gg for six days) and were followed up during pregnancy and delivery.

In all women enrolled for components two and three, detailed obstetric history was taken; height (to the nearest mm using a microtoise), weight (to the nearest 100 g using a beam balance) and blood pressure (using mercury sphygmo-manometer) were measured; and obstetric examination findings were recorded. In women who delivered in the DCMC, Hb estimation was done and birth weights were recorded.

Those who received intramuscular therapy were followed up during pregnancy. Attempt was made to get repeat Hb estimation done 4-6 wk after completion of treatment; Hb estimation was repeated at the time of delivery (if delivered in DCMC). Information on women who received therapy but delivered in other hospitals was also collected. Efforts were made to keep in touch with all those who received IM therapy; (often through mobile telephone); and delivery details and birth weights were obtained in majority of women even if they had delivered in other hospitals.

Data were analysed using SPSS (version 10 SPSS Inc, Chicago, Illinois). The frequency distributions were computed for prevalence of anaemia. Means and SDs were calculated for various parameters. Students' t test was used for comparison between groups. Paired t test was used for assessing concordance between duplicates in Hb estimation and for assessment of impact of therapy on Hb status.

Results

Standardization and quality control of Hb estimation: In addition to the routine external (using the standards provided with the reagents) and internal quality control measures (running at least one sample from the previous day along with the samples for the next day) in the laboratory, as a part of the routine quality control, duplicate samples were taken from the same needle prick randomly once in about 8-10 women attending the OPD (422 women during the study period). In 71 women with moderate anaemia, repeat blood estimation was done from a second needle prick later. There was concordance between duplicates irrespective of the fact whether the blood sample was collected from the same needle prick or from a second needle prick later.

Operationalization of screening for anaemia in antenatal OPD: All pregnant women who came to the OPD were first sent for Hb estimation, urine examination, height, weight, and blood pressure recording; then obstetric history was taken and entered in the antenatal card. By the time this was done, their urine and Hb results were available and could be entered in the antenatal card. The doctor then examined the women and recorded findings. Based on their Hb level and period of gestation, all pregnant women were given appropriate advice regarding the management of anaemia.

Prevalence of anaemia: A total of 3698 women were screened during the study. Of these 10 (0.3%) had Hb <5.0 g/dl, 745 (20.1%) had between 5.0 and 7.9 g/dl and 2491 (67.4%) had between 8.0-10.9 g/dl. Only 452 (12.2%) women had Hb > 11g/dl. Majority of the women had mild anaemia. Severe anaemia was uncommon; 10 women with severe anaemia were immediately referred to tertiary care centres.

Effect of period of gestation on haemoglobin levels: The mean Hb level in relation to period of gestation was computed in 6348 samples obtained from women who had attended the antenatal OPD for the first time or had attended OPD earlier but not taken iron folic acid tablets regularly (Table I). The mean Hb declined from 10.3 g/ dl at 8 wk to 9.7 g/dl during 21-28 wk gestation; thereafter, the mean Hb rose to 9.9 g/dL by 36 wk. The mid-trimester fall in mean Hb was less than 0.5 g/dl.

Profile of women in relation to Hb status: There were no significant differences in the obstetric profile of women who were anaemic compared to those who were not. However, the mean body weights of anaemic women were significantly (P<0.001) lower as compared to non anaemic women (Table II).

Intramuscular iron therapy: During the screening for anaemia in the antenatal clinic, 745 women were detected to have Hb between 5.0 and 7.9 g/dl. Of these, 419 women expressed their willingness to come for iron injections daily. After a test dose, the maternity centre staff administered the injection was given. These women were advised to rest in the hospital for an hour after injection and were requested to report if they had nausea or vomiting. Those who had nausea, vomiting or giddiness were given symptomatic treatment and observed for an hour and then sent home. All these women were requested to come for intramuscular therapy at any time suitable for them on six consecutive days. Majority did so; even those who could not come on consecutive days did complete six injections over the next few days because the side effects were not severe or troublesome; 367 women (87.6%) received all the six injections, 10, 14, 12 and 16 women received 4, 3, 2 and 1 injection respectively. After completing the injections, these women were advised to take iron and folic acid (IFA) tablets from the antenatal clinic regularly. However, supply of IFA tablets during this period was erratic and compliance with regular oral iron and folate medication was poor.

The most common side effect was metallic taste on the tongue; 150 women had nausea and vomiting. They were given symptomatic treatment during the episode and anti-emetic tablets for use in case they get nausea at home and 196 reported pain at the site of injection; they were given paracetamol tablets. One woman developed infection at the site of injection and she was treated with antibiotics.

All women who received injections were advised to get their Hb levels checked at the clinic after one month and just before delivery. However, many women requested that Hb examination may be done when they come for antenatal check up, as they may not be able to come specially for Hb estimation and their requests were acceded to. Even at two weeks after therapy, the Hb levels of the treated subjects showed a significant (P<0.001) improvement. By nine weeks the mean Hb in the treated group was 9.7 g/dl (Table III).

Follow up Hb examination in third trimester after they completed the iron therapy showed that only 28 (7.6%) women had Hb [greater than or equal to] 11 g/dl; in 47 women (12.8%) the Hb levels were less than 8 g/dl and they were referred to the tertiary care hospitals.

Special efforts were made to follow up women who received intramuscular therapy till delivery and obtain information on birth weight. Of the 367 women who completed 6 injections, it was possible to trace 340 (105 who delivered in DCMC and 235 in other hospitals) and obtain information on birth weight. All of them except one (unexplained intrauterine death) had live births. Follow up after delivery was difficult; five women reported death of their infants in the neonatal period (2 from jaundice on second day, 2 with respiratory problems on third day and one due to prematurity on day 3). One mother reported a cot death after 2 months.

Effect of intramuscular therapy on birth weight: Data on birth weight and maternal Hb in all women who delivered in DCMC were analysed to assess the effect of maternal anaemia on birth weight. There was a progressive reduction in mean birth weight with decreasing Hb levels. The mean birth weight was lowest in women with Hb less than 8.0 g/dl (Table IV). Mean birth weight was higher in women who received intramuscular injections as compared to those women who had Hb between 5.0 and 7.9 g/dl at delivery.

Discussion

The first objective of the present study was to assess the feasibility of screening all pregnant women attending antenatal clinic in an urban primary health centre for anaemia. With provision of a colorimeter in the OPD laboratory and minimal modifications in the routine of the antenatal clinic, it was possible to ensure screening of all women attending the OPD for anaemia. This model could be replicated in other primary health care institutions in other urban and rural areas.

Data from the present study showed that even in a maternity centre located in relatively prosperous south Delhi area, the prevalence of anaemia was quite high; over two thirds of the women had mild anaemia, which is readily treatable through oral iron folate medication. About one fifth of the pregnant women had Hb levels between 5.0 -7.9 g/dl at the time of their first visit to antenatal OPD. Majority of these women reported in the mid trimester. For women who report in mid trimester with moderate anaemia but with no obstetric or systemic complication, intramuscular therapy is the mest appropriate option for improving haemoglobin levels in the short time available so that the mother and the foetus in utero benefit from improved maternal Hb.

During the fifties moderate anaemia in pregnancy was a major public health problem not only in developing but also in developed countries. Of the many parenteral iron preparations developed, two viz., iron dextran complex (Imferon) and iron sorbitol citric acid complex (Jectofer) have been widely used. Iron dextran complex has a high molecular weight, can be given intravenously (iv) (1,17-19) or intramuscularly (20,21). Iron dextran iv infusions are no longer used due to severe anaephylactic reactions. Intramuscular iron dextran was fairly widely used and response in terms of improvement in Hb was good (20-24). But arthralgia, arthritis and fever occurred as side effects. These symptoms readily respond to paracetamol medication but once the side effects occur the women are often reluctant to continue the injections. Iron sorbitol citric acid complex has molecular weight less than 5000. It is readily absorbed from the injection site (25,26) and response in terms of improvement in Hb is good (1,27,28). But about a third of the injected drug gets excreted in the urine, so a higher dosage has to be given. The major advantage with iron sorbital citric acid complex is that the side effects are relatively rare and mild (1,28,29).

In India, mojority of pregnant women report to antenatal clinic only in second trimester and time available for correction of moderate anaemia is limited. Also, bioavailability of iron in Indian diet is very low (3-5%) (30) and so even oral administration of 240 mg of elemental iron, along with folic acid and vitamin [B.sub.12] under supervision, did not result in correction of moderate anaemia (31). Many women discontinue oral iron medication, especially higher doses because of minor but persistent gastrointestinal side-effects. Because of all these problems, moderate anaemia in pregnancy continues to be a major problem in India and parenteral iron therapy (13,32-34) remains the optimal mode of management of moderate anaemia in mid trimester. Intramuscular iron therapy for treatment of moderate anaemia though in use in some medical college hospitals and has not been operationalized in primary health care settings.

As the reluctance for intramuscular therapy use stems mainly from side effects reported with iron dextran, it was decided to use iron sorbitol citric acid complex in the present study. The fact that over 80 per cent of the women who had been enrolled for im therapy came to the OPD for six injections indicated that the iron sorbitol citric acid complex was well tolerated. The high compliance rate may also be due to individualized counselling, administering injections at times suitable for women, reassurance and support by all the health personnel when side effects occurred.

Of the 367 women who had received 900 mg of elemental iron as iron sorbitol citric acid complex and had Hb levels estimated in the third trimester, 292 had Hb levels between 8.0-10.9 g/dl; only 28 had Hb levels over 11 g/dl. The increase in mean Hb levels over 8 wk after completion of intramuscular therapy was less than 2.5 g/dl. These data suggested that the dosage of iron sorbitol citric acid complex was inadequate to improve the Hb much beyond 8 g/dl in women who are having initial Hb of 5.0-6.0 g/dl range. In 47 women the Hb levels were less than 8.0 g/dl in third trimester after therapy; of these 16 women who had Hb done 4 wk or more after completion of iron therapy were considered as non-responders.

The mean haemglobin levels after im injection of iron sorbitol citric acid complex containing 900 mg of elemental iron was about 1.5 g/dl lower than the mean haemoglobin levels reported in an earlier study after an injection of 1000 mg of iron dextran complex (22). This might be because unlike iron dextran one third iron sorbitol citric acid complex gets excreted in urine and therefore there is a need for higher dose. Also the pregnant women in the present study were 5-7 kg heavier than the women in the earlier study (22).

Majority of women who had received 900 mg of iron as iron sorbitol citric acid complex had Hb between 8.0-10.9 g/dl and the birth weights of their infants were comparable to the infants of women with Hb between 8.0-10.9 g/dl but lower than the infants born to nonanaemic women. Based on our findings it can be suggested that pregnant women in Delhi with an average weight of about 50 kg in pregnancy with Hb between 5.0-7.9 g/dl may require about 1500 mg of iron as iron sorbitol citric acid complex to achieve optimal improvement in Hb and birth weight. As these women tolerated the injections well, continuing the injection for ten days may not pose major problems.

Cost of outpatient intramuscular therapy for six injections works out to be Rs. 270/- and for 10 injections Rs. 450/-. While the pregnant woman will have to bear the cost of travel, the cost of injections can be borne by the government. If the government supplies the drug to all such centres, more women may be able to access im therapy for moderate anaemia in the centres near their home. This will result in reduction in the travel cost incurred and time spent by the woman in travel. Flexible timing for administration of injection, counselling and support by the health personnel can result in good compliance rates and reduction in moderate anaemia and its adverse consequences in pregnant women.

Acknowledgment

Authors acknowledge financial support provided by the Indian Council of Medical Research, New Delhi and thank the staff of DCMC, Delhi and the officials of the Delhi Health and Family Welfare Department for their support. Assistance of Shri Kanti Prasad in Hb estimation, Shrimati Karuna Sharma in data entry and Dr Hema S. Gopalan in data analysis is thankfully acknowledged.

Received March 14, 2007

References

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Reprint requests: Dr Prema Ramachandran, C-13 Qutab Institutional Area, New Delhi 110 016, India e-mail: premaramachandran@gmail.com

Anshu Sharma, Rita Patnaik, Suman Garg * & Prema Ramachandran

Nutrition Foundation of India & * Defence Colony Maternity Centre, New Delhi, India
Table I. Hb levels (g/dl) in different periods of pregnancy

Gestation (wk) Mean Hb (g/dl) SD N

up to 8 10.3 1.12 105
9-12 10.2 1.21 260
13-16 10 1.11 517
17-20 9.9 0.99 741
21-24 9.8 0.98 824
25-28 9.7 1.03 953
29-32 9.8 1.03 1028
33-36 9.8 1.06 1077
>36 9.9 1.16 843

Table II. Obstetric and nutritional profile of pregnant women
in relation to Hb

Parameters Haemoglobin (g/dl)

 I - <5.0-7.9 II - 8.0-10.9

Age (yr) 23.7 [+ or -] 3.47 (755) 23.8 [+ or -] 3.64 (2491)
Gravida (no.) 2.0 [+ or -] 1.06 (755) 1.9 [+ or -] 1.03 (2491)
IPI (months) 30.5 [+ or -] 21.55 (436) 30.2 [+ or -] 20.29 (1335)
Height (cm) 151.0 [+ or -] 4.31 (477) 151.2 [+ or -] 4.99 (1186)
Weight (kg) 48.8 [+ or -] 7.35 (731) 49.9 [+ or -] 8.39 (2412)
Haemoglobin 7.6 [+ or -] 0.86 (755) 9.7 [+ or -] 0.71 (2491)
 (g/dl)

Parameters Haemoglobin (g/dl)

 III - [greater than or
 equal to]11.0

Age (yr) 23.6 [+ or -] 3.34 (452)
Gravida (no.) 1.8 [+ or -] 0.97 (452)
IPI (months) 28.3 [+ or -] 20.39 (233)
Height (cm) 151.6 [+ or -] 5.51 (246)
Weight (kg) 51.1 [+ or -] 10.12 * # (445)
Haemoglobin 11.6 [+ or -] 0.40 (452)
 (g/dl)

Parameters Haemoglobin (g/dl)

 Total

Age (yr) 23.8 [+ or -] 3.57 (3698)
Gravida (no.) 1.9 [+ or -] 1.03 (3698)
IPI (months) 30.1 [+ or -] 20.58 (2004)
Height (cm) 151.2 [+ or -] 4.90 (1909)
Weight (kg) 49.9 [+ or -] 8.45 (3588)
Haemoglobin 9.5 [+ or -] 1.36 (3698)
 (g/dl)

The values are mean[+ or -]SD. The number in parentheses indicates
the sample size. P * <0.01 as compared to II; # <0.001 as compared
to I

Table III. Changes in haemoglobin levels (g/dl) after completing
intramuscular therapy

 Initial Final

Weeks after N Mean Hb N Mean Hb
IM therapy

1-2 45 7.2 45 8.3 *
3-4 156 7.5 156 8.9 *
5-6 173 7.3 173 9.1 *
7-8 94 7.4 94 9.3 *
[greater than 410 7.4 410 9.7 *
 or equal to] 9

P<0.001 as compared to the initial levels (Paired 't' test)

Table IV. Impact of maternal Hb /im therapy for anaemia on
birth-weight of the infant

Maternal Hb (g/dl) N Birth weight (g)

I - 5.0-7.9 97 2577 [+ or -] 378.3
II - 8.0 - 10.9 645 2796 [+ or -] 394.7
III - [greater than or equal to] 11.0 103 2921 [+ or -] 418.1
Total 845 2786 [+ or -] 405.5
IV Women who had IM therapy
 and delivered in DCMC 105 2862 [+ or -] 385.6
V All women who had IM
 therapy and provided data on
 birth weight 340 2805 [+ or -] 379.3

Values are mean [+ or -]SD; t-test P value I vs. II < 0.001;
I vs. III < 0.001; II vs. III < 0.0111 vs V NS; III vs V .01;
I vs V and I vs IV 0.001; IV vs II, IV vs III, and IV vs V NS
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Author:Sharma, Anshu; Patnaik, Rita; Garg, Suman; Ramachandran, Prema
Publication:Indian Journal of Medical Research
Article Type:Clinical report
Geographic Code:9INDI
Date:Jul 1, 2008
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