Effect of home-based newborn care on neonatal and infant mortality: a cluster randomised trial in India.

BACKGROUND: Home-based newborn care has been found to reduce neonatal mortality in rural areas. Study evaluated effectiveness of home-based care delivered by specially recruited newborn care workers- Shishu Rakshak (SR) and existing workers- anganwadi workers (AWW) in reducing neonatal and infant mortality rates. METHODS: This three-arm, community-based, cluster randomised trial was conducted in five districts in India. Intervention package consisted of pregnancy surveillance, health education, care at birth, care of normal/low birthweight neonates, identification and treatment of sick neonates and young infants using oral and injectable antibiotics and community mobilisation. The package was similar in both intervention arms-SR and AWW; difference being healthcare provider. The control arm received routine health services from the existing health system. Primary outcomes were neonatal and young infant mortality rates at 'endline' period (2008-2009) assessed by an independent team from January to April 2010 in the study clusters. FINDINGS: A total of 6623, 6852 and 5898 births occurred in the SR, AWW and control arms, respectively, during the endline period; the proportion of facility births were 69.0%, 64.4% and 70.6% in the three arms. Baseline mortality rates were comparable in three arms. During the endline period, the risk of neonatal mortality was 25% lower in the SR arm (adjusted OR 0.75, 95% CI 0.57 to 0.99); the risks of early neonatal mortality, young infant mortality and infant mortality were also lower by 32%, 27%, and 33%, respectively. The risks of neonatal, early neonatal, young infant, infant mortality in the AWW arm were not different from that of the control arm. INTERPRETATION: Home-based care is effective in reducing neonatal and infant mortality rates, when delivered by a dedicated worker, even in settings with high rates of facility births. TRIAL REGISTRATION NUMBER: The study was registered with Clinical Trial Registry of India (CTRI/2011/12/002181).

Rural poverty reduction through centrally sponsored schemes.

This paper discusses the evolving profile of poverty in India and reviews the national performance of selected anti-poverty programmes between 1997-1998 and 2005. For each programme, it outlines the budgetary allocation principle used for the States and districts and analyzes budgetary performance over the period. The main objective is to explore the extent to which the anti-poverty programmes are reaching their target groups effectively. Finally, it identifies the specific factors responsible for under-performance and provides a set of recommendations for policy makers and programme implementers which could help improve the outcomes of the schemes.

Oral misoprostol for prevention of postpartum hemorrhage by paramedical workers in India.

OBJECTIVE: To study whether paramedical workers from rural primary health centers in India are able to administer oral misoprostol and actively manage the third stage of labor to prevent postpartum hemorrhage (PPH). METHOD: Cluster randomization was used to enroll 1200 women at 30 peripheral health centers from 5 states in India, 600 forming the study's intervention group (active management of the third stage of labor with 600 mug of oral misoprostol) and 600 forming the comparison group (in which the current government guidelines for the prevention of PPH were followed). The primary outcome was blood loss after delivery, which was measured using a calibrated blood collection drape. RESULTS: Age, literacy level, occupation, and gravidity were similar in the 2 groups. More than 70% of women in both groups had moderate anemia (hemoglobin level <10 g/dL). Paramedical workers followed instructions in almost all deliveries in the intervention group (99%). There was a significant reduction in duration of the third stage of labor (7.9 +/- 4.2 min vs. 10.9 +/- 4.3 min; p < .001) and median blood loss after delivery (100 mL vs. 200 mL; p < .001) in the intervention group. Overall, a low incidence of PPH was observed (<1%) in both groups. A greater number of women had moderate to severe shivering (12.7% vs. 0.5%) and a temperature higher than 38 degrees C (9.7% vs. 4.3%) in the intervention group, which was statistically significant. CONCLUSION: Simple interventions can be easily implemented in rural health care settings to reduce the blood loss during labor. This finding has significant implications for developing countries, in which the prevalence of anemia is high.

Nonoxynol-9 vaginal pessary: a preliminary Indian experience.

BACKGROUND: Barrier methods of contraception do not have systemic effects and allow the user complete control over their use. For women, the ease of use of a contraceptive is often more important than its efficacy. Hence, barrier methods could be offered as a useful alternative method of contraception. Nonoxynol-9 (a spermicide) is a locally acting, non-hormonal method free from systemic side-efforts. It is a woman-controlled, reversible method which is to be used before intercourse. There are little data available on its efficacy, side-effects and acceptability among Indian women. METHODS: The vaginal pessary nonoxynol-9 was offered as a contraceptive option to 3200 women attending the Family Planning clinics at 31 Human Reproduction Research Centres (HRRCs) of the Indian Council of Medical Research. The other contraceptives offered included an intrauterine device, oral pills, condoms, Norplant, tubal sterilization and vasectomy using the cafeteria approach. Those who accepted nonoxynol-9 were followed up to assess the rates of continuation, failure and side-effects. RESULTS: The nonoxynol-9 pessary was accepted by 541 women who were followed up for 3470 woman-months of use. The reasons given for acceptance were that it was user-controlled and/or they did not wish to use other methods because of the side-effects or contraindications of these methods. The overall continuation rates were 41.2% and 33% at 9 and 12 months of use, respectively. Most women (31.3%) discontinued its use due to personal reasons such as husband dissatisfaction, desire for further pregnancy, irregular use of pessary and difficulty in insertion. Twenty-nine women became pregnant during the study period (15 due to method failure and 14 due to user failure) giving a use-effectiveness of 8.8% at 12 months. The method failure rate was 4.3% at 12 months of use. The failure rates were lower compared with the reported failure rates of barrier contraceptives (1%-30% at 1 year of use) and the side-effects were minimal. CONCLUSION: Nonoxynol-9 had low acceptability (16.9%) and overall continuation rates--41.2% and 33% at 9 and 12 months of use. It could be offered to women looking for a short term, user-controlled contraceptive.

Maternal mortality in seven districts of Uttar Pradesh--an ICMR task force study.

Maternal mortality is a major health and development concern. The available information on maternal mortality in rural India is inadequate and scanty. This study presented maternal mortality data from the demographically and developmentally (including for health) poor performing state of Uttar Pradesh. A descriptive, cross-sectional survey was conducted utilizing a stratified cluster sampling design between 1989-90 in eight districts of Uttar Pradesh. Four good performing districts namely, Agra, Farrukhabad, Ghaziabad and Badaun from the western region and four poor performing districts from the eastern region namely, Gorakhpur, Basti, Varanasi and Pratapgarh were chosen. A door-to-door household interview survey was carried out in the selected villages covering a population of 11.67 lakhs in 889 villages. Maternal mortality rates during 1989 ranged between 533745 per 100,000 live births except in Ghaziabad district where the rate was as low as 101 per 100,000 live births. The rate in Eastern U.P. was higher (573 per 100,000 live births) as compared to that in Western U.P. (472 per 100,000 live births). A total of 286 maternal deaths were reported during the study period. The direct obstetric causes accounted for 55.7% of maternal deaths with haemorrhage (26.4%) being the most prevalent. Anaemia and jaundice (17.4%) were the most prevalent indirect causes of maternal deaths. Most of the maternal deaths could have been prevented if timely medical care was available.

Effects of elevating [Na]i on membrane currents of canine ventricular myocytes: role of intracellular Ca ions.

OBJECTIVES: Our first objective was to study how elevating [Na]i can modify the background membrane conductance in canine ventricular myocytes (CVM). In particular, we wanted to find evidence for a Nai-activated K current (IK,Na) in these cells. The second objective was to compare the effects of elevating [Na]i on membrane currents without and with intracellular Ca buffering. METHODS: Whole-cell currents were recorded and [Na]i was elevated either by using a pipette perfusion device that allowed [Na] in the pipette solution to be varied (from 0 to 50 mM), or by 50 microM ouabain. RESULTS: Although an outward current attributable to IK,Na was confirmed in guinea-pig ventricular myocytes (GPVM) under our recording conditions, no such current was seen in 29 CVM examined. With Cai buffering, the main effect of elevating [Na]i on CVM was an increase in inward current around and negative to the resting membrane potential. Based on the dependence of this Nai-induced inward current on K ions and its pharmacological properties, especially the effects of low concentrations of external Ba ions (< or = 5 microM) at strongly hyperpolarized voltages, we hypothesize that this current was carried by extracellular K ions through the inward rectifier (IK1) channels that had been modified by the high level of [Na]i. With Cai buffering, elevating [Na]i by ouabain had few or no effects on the L-type Ca channel current (ICa) or the slow delayed rectifier current (IKs). Without Cai buffering, ouabain induced a rapid reduction of both currents along with an increase in a time-independent outward current at voltages positive to -60 mV. CONCLUSION: Our data suggest that there are species variations in K channel expression and/or K channel modulation by intracellular Na ions. Furthermore, intracellular Ca ions play a crucial role in mediating the effects of Nai loading on membrane currents in canine ventricular myocytes.

Transatrial repair of tetralogy of Fallot.

In 12 months since March, 1975, 25 of 27 patients with tetralogy of Fallot have had corrective operations without ventriculotomy. Infundibular obstructions were excised and ventricular septal defects were closed through a right artiotomy with retraction of the anterior leaflet of the tricuspid valve. Pulmonary valve stenosis was relieved through a pulmonary arteriotomy. In five patients the pulmonary annulus was patched 0.5 to 1.5 cm. into the right ventricle. Immediately after repair peak right ventricular-pulmonary arterial systolic pressure difference averaged 17 mm. Hg and ranged between zero and 40 mm. Hg. Cardiac indices averaged 2.85 L. per square meter per minute 4 hours after operation. All but two patients developed right bundle branch block. One patient with severe pulmonary hypertension died. Fourteen patients have been recatheterized. Right ventricular-pulmonary peak systolic pressure differences ranged between zero and 45 mm. Hg (mean, 22). Cineangiograms show contraction of the free right ventricular wall during systole. Transatrial repair of tetralogy of Fallot is feasible technically in many patients, avoids muscle necrosis and coronary arterial injury, and improves cardiac output in the immediate postoperative period.

Relationship between platelet count and cardiotomy suction return.

A simple, inexpensive, accurate method of measuring the amount of blood returned by the cardiotomy suction system was devised and calibrated. Preoperative and postoperative platelet counts were obtained in 76 patients with congenital heart disease in whom the amount of cardiotomy suction return was measured. The mean percentage of total perfusate returned by the cardiotomy suction system was 8.9%. Both postoperative platelet count and the percentage change between preoperative and postoperative platelet counts correlated with the amount of blood returned by the cardiotomy suction system, time on bypass, and the percentage of total perfusate aspirated by the system.

Phase II randomized comparative clinical trial of Norplant (six capsules) with Norplant-2 (two covered rods) subdermal implants for long-term contraception: report of a 24-month study. National Programme of Research in Human Reproduction.

In a randomized clinical study, contraceptive efficacy and bleeding patterns were studied in a group of healthy, regularly menstruating, non-lactating women (n = 84) using two 4.4 cm covered silastic rods containing levonorgestrel, Norplant(R)-2, and compared with another group of women (n = 88) using six 3.4 cm capsules also containing levonorgestrel, Norplant(R). The silastic rods or capsules were placed subdermally in the medial aspect of the upper arm. No method failure was reported up to 24 months of use in this study with either of the device. The bleeding pattern was also similar for both devices as indicated by average episode length, number of bleeding runs and number of spotting days. The continuation rates with both devices were over 80 per 100 users at the end of 12 months and over 65 per 100 users at the end of 24 months. Discontinuations due to expulsion of the device, bleeding problems or personal reasons were few and similar for both devices. The results suggest that silastic-covered rods, Norplant(R)-2, which are comparatively easier to insert and remove and have similar clinical effect, could replace capsules, Norplant(R), as a long-term reversible subdermal contraceptive.

Indian Council of Medical Research. Task Force on Hormonal Contraception: Phase II randomized clinical trial with norethisterone oenanthate 50 mg alone and in combination with 5 mg or 2.5 mg of either estradiol valerate or cypionate as a monthly injectable contraceptive.

A Phase II multicentric study was carried out to compare the different contraceptive treatment schedules of the monthly injectable consisting of norethisterone oenanthate (NET OEN) 50 mg either given alone or in combination with estrogen esters, 2.5 or 5 mg of estradiol valerate (E2 Val.) or estradiol cypionate (E2 Cyp.). A total of 364 women were observed for 1686 months of use. Analysis of the bleeding pattern data indicated that NET OEN 50 mg when given alone gave rise to delayed cycles and/or amenorrhoea. However, the addition of estrogen esters in a dose of either 2.5 or 5 mg provided significantly better bleeding patterns. Of the different treatment schedules investigated, the combination of NET OEN 50 mg with E2 Val. 5 mg provided more consistent and better cycle control. These findings however need further validation on a larger study sample.

Evaluating contraceptive choice through the method-mix approach. An Indian Council of Medical Research (ICMR) task force study.

The method-mix approach was used to evaluate informed contraceptive choices in the present study. A total of 8,077 potential clients were given a balanced presentation of all available contraceptive methods in the national program, ie, the CuT 200 intrauterine device (IUD), low-dose combined oral pills (OC), condom, and sterilization (female/male) along with a new method, Norplant(R).(1) The majority of women opted for spacing methods; among them, the IUD was preferred by about 60% of clients, followed by condoms (9%), OC (6%), and Norplant (5%). Sterilization, mainly female, was accepted by about 17% of the women making an informed choice. The economic status of couples did not influence the contraceptive choices, as all the methods were offered free of cost in the present study, which is the current practice in the national program. Illiterate women more often accepted sterilization (about 25%) than did literate women (15%). This is because illiterate women had more children; about 30% of illiterate women had three or more children, as opposed to 16.2% of literate women. However, literacy status did not influence the choice of any specific spacing method. The study also revealed that, by encouraging potential clients to make an informed choice, they could override the provider's bias while accepting a particular type of spacing method. This is evident from the observation that Norplant was the first choice of the provider for 35% of the women, whereas only 5% of women preferred and accepted Norplant. The present study stresses an urgent need to promote the practice of informed choices in the national program with a variety of contraceptive options-especially, spacing methods for improving contraceptive prevalence and reproductive health in the country.

Estimation of parity progression ratios from the truncated distribution of closed and open birth intervals.

A procedure to estimate parity progression ratios in a population from the truncated distribution of open and closed birth intervals is presented. The approach is quite simple in computation and data needs. It does not require any separate data on age at last birth to the women of completed fertility as in earlier methods. The procedure is illustrated with an observed set of data.

First reported successful management of Serratia marcescens bacteremia after open heart surgery in a child.

A 7 and one-half yr-old girl developed bacteremia from S. marcescens following debanding of the pulmonary artery and closure of multiple ventricular septal defects with a Dacron patch and multiple Teflon pledgets. The site of entry was probably a radial arterial catheter left in place for 8 days. Infection was eradicated by a combination of gentamicin and carbenicillin over a 4-wk period. Of 12 cases of postoperative Serratia bacteremia in adults following valve replacement, only four survived. Antibiotics of proven effectiveness against the specific isolated Serratia strain, prompt therapy sustained for 6 wk offers the prospect for cure of this serious complication of cardiac surgery.

Use of the spiral coil membrane oxygenator during open heart surgery in infants and children.

The spiral coil membrane oxygenator was used without an arterial line filter during short term total cardiopulmonary bypass in 50 infants and children. The compact oxygenator proved to be efficient and reliable, was easy to operate in a simple perfusion circuit, has a high flow rate to priming volume ratio and eliminated gaseous emboli. During perfusion, platelet counts and fibrinogen concentrations descreased 51 and 31% respectively. Coagulation studies in eight infants less than 15 kilograms perfused with the membrane oxygenator system did not differ from those in 7 infants perfused by a bubble oxygenator system.

A critical appraisal of cesarean section rates at teaching hospitals in India.

OBJECTIVES: To obtain an estimate of cesarean section rates and examine the indications and consequences at teaching hospitals in India. METHODS: Information was obtained on total number of normal and cesarean deliveries during 1993-1994 and 1998-1999 from 30 medical colleges/teaching hospitals. In addition, prospective data were recorded for a period of 2 months on 7017 consecutive cesarean sections on indications for cesarean delivery, associated complications and mortality. RESULTS: The overall rate of cesarean section increased from 21.8% in 1993-1994 to 25.4% in 1998-1999. Among the 7,017 cesarean section cases, 42.4% were primigravidas, 31% had come from rural areas, 20.8% were referred including 8% with history of interference, 66% were booked cases, period of gestation was less than 37 weeks in 21.7% and in 18% the surgery was elective. Major indications for cesarean section included dystocia (37.5%), fetal distress with or without meconium aspiration (33.4%), repeat section (29.0%), malpresentation (14.5%) and PIH (12.5%). Maternal and perinatal mortality was 299/100,000 and 493/1,000 deliveries, respectively, and is high in spite of the increase in the cesarean section rates. CONCLUSIONS: There is need for standardized collection of information on all aspects of childbirth to ascertain the incidence and indications of cesarean section nationally so that comparison and improvements of care can take place.

An unusual mediastinal mass due to metastasis.

During childhood the common anterior middle mediastinal masses are either lymph node enlargement or teratomas/dermoids. A case of ossific mediastinal metastasis and pleural metastases from osteosarcoma, presenting three years after the primary disease (late metastasis) is reported for its rarity.

Reproductive health awareness of school-going, unmarried, rural adolescents.

OBJECTIVE: In 1996, India included Adolescent Health in Reproductive and Child Heatlh Programme. This Task-Force Study was planned to test the awareness level of adolescents regarding various reproductive health issues and to identify lacunae in knowledge, particularly in legal minimum age of marriage, number of children, male preference, contraceptive practices, about STIs /AIDS etc. METHODS: It was a multicentre study, done in rural co-education/higher secondary schools of 22 districts located in 14 states through Human Reproductive Research Centre (HRRC's) of the Indian Council of Medical Research (ICMR). A sample of 8453 school going adolescents (aged 10-19 years) was surveyed by means of open ended, self-administered questionnaires maintaining confidentiality. RESULTS: Mean age of adolescents was 14.3 +/- 3.4 years. Awareness of legal minimum age of marriage was present in more than half of adolescents. Attitude towards marriage beyond 21 years in boys and 18 years in girls was favorable. Mean number of children desired was 2.2 +/- 1.4. However, number of children desired by boys (2.2+/-1.6) was significantly more (p< 0.000) than those desired by girls (2.0+/-1.1). More boys (23.7%) than girls (9.4%) wanted three or more children with male preference. Only 19.8% of adolescents were aware of at least one method of contraception. Only two-fifth (39.5%) were aware of AIDS and less than one-fifth (18%) were aware of STDs and most of them thought it is same as AIDS. Awareness of at least one method of immunization was present in three-fifth (60.1%) of students. It was least for DPT (13.5%) and most (55%) were aware of polio only. Awareness of all Reproductive Health matters was more in boys than girls and more in late teens (15-19) than earlier teens (10-14). CONCLUSION: The study showed tremendous lacunae in awareness of all Reproductive Health (RH) matters. There is a need for evolving information, education, and communication strategies to focus on raising awareness on RH and gender related issues. A sociocultural research is needed to find the right kind of sexual health services for young girls and boys.

Indian experience of home based mothers card: ICMR task force study.

To improve the quality of MCH services, a Home Based Mothers Card (HBMC) prepared and recommended by World Health Organization was adapted to Indian situation, and introduced in 1.5 lakh population of rural area covered by 6 participating centres under the aegis of Indian Council of Medical Research. Two thousand four hundred and forty six mothers were given this card and were followed up for a period of 2 years. Only 89.2 percent retrieval of the cards was possible after a period of 18 months. Screening of the population for "at risk" women monitoring and referral could be undertaken with the help of this card. Improved antenatal, and referral services were observed during the study period. The card (HBMC) was acceptable to the mothers as well as to the health workers, as a tool for improving the quality and coverage of MCH services being rendered at the Primary Health Centre.

PIP: Health workers at 6 primary health centers in different areas of India introduced the home-based mothers card (HBMC) to 2446 pregnant and mostly illiterate women in November 1984-October 1985 and followed them for 2 years to evaluate the acceptability and feasibility of the HBMC among rural women. Overall retrieval of the HBMCs after 18 months was 89.2%. 66.9% had at least 1 maternal risk factor. The most common risk factors were previous abortions (7.8%), neonatal deaths (5.9%), and fetal deaths (5%). The risk factors associated with the highest perinatal mortality rates were eclampsia (133.3) and fetal deaths (118.2). The researchers learned that they needed to revise the criteria for identifying at-risk mothers by using risk factors associated with the higher risk of perinatal mortality. Women with 3-4 risk factors were more likely to experience perinatal mortality than those with 1-2 risk factors (39.7 and 56.5 vs. 122.5 and 105). Health workers should refer women at highest risk (3-4 risk factors) to a health care facility for delivery. Of the 66.9% at-risk mothers, only 10% experienced risk factors during delivery. The risk factors during delivery were associated with a high relative risk (RR) of perinatal death, e.g., RRs ranged from 1.8 to 4.6. Prenatal care can detect the 2 delivery risk factors with the highest perinatal mortality (multiple pregnancy and abnormal presentation). Health workers should also refer mothers with these risk factors to a health care facility. 78% of at-risk mothers who had been referred to a health facility did indeed go for referral care. Health workers at the centers found the HBMC to be helpful, but it would be more so if it were to include infant health. Anganwadi workers would be more accepting of the card if it had pictorial illustrations.

Contraceptive knowledge, practices and utilization of services in the rural areas of India (an ICMR task force study).

To obtain information from rural women regarding their contraceptive knowledge, practices and utilization of services, a cross-sectional survey of 117,465 eligible women was carried out in the sampled areas of 28 districts from January 1996 to February 1997. From among the current contraceptive users all of IUD, OC and acceptors of a permanent method in the last one-year (14,276) were interviewed in detailed. In addition a systematically selected sample of 17,082 non users were also interviewed. Overall contraceptive prevalence was 45.2% of which 34.2% had used a permanent method. Among the current users, the contraceptive had been availed mainly from either PHC (31.5%) or hospital (42.1%). Around half the women (53.1%) had received counseling and in 20.3% information regarding other methods. Pelvic examination was done in 39.1% Most of the women (>97%) expressed satisfaction with the method, provider and services. Almost all the women (98.8%) were using a contraceptive method with the knowledge of their husband and had his support for continuing the same. There was no concept of using any family planning method for either postponing the first conception after marriage or spacing between the two child births. A large majority of women (70.5%) used a family planning method for the first time only after completing their desired family size. Among the never users, 73.5% mentioned at least one modern method of family planning available in the national programme and 64.3% mentioned the service source where it would be available. Fewer women in most of the districts mentioned spacing methods as compared to female sterilization. The main reason given for not using any family planning method was "family not complete" (34.6%). There is need to promote spacing methods by policy makers and field workers and motivate couples to accept them.

Induced abortion and concurrent adoption of contraception in the rural areas of India (an ICMR task force study).

BACKGROUND: Despite a liberal Medical Termination of Pregnancy (MTP) act and awareness of family planning, maternal mortality attributable to induced abortion is high. AIMS: Assess attitude, behavior, practices and utilization of services by rural women for induced abortion and concurrent acceptance of contraception. SETTINGS AND DESIGN: Cross sectional survey of eligible married women in 13 states in India over one year. MATERIAL AND METHODS: A total of 1851 women who had an induced abortion during the previous 3 years were interviewed. STATISTICAL ANALYSIS USED: Includes proportions, rates and chi-square test. RESULTS: The main reason for seeking abortion was "don't need any more children" (42%), and in 12.4 per cent they specifically mentioned that they "don't need any more daughters". Around 46% of women accessed abortion services from private clinics as compared to government hospital (37.1%) and Primary Health Centre/Community Health Centre (14.0%). The decision to terminate the pregnancy and place of abortion was made by the husband in 42.8% and 52.5% respectively. Regret for abortion was expressed by 29.6% of the women. However, only 7.2% said they would not advice others for induced abortion. Nearly one half of the women undergoing abortion accepted a family planning method concurrently; of these Intra Uterine Device/oral contraceptives and a permanent method was adopted by 37.2% and 49.1% respectively. Acceptance of vasectomy by male partner was found to be low (1.3%). "Husband objected" (32.3%) was the main reason for not accepting post abortal contraception. Majority of the acceptors said they would recommend to others the same place where they had undergone abortion, thus indicating their satisfaction with the source and services received. CONCLUSIONS: Counselling for post-abortal contraceptive should be provided to the couple so that they can make an informed choice.