Prevalence of preconception risk factors for adverse pregnancy outcome among women from tribal and non-tribal blocks in Nashik district, India: a cross-sectional study.

BACKGROUND: Although critical, the preconception phase in women's lives is comparatively ignored. The presence of some risk factors during this phase adversely affects the wellbeing of the woman and the pregnancy outcome. The study objectives were to measure the prevalence of various known risk factors for adverse pregnancy outcome in the preconception period of women and their comparison between blocks. METHODS: This was a community-based cross-sectional study in two tribal and two non-tribal blocks each in Nasik district, Maharashtra, India. The study included married women desiring to conceive within 1 year. Trained Accredited Social Health Activists (field level health worker) collected information from women using a validated interview schedule through house-to-house visits and obtained women's anthropometric measurements in a standard manner. The study assessed the presence of 12 documented risk factors. RESULTS: The study enlisted 7875 women desiring pregnancy soon. The mean age of women was 23.19 (± 3.71) years, and 16% of them were adolescents. Women's illiteracy was higher in tribal areas than non-tribal (p < 0.001). About two-thirds of women have at least one risk factor, and 40.0% have a single risk factor. The most common risk factor observed was no formal education (44.35%). The prevalence of selected risk factors was significantly higher among women from tribal areas. The mean BMI of women was 19.73 (± 3.51), and a higher proportion (40.5%) of women from tribal areas had BMI < 18.5. Despite being of high parity status (≥ 4), about 7.7% of women from the tribal area and 3% from non-tribal desired pregnancy. Tobacco and alcohol consumption was higher among tribal women. The majority of women consumed meals with family members or husbands. Protein and calorie intake of about 1.4% of women was less than 50% of the recommended daily allowance; however, most of them perceived to have abundant food. CONCLUSIONS: Health risks, namely younger age, illiteracy, high parity, consumption of tobacco, low protein, and calorie intake, were quite prevalent, and the risks were significantly more among women from tribal areas. "Continuum of care" must comprise preconception care inclusive of Behavioral Change Communication, particularly for easily modifiable risk factors and specially for tribal women.

Women's health during the preconception phase although important, is an ignored period in her life cycle. Literature has shown that the presence of risk factors in women during the preconception phase is hazardous to the health of women and newborns. The present study is a cross-sectional study conducted in four blocks of Nasik district, Maharashtra, India, to measure risk factors for adverse pregnancy outcome among women and its comparison between blocks.We included married women desiring conception within 1 year. Accredited Social Health Activists asked questions using a validated interview schedule and recorded women's anthropometric measures.Of the 7875 women, 16% were adolescents, and the mean age of women was 23.19 ± 3.71 years. About two-fifth of women had one risk factor, the commonest being no formal education. Overall mean BMI of women was 19.73 (± 3.51). The prevalence of risk factors was significantly higher among women from tribal areas. Despite having ≥ 4 parity a higher proportion of women from tribal areas desired to conceive. About 1.4% of women had protein and calorie intake below 50% recommended consumption.In conclusion, the prevalence of selected risk factors was significantly higher among tribal women. The study identifies the need for preconception care services.

Association between adverse pregnancy outcomes and preceding risk factors: a cross-sectional study from Nashik District, India.

BACKGROUND: The preconception phase of women's life cycle is critical but comparatively ignored. The presence of health risks is judged as hazardous to the wellbeing of women and their offspring. This study aimed to estimate the prevalence of various pregnancy outcomes and assess the association between certain risk factors and adverse outcomes. METHODS: As a part of a preconception care intervention project, a baseline survey was conducted in four blocks of Nashik District, India. In this population-based cross-sectional analytical study, we compared cases in the study group (randomly selected one tribal and one non-tribal block) with those of the control group (one tribal and one non-tribal block). A comparison was also made between the tribal and non-tribal blocks in each group. All women who had a pregnancy outcome in the preceding 12 months (01 April 2017 to 31 March 2018) were interviewed. Trained Accredited Social Health Activists conducted the survey under the direct supervision of Auxiliary Nurse Midwives and Medical Officers. Multivariate analysis was carried out to find the adjusted prevalence ratio of having a particular adverse outcome because of the prespecified potential risk factors. RESULTS: A total of 9307 women participated in the study. The prevalence of adverse pregnancy outcomes was as follows: abortion in 4.1%, stillbirth in 1.7%, preterm birth in 4.1%, low birth weight in 13.2%, and congenital physical defect in 2.8%. Prevalence of parental consanguinity, pre-existing maternal illness at conception, heavy work during the last six months of pregnancy, tobacco consumption, alcohol consumption, direct exposure to pesticides and domestic violence during pregnancy was 18.5, 2.2, 18.7, 5.6, 0.5, 2.3, and 0.8% respectively. Risk factors associated with abortion included pre-existing illness and heavy work in the last six months of the pregnancy. Consanguinity, tobacco consumption during pregnancy and pre-existing illness were identified as risk factors for stillbirth. Significant risk factors of low birth weight were heavy work in the last six months of pregnancy, pre-existing illness and residence in a tribal area. CONCLUSION: There is a need to emphasize on maternal behaviour, including tobacco consumption, and heavy work during pregnancy, as well as on parental consanguinity and pre-existing maternal illnesses, in order to achieve the best possible pregnancy outcomes.

Perceptions of and challenges faced by primary healthcare workers about preconception services in rural India: A qualitative study using focus group discussion.

Background: Providing preconception care through healthcare workers at the primary health care level is a crucial intervention to reduce adverse pregnancy outcomes, consequently reducing neonatal mortality. Despite the availability of evidence, this window of opportunity remains unaddressed in many countries, including India. The public health care system is primarily accessed by rural and tribal Indian population. It is essential to know the frontline healthcare workers perception about preconception care. The study aimed to identify barriers and suggestions for framing appropriate strategies for implementing preconception care through primary health centers. Methods: The authors conducted a qualitative study using focus group discussions (FGDs) with 45 healthcare workers in four FGDs (8-14 participants in each), in four blocks of Nashik district. The transcribed discussions were analyzed in MAXQDA software using the Socio-Ecological Model as an initial coding guide, including four levels of factors (individual, interpersonal, community, and institutional) that influenced an individual's behavior to use preconception care services. Results: Healthcare workers had some knowledge about preconception care, limited to adolescent health and family planning services. The interpersonal factors included heavy workload, stress, lack of support and co-operation, and paucity of appreciation, and motivation. The perceived community factors included poverty, migration, poor knowledge of preconception care, lack of felt need for preconception services, the influence of older women in the household decision, low male involvement, myths and misconceptions regarding preconception services. The identified institutional factors were lack of human resources, specialized services, logistics, and challenges in delivering adolescent health and family planning programs. Healthcare workers suggested the need for program-specific guidelines, training and capacity building of human resources, an un-interrupted supply of logistics, and a unique community awareness drive supporting preconception care services. Conclusion: Multi-level factors of the Socio-Ecological Model influencing the preconception care services should be considered for framing strategies in the implementation of comprehensive preconception care as a part of a continuum of care for life cycle phases of women.

Meager Perception of Preconception Care Among Women Desiring Pregnancy in Rural Areas: A Qualitative Study Using Focus Group Discussions.

Background: India has the second-highest number of under-five deaths in any country in the world. WHO and the Government of India recommended the rollout of preconception care (PCC) to reduce maternal and child mortality. However, very few countries, including India, have started a comprehensive package of PCC services. It implies that women, mainly from rural and tribal areas, are not aware of PCC. PCC has been rolled out through the government health system in two blocks of Nashik district in Maharashtra state, India, among all women who desire to be pregnant within 1 year. This project is the first of its kind in India. To assess basic perceptions, knowledge, and behavior of women on PCC before the implementation of the project, focus group discussions (FGDs) were carried out. The authors think that the finding may help to develop strategies for behavioral change communication. Methods: From each of the four blocks, two villages having subcenter were selected for conducting FGD. A house-to-house survey was conducted by Accredited Social Health Activist (ASHA) to enlist women who desire a baby in 1 year and invite them to subcenter for FGDs, which were conducted in June 2018. Results: A total of 76 women having a mean age of 23.97 years participated in the FGDs. Most of them (46.05%) had completed 10 years of education. About 50% of pregnancies were planned. The decision about the timing of the first pregnancy is influenced by the mother-in-law. Women knew that they should not conceive before 20 years of age, and their suboptimal weight may have an adverse impact on the health of the newborn. There are many myths about food like "hot and cold foods" and "forbidden food" etc. Women had some knowledge about the adverse effects of tobacco and alcohol; very few consumed these. Most of them did not practice behaviors or accessed services related to PCC. Conclusions: Women neither have the knowledge nor adopt behaviors or accessed services related to PCC. Roll out of PCC among them may help in further reduction of maternal and neonatal morbidity and mortality in India.

Safety & immunogenicity of tgAAC09, a recombinant adeno-associated virus type 2 HIV-1 subtype C vaccine in India.

BACKGROUND & OBJECTIVES: A phase 1 trial of adeno-associated virus based HIV-1 subtype C vaccine (tgAAC09) was conducted at two sites in Germany and Belgium and one site in India. This paper reports the safety and immunogenicity of tgAAC09 in healthy adult Indian volunteers. METHODS: Between January 2005 and December 2006, 30 consenting volunteers were enrolled in the placebo controlled double-blind dose-escalation trial [3x10(9), 3x10(10) and 3x10(11) DNase resistant particles (DRPs)/ml]. Single injection of the candidate vaccine was administered to ten volunteers randomized in 8:2 ratio in vaccine and placebo arms at each dosage level. RESULTS: The mean age of study volunteers (16 men and 14 women) was 34 yr. Six local reactogenicity events and 14 systemic reactogenicity events like malaise, fever, headache and myalgia were reported, both were dose-dependent. The difference between the adverse events reported by vaccine and placebo recipients (79 and 67%) was not significant. A modest IFN-gamma ELISPOT response [248 spot forming units (SFU)/million cells] was detected in one volunteer from high dose group and low response (56 and 75 SFU/million cells) in two volunteers in low and mid-dose groups. A post-vaccination dose-dependent increase was observed in anti AAV2 neutralizing titres. None of the volunteers showed a positive antibody response to HIV-1. INTERPRETATION & CONCLUSIONS: The trial was a benchmark in phase I clinical evaluation of HIV candidate vaccines in India. The vaccine was generally well tolerated and raised no safety concerns. The vaccine was found to be weakly immunogenic. It is essential to understand the role of pre-existing immunity against vectors and significance of evaluation in a prime-boost strategy.

Knowledge and Skills of Ayurvedic and Homeopathic Practitioners to Provide Skilled Birth Attendance in India: An Observational Study.

BACKGROUND: To overcome the dearth of trained skilled birth attendants, mainstreaming of doctors from the alternative systems of medicine has been adopted by some states in India. OBJECTIVES: The objectives of the study were to explore the adequacy of knowledge and clinical skills of AYUSH practitioners (APs) (ayurvedic and homeopathic) engaged by the state governments to provide maternity care services, with a view to identify gaps if any, and to suggest measures for improvement. MATERIALS AND METHODS: A cross-sectional observational study was conducted in three states of India (Maharashtra, Rajasthan, and Odisha). The APs were assessed for (a) knowledge of essential obstetric care and identification and management of complications of pregnancy and (b) clinical skills during provision of antenatal and postnatal care (PNC) and during the conduct of deliveries. Adequate knowledge or skill demonstration was defined as a score of 70% or more. RESULTS: A total of 109 APs engaged in 37 peripheral level facilities were assessed. Nearly 76% of APs had adequate theoretical knowledge of essential obstetric care and identification and management of complications of pregnancy. Most APs demonstrated adequate skills while providing antenatal care but were deficient in taking past history and counseling pregnant women for danger signs during pregnancy and childbirth. APs in Maharashtra and Rajasthan had adequate skills for conducting vaginal deliveries but performed poorly in Odisha. Skills for resuscitation of newborn were deficient. Skills for providing PNC were adequate only among APs in Maharashtra. CONCLUSION: Through provision of appropriate in-service training and an enabling environment, APs may be a useful human resource for providing maternity care in the primary health-care settings in India.

Task-shifting challenges for provision of skilled birth attendance: a qualitative exploration.

BACKGROUND: Shortage of skilled birth attendants (SBA) is one of the determinants of maternal mortality in India. To combat this shortage, innovative task-shifting strategies to engage providers of the Indian system of medicine (Ayurveda and Homeopathy), called AYUSH practitioners (AP), to provide SBA services is being implemented. METHODS: Engagement of APs for SBA service provision was assessed in 3 states of India (Maharashtra, Rajasthan and Odisha) through 73 in-depth interviews (37 with APs and 36 with programme managers). The interviews explored the providers' SBA training experience, barriers for SBA service provision, workplace and community acceptance, and the perspective of programme managers on the competence and quality of SBA services provided. RESULTS: SBA training led to skill enhancement with adoption of appropriate maternal and newborn care practices. A dedicated trainer, more hands-on practice, and strengthening training on newborn care practices and management of complications emerged as the training needs. Conditional involvement in SBA-related work, a discriminatory attitude at the workplace and lack of legal/regulatory authorisation were identified as barriers to the inclusion of APs in SBA service provision. CONCLUSIONS: Quality skill enhancement measures, an enabling work environment, a systematic task-shifting process, role definition, supportive supervision and credentialing could be key for the integration of APs and their acceptance in the health system.

Feasibility of using partograph by practitioners of Indian system of medicine (AYUSH): An exploratory observation.

OBJECTIVE: to understand the use of the partograph by Skilled Birth Attendance/Basic Emergency Obstetric Care (SBA/BEmOC) trained practitioners from Indian systems of medicine called AYUSH practitioners (APs). DESIGN: mixed method observational study, including an exploration of the views of APs, programme managers and SBA trainers on the necessity, feasibility and barriers to the use of partograph. SETTING: primary and community health centres in two purposively selected districts in each of the three states (Rajasthan, Maharashtra and Odisha) in India where SBA/BEmOC trained APs are deployed to provide SBA services. In-depth interviews with state, district and block level programme managers were held at their respective headquarters. PARTICIPANTS: 83 APs plotted the simplified partograph based on a given labour case scenario. In-depth interviews were conducted with 36 programme managers and 37 APs (24 Ayurvedic and 13 Homoeopathic). MEASUREMENTS AND FINDINGS: the completed simplified partograph was analysed according to a previously devised scoring system with a score of 70% or more indicating competency. APs in Rajasthan and Maharashtra demonstrated good partograph plotting skills (72.1% and 82% respectively) obtaining a competency score of more than 70%. However, overall performance of APs in Odisha was poor (11.1%) and except correct recording of fetal condition, the APs did not score well in the plotting of the other partograph components. Errors occurred mainly in the recording of cervical dilatation and uterine contractions. The in-depth interviews revealed that most APs demonstrated a good understanding of the tool in the context of decision making regarding timely referral in case of prolonged labour or fetal distress. There was a high perception of the need for more hands-on training in the SBA training curriculum. The programme managers also expressed the need for appropriate training and supervision to ensure good plotting of partograph. The barriers for partograph use included increased workload, insufficient training, unavailability of partograph forms and its non-utility for women coming late in labour. KEY CONCLUSIONS: knowledge of plotting and correct interpretation of partograph were generally good in two states but more practice is needed to improve providers׳ skills. Identified barriers could be addressed with further training and local managerial support. An analysis of the causes for the poor performance of APs in Odisha should be carried out. Pre-service and periodic in-service training of APs on the completion of the partograph, regular supportive supervision, implementation of programme guidelines on mandatory completion of partograph and an environment that supports its correct and consistent use are recommended. IMPLICATIONS FOR PRACTICE: with appropriate training, it is feasible for AYUSH practitioners to use partograph for monitoring progress of labour.

Primary squamous cell carcinoma of the ovary in a young patient. A case report.

A case report of a squamous cell carcinoma arising in a dermoid cyst of the ovary in a 29 year old patient is presented. Such an occurrence in young patients is unusual.

Feasibility of use of color-coded rings by nurse midwives: an appropriate technology based on partographic principles.

OBJECTIVES: To study the feasibility of use of color-coded rings as a proxy for partograph for early identification of slow progress of labor. MATERIALS AND METHODS: Color-coded rings were devised as a tool using appropriate technology to translate the partographic principles into simpler, easy to understand methodology. The rings were in pairs of 4 colors i.e., red, blue, yellow, and green, ranging from 3 cm to 10 cm in diameter with a difference of 4 cm between rings of the same color. The midwife performed p/v examination of the woman in labor to assess the initial cervical dilatation and identify corresponding ring. P/V was to be repeated after 4 hours to reassess the cervical dilatation and compare it with the bigger ring of the same color indicating expected cervical dilatation. If existing cervical dilatation measured lesser, it was interpreted as slow progress of labor indicating referral. RESULTS: 44 women [23 (22.1%) primis and 21 (13%) multis] showed delayed progress of labor as judged by use of color-coded rings. 20 women (4 primis and 16 multis) showed satisfactory progress or delivered by the time arrangements for referral were made. CONCLUSION: Use of color-coded rings may serve as a valuable tool based on appropriate technology to assess slow progress of labor not only in the hands of nurse midwives but it also can serve as a training tool for TBAs to help facilitate timely referral of such cases.

Safety and immunogenicity of DNA and MVA HIV-1 subtype C vaccine prime-boost regimens: a phase I randomised Trial in HIV-uninfected Indian volunteers.

STUDY DESIGN: A randomized, double-blind, placebo controlled phase I trial. METHODS: The trial was conducted in 32 HIV-uninfected healthy volunteers to assess the safety and immunogenicity of prime-boost vaccination regimens with either 2 doses of ADVAX, a DNA vaccine containing Chinese HIV-1 subtype C env gp160, gag, pol and nef/tat genes, as a prime and 2 doses of TBC-M4, a recombinant MVA encoding Indian HIV-1 subtype C env gp160, gag, RT, rev, tat, and nef genes, as a boost in Group A or 3 doses of TBC-M4 alone in Group B participants. Out of 16 participants in each group, 12 received vaccine candidates and 4 received placebos. RESULTS: Both vaccine regimens were found to be generally safe and well tolerated. The breadth of anti-HIV binding antibodies and the titres of anti-HIV neutralizing antibodies were significantly higher (p<0.05) in Group B volunteers at 14 days post last vaccination. Neutralizing antibodies were detected mainly against Tier-1 subtype B and C viruses. HIV-specific IFN-γ ELISPOT responses were directed mostly to Env and Gag proteins. Although the IFN-γ ELISPOT responses were infrequent after ADVAX vaccinations, the response rate was significantly higher in group A after 1(st) and 2(nd) MVA doses as compared to the responses in group B volunteers. However, the priming effect was short lasting leading to no difference in the frequency, breadth and magnitude of IFN-γELISPOT responses between the groups at 3, 6 and 9 months post-last vaccination. CONCLUSIONS: Although DNA priming resulted in enhancement of immune responses after 1(st) MVA boosting, the overall DNA prime MVA boost was not found to be immunologically superior to homologous MVA boosting. TRIAL REGISTRATION: Clinical Trial Registry CTRI/2009/091/000051.

Use of 'Mishri' A Smokeless form of Tobacco During Pregnancy and its Perinatal Outcome.

BACKGROUND: Use of 'Mishri' (Tobacco containing teeth cleaning powder) is common in the central and southern part of India. OBJECTIVES: To study the effects of Mishri use on the fetus during pregnancy and the perinatal outcome, and stopping its use. MATERIALS AND METHODS: All apparently healthy pregnant women were enrolled at 20 weeks of gestation from rural Maharashtra, India. Information related to use and giving up of Mishri, previous obstetrical history, current pregnancy, delivery and outcome during the perinatal period were recorded. Appropriate tests of significance were applied. RESULTS: Out of 705 enrolled pregnant women, 218 (30.9%) were using Mishri. The proportion of women with complications during the previous perinatal period, complaints and complications during the current pregnancy/delivery and the number of stillbirths were significantly more among Mishri users. A relative risk of abnormal delivery was 2.7 for the users. In spite of counseling, 153 women never stopped the use of Mishri and gave birth to babies weighing on an average 169.9 gm less (statistically significant) than babies born from the group that never used it. Babies of 28.8% who stopped/reduced consumption of Mishri were significantly benefited. CONCLUSIONS: The improvement seen in babies born to 28.8% mothers who stopped/reduced consumption of Mishri by 32 weeks during the current pregnancy is of paramount importance in the developing world for primary prevention of low birth weight.

Infant feeding practices of HIV-positive mothers in India.

Exclusive breast-feeding is widely accepted and advocated in India; however, clinicians are now faced with advising women infected with human immunodeficiency virus (HIV) about the risks and benefits of other infant feeding options. This study assessed factors that influence the infant feeding decisions of HIV-infected mothers in Pune, India. From December 2000 to April 2002, HIV-positive (HIV(+)) pregnant women (n = 101) from a government hospital antenatal clinic were interviewed prepartum about infant feeding intention, feeding practice immediately postpartum and feeding after a minimum of 2 wk postpartum. Of the HIV(+) sample, the last 39 were interviewed more intensively to examine factors affecting feeding decision making. We found that an equal number of HIV(+) women intended to breast-feed (44%) or give top milk (44%) (diluted animal milk). Women who chose to top feed were also more likely to disclose their HIV status to family members. Mixed feeding occurred frequently in our sample (29%); however, for the majority of those (74%), it lasted only 3 d postpartum. The hospital counselor had an important role in assisting women in their intended feeding choice as well as actual practice. The time immediately after delivery was noted as critical for recounseling about infant feeding and further support of the woman's decision, thus lowering the risk of mixed feeding. Lack of funds, poor hygienic conditions and risk of social repercussions were more commonly noted as reasons to breast-feed. Top milk, the alternative for breast-milk used in this population, however, must be investigated further to assess its nutritional value and safety before it can be endorsed widely for infants of HIV(+) women.

Replacement-fed infants born to HIV-infected mothers in India have a high early postpartum rate of hospitalization.

Access to safe breast-feeding alternatives for HIV-infected mothers and their infants in many settings is limited. We compared the rates of early postpartum hospitalization of infants born to HIV-infected mothers using different infant-feeding practices in a large government hospital in Pune, India. From March 1, 2000 to November 30, 2001, infants born to HIV-infected mothers were followed in a postpartum clinic. All mothers had received a standard short course of antenatal zidovudine. Infant-feeding practices were assessed within 3 d of delivery, prior to postpartum hospital discharge. Sixty-two of 148 mothers (42%) were breast-feeding their infants. Eighty-six of the mothers (58%) were providing replacement feeding, primarily diluted cow, goat or buffalo milk (top feeding). Twenty-one of the 148 participating infants (14.2%) born during the study period required hospitalization within the 1st 6 mo of life and 6 infants required repeat hospitalization. All hospitalized infants were receiving replacement feeding with a rate of 0.093 hospitalizations per 100 person-days (95% CI, 0.062 to 0.136). The reasons for hospitalization included acute gastroenteritis (48.1%), pneumonia (18.5%), septicemia (11.1%) and jaundice (11.1%). A high risk for early postpartum hospitalization was seen in replacement-fed infants born to HIV-infected mothers in Pune, India. In settings such as India, where access to safe replacement feeding is limited, interventions making exclusive breast-feeding safer for HIV-infected mothers and infants are needed. Such interventions would be valuable additions to the very effective national prevention programs that currently rely on the provision of short-course zidovudine and nevirapine.