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Dhanusha  

Nutritional supplementation during pregnancy in Janakpur, Nepal

Antenatal multiple micronutrient supplementation in Janakpur, Nepal: Effects on birthweight, gestation and perinatal infection in infants

The study in brief
Neonatal mortality is the biggest contributor to global mortality of children younger than 5 years, and low birthweight is a crucial underlying factor. This study is a double blind, randomised controlled trial of the effects of antenatal multiple micronutrient supplementation on birthweight, gestation and perinatal infection, conducted in Dhanusha district, Nepal (ISRCTN88625934). The study is based at Janakpur Zonal Hospital, close to the Indian border.

Elements
The study enrolled its first participant on 11th August 2002 and has enrolled a total of 1200 pregnant women over the course of the trial. A control group of 600 randomly selected participants received iron and folic acid supplement tablets, in accordance with general practice for all pregnant women attending antenatal clinics in Nepal. The intervention group received multiple micronutrient supplement tablets. The two groups were compared at 32 weeks of pregnancy, at the time of birth and one week after birth. For further information, please download the study protocol (below).

Progress
Birthweight was available for 523/600 infants in the control group and 529/600 in the intervention group. Mean birthweight was 2733 g (SD 422) in the control group and 2810 g (453) in the intervention group, representing a mean difference of 77 g and a relative fall in the proportion of low birthweight by 25%.
No difference was recorded in the duration of gestation, infant length, or head circumference.
Therefore, in a poor community in Nepal, consumption of a daily supplement containing a recommended daily allowance of 15 micronutrients in the second and third trimesters of pregnancy was associated with increased birthweight when compared with a standard iron and folic acid preparation. The effects on perinatal morbidity and mortality need further comparisons between studies.
The results are contained in a paper by Osrin et al titled 'Effects of antenatal multiple micronutrient supplementation on birthweight and gestational duration in Nepal: double-blind, randomised controlled trial' . Lancet. 2005; 365: 955-62.

Study protocol (Adobe PDF file, 1.0 MB)
Annual report (Adobe PDF file, 397 KB)

Community-based interventions for infant health in Dhanusha, Nepal
The overall objective of the project is to evaluate potentially replicable and scalable interventions in poor communities of Dhanusha, Nepal, to improve child survival.

In particular:

  • to evaluate the impact of a participatory intervention with women’s groups on neonatal mortality
  • to evaluate the impact on maternal and infant nutritional status of the inclusion of diet as an issue for discussion in women's groups
  • to evaluate the additional impact of training of community volunteers in the recognition and management of neonatal sepsis.

 

 

Participatory intervention

Community-based participatory intervention to improve essential newborn care in rural  Makwanpur, Nepal

The Study in brief
The MIRA Makwanpur study is a cluster randomised, controlled trial of a community-based participatory intervention to improve the health of pregnant mothers and their newborn infants in Makwanpur district, Nepal (ISRCTN31137309).
There is an urgent need to improve the outlook for mothers and infants in developing countries. Policy makers are therefore seeking ways to reduce illness and prevent deaths by improving perinatal care in the home and at local facilities. Building on experiences in Nepal and elsewhere, the MIRA study aims to examine the potential of community action cycles to bring about real improvements in health outcomes, and to serve as a model for sustainable replication.

Elements
The key elements of the intervention are the activities of women facilitators. Each facilitator works within one Village Development Committee (VDC) covering an average population of 7500. She facilitates the activities of women's groups within the VDC as they address the issues of pregnancy, childbirth and newborn health. Each women's group will move through a participatory planning cycle of assessment, sharing experiences, planning, action and reassessment with the aim of improving essential maternal and newborn care. The facilitation process takes place in 12 intervention VDCs, which will be compared with 12 control VDCs. The manual used for this study and an interview with a women's group member are available below.

Outcomes
Married women of reproductive age (15-49 years) within the study area have been identified and are visited monthly by study personnel. All pregnancies occuring within the cohort will be followed until at least six weeks after delivery to determine the outcome of birth.

The study's primary outcome measures are neonatal and perinatal mortality rates. Secondary outcomes include changes in patterns of home care, health seeking and referral.

The intervention is to use trained local facilitators as change agents to assist mothers’ groups to bring about perinatal care behaviour change. We shall also train women identified by local community groups as baby monitors to spot high risk newborn infants soon after birth. The study will compare outcomes including mortality rates, perinatal care practices and health service utilisation in 12 village development committee areas (8,000 people per village development committee (VDC), compared with 12 matched areas where the intervention is not implemented.

Progress
Since the study started, project staff have completed a baseline survey with mapping and census of 180,000 people, in a remote, hilly, rural district of southern Nepal. This was achieved by recruiting a mapping and interviewing team of 96 local people who received support from nine field co-ordinators and a senior MIRA officer. Team members participated in an orientation process and received training in mapping, questionnaire techniques, building community rapport and communication skills. An enumeration process was delivered between September 1999 and June 2000, in which all households were mapped and a household questionnaire completed with the head of each household. This questionnaire recorded details on the marital status and age of every woman in the household. A second questionnaire used a cross-sectional, descriptive method to collect information from the 25,702 married women of reproductive age in the study area on their most recent deliveries.
During the final year of phase one of this randomised controlled trial we have successfully monitored the pregnancy status of 28931 married women of reproductive age, and obtained data on birth outcomes and perinatal health care behaviours in this population. The final analysis of the primary and secondary outcome measures is complete, and this has shown a statistically significant impact on neonatal mortality in intervention areas as compared with control areas. These findings are of international importance in meeting the Millennium Development Goals, and demonstrating the potential in community-based participatory, demand led interventions. The results are contained in a number of papers published since 2002.

Study protocol (Adobe PDF file, 3.0 MB)
Women's Group Manual (Adobe PDF file, 238 KB)
Experiences of a local women's group member (Adobe PDF file, 36 KB)

Other completed studies:

  • Perinatal nutrition and neonatal hypoglycemia

  • Impact and cost effectiveness of focused perinatal health education for mothers on infant care, neonatal mortality and postnatal family planning practices

  • Incidence of Hypoxic-Ischaemic Encephalopathy of newborns in Nepal – risk factors, mortality and neonatal sequelae

  • Screening of glucose 6 phosphate dehydrogenase enzyme deficiency in the newborns

  • Continuous temperature monitoring of newborns in Nepal

  • Gestational age specific birth weight centiles in Nepal

  •  Mothers’ recall of infant size at birth in the evaluation of low birth weight prevalence

  • Prevalence of and Factors associated with Low Birth Weight in Nepal (in association with UNICEF) – study done in 4 major hospitals of the country – Prasuti Griha, Biratnagar, Pokhara and Nepalgunj Hospitals

  • Impact of a community based participatory intervention to improve essential newborn care in rural Nepal

 

Ongoing Studies                                          

 
 
 Dhanusha  

Research Proposal Description Sheet

 Because of the success of the MIRA Makwanpur study, which showed the potential for community work with women's groups, we are building on our success by starting another programme in Dhanusha district, southern Nepal. The programme will involve large areas of the district and will look at some new areas. Firstly, the district lies in Nepal's Terai or southern plains. The cultural mix and geography are substantially different from that of Makwanpur district. Secondly, the programme will test a new intervention aimed at treating newborn infections. Thirdly, it will look at nutrition as an added objective.

Title
Community interventions to improve child survival in rural Nepal: a cluster, randomized controlled trial of the impact of women’s groups on perinatal and neonatal mortality and maternal and infant nutrition, augmented by treatment of neonatal sepsis by community volunteers.

Objectives

General
The overall objective of the programme is to evaluate potentially replicable and scalable interventions in poor communities to improve child survival.

Specific
   1.  To evaluate the impact of a participatory intervention with women’s groups on neonatal mortality.

  1. To evaluate the impact on maternal and infant nutritional status of the inclusion of diet as an issue for discussion in women's groups.
     

  2. To evaluate the additional impact of training of community volunteers in the recognition and management of neonatal sepsis.

 
Makwanpur

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MIRA Makwanpur study: second phase

The success of the MIRA Makwanpur study has led to a second phase of activities. This will build on the findings and introduce some new objectives. 

  1. At the beginning of the study, we discussed the programme with Makwanpur's stakeholders and planned to extend the activities to areas that were not involved in the first phase if the findings were positive. This being the case, we are now extending the scope of the programme to involve the district's remaining Village Development Committees. Likewise, the women's group activities will now take place in areas which had previously served as controls.
     

  1. The first phase analysis suggested that the intervention had improved maternal survival, but the numbers involved were low. By extending the programme we should be able to look at maternal mortality in more detail and with more statistical power.
     

  1. The success of the women's group intervention with respect to newborn survival makes us wonder if it could also affect older children. We are introducing work on the Integrated Management of Childhood Illness (IMCI) to the groups to see how they will tackle childhood problems.
     

  1. We are supporting existing groups if they would like to extend their activities. One of the main ideas is to involve men; another is to develop new or existing strategies; a third is to support group members in themselves facilitating change in the wider community.