The Maternal and Child Health (MCH) Handbook in Mongolia: A Cluster-Randomized, Controlled Trial

Objective To assess the effectiveness of the Maternal and Child Health (MCH) handbook in Mongolia to increase antenatal clinic attendance, and to enhance health-seeking behaviors and other health outcomes. Methods A cluster randomized trial was conducted using the translated MCH handbook in Bulgan, Mongolia to assess its effectiveness in promoting antenatal care attendance. Pregnant women were recruited from 18 randomly allocated districts using shuffled, sealed envelopes. The handbook was implemented immediately for women at their first antenatal visit in the intervention group, and nine months later in the control group. The primary outcome was the number of antenatal care visits of all women residing in the selected districts. Cluster effects were adjusted for using generalized estimation equation. Masking was not possible among care providers, pregnant women and assessors. Findings Nine districts were allocated to the intervention group and the remainder to the control group. The intervention group (253 women) attended antenatal clinics on average 6•9 times, while the control group (248 women) attended 6•2 times. Socioeconomic status affected the frequency of clinic attendance: women of higher socioeconomic status visited antenatal clinics more often. Pregnancy complications were more likely to be detected among women using the handbook. Conclusion The MCH handbook promotes continuous care and showed an increase in antenatal visits among the intervention group. The intervention will help to identify maternal morbidities during pregnancy and promote health-seeking behaviors. Trial Registration UMIN Clinical Trial Registry UMIN000001748

Japan has now claimed their successful promotion of maternal and child health with the extremely low perinatal mortality. One of the major features of the maternal and child health handbook is not only to provide the information about growth and development of the child to share it between parents and healthcare professionals, but also to provide continuous record and basic educational information for the family from antenatal care up to milestones of growth and development of these children, which facilitate the Continuum of Care. The handbook has been implemented in other countries, too, such as Indonesia and Bangladesh. [3] The handbook has been evaluated in a previous study. [4] However, there has not been a high-quality study assessing effectiveness of use of such a handbook to facilitate sharing continuous information.
Providing Maternal and Child Health Handbook has cost implication for all children born, and it is extremely important to appropriately assess its effectiveness when firstly initiated or before the implementation.
It also has implication to a better data collecting system to provide evidence-base for policy development in maternal and child health. [5] AIM AND OBJECTIVES

JUSTIFICATION
A randomised controlled trial is so far the best study to prove effectiveness of a public health intervention. As the unit of the intervention, implementation of maternal and child health hand book, is by sums, the best possible study design is a cluster randomised controlled trial. There are 17 soums in Bulgan, Mongolia, though these are different in their size, health outcome index, and care they receive. It is therefore considered that cluster controlled trial with 15 soums and not controlled survey a bug ( No 3 bug in Bulgan city) and a soum (NAME) is the best possible option for the research question.

MORTALITY AND MORBILITY:
All mortality and morbidity are derived from the routinely collected national statistics system by ICD-10 code.

CHARACTERRISTICS AND OTHER OUTCOMES OF MOTHERS AND CHILD:
This is collected by using questionnaire by interview after 28 days at birth. The data collectors for survey visit the family clinic or Aimag hospitals and the household with mother in routine check-up for children.

STUDY IMPLICATION
There are three major implications expected from this study: 1) Distribution of maternal and child health handbook for all pregnancies has cost implication, and the results will inform the Mongolian government to make informed judgement whether this is to be implemented for all sums continuously after the study is finished.  LOGISTICS 18 soums will be selected for this study. All data collectors will selected from local soums medical stuff (each 2 persons). The data checker will selected from Aimag health ceter (2 persons) The data management and analysis will take place in Bulgan aimag, Ulaanbaatar city, Mongolia and Japan. The report will be published in Mongolian and English. The dissemination workshop will include representatives from local communities involved in the study, representatives from governmental, non-governmental and international organizations.
The local logistics will be taken care by the staff of the National Center fro Health Development.

RESEARCH GRANT
All the research grant is from International Cooperation Research Grant by Ministry of Health, Labour and Welfare