Condition category
Pregnancy and Childbirth
Date applied
07/06/2015
Date assigned
03/07/2015
Last edited
07/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The 2011 Nepal Demographic and Health survey showed that only 50% of women have four Antenatal Care (ANC) visits and 45% have postnatal visits. 35% of births take place in a health facility and the rest at home. Despite a decrease in maternal mortality (death rate), neonatal mortality has remained the same over the past five years. These poor health indicators show that there is a need to increase the use of Maternal and Child Health (MCH) services especially in rural areas. Although the study area is one of the districts where governmental and non-governmental organizations provide all maternal health services free of cost, the utilization of MCH services is very low. The aim of this study is to assess whether the intervention will help increase the use of MCH services, promote good nutrition, address possible barriers and improve pregnancy outcomes.

Who can participate?
Pregnant women in the second trimester (12-24 weeks).

What does the study involve?
48 wards from six village Development Committees (Dhalkewar, Digambarpur, Hariharpur, Sakhuwa, Shantipur and Tulsi ) will be randomly allocated to either the intervention or the control group.
For the intervention group the intervention involves training, supervision and monitoring of Female Community Health Volunteers (FCHVs), and sending text messages about MCH services and diet to pregnant women or their close relatives. The control group does not receive any intervention.

What are the possible benefit and risks of participating?
This intervention will help the participants to use MCH services and this will lead to better health for pregnant women, their children and their communities. There are no risks associated with this study.

Where is the study run from?
BHORE Janakpur based in Janakpur, Nepal.

When is the study starting and how long is it expected to run for?
June 2015 to May 2016.

Who is funding the study?
Janaki Health Care & Research Center, Janakpur, Nepal.

Who is the main contact?
Jitendra Kumar Singh (PhD Scholar)
jsingdj@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Mr Jitendra Kumar Singh

ORCID ID

http://orcid.org/0000-0002-1387-4642

Contact details

Department of Community Medicine
Faculty of Medicine
Banaras Hindu University
Varanasi
221005
India
+977 (0)8576855452
jsingdj@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MATRI SUMAN 2015

Study information

Scientific title

Effect of capacity building and technological intervention on utilization of maternal and child health services in rural communities of Dhanusha district (Southern Terai) in Nepal: a cluster randomized controlled trial

Acronym

Study hypothesis

It is hypothesized that capacity building and technological intervention will enhance the utilization of Maternal and Child Health (MCH) services by the pregnant women and will be associated with positive changes in food consumption pattern, pregnancy outcomes and child feeding practices. Supervision, monitoring and reinforcement training will enhance the performance of Female Community Health Volunteers (FCHVs) and the use of mobile phone text messages will be feasible as a tool for health education for MCH service utilization in the intervention group as compared to the control group.

Ethics approval

1. Ethical Review Board of Nepal Health Research Council, 01/07/2015, reg. no. 101/2015
2. Ethical Review Committee, Institute of Medical Sciences, Banaras Hindu University, 17/10/2015, EC reg. no.: ECR/526/Inst/UP/2014 Dt. 31.1.14

Study design

Prospective cluster randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Pregnancy

Intervention

The intervention package to be implemented has two components to address MCH Service utilization and dietary intake.

Component 1: Capacity Building of FCHVs through Reinforcement Training and their Supervision and Monitoring.
FCHVs in the intervention arm were sensitized to the extent at they can make frequent visits to the pregnant women in their respective wards. They underwent one day extensive orientation/reinforcement training, equipping them with the knowledge and skills at the community level. The content includes the materials prepared by combining three packages:
1. Maternal and Neonatal Health (MNH) counselling package “Jeevan Suraksha” developed by USAID
2. Nutritional package by “micronutrient initiative, Nepal” which has been adopted by the Department of Health Services, Ministry of Health and Population, Government of Nepal
3. “Bal Paribar Mitra” monitoring format; Training of Trainers (ToT) module of Community Based - Maternal and Child Health Nutrition (CB-MCHN) project (motivation for change), UP, India.
A system for monitoring of FCHVs is prepared. A researcher will make monthly visits to FCHVs in the intervention areas. The monitoring format for FCHVs is developed which is adopted from the “ Bal Paribar Mitra” monitoring format; ToT module of CB-MCHN project (motivation for change), UP, India.

Component 2: Text messages through mobile phone to the pregnant women:
All the pregnant women in the intervention arm will receive text messages (SMS) either in Nepali or Maithili, based on the participant’s language preference. The text message will be delivered manually by the researcher himself through a mobile phone. The frequency will be one message per fortnight during the 4-5-6th month and thereafter every week until delivery. During the postnatal period up to 6 months one message will be sent per week. A package of common messages for all is prepared according to stage of pregnancy (i.e. trimester specific) and postnatal. The SMS message will be short and concise informing what they should do. Altogether 10-15 messages are created for each stages of the pregnancy and postpartum. These messages are also adopted from the training materials Jeevan Suraksha, Micronutrient Initiative-Nepal.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Utilization of Skilled Birth Attendant (SBA) by pregnant women at delivery. % of births for which pregnant women delivered with a skilled birth attendant (doctor, Auxiliary Nurse Midwife [ANM], or nurse) either at a health facility or at home
2. Consumption of diversified diet. % of women who consumed diversified food (number of food groups consumed) by Food and Agriculture Organization (FAO) 2007 recommendations for pregnant women

Secondary outcome measures

1. % of women who received four Antenatal Care (ANC) visits from a skilled provider (doctor, ANM, or other nurse)
2. Institutional delivery: % of births that took place at health facility (public or private)
3. % of mothers who received three postnatal check-ups from a skilled provider (doctor, ANM or other nurse)
4. Weight gain during pregnancy: % of pregnant women with a weight gain during pregnancy (per kg/month) from the 4th month of pregnancy
5. Changes in child feeding practices: % of women who initiate breast milk within ½ hour, fed colostrums, practices exclusive breastfeeding and complementary feeding in time
6. Performance of FCHV: % of FCHV reporting timely and correctly and conducted mothers meetings regularly
7. Feasibility of mobile phone text messages as tool for health education in MCH service utilization: % of women who utilized MCH Services followed by text messages

Overall trial start date

01/06/2015

Overall trial end date

01/05/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Pregnant women in the second trimester (12-24 weeks) of any age who visit or do not visit health facilities for MCH services in 54 clusters in given period of time
2. Dhanusha district has 101 Village Development Committees (VDCs). 64 VDCs were excluded. 39 VDCs were excluded because of Maternal and Infant Research Activities by MIRA Dhanusha and 25 VDCs were excluded because of programmatic activities (Sunaula Hazar Din) of Government of Nepal. Baseline survey was done only in 54 wards (cluster) of six VDCs selected randomly
2. The intervention in this research involved only VDCs which have SBA utilization less than 12% and 4ANC less than 40%
3. Evaluation will be done longitudinally at different points of time until 6 months after childbirth

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

360 (48 clusters, 6-8 pregnant women from each cluster)

Participant exclusion criteria

1. Women in the third trimester of pregnancy
2. Women with a disability that makes the intervention difficult (for example, with hearing or sight problem or mentally handicapped)

Recruitment start date

01/06/2015

Recruitment end date

30/09/2015

Locations

Countries of recruitment

Nepal

Trial participating centre

Dhanusha district of Nepal
-
Nepal

Sponsor information

Organisation

BHORE Janakpur

Sponsor details

Ramanand Chowk-8
Dhanusha
Janakpur
00977
Nepal
+977 (0)9844059173
bhorejanakpur@gmail.com

Sponsor type

Charity

Website

Organisation

Janaki Medical College Teaching Hospital

Sponsor details

Tribhuvan University
Janakpur
-
Nepal
-
researchjanaki@gmail.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

BHORE Janakpur

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Protocol: 01/07/2015
2. Results from recruitment and baseline data: from 15/08/2015
3. Results from follow-up: from 15/01/2016
4. Final results: from 15/07/2016

Intention to publish date

15/07/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes