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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 5 June 2017
Main ID:  ISRCTN78892490
Date of registration: 24/10/2013
Prospective Registration: No
Primary sponsor: World Health Organization (Switzerland)
Public title: Overcoming barriers to scaling skilled birth attendants? utilization in improving maternal, newborn and child health in Nepal
Scientific title: Implementation research to overcome barriers to scaling skilled birth attendants? utilization in improving maternal, newborn and child health in Nepal: a cluster randomized controlled trial
Date of first enrolment: 01/04/2011
Target sample size: 5000
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN78892490
Study type:  Interventional
Study design:  Cluster randomized controlled trial (Quality of life)  
Phase:  Not Applicable
Countries of recruitment
Nepal
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name: Sharad    Onta
Address:  Nepal Public Health Foundation Dhara Marga 101/2, Maharajgunj 44600 Kathmandu Nepal
Telephone: +977 (0)9851085061
Email: sharadonta@gmail.com
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: 1. Bajhang, Dailekh and Kanchanpur has 120 Village Development Committees (VDCs). Baseline survey involved only women having children under 1 year of age in 50 VDCs. 20 VDCs were excluded because of their proximity to district hospital. Only 50% of the remaining 100 VDCs were selected for the baseline survey.
2. The intervention phase of the project involved only VDCs which have SBA utilization less than 60%. All mothers groups, youth groups, SBA, Female Community Health Volunteer (FCHV) of 36 VDCs were involved. One VDC with 57% utilization rate has been excluded to distribute clusters equally and evenly.
3. Evaluation phase will be similar to baseline phase. It will involve mothers having children under 1 year of age.

Exclusion criteria: Does not meet inclusion criteria

Age minimum:
Age maximum:
Gender: Female
Health Condition(s) or Problem(s) studied
Maternal and Newborn Health
Pregnancy and Childbirth
Intervention(s)
Village Development Committees (VDCs) from three districts (Bajhang, Dailekh and Kanchanpur) were allocated to intervention and control clusters by randomization.

The intervention package to be implemented has five components to directly address these barriers. Each component has several activities, described below.

Component 1: Increased family support for the pregnant women to reach a facility for childbirth.
Female Community Health Volunteers (FCHVs) were oriented by project staff to discuss with the pregnant women and family members the importance of birth with a skilled attendant and review with the family the birth and emergency preparedness card which the woman has completed in her antenatal care visits. Mothers groups were given an orientation by FCHV with the support of project staff to invite the family of identified pregnant women (identify through FCHV and mothers group members in each ward) to regular meetings to discuss the importance of birth with a skilled attendant and family member?s support to the pregnant women to reach this care.
The mothers groups provide information to the family members about the fund and transportation arrangement mechanism.

Component 2: Develop a system to provide funds to support women and families to seek childbirth care with a SBA
The research team organized discussions with the Health Facility Management Committees (HFMCs) of respective Health Post, Sub Health Post on the operation of a fund by the mothers groups. Discussion on the roles and scope of HFMC to support mothers groups in operating the emergency fund and possible modalities for the operation of the fund, particularly how to protect against losses and replenishment of the fund was done.The project staff supported the HFMC in their discussions with mothers groups for the expansion of the current fund, to agree upon a modality of operation and to establish regular coordination and feedback between the Committee and mothers group. All mothers group agreed
Primary Outcome(s)
1. Utilization of SBA services by pregnant women for childbirth (% of women who give birth with a SBA [facility and home])
Secondary Outcome(s)
1. Ante-natal check-up four times by pregnant women (% of pregnant women who had one and who had four ante-natal checkups during pregnancy)
2. Post-natal check-up of mothers and babies (% of mothers who received at least one post-natal check of mother and newborn baby)
3. Availability of transport to the women to visit a health institution for childbirth (% of women who used services and % of women who informed they did not receive SBA services because of transport problems)
4. Functional operation of emergency fund (% of women who perceived lack of finances as a problem in utilizing SBA services; % of women who received a loan from emergency fund and % of women who paid back the loan)
5. Security of SBA (% of SBAs who perceived security as a problem in work)
6. Support from family to the women for childbirth at health institution (% of women who perceived they had support from their family to use SBA services; % of women who informed lack of support from their family as a reason for not using SBA services)
7. Women-friendly health facility environment (% of women who inform that health workers were supportive at the facility; % of women who informed that they did not use SBA services because of unsupportive behaviour of health workers)
Secondary ID(s)
N/A
Source(s) of Monetary Support
The Implementation Research Platform, World Health Organization (WHO) (Switzerland)
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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