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Improved Accessibility of EmONC Services for Maternal and Newborn Health: a Community Based Project (EmONC)

Primary Purpose

Sepsis, Pneumonia, Omphalitis

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
EmONC package
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sepsis focused on measuring EmONC, Neonatal mortality, Perinatal mortality

Eligibility Criteria

15 Years - 49 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Expectant women and their newborns in the study area

Exclusion Criteria:

  • Pregnant women not belonging to the study area

Sites / Locations

  • Field Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

EmONC package

Standard of care

Arm Description

The EmONC package consists of: Maternal and neonatal health pack(clean delivery kit, emollient, chlorhexidine, sms messages) for safe motherhood and newborn wellbeing. Enhanced trainings of community-level health care providers to provide effective maternal and neonatal health services and referral of complicated cases to health facilities and creation of linkages amongst health care providers. Community mobilisation

Standard care as per national policy

Outcomes

Primary Outcome Measures

Perinatal mortality

Secondary Outcome Measures

Full Information

First Posted
November 16, 2012
Last Updated
June 8, 2016
Sponsor
Aga Khan University
Collaborators
Department for International Development, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT01751945
Brief Title
Improved Accessibility of EmONC Services for Maternal and Newborn Health: a Community Based Project
Acronym
EmONC
Official Title
Improved Accessibility of EmONC Services for Maternal and Newborn Health: a Community Based Project.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University
Collaborators
Department for International Development, United Kingdom

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether an integrated EmONC package (community mobilization, training of community-based health care providers and a maternal and neonatal health pack) reduce perinatal and neonatal mortality.
Detailed Description
Deaths during birth are particularly critical to address as these occur because of complications during childbirth and leads to emergency situation with a slim window of time to intervene. Every year an estimated 3.6 million newborns and 360,000 mothers die globally. Of these, maternal health complication contribute to 1.5 million of neonatal deaths in the first week of life and 1.4 million stillborn neonates, suggesting a major gap of intervention subsists around childbirth and in the early postnatal period, a time when mothers and babies are most at risk. While many factors contribute to maternal and neonatal deaths, one of the most effective means of solving this problem requires effective preventive measures or treatment provided rapidly to women and newborns, often at home or in primary health care settings. It is often addressed that these overwhelming mortalities and morbidities are closely linked with a number of interrelated delays that prevent a pregnant women from accessing the health care she needs. Each delay is closely related to services, logistics, facilities and conditions, which are important elements for their health. These delays are: 1) delay in seeking appropriate medical help for an obstetric emergency or neonatal complication for reasons of cost, lack of recognition of an emergency, poor education, lack of access to information and gender inequality; 2) delay in reaching an appropriate facility for reasons of distance, infrastructure and transport; 3) delay in receiving adequate care when a facility is reached because there are shortages in staff, their competency, or due to unavailability of required medical facilities and equipment. As a result, many preventable maternal deaths occur, most often in resource poor settings, where births are home-based and in the event of complications the woman is unable to access the required care in time. While many proven, cost-effective ways to save the lives of mothers, and newborns exist, they are not always available to those who need them most. There is bulk of literature that has identified number of interventions that can improve maternal and newborn health. The lancet maternal and neonatal survival series emphasized the model of "Basic essential obstetric care" as one of the most feasible and effective strategies to reduce maternal mortalities. For the reasons above, it is essential to create demand of uptake of services and strengthen primary health care infrastructure at the community level, and improve the liaison of Lady Health Workers/Traditional Birth Attendants/Community Midwives with local and district health system for early and timely referral of complicated cases and sick newborns. While several previous studies from Pakistan have documented the beneficial impact of community-based interventions in improving maternal and new-born health, further evidence is required to assess the effectiveness of community-based interventions that can increase the uptake of EmONC services and reduce the delays that are responsible for poor maternal and new-born health. Context-specific evidence is also needed on the appropriate mix of interventions, their delivery strategies, task shifting and sharing options, functional link and assessment in the primary health care, and complementary health systems and community support and demand mechanisms. Therefore, the main target audience and beneficiary of this project is the women which usually do not have a say in the decision making and cannot have choices for her to opt for a better treatment. The women usually depend upon the decisions being made by the husbands and elders as the society is male dominant. We have attempted to take care of this factor to maximize the uptake of intervention and services by developing the community support groups. The specific objectives of this study are: To conduct an in-depth analysis of maternal and neonatal health seeking patterns and behaviors of the target population and care provision at health facilities for understanding the context and requirements for improved EmONC service delivery. To provide a maternal and neonatal health pack(clean delivery kit, emollient, chlorhexidine, sms health messages) for safe motherhood and newborn well-being. To mobilize community for creation of demand for improved MNH services and practices through community mobilization. To train and implement integrated EmONC package for community-level health care providers (Lady Health Workers, Traditional Birth Attendants, Community Midwives to provide antenatal, natal and postnatal care services, and recognize and refer complicated pregnancy and childbirth cases and sick newborns to health facilities. To strengthen and improve the quality of care at health facilities in providing EmONC services through capacity building of health care providers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Pneumonia, Omphalitis, Birth Asphyxia, Respiratory Distress Syndrome, Eclampsia, Postpartum Hemorrhage, Puerperal Sepsis
Keywords
EmONC, Neonatal mortality, Perinatal mortality

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EmONC package
Arm Type
Experimental
Arm Description
The EmONC package consists of: Maternal and neonatal health pack(clean delivery kit, emollient, chlorhexidine, sms messages) for safe motherhood and newborn wellbeing. Enhanced trainings of community-level health care providers to provide effective maternal and neonatal health services and referral of complicated cases to health facilities and creation of linkages amongst health care providers. Community mobilisation
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Standard care as per national policy
Intervention Type
Behavioral
Intervention Name(s)
EmONC package
Intervention Description
The EmONC package consists of: Maternal and neonatal health pack(clean delivery kit, emollient, chlorhexidine, sms messages) for safe motherhood and newborn wellbeing. Enhanced trainings of community-level health care providers to provide effective maternal and neonatal health services and referral of complicated cases to health facilities and creation of linkages amongst health care providers. Community mobilisation
Primary Outcome Measure Information:
Title
Perinatal mortality
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Expectant women and their newborns in the study area Exclusion Criteria: Pregnant women not belonging to the study area
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Sajid Soofi, MBBS, FCPS
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Field Site
City
Rahimyar Khan
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
23800194
Citation
Turab A, Ariff S, Habib MA, Ahmed I, Hussain M, Rashid A, Memon Z, Khan MI, Soofi S, Bhutta ZA. Improved accessibility of emergency obstetrics and newborn care (EmONC) services for maternal and newborn health: a community based project. BMC Pregnancy Childbirth. 2013 Jun 24;13:136. doi: 10.1186/1471-2393-13-136.
Results Reference
derived

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Improved Accessibility of EmONC Services for Maternal and Newborn Health: a Community Based Project

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