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

NCT ID: NCT01751945

Last Updated: 2016-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-12-31

Brief Summary

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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

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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:

1. 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.
2. To provide a maternal and neonatal health pack(clean delivery kit, emollient, chlorhexidine, sms health messages) for safe motherhood and newborn well-being.
3. To mobilize community for creation of demand for improved MNH services and practices through community mobilization.
4. 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.
5. To strengthen and improve the quality of care at health facilities in providing EmONC services through capacity building of health care providers.

Conditions

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Sepsis Pneumonia Omphalitis Birth Asphyxia Respiratory Distress Syndrome Eclampsia Postpartum Hemorrhage Puerperal Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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EmONC package

The EmONC package consists of:

1. Maternal and neonatal health pack(clean delivery kit, emollient, chlorhexidine, sms messages) for safe motherhood and newborn wellbeing.
2. 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.
3. Community mobilisation

Group Type EXPERIMENTAL

EmONC package

Intervention Type BEHAVIORAL

The EmONC package consists of:

1. Maternal and neonatal health pack(clean delivery kit, emollient, chlorhexidine, sms messages) for safe motherhood and newborn wellbeing.
2. 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.
3. Community mobilisation

Standard of care

Standard care as per national policy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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EmONC package

The EmONC package consists of:

1. Maternal and neonatal health pack(clean delivery kit, emollient, chlorhexidine, sms messages) for safe motherhood and newborn wellbeing.
2. 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.
3. Community mobilisation

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Expectant women and their newborns in the study area

Exclusion Criteria

* Pregnant women not belonging to the study area
Minimum Eligible Age

15 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Department for International Development, United Kingdom

OTHER_GOV

Sponsor Role collaborator

Aga Khan University

OTHER

Sponsor Role lead

Responsible Party

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Dr Sajid Bashir Soofi

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr. Sajid Soofi, MBBS, FCPS

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University

Locations

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Field Site

Rahim Yar Khan, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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Ariff S, Jiwani U, Rizvi A, Muhammad S, Hussain A, Ahmed I, Hussain M, Usman M, Iqbal J, Memon Z, Soofi SB, Bhutta ZA. Effect of Maternal and Newborn Care Service Package on Perinatal and Newborn Mortality: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 Feb 5;7(2):e2356609. doi: 10.1001/jamanetworkopen.2023.56609.

Reference Type DERIVED
PMID: 38372998 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23800194 (View on PubMed)

Other Identifiers

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RAF/FIN/AKU-2/2012/00030

Identifier Type: -

Identifier Source: org_study_id

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