SepsisEmONCNCT01751945
Improved Accessibility of EmONC Services for Maternal and Newborn Health: a Community Based Project
A study testing EmONC package in people with Sepsis and Pneumonia, run by Aga Khan University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Pneumonia, Omphalitis
- What is being tested?
- EmONC package
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,000 participants
- Where
- 1 sitePakistan
- Study dates
- Nov 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Expectant women and their newborns in the study area
Who cannot join
- Pregnant women not belonging to the study area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improved Accessibility of EmONC Services for Maternal and Newborn Health: a Community Based Project.
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.
Read the 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.
- Conditions
- Sepsis, Pneumonia, Omphalitis, Birth Asphyxia, Respiratory Distress Syndrome, Eclampsia
- Being tested
- EmONC package
- Keywords
- EmONC, Neonatal mortality, Perinatal mortality
- Medical subject headings
- Sepsis, Pneumonia, Asphyxia Neonatorum, Respiratory Distress Syndrome, Eclampsia, Postpartum Hemorrhage, Puerperal Infection, Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmONC packageBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| EmONC package | Experimental | 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 Receives: Behavioral: EmONC package |
| Standard of care | No intervention | Standard care as per national policy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perinatal mortality
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Department for International Development, United Kingdom
- Responsible party
- Principal investigator, Dr Sajid Bashir Soofi, Aga Khan University
- Investigators
- Dr. Sajid Soofi, MBBS, FCPS, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751945
- Sponsor's protocol ID
- RAF/FIN/AKU-2/2012/00030
- Acronym
- EmONC
- Status last verified
- Jun 2016
- First submitted
- 16 Nov 2012
- Last updated
- 9 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 38372998Turab 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.
PubMed 23800194
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Accessibility of EmONC Services for Maternal and Newborn Health: a Community Based Project.
- ClinicalTrials.gov ID
- NCT01751945
- Acronym / sponsor ID
- EmONC / RAF/FIN/AKU-2/2012/00030
- Conditions
- Sepsis, Pneumonia, Omphalitis, Birth Asphyxia, Respiratory Distress Syndrome, Eclampsia
- Keywords
- EmONC, Neonatal mortality, Perinatal mortality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12,000 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- Department for International Development, United Kingdom
- Study start
- Nov 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 18 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EmONC package | Experimental | Behavioral: EmONC packageThe 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 | No intervention | –Standard care as per national policy |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Expectant women and their newborns in the study area
Key exclusion criteria (1 listed)
- Pregnant women not belonging to the study area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmONC packageThe 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 | Behavioural | EmONC package |
Primary outcome
Perinatal mortality
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2016.
- Derived from this study: PubMed 38372998Ariff 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.
- Derived from this study: PubMed 23800194Turab 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Sajid Soofi, MBBS, FCPS principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EmONC package in people with Sepsis and Pneumonia, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perinatal mortality (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01751945, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2016.