Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2026-03-01 @ 3:17 AM
Study NCT ID:
NCT03904706
Status:
TERMINATED
Last Update Posted:
2020-07-10
First Post:
2019-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Linking Facility-based Mortality Audits With Community Engagement in Gilgit-Baltistan, Pakistan
Sponsor:
Aga Khan University
Organization:
Study Overview
Official Title:
A Pilot Study: Linking Facility-based Mortality Audits With Community Engagement to Improve Maternal and Newborn Outcomes in Gilgit-Baltistan, Pakistan
Status:
TERMINATED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
We were unable to continue field activities due to COVID-19
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pakistan is one of the countries in South Asia where neonatal mortality rates remain stagnant. Babies born in Pakistan encounter the highest risk of dying; of every 1,000 babies born, 46 die before the end of their first month (UNICEF, 2018). Some of the highest perinatal and neonatal mortality rates in Pakistan are found in districts of Pakistan's mountainous northern region (Bhutta ZA, 2013), where geography, climate and security risks make it challenging for women in remote communities to reach health services in a timely manner. According to 2013 PDHS, the neonatal and perinatal mortality rate in the northern area of Gilgit Baltistan was 39/1,000 and 37/1,000, respectively. In the rural area of Khyber Pakhtunkhwa, the neonatal and perinatal mortality rate was 42/1,000 and 63/1,000, respectively.
Implementation of a health facility mortality audit cycle has proved successful in reducing perinatal mortality by upto 30% in other LMICs. Meanwhile evidence suggests that the most common factors contributing to high mortality rates are due to phase-one delays (delay in the decision to seek care). This study will attempt to operationalize linkages between the community and facility to not only improve facility-based quality of care, but to bring change in the community through community-feedback meetings to mitigate phase one and two delays and improve maternal, perinatal and neonatal outcomes. Data from this study will inform MoH policy decisions about standardized mortality audits with community feedback.
Given the geographical location of Gilgit-Baltistan (GB) and accompanying constraints such as terrain and security, this study will attempt to operationalize linkages between the community and facility to not only improve facility-based quality of care, but to bring change in the community through community-feedback meetings to mitigate phase one and two delays and improve maternal, perinatal and neonatal outcomes. Data from this study will inform MoH policy decisions about standardized mortality audits with community feedback.
Implementation of a health facility mortality audit cycle has proved successful in reducing perinatal mortality by upto 30% in other LMICs. Meanwhile evidence suggests that the most common factors contributing to high mortality rates are due to phase-one delays (delay in the decision to seek care). This study will attempt to operationalize linkages between the community and facility to not only improve facility-based quality of care, but to bring change in the community through community-feedback meetings to mitigate phase one and two delays and improve maternal, perinatal and neonatal outcomes. Data from this study will inform MoH policy decisions about standardized mortality audits with community feedback.
Given the geographical location of Gilgit-Baltistan (GB) and accompanying constraints such as terrain and security, this study will attempt to operationalize linkages between the community and facility to not only improve facility-based quality of care, but to bring change in the community through community-feedback meetings to mitigate phase one and two delays and improve maternal, perinatal and neonatal outcomes. Data from this study will inform MoH policy decisions about standardized mortality audits with community feedback.
Detailed Description:
Pakistan has the highest global newborn mortality rate (45.6/1,000 live births), with 1 in 22 babies dying before the end of their first month (UNICEF, 2018). Some of the highest perinatal and neonatal mortality rates are found in districts of Pakistan's mountainous northern region, where geography, climate and security risks make it challenging for women in remote communities to reach health services in a timely manner. Implementation of a health facility mortality audit cycle has proved successful in reducing perinatal mortality by up to 30% in other LMICs. Meanwhile evidence suggests that the most common factors contributing to high mortality rates are due to phase-one delays. Given the geographical location of GB and accompanying constraints such as terrain and security, this study will attempt to operationalize linkages between the community and facility to not only improve facility-based delivery services, but to effect change at the community, through community-feedback meetings to mitigate phase one and two delays and improve maternal, perinatal and neonatal outcomes. Data from this study may help inform government policy decisions about standardized mortality audits with community feedback.
Objectives of the study
Broad objective:
The overall aim of the study is to assess whether implementation of facility-based maternal, perinatal and neonatal mortality audits (systemic clinical reviews of near misses and deaths), in combination with targeted community engagement and awareness activities, increases the recognition of danger signs during pregnancy, the number of facility deliveries and encourages the discussion of a birthing plan, thereby reducing phase -one, two and three delays as compared to implementing facility-based mortality audits only. This will be assessed by monitoring births and outcomes in public and private health facilities and their associated catchment communities in GB. The study will also evaluate whether these targeted community-engagement activities, informed by the clinical audits improve the quality of delivery services through better utilization of local resources and improvements in clinical signal functions.
Specific objectives Primary objective
To determine the effect of a combined approach of facility-based audits (clinical reviews) linked to community engagement on core community behaviours/practices to improve obstetric, perinatal and neonatal outcomes as compared to standard perinatal and neonatal facility-based audits only and no facility-based audits. Key practices include:
1. Recognition of danger signs among women during pregnancy, labour and delivery, after delivery and in newborns
2. Actions taken for a birthing preparation plan
Secondary objectives
1. Assess facility deliveries
2. Assess severe maternal morbidity outcomes during delivery (including maternal near misses )
3. Assess changes in quality of delivery services as measured through the delivery room checklist
4. Assess changes in first delay (care-seeking decision) I. Delay due to lack of knowledge II. Lack of empowerment (sociocultural factors/barriers such as women's decision making, women's status)
5. Assess changes in second delay (identification and reaching health facility)
6. Assess changes in third delay (receiving adequate care and treatment at facilities)
7. Assess perinatal mortality rates (fresh still birth or neonatal death in the first week of life)
8. Assess neonatal mortality rates (deaths in the first 28 days of life)
Objectives of the study
Broad objective:
The overall aim of the study is to assess whether implementation of facility-based maternal, perinatal and neonatal mortality audits (systemic clinical reviews of near misses and deaths), in combination with targeted community engagement and awareness activities, increases the recognition of danger signs during pregnancy, the number of facility deliveries and encourages the discussion of a birthing plan, thereby reducing phase -one, two and three delays as compared to implementing facility-based mortality audits only. This will be assessed by monitoring births and outcomes in public and private health facilities and their associated catchment communities in GB. The study will also evaluate whether these targeted community-engagement activities, informed by the clinical audits improve the quality of delivery services through better utilization of local resources and improvements in clinical signal functions.
Specific objectives Primary objective
To determine the effect of a combined approach of facility-based audits (clinical reviews) linked to community engagement on core community behaviours/practices to improve obstetric, perinatal and neonatal outcomes as compared to standard perinatal and neonatal facility-based audits only and no facility-based audits. Key practices include:
1. Recognition of danger signs among women during pregnancy, labour and delivery, after delivery and in newborns
2. Actions taken for a birthing preparation plan
Secondary objectives
1. Assess facility deliveries
2. Assess severe maternal morbidity outcomes during delivery (including maternal near misses )
3. Assess changes in quality of delivery services as measured through the delivery room checklist
4. Assess changes in first delay (care-seeking decision) I. Delay due to lack of knowledge II. Lack of empowerment (sociocultural factors/barriers such as women's decision making, women's status)
5. Assess changes in second delay (identification and reaching health facility)
6. Assess changes in third delay (receiving adequate care and treatment at facilities)
7. Assess perinatal mortality rates (fresh still birth or neonatal death in the first week of life)
8. Assess neonatal mortality rates (deaths in the first 28 days of life)
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: