Linking Facility-based Mortality Audits With Community Engagement in Gilgit-Baltistan, Pakistan

Stillbirth Clinical Trial

Official title:

A Pilot Study: Linking Facility-based Mortality Audits With Community Engagement to Improve Maternal and Newborn Outcomes in Gilgit-Baltistan, Pakistan

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03904706
• Other study ID #: GB mortality audits study
• Status: Terminated
• Phase: N/A
• Start date: April 16, 2019
• Est. completion date: May 31, 2020

Study information

• Verified date: July 2020
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1871
• Est. completion date: May 31, 2020
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 49 Years

Eligibility

Inclusion Criteria:

• Women aged 15-49 years who have had a pregnancy in the last 12 months who reside in the five targeted districts. Public and private health facilities in five districts in GB that offer obstetric and postnatal care, and respective catchment areas are supported by LHWs, Lady Health Volunteers (LHVs), CMWs, and CHWs will be included in the study. Data for all maternal 'near misses', perinatal and neonatal mortality and morbidity outcomes will be recorded for all women and newborns who deliver at home (through LHW, LHV, CMW monthly reports) and who contact the health facility within 42 days post-delivery, regardless of whether or not they delivered in the health facility.

Exclusion Criteria:

• Women aged 15-49 years who have not had a pregnancy in the last 12 months, who reside in the five targeted districts. Health facilities in five districts of GB that do not provide any obstetric and postnatal care and are not affiliated with any LHWs, or CMWs will be excluded.

Related Conditions & MeSH terms

• External Causes of Morbidity and Mortality
• Neonatal Death
• Perinatal Death
• Stillbirth

Intervention

Other:
• Audits only
Formalized audit teams with monthly meetings at each facility.
• Audits with community feedback
This intervention will implement the audits as described in arm 1; however, key community representatives (approximately 3-5 members) will be identified to attend monthly follow-up meetings with audit team leaders to discuss the community aspects (phase one and two-delays) that could have prevented the death, near miss or severe adverse outcome. Information regarding the cause(s) of death in the community will be collected by the LHW or CMW, who reports to the health facility on a monthly basis.

Locations

Country	Name	City	State
Pakistan	Government and AKHSP Health Facilities in Gilgit-Baltistan	Gilgit, Astore, Ghizer, Hunza And Nagar	Gilgit-Baltistan

Sponsors (8)

Lead Sponsor	Collaborator
Aga Khan University	Aga Khan Development Network - Islamabad, Pakistan, Aga Khan Foundation, Canada, Aga Khan Foundation, Pakistan, Aga Khan Health Services, Aga Khan University, Nairobi, Kenya, Centre for Global Child Health, SickKids Research Institute - Toronto, Canada, Department of Health Gilgit-Baltistan - Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in proportion of women who can correctly identify at least 3 danger signs at each stage across the continuum of care	Change in proportion of women who can correctly identify at least 3 danger signs at each stage across the continuum of care	12 months
Primary	Change in proportion of women for which at least 5 birthing plan actions were taken for the birth of the index child	Change in proportion of women for which at least 5 birthing plan actions were taken for the birth of the index child: Discussed place of delivery, Discussed who will perform delivery, Set aside funds for delivery, Set aside alternate funds for costs of skilled and emergency care, Made arrangements for transport, Identified a blood donor, Discussed accompaniment to planned delivery location.	12 months
Secondary	Change in number of facility deliveries	Change in number of facility deliveries (including number of postnatal visits).	12 months
Secondary	Change in severe maternal morbidity outcomes	Change in severe maternal morbidity outcomes: proportion of assisted deliveries, emergency caesarean sections, transfusions and hysterectomies.	12 months
Secondary	Change in the quality of delivery services	Change in the quality of delivery services as measured through the delivery room checklist	12 months
Secondary	Change in proportion of first, second and third delays	Change in proportion of first, second and third delays	12 months
Secondary	Perinatal mortality (fresh stillbirth or neonatal death in the first week of life)	Perinatal mortality (fresh stillbirth or neonatal death in the first week of life)	12 months
Secondary	Neonatal mortality (deaths in the first 28 days of life)	Neonatal mortality (deaths in the first 28 days of life)	12 months