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
Verified date | July 2020 |
Source | Aga Khan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Pakistan | Government and AKHSP Health Facilities in Gilgit-Baltistan | Gilgit, Astore, Ghizer, Hunza And Nagar | Gilgit-Baltistan |
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 |
Pakistan,
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 |
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