External Causes of Morbidity and MortalityNCT03904706
Linking Facility-based Mortality Audits With Community Engagement in Gilgit-Baltistan, Pakistan
A study testing Audits only and Audits with community feedback in people with External Causes of Morbidity and Mortality and Stillbirth, run by Aga Khan University at 1 site in Pakistan.
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). Read more about this study
- Who is it for?
- Ages 15 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- External Causes of Morbidity and Mortality, Stillbirth, Neonatal Death
- What is being tested?
- Audits only and Audits with community feedback
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,871 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Apr 2019to 31 May 2020
- 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
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Government and AKHSP Health Facilities in Gilgit-Baltistan
Gilgit, Astore, Ghizer, Hunza and Nagar, Gilgit-Baltistan, 74800
About this study
Official title: A Pilot Study: Linking Facility-based Mortality Audits With Community Engagement to Improve Maternal and Newborn Outcomes in Gilgit-Baltistan, Pakistan
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.
Read the 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:
- Recognition of danger signs among women during pregnancy, labour and delivery, after delivery and in newborns
- Actions taken for a birthing preparation plan
Secondary objectives
- Assess facility deliveries
- Assess severe maternal morbidity outcomes during delivery (including maternal near misses )
- Assess changes in quality of delivery services as measured through the delivery room checklist
- 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)
- Assess changes in second delay (identification and reaching health facility)
- Assess changes in third delay (receiving adequate care and treatment at facilities)
- Assess perinatal mortality rates (fresh still birth or neonatal death in the first week of life)
- Assess neonatal mortality rates (deaths in the first 28 days of life)
- Being tested
- Audits only, Audits with community feedback
- Keywords
- Facility-based, Mortality, Audits, Community engagement, Gilgit-Baltistan, Pakistan
- Medical subject headings
- Stillbirth, Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audits onlyOther
Formalized audit teams with monthly meetings at each facility.
Audits with community feedbackOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Audits only | Experimental | Formalized audit teams with monthly meetings at each facility.
Audit Intervention phases:
1. Identification of facility leadership (i.e physicians or leading health care providers) to be trained on best practices in obstetric and perinatal care in the implementation of the audits.
2. Training of identified audit leaders (main investigator is typically a physician)
a. 5-day training workshop to include: i. Day 1: maternal death and near misses, perinatal, neonatal deaths and morbidity outcomes ii. Day 2: 'Three-delay' framework and identifying modifiable factors iii. Day 3: data collection and setting up the audit system iv. Days 4-5: mentoring on the identification of the audit teams and initiating audit implementation
3. Creating audit team (composed of at least two obstetricians, 2 pediatricians plus the main investigator)
4. Establishing and launching the audit cycle (monthly meetings)
5. Annual re-certification of audit leaders Receives: Other: Audits only |
| Audits with community feedback | Experimental | 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. Receives: Other: Audits with community feedback |
| Control | No intervention | Monthly outcome data will be collected from health facilities where no audits will be conducted. Data from this group will help evaluate the effectiveness of the intervention arms on perinatal and neonatal mortality. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
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.
Measured: 12 months
Secondary outcomes (6)
Change in number of facility deliveries
Change in number of facility deliveries (including number of postnatal visits).
Measured: 12 months
Change in severe maternal morbidity outcomes
Change in severe maternal morbidity outcomes: proportion of assisted deliveries, emergency caesarean sections, transfusions and hysterectomies.
Measured: 12 months
Change in the quality of delivery services
Change in the quality of delivery services as measured through the delivery room checklist
Measured: 12 months
Change in proportion of first, second and third delays
Change in proportion of first, second and third delays
Measured: 12 months
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)
Measured: 12 months
Neonatal mortality (deaths in the first 28 days of life)
Neonatal mortality (deaths in the first 28 days of life)
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 posted5 Apr 2019
- Study start16 Apr 2019
- Primary completion20 Mar 2020
- Study completion31 May 2020
Why it stopped: We were unable to continue field activities due to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for External Causes of Morbidity and MortalityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a three-arm cluster randomized controlled study to evaluate a novel intervention. Each facility is a cluster and includes all deliveries (including stillbirths and live births) in health facilities and respective catchment areas that provide obstetric and post-natal services.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,871 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Aga Khan Foundation, Pakistan, Aga Khan Health Services, Centre for Global Child Health, SickKids Research Institute - Toronto, Canada, Aga Khan Development Network - Islamabad, Pakistan, Department of Health Gilgit-Baltistan - Pakistan, Aga Khan Foundation, Canada
- Responsible party
- Principal investigator, Dr Sajid Bashir Soofi, Aga Khan University
- Investigators
- Sajid Soofi, FCPS, MBBS, Principal investigator, Aga Khan UniversityDiego Bassani, PhD, Principal investigator, Centre for Global Child Health, SickKids Research Institute - Toronto, CanadaAminah Jahangir, MBBS, HPM, Principal investigator, Aga Khan Foundation, PakistanZulfiqar A Bhutta, PhD, Principal investigator, Centre for Global Child Health, SickKids Research Institute - Toronto, CanadaGul Nawaz Khan, MA, MPH, Principal investigator, Aga Khan UniversitySuzanne E Powell, MSc, Principal investigator, Centre for Global Child Health, SickKids Research Institute - Toronto, CanadaMiraj Uddin, MA, Principal investigator, Aga Khan Health ServicesSaad Y Sulaimani, MSc, Principal investigator, Aga Khan Foundation, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904706
- Sponsor's protocol ID
- GB mortality audits study
- Status last verified
- Jul 2020
- First submitted
- 4 Apr 2019
- Last updated
- 10 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study: Linking Facility-based Mortality Audits With Community Engagement to Improve Maternal and Newborn Outcomes in Gilgit-Baltistan, Pakistan
- ClinicalTrials.gov ID
- NCT03904706
- Acronym / sponsor ID
- GB mortality audits study
- Keywords
- Facility-based, Mortality, Audits, Community engagement, Gilgit-Baltistan, Pakistan
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We were unable to continue field activities due to COVID-19
- Enrolment
- 1,871 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- Aga Khan Foundation, Pakistan, Aga Khan Health Services, Centre for Global Child Health, SickKids Research Institute - Toronto, Canada, Aga Khan Development Network - Islamabad, Pakistan, Department of Health Gilgit-Baltistan - Pakistan, Aga Khan Foundation, Canada
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 5 Apr 2019 (actual)
- 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.
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.
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:
- Recognition of danger signs among women during pregnancy, labour and delivery, after delivery and in newborns
- Actions taken for a birthing preparation plan
Secondary objectives
- Assess facility deliveries
- Assess severe maternal morbidity outcomes during delivery (including maternal near misses )
- Assess changes in quality of delivery services as measured through the delivery room checklist
- 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)
- Assess changes in second delay (identification and reaching health facility)
- Assess changes in third delay (receiving adequate care and treatment at facilities)
- Assess perinatal mortality rates (fresh still birth or neonatal death in the first week of life)
- Assess neonatal mortality rates (deaths in the first 28 days of life)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This will be a three-arm cluster randomized controlled study to evaluate a novel intervention. Each facility is a cluster and includes all deliveries (including stillbirths and live births) in health facilities and respective catchment areas that provide obstetric and post-natal services.
| Arm | Type | Receives |
|---|---|---|
| Audits only | Experimental | Other: Audits onlyFormalized audit teams with monthly meetings at each facility. Audit Intervention phases: 1. Identification of facility leadership (i.e physicians or leading health care providers) to be trained on best practices in obstetric and perinatal care in the implementation of the audits. 2. Training of identified audit leaders (main investigator is typically a physician) a. 5-day training workshop to include: i. Day 1: maternal death and near misses, perinatal, neonatal deaths and morbidity outcomes ii. Day 2: 'Three-delay' framework and identifying modifiable factors iii. Day 3: data collection and setting up the audit system iv. Days 4-5: mentoring on the identification of the audit teams and initiating audit implementation 3. Creating audit team (composed of at least two obstetricians, 2 pediatricians plus the main investigator) 4. Establishing and launching the audit cycle (monthly meetings) 5. Annual re-certification of audit leaders |
| Audits with community feedback | Experimental | Other: Audits with community feedbackThis 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. |
| Control | No intervention | –Monthly outcome data will be collected from health facilities where no audits will be conducted. Data from this group will help evaluate the effectiveness of the intervention arms on perinatal and neonatal mortality. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Audits onlyFormalized audit teams with monthly meetings at each facility. | Other | Audits only |
| Audits with community feedbackThis 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. | Other | Audits with community feedback |
Primary outcome
Change in proportion of women who can correctly identify at least 3 danger signs at each stage across the continuum of care
Time frame: 12 months
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 for which at least 5 birthing plan actions were taken for the birth of the index child
Time frame: 12 months
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.
6 secondary outcomes
Change in number of facility deliveries
Time frame: 12 months
Change in severe maternal morbidity outcomes
Time frame: 12 months
Change in the quality of delivery services
Time frame: 12 months
Change in proportion of first, second and third delays
Time frame: 12 months
Perinatal mortality (fresh stillbirth or neonatal death in the first week of life)
Time frame: 12 months
Neonatal mortality (deaths in the first 28 days of life)
Time frame: 12 months
Results and safety
The study was stopped early (reason given: We were unable to continue field activities due to COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
- Individual participant dataSharing planned: No
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.
Sajid Soofi, FCPS, MBBS principal investigator
Aga Khan University
Diego Bassani, PhD principal investigator
Centre for Global Child Health, SickKids Research Institute - Toronto, Canada
Aminah Jahangir, MBBS, HPM principal investigator
Aga Khan Foundation, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audits only and Audits with community feedback in people with External Causes of Morbidity and Mortality and Stillbirth, 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: stopped early, as of the sponsor's last update on 10 Jul 2020. 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 was stopped early (reason given: We were unable to continue field activities due to COVID-19). Results are not available in the source record.
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?
Change in proportion of women who can correctly identify at least 3 danger signs at each stage across the continuum of care (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2020.