Maternal Complication of PregnancyUeNNCT04184544
Scaling up Evidence Based MNCH Interventions : A Quasi Experimental Study Umeed e Nau (UeN) Project
A study testing Improving of quality of care at health facility and outreach level in people with Maternal Complication of Pregnancy and Newborn Morbidity, run by Aga Khan University at 1 site in Pakistan.
Trial summary
The Umeed-e-Nau (UeN) initiative aims to support the introduction, scale up, and further piloting of high quality and high impact interventions to improve Maternal, Newborn And Child Health (MNCH)in Pakistan by harnessing the potential of both public and private sectors, coupled with introduction of women and girls… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Maternal Complication of Pregnancy, Newborn Morbidity, Perinatal Problems
- What is being tested?
- Improving of quality of care at health facility and outreach level
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000,000 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2017to 30 Jun 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All women of reproductive age in the project areas
- All children under the age of five years
Who cannot join
- The subjects not residing in the project catchment population
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supporting Women and Girls in Pakistan: Scaling up Empowerment and Care Strategies to Address Health and Survival
The Umeed-e-Nau (UeN) initiative aims to support the introduction, scale up, and further piloting of high quality and high impact interventions to improve Maternal, Newborn And Child Health (MNCH)in Pakistan by harnessing the potential of both public and private sectors, coupled with introduction of women and girls empowerment interventions. UeN has two major components: 1) Introducing proven effective MNCH interventions at scale in 8 rural districts of Pakistan, and 2) Generating evidence on innovative approaches to improve MNCH while included in public health programs in Pakistan. There are six trials that are being conducted to address different evidences gaps to improve maternal, newborn and child health in Pakistan. The protocols of the trials will be registered separately.
Read the detailed description
Pakistan's continued high maternal, neonatal, and child mortality is affecting the overall development and national growth. The estimated national maternal mortality ratio ranges from 250 - 750 per 100,000 live births per year, while neonatal mortality rate ranges from 43 - 66 per 1,000 live births per year across the provinces of Pakistan. The under-five mortality rate is 89 per 1,000 live births per year, and diarrhea and pneumonia are two of the most common causes of post-neonatal mortality. Together, they account for more than 30% of all under five deaths in Pakistan.
Majority of maternal, newborn and child deaths are preventable and treatable given programs are designed and delivered through an efficient public health system that takes into account the geographic and social structures. There are several factors resulting in slow progress and improvement of MNCH indicators. These include poor coverage, delayed scale up of effective interventions within the existing health system platforms, lack of women's and girls' empowerment, voice, and participation, and lack of community awareness and support regarding health conditions and poverty. Many of the risk factors that impact maternal and newborn health, such as nutritional deficiencies, exist from adolescence, and becoming pregnant during this sensitive life stage has been found to slow and stunt one's growth In order to evaluate the impact of the UeN initiative quasi experimental study design will be used. The intervention groups are broadly divided into two groups. Both groups will serve as control against each other due to nature of targeting of age group by each intervention group type. Group one included maternal and newborn health districts. These districts are further divided into three sub groups. Sub group 1 will receive only interventions focusing on maternal health (1 district (Sangher)); sub group 2 will receive interventions focusing only on newborn health (1 district (Nasirabad)); sub group 3 will receive combined maternal and newborn interventions (two districts (Lasbila and Badin). Group two will receive child health interventions focusing on the implementation of the global action plan for pneumonia and diarrhea (GAPPD [4districts, Qamabar Shahdadkot Muzaffargarh, Rahim Yar Khan Jafferabad). This design will help us to evaluate independent and combined effect of maternal, newborn, and child health interventions to address maternal, newborn and child health outcomes. We hypothesize that the roll out of proven and effective interventions within existing health delivery platforms for maternal, newborn, child and adolescent health will lead to significant reduction in perinatal mortality rate (20% compared to baseline) and at least 30% reduction in diarrhea and pneumonia case fatality rate in the target project districts.
UeN design justification: The conceptual framework for UeN postulates that increased engagement with communities, empowering women and girls, including addressing access barriers; 2) strengthening capacity of the public and private health sectors mainly through revision of curricula based on new evidence, developing management protocols for different cadre of health workers and providers on MNCH and training; private Sector engagement; 3) provision of sustained supplies and 4) District Health Information System (DHIS) data use for decision making will lead to greater responsiveness of public and private service providers to women's and girls' needs - particularly those of undeserved women, girls and children. The UeN initiative aims to create opportunities in governance processes through revival and participation in District Health Management team (DHMTs), service delivery and citizens' voice and empowerment to transform public and private health sector interactions to drive improvements in MNCH and survival
- Being tested
- Improving of quality of care at health facility and outreach level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improving of quality of care at health facility and outreach levelOther
Community Mobilization and engagement; Use of DHIS data for decision making; Capacity building of health care workers and providers and other Community level and facility level interventions to improve MNCH outcomes
| Study group | Role | What they receive |
|---|---|---|
| Maternal and Newborn health districts | Experimental | Group one included maternal and newborn health districts. These districts are further divided into three sub groups. Sub group 1 will receive only interventions focusing on maternal health (1 district (Sangher)); sub group 2 will receive interventions focusing only on newborn health (1 district (Nasirabad)); sub group 3 will receive combined maternal and newborn interventions (two districts (, Lasbila and Badin). Receives: Other: Improving of quality of care at health facility and outreach level |
| Child Health | Experimental | Group two will receive child health interventions focusing on the implementation of the global action plan for pneumonia and diarrhea (GAPPD [4districts, Qamabar Shahdadkot Muzaffargarh, Rahim Yar Khan Jafferabad). Receives: Other: Improving of quality of care at health facility and outreach level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perinatal deaths
20% reduction in perinatal mortality
Measured: three years
case fatality rate
30% reduction in Pneumonia and diarrhea case fatality in participating health facilities
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start1 Mar 2017
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
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 Maternal Complication of PregnancyStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- Implementation research to Scale up of evidence based interventions comprising four components 1) Designing of management protocol and revision of training curricula and Capacity building of outreach and facility based health care providers; 2) sustained supplies of essential drugs and commodities; 3) community engagement through Lady health worker program and 4) Health Management information data improvement and use of the data for decision making to improve provision and quality of services
- Masking
- None (open label)
- Enrolment
- 5,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, The Hospital for Sick Children
- Responsible party
- Principal investigator, Dr Zulfiqar Ahmed Bhutta, Aga Khan University
- Investigators
- Zulfiqar A Bhutta, PhD, Principal investigator, AKU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184544
- Sponsor's protocol ID
- 0979-3131
- Acronym
- UeN
- Status last verified
- Aug 2021
- First submitted
- 29 Nov 2019
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Muhammad S, Memon ZA, Mian A, Wasan Y, Rizvi A, Ahmed I, Soofi S, Cousens S, Bhutta ZA. A cross-sectional analysis of the impact of lady health worker visits in the prenatal and postnatal period on the uptake of continuum of care interventions and childhood mortality in Pakistan. J Glob Health. 2025 Jun 2;15:04158. doi: 10.7189/jogh.15.04158.
PubMed 40452336Memon ZA, Muhammad S, Soofi S, Khan N, Akseer N, Habib A, Bhutta Z. Effect and feasibility of district level scale up of maternal, newborn and child health interventions in Pakistan: a quasi-experimental study. BMJ Open. 2020 Jul 14;10(7):e036293. doi: 10.1136/bmjopen-2019-036293.
PubMed 32665387
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Women and Girls in Pakistan: Scaling up Empowerment and Care Strategies to Address Health and Survival
- ClinicalTrials.gov ID
- NCT04184544
- Acronym / sponsor ID
- UeN / 0979-3131
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,000,000 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, The Hospital for Sick Children
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 3 Dec 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.
The Umeed-e-Nau (UeN) initiative aims to support the introduction, scale up, and further piloting of high quality and high impact interventions to improve Maternal, Newborn And Child Health (MNCH)in Pakistan by harnessing the potential of both public and private sectors, coupled with introduction of women and girls empowerment interventions. UeN has two major components: 1) Introducing proven effective MNCH interventions at scale in 8 rural districts of Pakistan, and 2) Generating evidence on innovative approaches to improve MNCH while included in public health programs in Pakistan. There are six trials that are being conducted to address different evidences gaps to improve maternal, newborn and child health in Pakistan. The protocols of the trials will be registered separately.
Detailed description
Pakistan's continued high maternal, neonatal, and child mortality is affecting the overall development and national growth. The estimated national maternal mortality ratio ranges from 250 - 750 per 100,000 live births per year, while neonatal mortality rate ranges from 43 - 66 per 1,000 live births per year across the provinces of Pakistan. The under-five mortality rate is 89 per 1,000 live births per year, and diarrhea and pneumonia are two of the most common causes of post-neonatal mortality. Together, they account for more than 30% of all under five deaths in Pakistan.
Majority of maternal, newborn and child deaths are preventable and treatable given programs are designed and delivered through an efficient public health system that takes into account the geographic and social structures. There are several factors resulting in slow progress and improvement of MNCH indicators. These include poor coverage, delayed scale up of effective interventions within the existing health system platforms, lack of women's and girls' empowerment, voice, and participation, and lack of community awareness and support regarding health conditions and poverty. Many of the risk factors that impact maternal and newborn health, such as nutritional deficiencies, exist from adolescence, and becoming pregnant during this sensitive life stage has been found to slow and stunt one's growth In order to evaluate the impact of the UeN initiative quasi experimental study design will be used. The intervention groups are broadly divided into two groups. Both groups will serve as control against each other due to nature of targeting of age group by each intervention group type. Group one included maternal and newborn health districts. These districts are further divided into three sub groups. Sub group 1 will receive only interventions focusing on maternal health (1 district (Sangher)); sub group 2 will receive interventions focusing only on newborn health (1 district (Nasirabad)); sub group 3 will receive combined maternal and newborn interventions (two districts (Lasbila and Badin). Group two will receive child health interventions focusing on the implementation of the global action plan for pneumonia and diarrhea (GAPPD [4districts, Qamabar Shahdadkot Muzaffargarh, Rahim Yar Khan Jafferabad). This design will help us to evaluate independent and combined effect of maternal, newborn, and child health interventions to address maternal, newborn and child health outcomes. We hypothesize that the roll out of proven and effective interventions within existing health delivery platforms for maternal, newborn, child and adolescent health will lead to significant reduction in perinatal mortality rate (20% compared to baseline) and at least 30% reduction in diarrhea and pneumonia case fatality rate in the target project districts.
UeN design justification: The conceptual framework for UeN postulates that increased engagement with communities, empowering women and girls, including addressing access barriers; 2) strengthening capacity of the public and private health sectors mainly through revision of curricula based on new evidence, developing management protocols for different cadre of health workers and providers on MNCH and training; private Sector engagement; 3) provision of sustained supplies and 4) District Health Information System (DHIS) data use for decision making will lead to greater responsiveness of public and private service providers to women's and girls' needs - particularly those of undeserved women, girls and children. The UeN initiative aims to create opportunities in governance processes through revival and participation in District Health Management team (DHMTs), service delivery and citizens' voice and empowerment to transform public and private health sector interactions to drive improvements in MNCH and survival
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Implementation research to Scale up of evidence based interventions comprising four components 1) Designing of management protocol and revision of training curricula and Capacity building of outreach and facility based health care providers; 2) sustained supplies of essential drugs and commodities; 3) community engagement through Lady health worker program and 4) Health Management information data improvement and use of the data for decision making to improve provision and quality of services
| Arm | Type | Receives |
|---|---|---|
| Maternal and Newborn health districts | Experimental | Other: Improving of quality of care at health facility and outreach levelGroup one included maternal and newborn health districts. These districts are further divided into three sub groups. Sub group 1 will receive only interventions focusing on maternal health (1 district (Sangher)); sub group 2 will receive interventions focusing only on newborn health (1 district (Nasirabad)); sub group 3 will receive combined maternal and newborn interventions (two districts (, Lasbila and Badin). |
| Child Health | Experimental | Other: Improving of quality of care at health facility and outreach levelGroup two will receive child health interventions focusing on the implementation of the global action plan for pneumonia and diarrhea (GAPPD [4districts, Qamabar Shahdadkot Muzaffargarh, Rahim Yar Khan Jafferabad). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All women of reproductive age in the project areas
- All children under the age of five years
Key exclusion criteria (1 listed)
- The subjects not residing in the project catchment population
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 |
|---|---|---|
| Improving of quality of care at health facility and outreach levelCommunity Mobilization and engagement; Use of DHIS data for decision making; Capacity building of health care workers and providers and other Community level and facility level interventions to improve MNCH outcomes | Other | Child Health, Maternal and Newborn health districts |
Primary outcome
Perinatal deaths
Time frame: three years
20% reduction in perinatal mortality
case fatality rate
Time frame: Three years
30% reduction in Pneumonia and diarrhea case fatality in participating health facilities
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Derived from this study: PubMed 40452336Muhammad S, Memon ZA, Mian A, Wasan Y, Rizvi A, Ahmed I, Soofi S, Cousens S, Bhutta ZA. A cross-sectional analysis of the impact of lady health worker visits in the prenatal and postnatal period on the uptake of continuum of care interventions and childhood mortality in Pakistan. J Glob Health. 2025 Jun 2;15:04158. doi: 10.7189/jogh.15.04158.
- Derived from this study: PubMed 32665387Memon ZA, Muhammad S, Soofi S, Khan N, Akseer N, Habib A, Bhutta Z. Effect and feasibility of district level scale up of maternal, newborn and child health interventions in Pakistan: a quasi-experimental study. BMJ Open. 2020 Jul 14;10(7):e036293. doi: 10.1136/bmjopen-2019-036293.
- Individual participant dataSharing planned: No
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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.
Zulfiqar A Bhutta, PhD principal investigator
AKU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Improving of quality of care at health facility and outreach level in people with Maternal Complication of Pregnancy and Newborn Morbidity, 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 2 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: status not confirmed, as of the sponsor's last update on 1 Sep 2021. 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?
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?
Perinatal deaths (time frame: three years). 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?
On the ClinicalTrials.gov record for NCT04184544, 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 1 Sep 2021.