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Scaling up Evidence Based MNCH Interventions : A Quasi Experimental Study Umeed e Nau (UeN) Project (UeN)

Primary Purpose

Maternal Complication of Pregnancy, Newborn Morbidity, Perinatal Problems

Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Improving of quality of care at health facility and outreach level
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Maternal Complication of Pregnancy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All women of reproductive age in the project areas
  • All children under the age of five years

Exclusion Criteria:

  • The subjects not residing in the project catchment population

Sites / Locations

  • Aga Khan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Maternal and Newborn health districts

Child Health

Arm Description

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).

Outcomes

Primary Outcome Measures

Perinatal deaths
20% reduction in perinatal mortality
case fatality rate
30% reduction in Pneumonia and diarrhea case fatality in participating health facilities

Secondary Outcome Measures

Full Information

First Posted
November 29, 2019
Last Updated
August 31, 2021
Sponsor
Aga Khan University
Collaborators
Bill and Melinda Gates Foundation, The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT04184544
Brief Title
Scaling up Evidence Based MNCH Interventions : A Quasi Experimental Study Umeed e Nau (UeN) Project
Acronym
UeN
Official Title
Supporting Women and Girls in Pakistan: Scaling up Empowerment and Care Strategies to Address Health and Survival
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University
Collaborators
Bill and Melinda Gates Foundation, The Hospital for Sick Children

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Complication of Pregnancy, Newborn Morbidity, Perinatal Problems

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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)
Allocation
Non-Randomized
Enrollment
5000000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Maternal and Newborn health districts
Arm Type
Experimental
Arm Description
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).
Arm Title
Child Health
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Improving of quality of care at health facility and outreach level
Intervention Description
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
Primary Outcome Measure Information:
Title
Perinatal deaths
Description
20% reduction in perinatal mortality
Time Frame
three years
Title
case fatality rate
Description
30% reduction in Pneumonia and diarrhea case fatality in participating health facilities
Time Frame
Three years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All women of reproductive age in the project areas All children under the age of five years Exclusion Criteria: The subjects not residing in the project catchment population
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zulfiqar A Bhutta, PhD
Organizational Affiliation
AKU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aga Khan University
City
Karachi
State/Province
Sindh
ZIP/Postal Code
47800
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32665387
Citation
Memon 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.
Results Reference
derived

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Scaling up Evidence Based MNCH Interventions : A Quasi Experimental Study Umeed e Nau (UeN) Project

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