NCT04184544

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 3, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

September 1, 2021

Status Verified

August 1, 2021

Enrollment Period

5.8 years

First QC Date

November 29, 2019

Last Update Submit

August 31, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Perinatal deaths

    20% reduction in perinatal mortality

    three years

  • case fatality rate

    30% reduction in Pneumonia and diarrhea case fatality in participating health facilities

    Three years

Study Arms (2)

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).

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).

Other: Improving of quality of care at health facility and outreach level

Interventions

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

Child HealthMaternal and Newborn health districts

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • The subjects not residing in the project catchment population

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University

Karachi, Sindh, 47800, Pakistan

Location

Related Publications (2)

  • 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.

  • 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.

Study Officials

  • Zulfiqar A Bhutta, PhD

    AKU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Founding Director

Study Record Dates

First Submitted

November 29, 2019

First Posted

December 3, 2019

Study Start

March 1, 2017

Primary Completion

December 31, 2022

Study Completion

June 30, 2023

Last Updated

September 1, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations