NCT02797353

Brief Summary

The Maternal Neonatal and Child health indicators in District Dadu of Pakistan portrays a dismal pictures and after the floods of 2010-2011 the health infrastructure of this district was badly affected. Aga Khan University Pakistan is intending to implement a service delivery project for the improvement of Maternal Neonatal and Child health situation through evidence based MNCH interventions.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
15,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 13, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

June 22, 2020

Status Verified

June 1, 2020

Enrollment Period

3.4 years

First QC Date

June 8, 2016

Last Update Submit

June 19, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Maternal, Neonatal and infant mortality

    A 20% reduction in mortality rates is expected

    24 months

Secondary Outcomes (4)

  • Antenatal Care

    12 months

  • Skilled Birth attendance

    12 months

  • Essential Neonatal Care

    24 months

  • Child hood Immunization Rates

    24 months

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Antenatal Care, Post natal care, Skilled birth attendance, recognition and referrals of complicated cases, immunization

Other: Maternal Neonatal and Child Health Interventions

Control

NO INTERVENTION

This arm will receive the standard MNCH services as outlined in the MNCH policy of Government of Pakistan

Interventions

Antenatal care, postnatal care, skilled birth attendance, recognition and referral of complicated cases, immunization

Intervention Arm

Eligibility Criteria

Age1 Day - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Be a resident of target areas and consent to participate in the study

You may not qualify if:

  • Do not fulfill the residence and consent criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Postpartum HemorrhageAnemiaEclampsiaNeonatal SepsisAsphyxia NeonatorumDiarrheaPneumonia

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsHematologic DiseasesHemic and Lymphatic DiseasesHypertension, Pregnancy-InducedSepsisInfectionsInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSystemic Inflammatory Response SyndromeInflammationSigns and Symptoms, DigestiveSigns and SymptomsRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Sajid Soofi, FCPS

    Aga Khan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 8, 2016

First Posted

June 13, 2016

Study Start

January 1, 2013

Primary Completion

June 1, 2016

Study Completion

August 1, 2016

Last Updated

June 22, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share