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Trial record 8 of 19 for:    "Asphyxia neonatorum"
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Improved Accessibility of EmONC Services for Maternal and Newborn Health: a Community Based Project

This study is currently recruiting participants.
Verified December 2012 by Aga Khan University
Sponsor:
Collaborator:
Department for International Development, United Kingdom
Information provided by (Responsible Party):
Dr Sajid Bashir Soofi, Aga Khan University
ClinicalTrials.gov Identifier:
NCT01751945
First received: November 16, 2012
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  Purpose

The purpose of this study is to determine whether an integrated EmONC package (community mobilization, training of community-based health care providers and a maternal and neonatal health pack) reduce perinatal and neonatal mortality.


Condition Intervention
Sepsis
Pneumonia
Omphalitis
Birth Asphyxia
Respiratory Distress Syndrome
Eclampsia
Postpartum Hemorrhage
Puerperal Sepsis
 Behavioral: EmONC package

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Improved Accessibility of EmONC Services for Maternal and Newborn Health: a Community Based Project.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • Perinatal mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 6000
Study Start Date: November 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EmONC package

The EmONC package consists of:

  1. Maternal and neonatal health pack(clean delivery kit, emollient, chlorhexidine, sms messages) for safe motherhood and newborn wellbeing.
  2. Enhanced trainings of community-level health care providers to provide effective maternal and neonatal health services and referral of complicated cases to health facilities and creation of linkages amongst health care providers.
  3. Community mobilisation
 Behavioral: EmONC package

The EmONC package consists of:

  1. Maternal and neonatal health pack(clean delivery kit, emollient, chlorhexidine, sms messages) for safe motherhood and newborn wellbeing.
  2. Enhanced trainings of community-level health care providers to provide effective maternal and neonatal health services and referral of complicated cases to health facilities and creation of linkages amongst health care providers.
  3. Community mobilisation
No Intervention: Standard of care

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Expectant women and their newborns in the study area

Exclusion Criteria:

  • Pregnant women not belonging to the study area
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01751945

Contacts
Contact: Dr. Ali Turab, MBBS, MPH turab.ali@aku.edu

Locations
Pakistan
Recruiting
Rahimyar Khan, Punjab, Pakistan
Contact: Dr. Ali Turab, M.B.B.S, M.P.H         turab.ali@aku.edu    
Sponsors and Collaborators
Aga Khan University
Department for International Development, United Kingdom
Investigators
Principal Investigator: Dr. Sajid Soofi, MBBS, FCPS Aga Khan University
  More Information

No publications provided

Responsible Party: Dr Sajid Bashir Soofi, Assistant Professor, Aga Khan University
ClinicalTrials.gov Identifier: NCT01751945     History of Changes
Other Study ID Numbers: RAF/FIN/AKU-2/2012/00030
Study First Received: November 16, 2012
Last Updated: December 19, 2012
Health Authority: Pakistan: Ministry of Health

Keywords provided by Aga Khan University:
EmONC
Neonatal mortality
Perinatal mortality

Additional relevant MeSH terms:
Asphyxia Neonatorum
Asphyxia
Eclampsia
Hemorrhage
Pneumonia
Postpartum Hemorrhage
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Sepsis
Toxemia
Death
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases
 Hypertension, Pregnancy-Induced
Pregnancy Complications
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Obstetric Labor Complications
Puerperal Disorders
Uterine Hemorrhage
Respiration Disorders
Infant, Premature, Diseases
Infection
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on May 21, 2013