Improved Accessibility of EmONC Services for Maternal and Newborn Health: a Community Based Project (EmONC)

This study has been completed.
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: June 8, 2016
Last verified: June 2016
  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:


Further study details as provided by Aga Khan University:

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

Enrollment: 12000
Study Start Date: November 2012
Study Completion Date: December 2013
Primary Completion Date: December 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
Standard care as per national policy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01751945

Locations
Pakistan
Field Site
Rahimyar Khan, Punjab, Pakistan
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: June 8, 2016
Health Authority: Pakistan: Ministry of Health
Individual Participant Data  
Plan to Share IPD: Yes

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

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

ClinicalTrials.gov processed this record on July 21, 2016