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

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ClinicalTrials.gov Identifier: NCT01751945
Recruitment Status : Completed
First Posted : December 18, 2012
Last Update Posted : June 9, 2016
Sponsor:
Collaborator:
Department for International Development, United Kingdom
Information provided by (Responsible Party):
Dr Sajid Bashir Soofi, Aga Khan University

Brief Summary:
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 or disease Intervention/treatment Phase
Sepsis Pneumonia Omphalitis Birth Asphyxia Respiratory Distress Syndrome Eclampsia Postpartum Hemorrhage Puerperal Sepsis Behavioral: EmONC package Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Improved Accessibility of EmONC Services for Maternal and Newborn Health: a Community Based Project.
Study Start Date : November 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Perinatal mortality [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 18, 2012    Key Record Dates
Last Update Posted: June 9, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Dr Sajid Bashir Soofi, Aga Khan University:
EmONC
Neonatal mortality
Perinatal mortality

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