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Community-based Perinatal and Newborn Care in Gilgit District, Northern Areas, Pakistan: an AKU-AKHSP Collaboration

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ClinicalTrials.gov Identifier: NCT02412293
Recruitment Status : Completed
First Posted : April 9, 2015
Last Update Posted : April 9, 2015
Sponsor:
Collaborator:
Aga Khan Health Services
Information provided by (Responsible Party):
Dr Zulfiqar Ahmed Bhutta, Aga Khan University

Brief Summary:

There is limited evidence from community-based interventions to guide the development of effective maternal, perinatal and newborn care practices and services in developing countries. Investigators planned to evaluate the impact of a low-cost package of community-based interventions implemented through government sector lady health workers (LHWs) and community health workers (CHWs) of a NGO namely Aga Khan Health Services on perinatal and neonatal outcomes in a sub-population of the remote mountainous district of Gilgit, Northern Pakistan.

A community-based package for use by LHWs and CHWs geared towards prevention and promotion of maternal and newborn health practices and services will be developed based on formative research in the study district. The package will include promotion of antenatal care, adequate nutrition, skilled delivery and healthy newborn care practices at household level. The health workers will be trained in recognition of danger sign that warrant referral to health care service. LHWs and CHWs will delivered the package via community awareness sessions and two one-to-one counselling sessions to pregnant women during third trimester and five newborn assessment visits in the neonatal period. In addition to this, community mobilization activities included formation of CHCs and creation of support for the uptake of the interventions. Control areas will continue to receive the routine standard health services of governmental and non-governmental organizations in the area. The intervention areas will receive the intervention package in addition to the routine standard health services. Outcome measures will include changes in maternal and newborn-care practices and perinatal and neonatal mortality rates between the intervention and control areas.


Condition or disease Intervention/treatment Phase
Perinatal Problems Still Births Neonatal Deaths Behavioral: Health Education & Promotion Other: Training of Health Workers Behavioral: Community Mobilization Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Community-based Perinatal and Newborn Care in Gilgit District, Northern Areas, Pakistan: an AKU-AKHSP Collaboration
Study Start Date : July 2001
Actual Primary Completion Date : February 2006
Actual Study Completion Date : September 2007

Arm Intervention/treatment
Experimental: Intervention

Health Education & Promotion: LHWs and CHWs will delivered the package via community awareness sessions and two one-to-one counselling sessions to pregnant women during third trimester and five newborn assessment visits in the neonatal period in intervention areas.

Training of Health Workers: The LHWs and CHWs will receive trainings on IMNCI-based training package.

Community Mobilization: For community mobilization and education, two types of tools will be used one group session by use of flip charts and group session by use of video.

Behavioral: Health Education & Promotion
Promotion of antenatal care, adequate nutrition, skilled delivery and healthy newborn care practices at household level.

Other: Training of Health Workers
Training of health workers on recognition of danger sign that warrant referral to health care service.

Behavioral: Community Mobilization
Community mobilization activities included formation of community health committees and creation of support for the uptake of the interventions.

No Intervention: Control
Control areas will continue to receive the routine standard health services of governmental and non-governmental organizations in the area.



Primary Outcome Measures :
  1. Reduction in perinatal and neonatal mortality [ Time Frame: 3 years ]
    Baseline & Endline Surveys


Secondary Outcome Measures :
  1. Improvements in antenatal care practices [ Time Frame: 3 Years ]
    Baseline & Endline Surveys

  2. Improvements in cord application practices [ Time Frame: 3 Years ]
    Baseline & Endline Surveys

  3. Improvements in delaying first bath after birth [ Time Frame: 3 Years ]
    Baseline & Endline Surveys

  4. Improvements in colostrum administration [ Time Frame: 3 Years ]
    Baseline & Endline Surveys

  5. Improvements in initiation of breastfeeding practices within 1 hour after birth [ Time Frame: 3 Years ]
    Baseline & Endline Surveys



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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women & participants who agree to participate in the study

Exclusion Criteria:

  • Pregnant women & participants who disagree to participate in the study

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): NCT02412293


Locations
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Pakistan
Aga Khan University
Karachi, Sindh, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
Aga Khan Health Services
Investigators
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Principal Investigator: Zulfiqar A Bhutta, PhD Aga Khan University

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Zulfiqar Ahmed Bhutta, Professor, Aga Khan University
ClinicalTrials.gov Identifier: NCT02412293     History of Changes
Other Study ID Numbers: AKU-AKHSP
First Posted: April 9, 2015    Key Record Dates
Last Update Posted: April 9, 2015
Last Verified: April 2015
Keywords provided by Dr Zulfiqar Ahmed Bhutta, Aga Khan University:
Perinatal
neonatal
newborn
mortality
Additional relevant MeSH terms:
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Perinatal Death
Stillbirth
Pregnancy Complications
Death
Pathologic Processes
Fetal Death