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Post Partum Maternal and Neonatal Intervention Package

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01389219
First Posted: July 8, 2011
Last Update Posted: July 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
United States Agency for International Development (USAID)
Pakistan Ministry of Health
John Snow, Inc.
Population Council
Information provided by:
Aga Khan University
  Purpose
Introduction of a community-based intervention package including prevention strategies, early recognition and management of common postpartum & neonatal problems, as well as prompt referral of high risk/complicated cases through trained first level primary health care workers, will result in a significant reduction in Postpartum maternal and neonatal mortality in Pakistan

Condition Intervention
Early Postpartum and Newborn Care Maternal Mortality Neonatal Mortality Other: Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Post Partum Maternal and Neonatal Intervention Package: A Cluster Randomized Control Trial in District Sukkur, Pakistan

Resource links provided by NLM:


Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • Visit by LHWs [ Time Frame: Within 48 - 72 hours of birth ]
    The aim is to increase the visits of LHWs and examine the newborn within 48- 72 hours of birth


Enrollment: 1200
Study Start Date: October 2007
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Control arm
Intervention clusters
Focus is to increase the number of visits by LHWs to the newborn baby and to ensure that this visit occurs within 48-72 hours of birth. The purpose of this visit was the provision of postpartum maternal and immediate newborn care, including postpartum visit, maternal nutrition supplementation, cord care, eye care, Kangaroo Care, delayed bathing, colostrum administration and linkages to immunization services), complications/illness management through stabilization/referral of cases.
Other: Intervention

A comprehensive package of intervention will be developed for the mothers and newborn infants which will be comprised of;

  1. Provision of postpartum maternal and immediate newborn care, including postpartum visit, maternal nutrition supplementation (iron & vitamin A), cord care, eye care, Kangaroo Care, delayed bathing, colostrum administration and linkages to immunization services), complications/illness management through stabilization/referral of cases.
  2. Provision of Information on family planning, birth spacing, LAM counseling, hygiene, danger signs recognition and complications readiness.
  3. Nutrition counseling regarding immediate and exclusive breastfeeding and optimum postpartum diets.

5. Danger signs of newborn illnesses and maternal complications associated with labor and the postpartum period, care seeking. Early referral for subsequent maternal and newborn morbidities, such as anemia, postpartum depression, fistulas, prolapsed uterus and infections.


Detailed Description:
Introduction of a community-based intervention package including prevention strategies, early recognition and management of common postpartum & neonatal problems, as well as prompt referral of high risk/complicated cases through trained first level primary health care workers, will result in a significant reduction in Postpartum maternal and neonatal mortality in Pakistan.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Neonates delivered within the study area

Exclusion Criteria:

  • Neonates delivered outside the study area
  Contacts and Locations
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): NCT01389219


Locations
Pakistan
Sukkur, Sindh, Pakistan
Sponsors and Collaborators
Aga Khan University
United States Agency for International Development (USAID)
Pakistan Ministry of Health
John Snow, Inc.
Population Council
Investigators
Principal Investigator: Zulfiqar A Bhutta, MBBS, PhD The Aga Khan University
  More Information

Responsible Party: Dr. Zulfiqar A. Bhutta (Principal investigator), Aga Khan University
ClinicalTrials.gov Identifier: NCT01389219     History of Changes
Other Study ID Numbers: 770-Ped/ERC-06
First Submitted: July 6, 2011
First Posted: July 8, 2011
Last Update Posted: July 8, 2011
Last Verified: October 2007

Keywords provided by Aga Khan University:
Post partum
Neonate
community health care workers

Additional relevant MeSH terms:
Maternal Death
Pregnancy Complications
Parental Death
Death
Pathologic Processes