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Post Partum Maternal and Neonatal Intervention Package

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ClinicalTrials.gov Identifier: NCT01389219
Recruitment Status : Completed
First Posted : July 8, 2011
Last Update Posted : July 8, 2011
Sponsor:
Collaborators:
United States Agency for International Development (USAID)
Pakistan Ministry of Health
John Snow, Inc.
Population Council
Information provided by:
Aga Khan University

Brief Summary:
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 or disease Intervention/treatment Phase
Early Postpartum and Newborn Care Maternal Mortality Neonatal Mortality Other: Intervention Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1200 participants
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
Study Start Date : October 2007
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care

Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. 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



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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

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

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 Posted: July 8, 2011    Key Record Dates
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