Post Partum Maternal and Neonatal Intervention Package

This study has been completed.
Sponsor:
Collaborators:
United States Agency for International Development (USAID)
Pakistan Ministry of Health
John Snow, Inc.
Population Council
Information provided by:
Aga Khan University
ClinicalTrials.gov Identifier:
NCT01389219
First received: July 6, 2011
Last updated: July 7, 2011
Last verified: October 2007
  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: 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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   up to 28 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Neonates delivered within the study area

Exclusion Criteria:

  • Neonates delivered outside 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: 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

No publications provided

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
Study First Received: July 6, 2011
Last Updated: July 7, 2011
Health Authority: Ethical Review Committee: Aga Khan University

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

ClinicalTrials.gov processed this record on July 24, 2014