Post Partum Maternal and Neonatal Intervention Package

Overview

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

Full Title of Study: “Post Partum Maternal and Neonatal Intervention Package: A Cluster Randomized Control Trial in District Sukkur, Pakistan”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2010

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.

Interventions

  • Other: Intervention
    • A comprehensive package of intervention will be developed for the mothers and newborn infants which will be comprised of; 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. Provision of Information on family planning, birth spacing, LAM counseling, hygiene, danger signs recognition and complications readiness. 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.

Arms, Groups and Cohorts

  • No Intervention: Control
    • Control arm
  • Other: 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.

Clinical Trial Outcome Measures

Primary 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

Participating in This Clinical Trial

Inclusion Criteria

  • Neonates delivered within the study area Exclusion Criteria:

  • Neonates delivered outside the study area

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 28 Days

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Aga Khan University
  • Collaborator
    • United States Agency for International Development (USAID)
  • Provider of Information About this Clinical Study
    • Dr. Zulfiqar A. Bhutta (Principal investigator), Aga Khan University
  • Overall Official(s)
    • Zulfiqar A Bhutta, MBBS, PhD, Principal Investigator, The Aga Khan University

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