Post Partum Maternal and Neonatal Intervention Package

Post Partum Maternal and Neonatal Intervention Package: A Cluster Randomized Control Trial in District Sukkur, Pakistan

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 Overview

• Status: Completed
• Conditions: Maternal Mortality; Neonatal Mortality; Early Postpartum and Newborn Care
• Intervention / Treatment: Other: Intervention

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
• Enrollment (Actual): 1200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Sukkur, Sindh, Pakistan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 weeks (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Neonates delivered within the study area

Exclusion Criteria:

• Neonates delivered outside the study area

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visit by LHWs	The aim is to increase the visits of LHWs and examine the newborn within 48- 72 hours of birth	Within 48 - 72 hours of birth

Collaborators and Investigators

• Sponsor: Aga Khan University
• Collaborators: United States Agency for International Development (USAID); Population Council; John Snow, Inc.; Pakistan Ministry of Health
• Investigators: Principal Investigator: Zulfiqar A Bhutta, MBBS, PhD, The Aga Khan University

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (ACTUAL): September 1, 2010
• Study Completion (ACTUAL): September 1, 2010

Study Registration Dates

• First Submitted: July 6, 2011
• First Submitted That Met QC Criteria: July 7, 2011
• First Posted (ESTIMATE): July 8, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): July 8, 2011
• Last Update Submitted That Met QC Criteria: July 7, 2011
• Last Verified: October 1, 2007

More Information

Terms related to this study

• Keywords: Neonate; Post partum; community health care workers
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Death; Parental Death; Maternal Death
• Other Study ID Numbers: 770-Ped/ERC-06