Post Partum Maternal and Neonatal Intervention Package - Full Text View

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:

MedlinePlus related topics: Postpartum Care

U.S. FDA Resources

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; 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

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;

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.

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

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 May 16, 2013