Post Partum Maternal and Neonatal Intervention Package

Sponsor

Aga Khan University (Other)

Overall Status

Completed

CT.gov ID

NCT01389219

Collaborator

United States Agency for International Development (USAID) (U.S. Fed), Pakistan Ministry of Health (Other), John Snow, Inc. (Industry), Population Council (Other)

1,200

Enrollment

Location

Arms

Duration (Months)

34.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Detailed Description

Study Design

Study Type:

Interventional

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 :

Oct 1, 2007

Actual Primary Completion Date :

Sep 1, 2010

Actual Study Completion Date :

Sep 1, 2010

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Visit by LHWs [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 28 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Neonates delivered within the study area

Exclusion Criteria:

Neonates delivered outside the study area

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01389219

Other Study ID Numbers:

770-Ped/ERC-06

First Posted:

Jul 8, 2011

Last Update Posted:

Jul 8, 2011

Last Verified:

Oct 1, 2007

Keywords provided by , ,

Post partum

Neonate

community health care workers

Additional relevant MeSH terms:

Maternal Death

Study Results

No Results Posted as of Jul 8, 2011