Post Partum Maternal and Neonatal Intervention Package

Neonatal Mortality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01389219
• Other study ID #: 770-Ped/ERC-06
• Status: Completed
• Phase: N/A
• First received: July 6, 2011
• Last updated: July 7, 2011
• Start date: October 2007
• Est. completion date: September 2010

Study information

• Verified date: October 2007
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ethical Review Committee: Aga Khan University
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

Inclusion Criteria:

• Neonates delivered within the study area

Exclusion Criteria:

• Neonates delivered outside the study area

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Early Postpartum and Newborn Care
• Maternal Death
• Maternal Mortality
• Neonatal Mortality

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Aga Khan University	John Snow, Inc., Pakistan Ministry of Health, Population Council, United States Agency for International Development (USAID)

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No